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CompletedNCT03858634Updated Mar 18, 2025Results posted

A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases

A Phase 2 interventional study of KPL-716 and Placebo in Chronic Idiopathic Urticaria, Chronic Idiopathic Pruritus and Lichen Planus, sponsored by Genentech, Inc.. Completed at 14 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-18.

Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study.

The diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs).

02

Conditions studied

  • Chronic Idiopathic Urticaria
  • Chronic Idiopathic Pruritus
  • Lichen Planus
  • Lichen Simplex Chronicus
  • Plaque Psoriasis

Keywords

  • pruritus, chronic pruritus, moderate to severe
03

In context

Chronic Urticaria

194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.

This study's enrollment of 58 is below the median of 80 across 145 interventional studies indexed under Chronic Urticaria.

Browse Chronic Urticaria studies →

Lead sponsor

Genentech, Inc. is the lead sponsor of 517 studies on the registry; 20 are open to participants now.

Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.

First submitted after Genentech, Inc. became part of Hoffmann-La Roche.

Browse Genentech, Inc. studies →All Hoffmann-La Roche studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female aged 18 to 75 years
  2. Have clinical diagnosis of chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs) for at least 6 months
  3. Moderate to severe pruritus
  4. Female participants of must have a negative pregnancy test, be nonlactating, and have agreed to use a highly effective method of , as specified in the protocol, from the Screening Visit until 10 weeks after final study drug administration
  5. Able to comprehend and willing to sign an Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study

Exclusion criteria

Exclusion Criteria:

  1. Use of prohibited medications within the indicated timeframe from Day 1 to the End of Study
  2. Is currently using medication known to cause pruritus
  3. Has any inflammatory, pruritic, and/or fibrotic skin condition other than the diagnosis that defines inclusion
  4. Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit
  5. Has an active infection, including skin infection
  6. Any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor, may place the participant at increased risk as a result of study participation, interfere with study participation or study assessments, affect compliance with study requirements, or complicate interpretation of study results
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    KPL-716

    Weekly for 8 weeks

    Drug: KPL-716

  • Placebo comparator
    Placebo

    Weekly for 8 weeks

    Drug: Placebo

Interventions

  • DrugKPL-716

    A loading dose of KPL-716 720 mg (2x maintenance dose) administered via 2 subcutaneous (SC) injections within 30 minutes on Day 1. All subsequent doses of KPL-716 (360 mg maintenance dose) administered via a single SC injection.

    Also known as: Vixarelimab, RG6536

  • DrugPlacebo

    Placebo dose administered via 2 SC injections within 30 minutes on Day 1. All subsequent doses of placebo administered via a single SC injection.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Weekly Average WI-NRS at Week 8

    WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.

    Time frame: Baseline, Week 8

  2. Percent Change From Baseline in Weekly Average WI-NRS at Week 8

    WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.

    Time frame: Baseline, Week 8

Secondary outcomes

  1. Change From Baseline in Weekly Average WI-NRS Over Time

    WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.

    Time frame: Baseline, Weeks 1-18

  2. Percent Change From Baseline in Weekly Average WI-NRS Over Time

    WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.

    Time frame: Baseline, Weeks 1-18

  3. Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time

    Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus.

    Time frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18

  4. Percent Change From Baseline in Pruritus VAS Over Time

    Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus.

    Time frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18

  5. Change From Baseline in 5-D Pruritus Total Score Over Time

    This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus).

    Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18

  6. Percent Change From Baseline in 5-D Pruritus Total Score Over Time

    This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus).

    Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18

  7. Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time

    WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.

    Time frame: Baseline, Weeks 1-18

  8. Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only

    Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort.

    Time frame: Baseline, Weeks 1-18

  9. Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only

    Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort

    Time frame: Baseline, Weeks 1-18

  10. Change From Baseline in Sleep Loss VAS Over Time

    Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit.

    Time frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18

  11. Percent Change From Baseline in Sleep Loss VAS Over Time

    Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit.

    Time frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18

  12. Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time

    Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult.

    Time frame: Baseline, Weeks 1-18

  13. Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time

    Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult.

    Time frame: Baseline, Weeks 1-18

  14. Change From Baseline in Weekly Average of Sleep Quality NRS Over Time

    Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep.

    Time frame: Baseline, Weeks 1-18

  15. Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time

    Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep.

    Time frame: Baseline, Weeks 1-18

  16. Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time

    The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked "Over the last week, has your skin prevented you from working or studying?" If answered yes, score=3; If no, a second question will be asked: "Over the last week how much has your skin been a problem at work or studying?" If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 18

  17. Percent Change From Baseline in DLQI Total Score Over Time

    The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked "Over the last week, has your skin prevented you from working or studying?" If answered yes, score=3; If no, a second question will be asked: "Over the last week how much has your skin been a problem at work or studying?" If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect.

    Time frame: Baseline, Weeks 4, 8, 12, 16, 18

  18. Change From Baseline in ItchyQoL Total Score Over Time

    ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110).

    Time frame: Baseline, Weeks 4, 8, 12, 16, 18

  19. Percent Change From Baseline in ItchyQoL Total Score Over Time

    ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110).

    Time frame: Baseline, Weeks 4, 8, 12, 16, 18

07

Results

Posted Dec 28, 2021

Participant flow

Participant flow — Overall Study
MilestoneKPL-716Placebo
Started3919
Participants with chronic idiopathic urticaria (ciu)42
Participants with chronic idiopathic pruritus (cip)149
Participants with lichen planus (lp)30
Participants with lichen simplex chronicus (lsc)41
Participants with plaque psoriasis (pps)147
Completed3617
Not completed32
Withdrew: Withdrawal by subject10
Withdrew: Adverse event10
Withdrew: Lost to follow-up01
Withdrew: Other, not specified11

Outcome measures

PrimaryChange From Baseline in Weekly Average WI-NRS at Week 8

WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.

Time frame:
Baseline, Week 8
Reported as:
Least squares mean · score on a scale
Change From Baseline in Weekly Average WI-NRS at Week 8
score on a scaleKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change From Baseline in Weekly Average WI-NRS at Week 8-4.3 ± 1.84-1.1 ± 2.66-4.3 ± 0.77-3.7 ± 0.96-3.1 ± 0.82—-6.9 ± 0.810.7 ± 1.84-5.6 ± 0.69-2.5 ± 0.98
Statistical analysis
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.3980 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Least squares (ls) mean difference: -3.3 · 80% CI -8.68 to 2.17
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.6653 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -0.5 · 80% CI -2.17 to 1.09
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0711 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -7.6 · 80% CI -11.63 to -3.56
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0186 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -3.1 · 80% CI -4.70 to -1.51
SecondaryChange From Baseline in Weekly Average WI-NRS Over Time

WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.

Time frame:
Baseline, Weeks 1-18
Reported as:
Mean · score on a scale
Change From Baseline in Weekly Average WI-NRS Over Time
score on a scaleKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 1-1.9 ± 0.59-0.9 ± 0.86-1.6 ± 0.55-1.4 ± 0.45-0.2 ± 0.13—-3.0 ± 1.23-0.9 ± NA-0.7 ± 0.17-0.2 ± 0.16
Change at Week 2-3.0 ± 0.79-1.3 ± 1.29-3.0 ± 0.60-2.9 ± 0.63-0.5 ± 0.58—-4.0 ± 1.64-1.0 ± NA-1.5 ± 0.27-0.7 ± 0.26
Change at Week 3-3.8 ± 1.25-1.6 ± 1.64-3.5 ± 0.61-2.4 ± 0.72-1.2 ± 0.99—-4.6 ± 1.73-1.4 ± NA-2.6 ± 0.39-0.9 ± 0.33
Change at Week 4-3.9 ± 1.59-1.5 ± 1.50-3.5 ± 0.64-3.0 ± 0.85-2.3 ± 1.78—-5.0 ± 1.48-2.4 ± NA-3.4 ± 0.48-1.2 ± 0.63
Change at Week 5-4.4 ± 1.83-1.6 ± 1.64-4.1 ± 0.73-3.1 ± 0.88-2.5 ± 1.91—-5.4 ± 1.58-2.0 ± NA-4.4 ± 0.65-1.5 ± 0.88
Change at Week 6-4.6 ± 1.72-1.8 ± 1.79-4.2 ± 0.74-3.7 ± 0.92-2.7 ± 1.90—-5.8 ± 1.58-2.6 ± NA-4.7 ± 0.65-1.6 ± 0.81
Change at Week 7-4.4 ± 1.75-2.6 ± 2.64-4.4 ± 0.77-3.7 ± 0.81-3.1 ± 1.94—-6.3 ± 1.48-2.3 ± NA-5.1 ± 0.69-1.9 ± 0.91
Change at Week 8-4.1 ± 1.84-1.6 ± 1.57-4.3 ± 0.75-3.7 ± 0.94-3.1 ± 1.94—-6.0 ± 1.61-2.7 ± NA-5.6 ± 0.66-2.5 ± 1.07
Change at Week 9-4.1 ± 1.73-1.6 ± 1.57-4.6 ± 0.88-3.8 ± 0.76-5.0 ± 1.00—-6.0 ± 1.76-3.3 ± NA-5.7 ± 0.70-2.5 ± 1.21
Change at Week 10-4.1 ± 1.69-2.2 ± 2.21-4.3 ± 0.87-4.7 ± 0.64-5.0 ± 1.00—-6.3 ± 1.46-3.0 ± NA-5.6 ± 0.75-2.2 ± 1.23
Change at Week 11-4.1 ± 1.74-2.2 ± 2.21-4.4 ± 0.90-4.9 ± 0.75-5.0 ± 1.00—-6.3 ± 1.42-2.9 ± NA-5.4 ± 0.78-2.2 ± 1.22
Change at Week 12-4.5 ± 1.72-2.2 ± 2.21-4.4 ± 0.86-4.3 ± 0.76-5.3 ± 0.71—-6.5 ± 1.27-2.7 ± NA-5.3 ± 0.80-2.2 ± 1.21
Change at Week 13-3.9 ± 1.85-2.2 ± 2.21-4.4 ± 0.83-4.2 ± 0.86-5.5 ± 0.50—-6.6 ± 1.32-2.0 ± NA-5.5 ± 0.83-2.3 ± 1.22
Change at Week 14-3.8 ± 1.75-2.2 ± 2.21-4.5 ± 0.80-4.1 ± 0.92-5.5 ± 0.50—-6.4 ± 1.42-1.9 ± NA-5.6 ± 0.81-2.3 ± 1.21
Change at Week 15-4.4 ± 1.68-2.2 ± 2.21-4.2 ± 0.85-3.8 ± 0.91-5.5 ± 0.50—-6.8 ± 1.23-2.0 ± NA-5.4 ± 0.86-2.6 ± 1.35
Change at Week 16-4.1 ± 1.74-2.2 ± 2.21-4.3 ± 0.87-3.5 ± 0.96-5.5 ± 0.50—-6.6 ± 1.25-1.6 ± NA-5.3 ± 0.86-2.6 ± 1.33
Change at Week 17-4.5 ± 1.81-2.2 ± 2.21-4.5 ± 0.89-3.4 ± 0.97-5.5 ± 0.50—-6.8 ± 1.11-1.4 ± NA-5.0 ± 0.99-2.7 ± 1.38
Change at Week 18-4.4 ± 1.67-2.2 ± 2.21-4.3 ± 0.97-3.4 ± 1.06-5.6 ± 0.57—-6.9 ± 1.01-1.4 ± NA-5.0 ± 1.01-2.7 ± 1.39
SecondaryPercent Change From Baseline in Weekly Average WI-NRS Over Time

WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.

Time frame:
Baseline, Weeks 1-18
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Weekly Average WI-NRS Over Time
percent changeKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 1-23.5 ± 8.22-16.2 ± 11.84-19.5 ± 6.57-18.3 ± 8.20-2.4 ± 2.19—-44.2 ± 12.5416.9 ± 28.60-8.8 ± 1.84-3.4 ± 2.61
Change at Week 2-37.2 ± 12.11-20.6 ± 17.45-36.7 ± 7.42-36.5 ± 9.25-6.1 ± 4.37—-59.8 ± 10.8029.3 ± 24.62-17.8 ± 3.16-8.4 ± 4.46
Change at Week 3-46.9 ± 18.33-25.0 ± 26.41-43.4 ± 7.37-31.5 ± 9.19-15.0 ± 8.02—-67.9 ± 12.8925.9 ± 29.39-31.2 ± 4.14-11.2 ± 5.86
Change at Week 4-48.9 ± 19.96-20.0 ± 28.76-43.9 ± 7.92-38.4 ± 9.87-29.3 ± 18.23—-71.7 ± 9.938.0 ± 22.65-41.7 ± 5.63-14.5 ± 7.96
Change at Week 5-54.7 ± 23.35-22.0 ± 33.65-51.6 ± 8.70-40.6 ± 10.84-31.1 ± 20.41—-76.9 ± 13.0813.8 ± 29.81-53.0 ± 7.11-17.7 ± 10.05
Change at Week 6-57.3 ± 21.58-23.8 ± 31.10-52.3 ± 9.11-47.9 ± 11.36-33.5 ± 17.50—-81.5 ± 13.077.0 ± 29.80-56.5 ± 6.88-18.7 ± 9.72
Change at Week 7-53.6 ± 24.07-36.4 ± 34.67-54.3 ± 8.98-48.1 ± 11.19-39.4 ± 10.21—-87.4 ± 11.027.8 ± 25.13-60.6 ± 7.48-22.5 ± 10.57
Change at Week 8-50.7 ± 21.56-19.0 ± 31.07-52.4 ± 9.32-48.8 ± 11.63-39.4 ± 10.21—-85.0 ± 11.767.0 ± 26.80-66.5 ± 7.78-29.0 ± 11.00
Change at Week 9-51.1 ± 19.68-19.0 ± 28.35-55.7 ± 9.95-48.6 ± 11.50-62.5 ± 12.50—-85.2 ± 14.004.0 ± 31.91-68.1 ± 8.42-28.5 ± 11.91
Change at Week 10-50.0 ± 20.26-27.9 ± 29.19-52.6 ± 9.40-58.7 ± 10.86-62.5 ± 12.50—-86.8 ± 11.34-1.2 ± 25.85-67.0 ± 8.73-24.5 ± 12.35
Change at Week 11-50.4 ± 20.87-27.3 ± 30.07-52.8 ± 9.91-61.4 ± 11.45-62.5 ± 12.50—-86.6 ± 10.72-0.4 ± 24.44-64.1 ± 8.66-24.8 ± 12.25
Change at Week 12-55.4 ± 21.36-28.2 ± 30.77-53.9 ± 9.88-53.2 ± 11.42-66.1 ± 8.93—-89.0 ± 8.84-2.8 ± 20.15-62.2 ± 8.85-24.8 ± 12.52
Change at Week 13-47.2 ± 22.72-27.6 ± 32.73-53.8 ± 10.04-52.2 ± 11.59-68.8 ± 6.25—-90.1 ± 10.046.1 ± 22.89-64.9 ± 9.22-25.2 ± 13.03
Change at Week 14-46.8 ± 20.94-27.7 ± 30.17-55.3 ± 10.15-51.4 ± 11.72-68.8 ± 6.25—-88.8 ± 10.8510.7 ± 24.74-65.9 ± 9.17-26.1 ± 12.97
Change at Week 15-53.6 ± 20.68-28.2 ± 29.79-50.8 ± 10.54-49.0 ± 12.18-68.8 ± 6.25—-91.8 ± 9.583.0 ± 21.85-63.7 ± 9.87-29.5 ± 13.96
Change at Week 16-50.0 ± 21.31-28.0 ± 30.70-51.7 ± 10.86-44.7 ± 12.54-68.8 ± 6.25—-90.6 ± 9.289.1 ± 21.17-62.7 ± 9.81-29.3 ± 13.88
Change at Week 17-55.0 ± 23.07-28.7 ± 33.24-54.2 ± 11.00-43.7 ± 12.70-68.8 ± 6.25—-92.2 ± 8.106.8 ± 18.46-58.0 ± 11.35-30.8 ± 16.05
Change at Week 18-54.5 ± 20.93-28.9 ± 30.15-51.5 ± 12.05-43.7 ± 13.92-69.6 ± 7.14—-92.1 ± 6.424.1 ± 14.63-58.1 ± 11.43-31.1 ± 16.17
Statistical analysis
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.6533 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -7.3 · 80% CI -31.52 to 16.84
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.9077 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -1.2 · 80% CI -15.16 to 12.69
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2065 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -61.2 · 80% CI -123.73 to 1.39
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1133 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -5.3 · 80% CI -9.56 to -1.07
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.4997 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -16.7 · 80% CI -52.29 to 18.98
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.9919 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -0.1 · 80% CI -15.83 to 15.59
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0891 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -89.2 · 80% CI -143.03 to -35.31
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1029 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -9.4 · 80% CI -16.67 to -2.12
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.5538 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -21.9 · 80% CI -75.82 to 32.05
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.3252 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -11.9 · 80% CI -27.51 to 3.73
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1106 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -93.8 · 80% CI -158.11 to -29.52
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0123 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -19.9 · 80% CI -29.48 to -10.40
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.4791 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -28.9 · 80% CI -87.63 to 29.81
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.6684 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -5.5 · 80% CI -22.28 to 11.27
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0937 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -79.7 · 80% CI -129.22 to -30.13
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0120 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -27.2 · 80% CI -40.21 to -14.27
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.4927 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -32.7 · 80% CI -101.39 to 36.02
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.4409 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -10.9 · 80% CI -29.35 to 7.49
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1197 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -90.7 · 80% CI -155.96 to -25.54
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANOVA · p = 0.0102 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -35.3 · 80% CI -51.68 to -18.92
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.4515 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -33.5 · 80% CI -96.97 to 30.02
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.7623 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -4.5 · 80% CI -23.76 to 14.83
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1247 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -88.5 · 80% CI -153.65 to -23.29
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0053 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -37.7 · 80% CI -53.59 to -21.90
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.7177 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -17.2 · 80% CI -87.97 to 53.62
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.6682 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -6.2 · 80% CI -25.26 to 12.78
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0823 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -95.2 · 80% CI -150.21 to -40.24
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0087 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -38.1 · 80% CI -55.38 to -20.92
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.4734 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -31.7 · 80% CI -95.11 to 31.76
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.8130 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -3.6 · 80% CI -23.33 to 16.18
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0979 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -92.0 · 80% CI -150.60 to -33.32
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0122 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -37.5 · 80% CI -55.48 to -19.61
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.4310 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -32.1 · 80% CI -89.98 to 25.81
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.6452 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -7.1 · 80% CI -27.38 to 13.12
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1375 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -89.2 · 80% CI -159.04 to -19.44
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0143 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -39.6 · 80% CI -58.97 to -20.15
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.5867 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -22.1 · 80% CI -81.70 to 37.52
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.6745 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 6.1 · 80% CI -12.99 to 25.27
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1039 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -85.6 · 80% CI -142.18 to -29.09
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0116 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -42.5 · 80% CI -62.60 to -22.36
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.5807 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -23.1 · 80% CI -84.55 to 38.26
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.5765 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 8.6 · 80% CI -11.55 to 28.80
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0933 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -86.2 · 80% CI -139.70 to -32.75
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0173 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -39.3 · 80% CI -59.29 to -19.37
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.5293 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -27.2 · 80% CI -90.04 to 35.62
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.9676 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -0.6 · 80% CI -20.73 to 19.49
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0663 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -86.2 · 80% CI -130.27 to -42.11
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0252 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -37.4 · 80% CI -57.81 to -17.02
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.6637 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -19.6 · 80% CI -86.45 to 47.22
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.9173 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -1.6 · 80% CI -22.04 to 18.81
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0685 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -96.2 · 80% CI -146.23 to -46.10
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0230 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -39.7 · 80% CI -60.91 to -18.44
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.6471 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -19.1 · 80% CI -80.69 to 42.54
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.8044 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -3.9 · 80% CI -24.56 to 16.75
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0741 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -99.5 · 80% CI -153.63 to -45.37
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0219 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -39.9 · 80% CI -61.00 to -18.72
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.5436 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -25.4 · 80% CI -86.21 to 35.46
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.9149 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -1.7 · 80% CI -23.20 to 19.71
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0646 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -94.8 · 80% CI -142.63 to -47.05
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0611 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -34.2 · 80% CI -56.89 to -11.41
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.6060 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -22.0 · 80% CI -84.68 to 40.71
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.6823 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -6.9 · 80% CI -29.00 to 15.18
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0556 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -99.7 · 80% CI -146.02 to -53.41
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0652 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -33.4 · 80% CI -55.98 to -10.76
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.5714 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -26.3 · 80% CI -94.14 to 41.62
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.5386 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -10.5 · 80% CI -32.93 to 11.83
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0438 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -99.0 · 80% CI -139.35 to -58.60
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1829 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -27.2 · 80% CI -53.38 to -1.08
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.5443 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -25.6 · 80% CI -87.20 to 35.94
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.6748 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -7.9 · 80% CI -32.39 to 16.66
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0297 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -96.2 · 80% CI -128.19 to -64.19
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1899 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -27.0 · 80% CI -53.33 to -0.63
SecondaryChange From Baseline in Pruritus Visual Analog Scale (VAS) Over Time

Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus.

Time frame:
Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Reported as:
Mean · units on a scale
Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time
units on a scaleKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 1-1.7 ± 0.980.0 ± 0.00-1.3 ± 0.79-2.0 ± 0.78-0.4 ± 0.26—-4.0 ± 1.61-0.7 ± NA-1.3 ± 0.29-0.3 ± 0.28
Change at Week 2-2.8 ± 1.430.0 ± 0.00-3.0 ± 0.96-2.6 ± 0.62-0.4 ± 0.19—-4.4 ± 1.80-1.0 ± NA-2.2 ± 0.55-0.7 ± 0.31
Change at Week 3-3.3 ± 1.52-0.1 ± 0.10-3.2 ± 1.09-3.4 ± 0.97-2.0 ± 1.36—-5.2 ± 1.85-2.2 ± NA-3.4 ± 0.55-0.9 ± 0.81
Change at Week 4-4.3 ± 1.670.0 ± 0.00-3.7 ± 0.94-3.9 ± 0.95-2.8 ± 1.88—-5.3 ± 1.66-2.2 ± NA-4.3 ± 0.54-1.4 ± 0.94
Change at Week 5-5.2 ± 1.820.0 ± 0.00-4.5 ± 1.01-4.7 ± 0.88-3.0 ± 1.86—-5.7 ± 1.67-3.7 ± NA-4.3 ± 0.51-1.6 ± 0.99
Change at Week 6-4.4 ± 1.880.0 ± 0.00-4.5 ± 1.00-4.2 ± 1.07-3.1 ± 1.85—-5.9 ± 1.57-2.0 ± NA-5.2 ± 0.54-1.9 ± 1.05
Change at Week 7-5.1 ± 1.78-0.1 ± 0.10-4.7 ± 1.05-4.7 ± 0.88-3.3 ± 1.85—-6.1 ± 1.45-1.4 ± NA-5.3 ± 0.57-2.1 ± 1.27
Change at Week 8-4.2 ± 2.000.0 ± 0.00-4.4 ± 1.03-4.3 ± 0.95-3.3 ± 1.85—-6.0 ± 1.42-1.8 ± NA-5.8 ± 0.61-2.2 ± 1.29
Change at Week 10-4.8 ± 1.860.0 ± 0.00-4.2 ± 1.07-5.8 ± 0.58-5.6 ± 0.85—-6.2 ± 1.50-3.5 ± NA-5.9 ± 0.66-3.1 ± 1.36
Change at Week 12-4.1 ± 2.110.0 ± 0.00-4.7 ± 1.10-4.8 ± 1.18-5.1 ± 1.30—-6.3 ± 1.37-3.5 ± NA-5.6 ± 0.71-3.8 ± 1.26
Change at Week 14-3.5 ± 2.190.0 ± 0.00-5.0 ± 1.00-4.2 ± 1.06-5.3 ± 1.10—-6.4 ± 1.31-1.4 ± NA-5.8 ± 0.75-3.6 ± 1.37
Change at Week 16-4.5 ± 1.91-0.1 ± 0.05-4.2 ± 1.07-4.0 ± 1.13-5.6 ± 0.85—-6.6 ± 1.12-0.8 ± NA-5.6 ± 0.79-3.5 ± 1.41
Change at Week 18-3.9 ± 2.070.0 ± 0.00-4.2 ± 1.22-3.6 ± 1.20-5.6 ± 2.40—-7.0 ± 0.74-0.9 ± NA-5.4 ± 0.90-3.9 ± 1.31
SecondaryPercent Change From Baseline in Pruritus VAS Over Time

Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus.

Time frame:
Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Pruritus VAS Over Time
percent changeKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 1-23.6 ± 13.76-8.3 ± 19.72-15.3 ± 9.17-24.8 ± 11.44-5.3 ± 1.80—-76.1 ± 27.1490.9 ± 85.95-15.4 ± 3.19-4.6 ± 4.52
Change at Week 2-37.4 ± 19.67-4.3 ± 28.19-34.2 ± 9.66-32.8 ± 12.04-5.1 ± 3.22—-79.6 ± 34.2881.3 ± 108.56-24.2 ± 5.50-10.1 ± 7.78
Change at Week 3-43.3 ± 19.79-2.6 ± 28.36-37.4 ± 12.12-44.5 ± 15.12-26.2 ± 8.32—-97.1 ± 28.9296.7 ± 91.57-40.6 ± 6.26-10.3 ± 8.87
Change at Week 4-54.9 ± 19.93-0.9 ± 28.57-44.4 ± 10.57-50.7 ± 13.18-37.3 ± 12.60—-93.6 ± 28.1374.8 ± 89.08-52.7 ± 6.55-16.0 ± 9.27
Change at Week 5-66.3 ± 21.37-0.2 ± 30.63-54.1 ± 10.84-60.4 ± 13.52-40.0 ± 15.97—-99.4 ± 26.6864.0 ± 84.47-52.5 ± 6.54-19.1 ± 9.26
Change at Week 6-57.2 ± 22.58-1.2 ± 32.37-53.0 ± 11.31-52.4 ± 14.11-41.6 ± 17.99—-101.0 ± 24.6876.3 ± 78.14-63.5 ± 6.90-21.5 ± 9.77
Change at Week 7-65.7 ± 18.990.1 ± 27.22-55.7 ± 10.97-60.8 ± 13.68-44.3 ± 21.36—-101.8 ± 22.5573.6 ± 71.40-64.6 ± 7.89-25.4 ± 11.18
Change at Week 8-54.1 ± 22.59-0.4 ± 32.38-52.1 ± 11.11-55.0 ± 13.86-44.3 ± 21.36—-99.2 ± 23.1163.8 ± 73.18-70.9 ± 8.44-25.2 ± 11.96
Change at Week 10-61.6 ± 20.310.7 ± 29.11-50.7 ± 10.73-72.2 ± 12.39-76.9 ± 0.00—-103.9 ± 22.6257.5 ± 71.64-70.6 ± 8.32-36.2 ± 12.71
Change at Week 12-51.9 ± 21.213.3 ± 30.40-56.3 ± 12.44-58.7 ± 14.37-69.7 ± 0.00—-102.9 ± 21.1346.3 ± 66.92-67.6 ± 8.32-45.5 ± 12.71
Change at Week 14-44.2 ± 20.404.4 ± 29.24-60.8 ± 11.32-51.2 ± 13.07-72.9 ± 0.00—-103.3 ± 19.7464.5 ± 62.52-69.6 ± 8.91-42.5 ± 13.61
Change at Week 16-56.8 ± 14.025.1 ± 20.09-49.5 ± 11.91-48.9 ± 13.75-76.9 ± 0.00—-102.0 ± 16.8757.2 ± 53.41-68.1 ± 9.43-41.6 ± 14.40
Change at Week 18-47.8 ± 14.976.8 ± 21.45-49.1 ± 13.66-45.0 ± 15.77-74.6 ± 0.00—-101.3 ± 9.9329.5 ± 31.43-64.5 ± 10.23-46.0 ± 15.63
Statistical analysis
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.5763 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -15.3 · 80% CI -55.37 to 24.78
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.5214 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 9.6 · 80% CI -9.86 to 29.01
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2536 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -167.0 · 80% CI -365.51 to 31.54
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0670 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -10.8 · 80% CI -18.20 to -3.44
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.4133 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -33.1 · 80% CI -90.43 to 24.15
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.9305 · Ls mean difference: -1.4 · 80% CI -21.83 to 19.11
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.3499 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -160.9 · 80% CI -411.65 to 89.86
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1588 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -14.0 · 80% CI -26.74 to -1.33
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.3319 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -40.6 · 80% CI -98.26 to 17.00
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.7179 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 7.1 · 80% CI -18.59 to 32.80
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2261 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -193.8 · 80% CI -405.34 to 17.67
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0123 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -30.3 · 80% CI -44.75 to -15.80
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.2253 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -54.0 · 80% CI -112.02 to 4.09
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.7149 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 6.3 · 80% CI -16.14 to 28.66
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2627 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -168.4 · 80% CI -374.16 to 37.36
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0047 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -36.7 · 80% CI -51.87 to -21.60
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.1803 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -66.1 · 80% CI -128.37 to -3.88
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.7174 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 6.4 · 80% CI -16.62 to 29.35
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2551 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -163.4 · 80% CI -358.51 to 31.72
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0086 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -33.5 · 80% CI -48.58 to -18.36
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.2576 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -56.0 · 80% CI -121.78 to 9.78
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.9722 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -0.6 · 80% CI -24.62 to 23.34
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2051 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -177.4 · 80% CI -357.85 to 3.13
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0025 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -42.0 · 80% CI -57.98 to -26.08
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.1465 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -65.8 · 80% CI -121.14 to -10.50
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.7734 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 5.1 · 80% CI -18.13 to 28.37
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1826 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -175.5 · 80% CI -340.37 to -10.56
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0105 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -39.2 · 80% CI -57.40 to -20.93
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.2737 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -53.7 · 80% CI -119.49 to 12.09
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.8692 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 3.0 · 80% CI -20.59 to 26.52
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2106 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -163.0 · 80% CI -332.06 to 5.99
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0060 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -45.7 · 80% CI -65.19 to -26.14
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.1831 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -62.3 · 80% CI -121.44 to -3.13
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.2061 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 21.5 · 80% CI -0.31 to 43.30
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2073 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -161.4 · 80% CI -326.83 to 4.12
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0371 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -34.4 · 80% CI -54.62 to -14.10
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.2393 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -55.2 · 80% CI -117.01 to 6.54
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.9019 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 2.4 · 80% CI -22.91 to 27.67
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2103 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -149.2 · 80% CI -303.77 to 5.35
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1634 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -22.1 · 80% CI -42.40 to -1.88
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.2727 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -48.6 · 80% CI -108.04 to 10.80
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.5839 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -9.6 · 80% CI -32.65 to 13.36
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1597 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -167.8 · 80% CI -312.25 to -23.45
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1138 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -27.1 · 80% CI -48.81 to -5.43
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.0888 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -62.0 · 80% CI -102.78 to -21.13
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.9741 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -0.6 · 80% CI -24.79 to 23.60
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1354 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -159.2 · 80% CI -282.59 to -35.87
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1425 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -26.5 · 80% CI -49.41 to -3.52
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.1326 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -54.6 · 80% CI -98.18 to -11.01
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.8433 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -4.2 · 80% CI -31.95 to 23.58
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0768 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -130.8 · 80% CI -203.39 to -58.19
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.3341 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -18.6 · 80% CI -43.49 to 6.34
SecondaryChange From Baseline in 5-D Pruritus Total Score Over Time

This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus).

Time frame:
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18
Reported as:
Mean · units on a scale
Change From Baseline in 5-D Pruritus Total Score Over Time
units on a scaleKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 2-6.3 ± 2.780.0 ± 0.00-4.4 ± 1.06-4.0 ± 1.35-2.3 ± 1.20—-6.8 ± 2.10-4.0 ± NA-5.0 ± 1.19-3.6 ± 1.29
Change at Week 4-8.5 ± 2.020.5 ± 0.50-4.5 ± 1.27-5.4 ± 1.65-7.3 ± 4.06—-7.3 ± 2.78-4.0 ± NA-7.7 ± 1.05-4.1 ± 1.81
Change at Week 6-8.3 ± 2.170.5 ± 0.50-6.6 ± 1.23-5.8 ± 1.47-8.0 ± 4.16—-8.5 ± 2.90-7.0 ± NA-8.2 ± 1.05-5.0 ± 1.79
Change at Week 8-7.5 ± 2.22-0.5 ± 0.50-6.5 ± 1.32-6.8 ± 1.23-8.0 ± 4.16—-8.8 ± 2.95-7.0 ± NA-9.4 ± 1.09-5.0 ± 1.75
Change at Week 10-8.0 ± 1.68-1.0 ± 1.00-6.6 ± 1.50-7.9 ± 0.63-12.0 ± 2.00—-9.5 ± 2.87-7.0 ± NA-9.4 ± 1.46-6.0 ± 1.81
Change at Week 12-7.0 ± 2.420.0 ± 0.00-6.3 ± 1.33-6.3 ± 1.04-12.0 ± 2.00—-9.8 ± 2.63-8.0 ± NA-9.6 ± 1.32-6.3 ± 1.71
Change at Week 14-4.0 ± 3.370.0 ± 0.00-6.7 ± 1.08-6.1 ± 1.17-12.0 ± 2.00—-9.5 ± 2.87-4.0 ± NA-9.6 ± 1.53-6.5 ± 1.78
Change at Week 16-7.8 ± 2.100.5 ± 0.50-7.1 ± 1.77-5.0 ± 1.47-11.5 ± 2.50—-10.0 ± 2.38-2.0 ± NA-9.6 ± 1.48-7.2 ± 1.97
Change at Week 18-6.5 ± 2.500.5 ± 0.50-6.3 ± 1.82-4.6 ± 1.42-13.5 ± 3.50—-10.0 ± 2.38-2.0 ± NA-8.9 ± 1.57-7.0 ± 1.65
SecondaryPercent Change From Baseline in 5-D Pruritus Total Score Over Time

This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus).

Time frame:
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18
Reported as:
Least squares mean · percent change
Percent Change From Baseline in 5-D Pruritus Total Score Over Time
percent changeKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 2-31.3 ± 13.400.0 ± 18.98-24.2 ± 6.00-20.6 ± 7.48-11.8 ± 8.46—-44.0 ± 3.438.4 ± 8.04-25.4 ± 5.38-18.8 ± 7.61
Change at Week 4-42.7 ± 9.402.4 ± 13.31-24.1 ± 7.03-29.2 ± 8.77-35.1 ± 12.38—-49.1 ± 2.0923.0 ± 4.90-40.3 ± 5.55-20.8 ± 7.85
Change at Week 6-41.4 ± 10.222.3 ± 14.48-35.9 ± 6.66-31.6 ± 8.31-38.8 ± 17.46—-56.5 ± 1.499.1 ± 3.49-43.3 ± 5.67-25.9 ± 8.02
Change at Week 8-37.7 ± 10.85-2.2 ± 15.36-34.4 ± 6.30-37.2 ± 7.85-38.8 ± 17.46—-58.1 ± 0.8310.1 ± 1.95-49.1 ± 5.49-25.7 ± 7.77
Change at Week 10-40.1 ± 8.46-4.5 ± 11.98-35.2 ± 6.47-43.1 ± 7.48-58.2 ± 0.00—-62.1 ± 3.766.6 ± 8.82-49.1 ± 6.55-29.6 ± 10.06
Change at Week 12-33.3 ± 9.21-0.8 ± 13.05-33.5 ± 6.64-34.4 ± 7.66-58.2 ± 0.00—-62.8 ± 3.53-3.4 ± 8.28-50.2 ± 5.86-31.4 ± 9.00
Change at Week 14-17.9 ± 14.08-1.1 ± 19.95-36.2 ± 5.83-33.3 ± 6.74-58.2 ± 0.00—-62.1 ± 3.7620.2 ± 8.82-49.7 ± 7.04-33.1 ± 10.81
Change at Week 16-37.7 ± 8.291.7 ± 11.74-37.0 ± 8.29-27.8 ± 9.57-55.4 ± 0.00—-63.6 ± 3.3318.5 ± 7.81-49.9 ± 7.08-36.8 ± 10.88
Change at Week 18-31.3 ± 10.411.6 ± 14.75-32.9 ± 8.83-25.0 ± 10.19-64.7 ± 0.00—-63.6 ± 3.3318.5 ± 7.81-46.6 ± 7.43-35.5 ± 11.41
Statistical analysis
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.4995 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -40.9 · 80% CI -166.52 to 84.74
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.7071 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -3.7 · 80% CI -16.37 to 9.06
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0305 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -52.5 · 80% CI -70.18 to -34.77
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.4884 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -6.6 · 80% CI -19.01 to 5.81
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.2885 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -45.3 · 80% CI -104.93 to 14.35
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.6505 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 5.2 · 80% CI -9.73 to 20.06
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0062 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -72.1 · 80% CI -82.91 to -61.34
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0571 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -19.6 · 80% CI -32.34 to -6.76
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · Ls mean difference: -50.1
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.6927 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -4.3 · 80% CI -18.38 to 9.84
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0038 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -65.6 · 80% CI -73.33 to -57.94
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0940 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -17.4 · 80% CI -30.43 to -4.30
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.1694 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -72.4 · 80% CI -133.10 to -11.65
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.7811 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 2.8 · 80% CI -10.50 to 16.18
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0011 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -68.2 · 80% CI -72.51 to -63.91
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0245 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -23.4 · 80% CI -36.02 to -10.70
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.0603 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -61.8 · 80% CI -79.88 to -43.74
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.4365 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 7.9 · 80% CI -5.29 to 21.04
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0218 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -68.7 · 80% CI -88.11 to -49.26
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1238 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -19.5 · 80% CI -35.65 to -3.45
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.1437 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -54.8 · 80% CI -98.88 to -10.72
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.9279 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 0.9 · 80% CI -12.56 to 14.43
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0254 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -59.5 · 80% CI -77.69 to -41.24
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0994 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -18.8 · 80% CI -33.23 to -4.43
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.3656 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -45.7 · 80% CI -119.90 to 28.54
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.7465 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -2.9 · 80% CI -14.79 to 8.94
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0153 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -82.3 · 80% CI -101.75 to -62.90
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.2184 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -16.6 · 80% CI -33.88 to 0.72
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.7726 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -8.1 · 80% CI -50.37 to 34.07
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.4760 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -9.2 · 80% CI -26.07 to 7.63
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0121 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -82.1 · 80% CI -99.26 to -64.87
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.3329 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -13.0 · 80% CI -30.43 to 4.40
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.9564 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -1.7 · 80% CI -48.31 to 44.92
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.5661 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -7.9 · 80% CI -25.84 to 10.06
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0121 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -82.1 · 80% CI -99.26 to -64.87
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.4275 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -11.1 · 80% CI -29.40 to 7.13
SecondaryPercentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time

WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.

Time frame:
Baseline, Weeks 1-18
Reported as:
Number · percentage of participants
Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time
percentage of participantsKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 10.0 (0.0 to 60.2)0.0 (0.0 to 84.2)21.4 (4.7 to 50.8)11.1 (0.3 to 48.2)0.0 (0.0 to 70.8)—50.0 (6.8 to 93.2)0.0 (0.0 to 97.5)0.0 (0.0 to 23.2)0.0 (0.0 to 41.0)
Change at Week 250.0 (6.8 to 93.2)0.0 (0.0 to 84.2)28.6 (8.4 to 58.1)33.3 (7.5 to 70.1)0.0 (0.0 to 70.8)—50.0 (6.8 to 93.2)0.0 (0.0 to 97.5)0.0 (0.0 to 23.2)0.0 (0.0 to 41.0)
Change at Week 350.0 (6.8 to 93.2)0.0 (0.0 to 84.2)42.9 (17.7 to 71.1)33.3 (7.5 to 70.1)0.0 (0.0 to 70.8)—50.0 (6.8 to 93.2)0.0 (0.0 to 97.5)21.4 (4.7 to 50.8)0.0 (0.0 to 41.0)
Change at Week 450.0 (6.8 to 93.2)0.0 (0.0 to 84.2)42.9 (17.7 to 71.1)44.4 (13.7 to 78.8)33.3 (0.8 to 90.6)—75.0 (19.4 to 99.4)0.0 (0.0 to 97.5)42.9 (17.7 to 71.1)14.3 (0.4 to 57.9)
Change at Week 550.0 (6.8 to 93.2)0.0 (0.0 to 84.2)50.0 (23.0 to 77.0)44.4 (13.7 to 78.8)33.3 (0.8 to 90.6)—75.0 (19.4 to 99.4)0.0 (0.0 to 97.5)50.0 (23.0 to 77.0)14.3 (0.4 to 57.9)
Change at Week 650.0 (6.8 to 93.2)0.0 (0.0 to 84.2)57.1 (28.9 to 82.3)66.7 (29.9 to 92.5)33.3 (0.8 to 90.6)—75.0 (19.4 to 99.4)0.0 (0.0 to 97.5)57.1 (28.9 to 82.3)14.3 (0.4 to 57.9)
Change at Week 750.0 (6.8 to 93.2)50.0 (1.3 to 98.7)57.1 (28.9 to 82.3)55.6 (21.2 to 86.3)66.7 (9.4 to 99.2)—75.0 (19.4 to 99.4)0.0 (0.0 to 97.5)64.3 (35.1 to 87.2)14.3 (0.4 to 57.9)
Change at Week 850.0 (6.8 to 93.2)0.0 (0.0 to 84.2)57.1 (28.9 to 82.3)66.7 (29.9 to 92.5)66.7 (9.4 to 99.2)—75.0 (19.4 to 99.4)0.0 (0.0 to 97.5)71.4 (41.9 to 91.6)28.6 (3.7 to 71.0)
Change at Week 950.0 (6.8 to 93.2)0.0 (0.0 to 84.2)58.3 (27.7 to 84.8)55.6 (21.2 to 86.3)100.0 (15.8 to 100.0)—75.0 (19.4 to 99.4)0.0 (0.0 to 97.5)78.6 (49.2 to 95.3)28.6 (3.7 to 71.0)
Change at Week 1025.0 (0.6 to 80.6)50.0 (1.3 to 98.7)50.0 (21.1 to 78.9)77.8 (40.0 to 97.2)100.0 (15.8 to 100.0)—75.0 (19.4 to 99.4)0.0 (0.0 to 97.5)78.6 (49.2 to 95.3)14.3 (0.4 to 57.9)
Change at Week 1150.0 (6.8 to 93.2)50.0 (1.3 to 98.7)58.3 (27.7 to 84.8)77.8 (40.0 to 97.2)100.0 (15.8 to 100.0)—75.0 (19.4 to 99.4)0.0 (0.0 to 97.5)64.3 (35.1 to 87.2)14.3 (0.4 to 57.9)
Change at Week 1250.0 (6.8 to 93.2)50.0 (1.3 to 98.7)58.3 (27.7 to 84.8)66.7 (29.9 to 92.5)100.0 (15.8 to 100.0)—75.0 (19.4 to 99.4)0.0 (0.0 to 97.5)64.3 (35.1 to 87.2)14.3 (0.4 to 57.9)
Change at Week 1325.0 (0.6 to 80.6)50.0 (1.3 to 98.7)58.3 (27.7 to 84.8)55.6 (21.2 to 86.3)100.0 (15.8 to 100.0)—75.0 (19.4 to 99.4)0.0 (0.0 to 97.5)71.4 (41.9 to 91.6)14.3 (0.4 to 57.9)
Change at Week 1425.0 (0.6 to 80.6)50.0 (1.3 to 98.7)58.3 (27.7 to 84.8)55.6 (21.2 to 86.3)100.0 (15.8 to 100.0)—75.0 (19.4 to 99.4)0.0 (0.0 to 97.5)71.4 (41.9 to 91.6)14.3 (0.4 to 57.9)
Change at Week 1550.0 (6.8 to 93.2)50.0 (1.3 to 98.7)50.0 (21.1 to 78.9)44.4 (13.7 to 78.8)100.0 (15.8 to 100.0)—75.0 (19.4 to 99.4)0.0 (0.0 to 97.5)71.4 (41.9 to 91.6)28.6 (3.7 to 71.0)
Change at Week 1625.0 (0.6 to 80.6)50.0 (1.3 to 98.7)58.3 (27.7 to 84.8)44.4 (13.7 to 78.8)100.0 (15.8 to 100.0)—75.0 (19.4 to 99.4)0.0 (0.0 to 97.5)71.4 (41.9 to 91.6)28.6 (3.7 to 71.0)
Change at Week 1775.0 (19.4 to 99.4)50.0 (1.3 to 98.7)50.0 (21.1 to 78.9)44.4 (13.7 to 78.8)100.0 (15.8 to 100.0)—75.0 (19.4 to 99.4)0.0 (0.0 to 97.5)71.4 (41.9 to 91.6)28.6 (3.7 to 71.0)
Change at Week 1875.0 (19.4 to 99.4)50.0 (1.3 to 98.7)58.3 (27.7 to 84.8)44.4 (13.7 to 78.8)100.0 (15.8 to 100.0)—100.0 (39.8 to 100.0)0.0 (0.0 to 97.5)71.4 (41.9 to 91.6)28.6 (3.7 to 71.0)
SecondaryChange From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only

Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort.

Time frame:
Baseline, Weeks 1-18
Reported as:
Mean · score on a scale
Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only
score on a scaleKPL-716: CIU CohortPlacebo: CIU Cohort
Change at Week 1-0.7 ± 0.130.3 ± 0.29
Change at Week 2-0.9 ± 0.15-0.2 ± 0.21
Change at Week 3-1.0 ± 0.36-0.4 ± 0.36
Change at Week 4-1.2 ± 0.30-0.2 ± 0.21
Change at Week 5-1.2 ± 0.28-0.2 ± 0.21
Change at Week 6-1.4 ± 0.22-0.1 ± 0.14
Change at Week 7-1.1 ± 0.30-0.4 ± 0.43
Change at Week 8-0.8 ± 0.40-0.1 ± 0.14
Change at Week 9-1.2 ± 0.27-0.1 ± 0.14
Change at Week 10-1.1 ± 0.35-0.5 ± 0.50
Change at Week 11-1.0 ± 0.39-0.6 ± 0.57
Change at Week 12-1.0 ± 0.39-0.6 ± 0.57
Change at Week 13-0.7 ± 0.44-0.6 ± 0.57
Change at Week 14-0.9 ± 0.41-0.6 ± 0.57
Change at Week 15-1.1 ± 0.38-0.6 ± 0.57
Change at Week 16-0.9 ± 0.39-0.6 ± 0.57
Change at Week 17-1.1 ± 0.35-0.6 ± 0.57
Change at Week 18-1.3 ± 0.24-0.6 ± 0.57
SecondaryPercent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only

Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort

Time frame:
Baseline, Weeks 1-18
Reported as:
Mean · percent change
Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only
percent changeKPL-716: CIU CohortPlacebo: CIU Cohort
Change at Week 1-26.6 ± 5.36-13.3 ± 13.33
Change at Week 2-36.4 ± 4.94-10.0 ± 10.00
Change at Week 3-40.8 ± 11.29-16.7 ± 16.67
Change at Week 4-45.5 ± 8.82-10.0 ± 10.00
Change at Week 5-48.7 ± 8.76-10.0 ± 10.00
Change at Week 6-54.6 ± 5.27-6.7 ± 6.67
Change at Week 7-43.8 ± 8.48-20.0 ± 20.00
Change at Week 8-31.5 ± 12.83-6.7 ± 6.67
Change at Week 9-48.3 ± 6.99-6.7 ± 6.67
Change at Week 10-41.5 ± 11.05-23.3 ± 23.33
Change at Week 11-36.9 ± 12.65-26.7 ± 26.67
Change at Week 12-38.4 ± 13.06-26.7 ± 26.67
Change at Week 13-26.4 ± 14.24-26.7 ± 26.67
Change at Week 14-33.7 ± 13.07-26.7 ± 26.67
Change at Week 15-41.4 ± 12.71-26.7 ± 26.67
Change at Week 16-33.8 ± 12.37-26.7 ± 26.67
Change at Week 17-44.0 ± 11.58-26.7 ± 26.67
Change at Week 18-51.5 ± 5.65-26.7 ± 26.67
SecondaryChange From Baseline in Sleep Loss VAS Over Time

Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit.

Time frame:
Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Reported as:
Mean · units on a scale
Change From Baseline in Sleep Loss VAS Over Time
units on a scaleKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 1-1.6 ± 1.120.1 ± 0.100.4 ± 0.78-2.1 ± 1.17-0.4 ± 0.31—-2.8 ± 1.810.1 ± NA-1.2 ± 0.25-0.1 ± 0.35
Change at Week 2-3.1 ± 1.460.1 ± 0.10-1.0 ± 0.60-2.6 ± 0.71-0.3 ± 0.15—-3.4 ± 1.980.0 ± NA-2.1 ± 0.48-0.4 ± 0.58
Change at Week 3-2.4 ± 1.860.1 ± 0.10-1.6 ± 0.70-3.6 ± 0.95-2.1 ± 1.49—-4.1 ± 1.97-0.1 ± NA-3.0 ± 0.62-1.0 ± 0.75
Change at Week 4-2.9 ± 2.300.1 ± 0.10-1.5 ± 0.80-3.4 ± 0.86-2.9 ± 1.87—-4.2 ± 1.81-0.1 ± NA-3.7 ± 0.62-0.3 ± 1.30
Change at Week 5-3.5 ± 2.340.1 ± 0.10-2.0 ± 0.72-3.9 ± 0.96-3.1 ± 1.85—-4.4 ± 1.75-2.6 ± NA-4.0 ± 0.59-1.2 ± 1.14
Change at Week 6-2.9 ± 2.690.1 ± 0.10-2.3 ± 0.74-3.6 ± 0.83-3.1 ± 1.85—-5.0 ± 1.46-1.3 ± NA-4.6 ± 0.56-1.6 ± 1.20
Change at Week 7-3.7 ± 2.160.0 ± 0.00-2.1 ± 0.67-3.9 ± 0.79-3.4 ± 1.86—-5.2 ± 1.33-1.0 ± NA-4.9 ± 0.58-1.8 ± 1.34
Change at Week 8-3.3 ± 2.480.1 ± 0.05-2.1 ± 0.67-3.8 ± 0.91-3.4 ± 1.86—-5.3 ± 1.27-1.0 ± NA-5.4 ± 0.59-2.1 ± 1.29
Change at Week 10-3.8 ± 2.200.1 ± 0.10-1.7 ± 0.66-5.4 ± 0.80-5.5 ± 0.90—-5.3 ± 1.29-2.4 ± NA-5.4 ± 0.63-3.1 ± 1.36
Change at Week 12-3.3 ± 2.140.1 ± 0.05-1.6 ± 0.73-4.3 ± 0.88-5.3 ± 1.15—-5.2 ± 1.32-2.3 ± NA-5.2 ± 0.68-3.2 ± 1.41
Change at Week 14-3.0 ± 2.360.1 ± 0.10-1.7 ± 0.67-4.9 ± 0.72-5.3 ± 1.15—-5.2 ± 1.33-0.1 ± NA-5.3 ± 0.70-3.0 ± 1.49
Change at Week 16-3.5 ± 2.140.1 ± 0.10-1.5 ± 0.78-4.0 ± 1.02-5.6 ± 0.85—-5.4 ± 1.23-0.4 ± NA-5.1 ± 0.75-2.8 ± 1.51
Change at Week 18-2.9 ± 2.280.1 ± 0.05-1.4 ± 0.84-3.1 ± 1.03-5.7 ± 2.25—-5.6 ± 1.11-0.6 ± NA-4.9 ± 0.90-3.3 ± 1.42
SecondaryPercent Change From Baseline in Sleep Loss VAS Over Time

Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit.

Time frame:
Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Reported as:
Mean · percent change
Percent Change From Baseline in Sleep Loss VAS Over Time
percent changeKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 1-25.1 ± 20.892.9 ± 31.37484.2 ± 401.19108.2 ± 483.26-5.1 ± 1.04—-45.5 ± 27.7022.2 ± 62.96-12.7 ± 5.20-0.3 ± 7.56
Change at Week 2-49.5 ± 20.049.9 ± 30.1012.4 ± 30.69-27.1 ± 36.97-4.1 ± 2.48—-55.1 ± 29.8322.1 ± 67.80-23.9 ± 8.20-5.1 ± 11.91
Change at Week 3-38.1 ± 25.2117.1 ± 37.859.9 ± 44.29-47.7 ± 53.35-27.6 ± 7.82—-66.1 ± 33.170.8 ± 75.41-34.7 ± 7.29-16.9 ± 10.59
Change at Week 4-46.8 ± 28.9222.4 ± 43.43244.8 ± 239.5315.4 ± 288.53-38.5 ± 13.99—-67.0 ± 28.944.2 ± 65.78-37.9 ± 11.302.4 ± 16.42
Change at Week 5-56.5 ± 27.8522.2 ± 41.828.2 ± 50.36-52.6 ± 60.66-41.1 ± 17.26—-70.4 ± 28.63-28.9 ± 65.09-47.2 ± 9.43-15.7 ± 13.70
Change at Week 6-47.6 ± 34.2527.1 ± 51.43-39.8 ± 14.56-61.6 ± 17.54-41.6 ± 17.91—-79.2 ± 21.45-15.2 ± 48.76-59.4 ± 8.54-21.7 ± 12.42
Change at Week 7-60.0 ± 22.5719.5 ± 33.89-17.8 ± 29.08-61.5 ± 35.03-45.3 ± 22.49—-83.1 ± 18.68-14.4 ± 42.45-62.3 ± 10.19-24.3 ± 14.80
Change at Week 8-54.0 ± 29.2324.2 ± 43.90-26.8 ± 24.06-58.4 ± 28.98-45.3 ± 22.49—-83.9 ± 17.07-14.3 ± 38.81-69.3 ± 9.15-29.0 ± 13.29
Change at Week 10-60.3 ± 23.3620.9 ± 35.07-43.8 ± 8.58-86.7 ± 9.51-75.0 ± 0.00—-84.2 ± 17.92-31.1 ± 40.73-68.2 ± 8.29-39.9 ± 12.85
Change at Week 12-53.6 ± 13.5823.7 ± 20.3945.6 ± 82.52-43.2 ± 91.47-71.1 ± 0.00—-83.4 ± 18.87-30.2 ± 42.89-66.1 ± 8.84-41.9 ± 13.71
Change at Week 14-49.5 ± 19.4627.2 ± 29.21-30.1 ± 14.43-75.6 ± 15.99-71.1 ± 0.00—-83.0 ± 19.35-6.5 ± 43.97-68.6 ± 9.28-38.0 ± 14.39
Change at Week 16-57.0 ± 17.0022.9 ± 25.53-34.4 ± 15.61-69.0 ± 17.30-75.7 ± 0.00—-85.9 ± 16.02-8.9 ± 36.40-66.0 ± 9.77-36.7 ± 15.16
Change at Week 18-47.3 ± 11.9427.7 ± 17.93-23.3 ± 15.15-56.1 ± 16.79-74.7 ± 0.00—-89.9 ± 11.26-9.8 ± 25.59-61.6 ± 11.11-43.6 ± 17.22
Statistical analysis
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.5403 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -27.9 · 80% CI -94.32 to 38.46
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.5587 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 376.1 · 80% CI -462.83 to 1214.97
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4516 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -67.7 · 80% CI -205.33 to 69.93
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.2052 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -12.5 · 80% CI -25.13 to 0.15
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.2240 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -59.4 · 80% CI -123.09 to 4.28
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.4242 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 39.5 · 80% CI -24.70 to 103.65
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4295 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -77.2 · 80% CI -225.44 to 71.01
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.2272 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -18.7 · 80% CI -38.64 to 1.20
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.3416 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -55.1 · 80% CI -135.23 to 24.95
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.4192 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 57.6 · 80% CI -35.02 to 150.19
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.5245 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -66.8 · 80% CI -231.66 to 98.02
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1988 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -17.8 · 80% CI -35.47 to -0.05
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.3054 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -69.2 · 80% CI -161.08 to 22.72
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.5504 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 229.4 · 80% CI -271.51 to 730.22
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4493 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -71.2 · 80% CI -214.96 to 72.65
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0665 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -40.3 · 80% CI -67.74 to -12.85
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.2411 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -78.7 · 80% CI -167.25 to 9.75
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.4528 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 60.8 · 80% CI -44.51 to 166.08
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.6381 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -41.4 · 80% CI -183.72 to 100.85
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0837 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -31.5 · 80% CI -54.44 to -8.62
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.3428 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -74.7 · 80% CI -183.53 to 34.13
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.3533 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 21.8 · 80% CI -8.63 to 52.27
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.3755 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -63.9 · 80% CI -170.51 to 42.66
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0268 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -37.6 · 80% CI -58.39 to -16.87
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.1672 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -79.5 · 80% CI -151.20 to -7.75
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.3518 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 43.7 · 80% CI -17.09 to 104.55
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2974 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -68.7 · 80% CI -161.52 to 24.09
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0555 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -38.1 · 80% CI -62.83 to -13.33
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.2614 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -78.3 · 80% CI -171.17 to 14.62
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.4134 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 31.7 · 80% CI -18.62 to 81.98
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2620 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -69.6 · 80% CI -154.44 to 15.24
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0269 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -40.2 · 80% CI -62.46 to -18.02
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.1709 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -81.2 · 80% CI -155.46 to -7.02
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.0042 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 42.9 · 80% CI 25.61 to 60.22
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.3772 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -53.2 · 80% CI -142.19 to 35.88
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0857 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -28.3 · 80% CI -49.06 to -7.63
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.0607 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -77.3 · 80% CI -120.48 to -34.20
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.4862 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 88.8 · 80% CI -77.57 to 255.22
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.3968 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -53.2 · 80% CI -146.96 to 40.58
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1624 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -24.2 · 80% CI -46.31 to -2.11
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.1349 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -76.8 · 80% CI -138.58 to -14.93
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.0525 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 45.5 · 80% CI 16.38 to 74.56
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2719 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -76.6 · 80% CI -172.71 to 19.55
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0957 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -30.7 · 80% CI -53.86 to -7.49
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.0942 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -79.8 · 80% CI -133.83 to -25.78
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.1606 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 34.6 · 80% CI 3.16 to 66.09
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2096 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -77.0 · 80% CI -156.58 to 2.58
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1279 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -29.3 · 80% CI -53.74 to -4.89
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.0479 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -75.0 · 80% CI -112.96 to -37.08
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.1700 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 32.8 · 80% CI 2.28 to 63.37
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1142 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -80.1 · 80% CI -136.03 to -24.15
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.3980 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -18.0 · 80% CI -45.80 to 9.71
SecondaryChange From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time

Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult.

Time frame:
Baseline, Weeks 1-18
Reported as:
Mean · score on a scale
Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time
score on a scaleKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 1-2.1 ± 0.67-0.3 ± 0.29-0.6 ± 0.44-1.7 ± 0.40-0.3 ± 0.08—-3.0 ± 1.31-1.0 ± NA-0.7 ± 0.160.0 ± 0.24
Change at Week 2-3.3 ± 0.78-0.4 ± 0.43-2.0 ± 0.52-3.1 ± 0.57-0.9 ± 0.30—-4.3 ± 1.96-1.0 ± NA-1.3 ± 0.26-0.6 ± 0.35
Change at Week 3-4.2 ± 1.21-0.5 ± 0.50-2.6 ± 0.59-2.9 ± 0.70-1.6 ± 0.87—-4.6 ± 2.10-1.6 ± NA-2.4 ± 0.56-0.8 ± 0.42
Change at Week 4-4.5 ± 1.350.0 ± 0.00-2.7 ± 0.72-2.9 ± 0.82-2.5 ± 1.57—-4.8 ± 1.91-2.1 ± NA-3.1 ± 0.55-1.0 ± 0.70
Change at Week 5-5.0 ± 1.57-0.4 ± 0.43-3.0 ± 0.76-3.0 ± 0.71-2.9 ± 1.64—-5.2 ± 1.95-2.0 ± NA-4.1 ± 0.72-1.5 ± 0.89
Change at Week 6-5.0 ± 1.45-0.5 ± 0.50-3.0 ± 0.69-3.8 ± 0.71-3.1 ± 1.61—-5.5 ± 1.82-2.6 ± NA-4.4 ± 0.69-1.4 ± 0.90
Change at Week 7-4.5 ± 1.56-0.2 ± 0.21-3.0 ± 0.65-3.7 ± 0.75-3.6 ± 1.65—-5.6 ± 1.76-2.6 ± NA-4.8 ± 0.72-1.8 ± 1.08
Change at Week 8-3.8 ± 1.66-0.3 ± 0.29-3.2 ± 0.64-2.9 ± 0.81-3.6 ± 1.65—-5.4 ± 1.94-3.3 ± NA-5.2 ± 0.70-2.1 ± 1.21
Change at Week 9-4.4 ± 1.460.7 ± 0.71-2.9 ± 0.69-3.7 ± 0.65-5.1 ± 0.86—-5.4 ± 1.88-3.4 ± NA-5.3 ± 0.70-2.4 ± 1.27
Change at Week 10-4.4 ± 1.64-0.5 ± 0.50-2.6 ± 0.65-4.5 ± 0.55-5.1 ± 0.86—-5.6 ± 1.69-3.0 ± NA-5.2 ± 0.77-2.4 ± 1.21
Change at Week 11-4.7 ± 1.78-0.5 ± 0.50-2.6 ± 0.76-4.6 ± 0.69-5.1 ± 0.86—-5.7 ± 1.61-3.1 ± NA-5.0 ± 0.77-2.4 ± 1.20
Change at Week 12-4.7 ± 1.73-0.5 ± 0.50-2.5 ± 0.73-4.1 ± 0.71-5.1 ± 0.86—-5.9 ± 1.50-2.6 ± NA-4.9 ± 0.78-2.5 ± 1.17
Change at Week 13-4.1 ± 1.90-0.5 ± 0.50-2.5 ± 0.65-4.3 ± 0.73-5.6 ± 0.43—-5.9 ± 1.53-1.9 ± NA-5.0 ± 0.80-2.5 ± 1.18
Change at Week 14-3.6 ± 1.92-0.5 ± 0.50-2.8 ± 0.65-4.3 ± 0.78-5.6 ± 0.36—-5.8 ± 1.58-2.1 ± NA-5.1 ± 0.78-2.6 ± 1.20
Change at Week 15-4.4 ± 1.77-0.5 ± 0.50-2.6 ± 0.61-4.1 ± 0.73-5.6 ± 0.36—-6.0 ± 1.45-2.4 ± NA-5.0 ± 0.83-2.8 ± 1.35
Change at Week 16-4.1 ± 1.86-0.5 ± 0.50-2.8 ± 0.68-3.8 ± 0.91-5.6 ± 0.36—-6.0 ± 1.43-1.9 ± NA-4.9 ± 0.81-2.7 ± 1.32
Change at Week 17-4.2 ± 1.91-0.5 ± 0.50-2.7 ± 0.64-3.5 ± 0.85-5.6 ± 0.36—-6.2 ± 1.32-1.4 ± NA-4.6 ± 0.97-3.0 ± 1.37
Change at Week 18-4.4 ± 1.79-0.5 ± 0.50-2.8 ± 0.72-3.6 ± 0.92-5.7 ± 0.43—-6.2 ± 1.32-1.3 ± NA-4.6 ± 0.98-3.0 ± 1.36
SecondaryPercent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time

Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult.

Time frame:
Baseline, Weeks 1-18
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time
percent changeKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 1-35.3 ± 9.68-22.2 ± 13.83-4.9 ± 8.21-26.6 ± 9.88-3.6 ± 1.17—-42.9 ± 17.69-7.4 ± 36.83-9.3 ± 2.321.2 ± 3.33
Change at Week 2-51.1 ± 13.32-34.9 ± 19.03-31.2 ± 7.80-48.7 ± 9.38-10.9 ± 5.13—-59.3 ± 23.10-0.5 ± 48.09-15.0 ± 3.50-9.3 ± 5.03
Change at Week 3-63.9 ± 20.16-40.9 ± 28.80-42.1 ± 8.81-48.7 ± 10.60-20.0 ± 15.28—-64.8 ± 24.87-6.2 ± 51.77-27.6 ± 6.38-11.2 ± 9.16
Change at Week 4-61.0 ± 15.91-1.4 ± 22.72-43.3 ± 10.71-50.3 ± 12.88-31.4 ± 27.58—-67.6 ± 21.14-14.2 ± 44.00-36.3 ± 6.64-12.2 ± 9.53
Change at Week 5-71.7 ± 22.82-36.4 ± 32.59-46.0 ± 11.47-50.4 ± 13.80-37.2 ± 28.02—-73.1 ± 23.65-15.4 ± 49.24-48.4 ± 7.51-20.8 ± 10.78
Change at Week 6-73.1 ± 21.37-42.1 ± 30.52-47.5 ± 9.49-60.6 ± 11.42-39.8 ± 26.65—-79.0 ± 25.98-30.3 ± 54.08-52.7 ± 7.40-19.0 ± 10.63
Change at Week 7-62.2 ± 19.51-19.4 ± 27.88-50.5 ± 8.27-61.5 ± 9.95-46.3 ± 23.22—-80.0 ± 24.71-30.3 ± 51.45-57.2 ± 8.21-24.5 ± 11.79
Change at Week 8-51.9 ± 21.00-25.8 ± 30.00-54.1 ± 8.75-47.9 ± 10.52-46.3 ± 23.22—-77.0 ± 28.52-38.6 ± 59.36-63.2 ± 8.55-27.5 ± 12.29
Change at Week 9-52.4 ± 10.6055.9 ± 15.15-50.6 ± 8.32-60.6 ± 9.20-66.9 ± 0.00—-78.0 ± 27.25-40.3 ± 56.72-64.3 ± 8.48-32.3 ± 12.17
Change at Week 10-62.3 ± 22.58-43.1 ± 32.26-45.5 ± 7.86-69.4 ± 8.70-66.9 ± 0.00—-80.6 ± 23.28-35.5 ± 48.46-62.0 ± 8.70-31.5 ± 12.50
Change at Week 11-66.4 ± 24.89-43.1 ± 35.55-43.2 ± 9.82-69.8 ± 10.86-66.9 ± 0.00—-82.1 ± 21.38-37.1 ± 44.50-58.9 ± 8.47-33.2 ± 12.17
Change at Week 12-66.4 ± 23.94-43.1 ± 34.20-43.4 ± 10.02-64.0 ± 11.08-66.9 ± 0.00—-85.2 ± 18.38-30.2 ± 38.26-58.5 ± 8.78-33.7 ± 12.60
Change at Week 13-55.7 ± 26.31-43.7 ± 37.59-43.5 ± 9.52-68.2 ± 10.53-72.8 ± 0.00—-84.6 ± 19.01-21.9 ± 39.57-60.6 ± 9.18-34.1 ± 13.19
Change at Week 14-48.5 ± 25.78-44.0 ± 36.83-49.4 ± 9.01-68.9 ± 9.97-73.8 ± 0.00—-83.6 ± 20.28-25.2 ± 42.21-61.7 ± 9.25-34.1 ± 13.28
Change at Week 15-62.3 ± 24.47-43.3 ± 34.96-44.1 ± 8.74-67.0 ± 9.67-73.8 ± 0.00—-86.2 ± 17.11-28.5 ± 35.62-60.2 ± 9.90-38.3 ± 14.22
Change at Week 16-56.4 ± 25.57-43.7 ± 36.52-47.8 ± 10.02-64.3 ± 11.08-73.8 ± 0.00—-86.7 ± 16.48-21.8 ± 34.30-58.9 ± 9.71-37.0 ± 13.95
Change at Week 17-58.5 ± 26.89-43.6 ± 38.41-45.1 ± 9.46-60.3 ± 10.47-73.8 ± 0.00—-89.3 ± 13.31-16.8 ± 27.70-53.7 ± 11.52-41.2 ± 16.54
Change at Week 18-61.1 ± 24.70-43.4 ± 35.29-48.1 ± 10.22-61.9 ± 11.30-74.7 ± 0.00—-89.3 ± 13.31-15.1 ± 27.70-53.4 ± 11.61-41.8 ± 16.68
Statistical analysis
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.4979 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -13.2 · 80% CI -41.17 to 14.86
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.1079 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 21.7 · 80% CI 4.63 to 38.83
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4837 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -35.6 · 80% CI -114.19 to 43.07
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0208 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -10.5 · 80% CI -15.99 to -4.98
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.5413 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -16.2 · 80% CI -54.74 to 22.38
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.1683 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 17.5 · 80% CI 1.28 to 33.74
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.3933 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -58.8 · 80% CI -161.43 to 43.89
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.3705 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -5.7 · 80% CI -14.06 to 2.58
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.5644 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -23.0 · 80% CI -81.36 to 35.34
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.6384 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 6.6 · 80% CI -11.75 to 24.94
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4229 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -58.6 · 80% CI -169.13 to 51.95
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1688 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -16.3 · 80% CI -31.47 to -1.18
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.1243 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -59.6 · 80% CI -105.59 to -13.53
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.6841 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 6.9 · 80% CI -15.35 to 29.22
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.3963 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -53.4 · 80% CI -147.31 to 40.59
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0571 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -24.1 · 80% CI -39.85 to -8.32
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.4457 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -35.3 · 80% CI -101.32 to 30.73
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.8075 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 4.4 · 80% CI -19.44 to 28.32
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4093 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -57.7 · 80% CI -162.84 to 47.40
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0543 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -27.6 · 80% CI -45.42 to -9.76
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.4711 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -31.0 · 80% CI -92.88 to 30.78
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.3925 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 13.0 · 80% CI -6.74 to 32.79
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.5095 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -48.7 · 80% CI -164.22 to 66.72
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0199 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -33.8 · 80% CI -51.35 to -16.18
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.3029 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -42.8 · 80% CI -99.26 to 13.69
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.4094 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 10.9 · 80% CI -6.28 to 28.16
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4828 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -49.8 · 80% CI -159.63 to 60.05
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0383 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -32.8 · 80% CI -52.26 to -13.26
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.5322 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -26.1 · 80% CI -86.66 to 34.65
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.6577 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -6.2 · 80% CI -24.38 to 12.03
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.6259 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -38.3 · 80% CI -165.08 to 88.40
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0312 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -35.7 · 80% CI -56.01 to -15.38
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.0103 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -108.3 · 80% CI -138.97 to -77.61
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.4330 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 10.0 · 80% CI -6.59 to 26.56
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.6165 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -37.7 · 80% CI -158.82 to 83.39
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0488 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -32.0 · 80% CI -52.11 to -11.84
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.6636 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -19.2 · 80% CI -84.53 to 46.16
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.0583 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 23.9 · 80% CI 8.18 to 39.52
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4975 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -45.1 · 80% CI -148.55 to 58.36
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0653 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -30.5 · 80% CI -51.17 to -9.82
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.6316 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -23.4 · 80% CI -95.42 to 48.62
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.0874 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 26.6 · 80% CI 7.05 to 46.18
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4662 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -45.0 · 80% CI -139.99 to 50.03
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1073 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -25.6 · 80% CI -45.76 to -5.51
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.6197 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -23.3 · 80% CI -92.62 to 45.96
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.1868 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 20.6 · 80% CI 0.63 to 40.55
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.3321 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -55.0 · 80% CI -136.65 to 26.71
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1310 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -24.8 · 80% CI -45.64 to -3.95
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.8128 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -12.0 · 80% CI -88.15 to 64.13
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.1004 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 24.7 · 80% CI 5.75 to 43.69
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2962 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -62.8 · 80% CI -147.28 to 21.71
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1236 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -26.5 · 80% CI -48.31 to -4.67
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.9276 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -4.5 · 80% CI -79.10 to 70.11
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.1657 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 19.5 · 80% CI 1.55 to 37.45
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.3461 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -58.4 · 80% CI -148.54 to 31.71
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1118 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -27.6 · 80% CI -49.58 to -5.64
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.6912 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -18.9 · 80% CI -89.75 to 51.89
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.0973 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 22.9 · 80% CI 5.50 to 40.35
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2890 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -57.7 · 80% CI -133.72 to 18.37
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.2310 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -21.9 · 80% CI -45.43 to 1.60
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.7967 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -12.7 · 80% CI -86.69 to 61.28
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.2868 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 16.5 · 80% CI -3.50 to 36.44
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2369 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -64.9 · 80% CI -138.08 to 8.37
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.2228 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -21.9 · 80% CI -44.97 to 1.17
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.7740 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -14.9 · 80% CI -92.74 to 62.89
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.3000 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 15.1 · 80% CI -3.74 to 33.98
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1472 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -72.4 · 80% CI -131.59 to -13.30
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.5536 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -12.4 · 80% CI -39.77 to 14.94
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.7131 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -17.6 · 80% CI -89.13 to 53.84
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.3762 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 13.9 · 80% CI -6.49 to 34.24
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1419 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -74.1 · 80% CI -133.26 to -14.97
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.5817 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -11.6 · 80% CI -39.22 to 15.95
SecondaryChange From Baseline in Weekly Average of Sleep Quality NRS Over Time

Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep.

Time frame:
Baseline, Weeks 1-18
Reported as:
Mean · score on a scale
Change From Baseline in Weekly Average of Sleep Quality NRS Over Time
score on a scaleKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 1-0.8 ± 1.32-0.3 ± 0.29-0.2 ± 0.33-1.6 ± 0.43-0.2 ± 0.17—-2.6 ± 1.26-1.0 ± NA-0.6 ± 0.20-0.3 ± 0.19
Change at Week 2-2.0 ± 1.63-0.4 ± 0.43-1.7 ± 0.56-2.7 ± 0.60-0.7 ± 0.41—-3.7 ± 1.75-0.7 ± NA-1.1 ± 0.30-0.4 ± 0.29
Change at Week 3-1.9 ± 1.86-0.5 ± 0.50-1.9 ± 0.54-2.7 ± 0.62-1.5 ± 1.02—-4.2 ± 1.98-1.0 ± NA-2.0 ± 0.52-0.5 ± 0.42
Change at Week 4-2.6 ± 2.120.0 ± 0.00-2.0 ± 0.65-2.7 ± 0.93-2.3 ± 1.67—-4.4 ± 1.78-2.0 ± NA-2.8 ± 0.59-0.9 ± 0.64
Change at Week 5-2.8 ± 2.35-0.4 ± 0.43-2.3 ± 0.68-2.8 ± 0.73-2.8 ± 1.75—-4.4 ± 1.61-1.9 ± NA-3.5 ± 0.75-1.2 ± 0.91
Change at Week 6-2.6 ± 2.45-0.5 ± 0.50-2.4 ± 0.69-3.7 ± 0.64-3.0 ± 1.73—-5.2 ± 1.53-2.4 ± NA-3.8 ± 0.70-1.1 ± 0.95
Change at Week 7-2.6 ± 2.31-0.2 ± 0.21-2.4 ± 0.65-3.6 ± 0.79-3.4 ± 1.78—-5.3 ± 1.43-2.0 ± NA-4.2 ± 0.71-1.5 ± 1.10
Change at Week 8-2.5 ± 2.38-0.3 ± 0.29-2.5 ± 0.67-3.6 ± 0.89-3.4 ± 1.78—-5.6 ± 1.24-3.0 ± NA-4.7 ± 0.72-1.8 ± 1.23
Change at Week 9-2.9 ± 2.120.7 ± 0.71-2.3 ± 0.69-4.1 ± 0.78-5.1 ± 0.86—-5.6 ± 1.28-3.0 ± NA-5.0 ± 0.70-2.0 ± 1.35
Change at Week 10-2.5 ± 2.23-0.5 ± 0.50-1.9 ± 0.65-4.9 ± 0.71-5.1 ± 0.86—-5.7 ± 1.21-2.6 ± NA-5.2 ± 0.74-1.9 ± 1.29
Change at Week 11-2.5 ± 1.93-0.5 ± 0.50-2.0 ± 0.72-4.9 ± 0.77-5.1 ± 0.86—-5.7 ± 1.21-2.9 ± NA-4.9 ± 0.78-2.0 ± 1.25
Change at Week 12-2.7 ± 2.04-0.5 ± 0.50-1.6 ± 0.80-4.4 ± 0.83-5.1 ± 0.86—-5.7 ± 1.21-2.7 ± NA-4.8 ± 0.80-2.0 ± 1.24
Change at Week 13-2.4 ± 2.11-0.5 ± 0.50-1.9 ± 0.72-4.6 ± 0.85-5.6 ± 0.43—-5.6 ± 1.24-1.7 ± NA-5.0 ± 0.80-2.1 ± 1.24
Change at Week 14-2.5 ± 2.43-0.5 ± 0.50-2.0 ± 0.62-4.3 ± 0.94-5.6 ± 0.36—-5.5 ± 1.30-1.9 ± NA-5.0 ± 0.77-5.0 ± 0.81
Change at Week 15-2.6 ± 2.31-0.5 ± 0.50-2.1 ± 0.62-4.1 ± 0.89-5.6 ± 0.36—-5.7 ± 1.22-2.1 ± NA-5.0 ± 0.81-2.3 ± 1.27
Change at Week 16-3.0 ± 2.23-0.5 ± 0.50-2.5 ± 0.70-3.6 ± 1.01-5.6 ± 0.36—-5.8 ± 1.19-1.4 ± NA-4.9 ± 0.80-2.2 ± 1.25
Change at Week 17-3.5 ± 2.03-0.5 ± 0.50-2.3 ± 0.66-3.7 ± 0.98-5.6 ± 0.36—-5.7 ± 1.21-1.4 ± NA-4.6 ± 0.95-2.5 ± 1.29
Change at Week 18-3.3 ± 2.12-0.5 ± 0.50-2.3 ± 0.74-3.6 ± 1.00-5.7 ± 0.43—-5.7 ± 1.21-1.3 ± NA-4.6 ± 0.96-2.5 ± 1.29
SecondaryPercent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time

Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep.

Time frame:
Baseline, Weeks 1-18
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time
percent changeKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 1-1.0 ± 32.15-28.7 ± 45.50-2.6 ± 5.75-26.3 ± 7.18-3.0 ± 2.92—-40.7 ± 17.63-1.4 ± 38.74-6.7 ± 2.75-4.9 ± 3.91
Change at Week 2-20.2 ± 34.79-42.6 ± 49.24-28.7 ± 8.26-45.6 ± 10.32-9.2 ± 7.29—-56.7 ± 24.076.8 ± 52.89-12.4 ± 3.67-6.0 ± 5.22
Change at Week 3-15.5 ± 39.26-49.7 ± 55.57-33.4 ± 7.94-47.2 ± 9.92-18.9 ± 17.50—-64.4 ± 26.926.3 ± 59.14-22.7 ± 6.03-7.1 ± 8.58
Change at Week 4-25.0 ± 31.15-2.2 ± 44.09-34.6 ± 10.18-47.9 ± 12.72-29.8 ± 28.43—-67.2 ± 22.95-6.6 ± 50.42-34.4 ± 6.75-11.7 ± 9.60
Change at Week 5-25.7 ± 42.76-43.4 ± 60.51-38.4 ± 9.11-50.7 ± 11.38-35.5 ± 30.62—-67.3 ± 23.31-16.9 ± 51.21-43.0 ± 7.95-15.9 ± 11.31
Change at Week 6-20.9 ± 47.36-50.4 ± 67.03-40.9 ± 8.43-62.7 ± 10.54-38.1 ± 30.62—-80.2 ± 22.99-32.7 ± 50.51-46.7 ± 7.82-13.0 ± 11.12
Change at Week 7-23.2 ± 37.03-22.9 ± 52.41-42.4 ± 8.45-61.6 ± 10.55-44.6 ± 30.62—-82.4 ± 20.44-27.3 ± 44.90-52.0 ± 8.41-19.4 ± 11.96
Change at Week 8-19.5 ± 40.74-29.9 ± 57.65-43.4 ± 8.98-60.7 ± 11.22-44.6 ± 30.62—-87.3 ± 14.69-37.0 ± 32.27-59.5 ± 8.96-23.1 ± 12.75
Change at Week 9-28.7 ± 15.9566.0 ± 22.57-42.2 ± 8.76-66.6 ± 10.13-66.9 ± 0.00—-86.2 ± 15.97-37.3 ± 35.08-63.6 ± 9.13-25.5 ± 12.99
Change at Week 10-21.5 ± 41.87-50.1 ± 59.26-37.4 ± 8.65-76.4 ± 10.00-66.9 ± 0.00—-88.4 ± 13.41-31.9 ± 29.47-65.9 ± 9.22-25.1 ± 13.11
Change at Week 11-29.0 ± 31.17-49.4 ± 44.11-37.1 ± 9.54-76.5 ± 11.03-66.9 ± 0.00—-88.4 ± 13.41-35.1 ± 29.47-61.1 ± 9.12-26.1 ± 12.97
Change at Week 12-29.3 ± 34.97-49.7 ± 49.49-30.9 ± 11.35-70.1 ± 13.12-66.9 ± 0.00—-88.4 ± 13.41-33.5 ± 29.47-60.2 ± 9.58-27.0 ± 13.63
Change at Week 13-24.0 ± 35.58-49.7 ± 50.36-35.9 ± 10.59-74.7 ± 12.24-72.8 ± 0.00—-87.3 ± 14.69-22.7 ± 32.27-63.9 ± 9.92-28.4 ± 14.11
Change at Week 14-20.4 ± 42.00-50.3 ± 59.44-38.2 ± 9.62-71.9 ± 11.12-73.8 ± 0.00—-85.7 ± 16.60-24.8 ± 36.48-64.9 ± 9.77-29.3 ± 13.90
Change at Week 15-25.9 ± 37.20-49.9 ± 52.64-38.6 ± 9.08-69.7 ± 10.50-73.8 ± 0.00—-87.9 ± 14.05-27.3 ± 30.87-63.9 ± 10.34-31.3 ± 14.70
Change at Week 16-33.5 ± 35.42-49.7 ± 50.13-44.1 ± 10.40-64.0 ± 12.02-73.8 ± 0.00—-89.0 ± 12.77-19.1 ± 28.06-63.6 ± 10.16-29.4 ± 14.45
Change at Week 17-48.6 ± 28.92-49.0 ± 40.94-41.3 ± 9.88-65.1 ± 11.42-73.8 ± 0.00—-88.4 ± 13.41-19.2 ± 29.47-58.7 ± 12.22-34.8 ± 17.38
Change at Week 18-41.8 ± 31.93-49.4 ± 45.20-42.8 ± 10.42-64.7 ± 12.04-74.7 ± 0.00—-88.4 ± 13.41-17.6 ± 29.47-58.7 ± 12.25-34.7 ± 17.43
Statistical analysis
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.6532 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 27.7 · 80% CI -63.60 to 119.06
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.0187 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 23.6 · 80% CI 11.38 to 35.85
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4707 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -39.3 · 80% CI -123.27 to 44.68
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.7108 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -1.8 · 80% CI -8.22 to 4.59
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.7355 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 22.4 · 80% CI -76.47 to 121.23
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.2167 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 16.9 · 80% CI -0.66 to 34.52
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4058 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -63.5 · 80% CI -178.16 to 51.13
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.3323 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -6.4 · 80% CI -14.95 to 2.15
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.6496 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 34.3 · 80% CI -77.29 to 145.80
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.2925 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 13.8 · 80% CI -3.12 to 30.70
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4074 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -70.7 · 80% CI -198.92 to 57.46
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1584 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -15.5 · 80% CI -29.60 to -1.49
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.7013 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -22.8 · 80% CI -111.31 to 65.69
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.4230 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 13.4 · 80% CI -8.30 to 35.05
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4055 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -60.6 · 80% CI -169.90 to 48.69
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0709 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -22.7 · 80% CI -38.41 to -6.96
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.8268 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 17.7 · 80% CI -103.77 to 139.17
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.4082 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 12.4 · 80% CI -7.03 to 31.75
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4818 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -50.4 · 80% CI -161.43 to 60.56
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0673 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -27.1 · 80% CI -45.64 to -8.58
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.7429 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 29.6 · 80% CI -105.00 to 164.10
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.1227 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 21.8 · 80% CI 3.88 to 39.79
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.4996 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -47.5 · 80% CI -156.95 to 62.02
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0244 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -33.6 · 80% CI -51.87 to -15.43
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.9967 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -0.3 · 80% CI -105.50 to 104.92
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.1739 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 19.1 · 80% CI 1.15 to 37.12
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.3978 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -55.1 · 80% CI -152.39 to 42.26
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0397 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -32.7 · 80% CI -52.26 to -13.07
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.8922 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 10.4 · 80% CI -105.32 to 126.14
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.2439 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 17.3 · 80% CI -1.80 to 36.45
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.3076 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -50.3 · 80% CI -120.29 to 19.61
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0322 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -36.4 · 80% CI -57.32 to -15.55
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.0418 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -94.7 · 80% CI -139.98 to -49.36
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.0865 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 24.4 · 80% CI 6.49 to 42.26
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.3489 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -48.9 · 80% CI -124.96 to 27.11
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0286 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -38.1 · 80% CI -59.34 to -16.79
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.7198 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 28.6 · 80% CI -90.32 to 147.59
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.0088 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 39.0 · 80% CI 21.32 to 56.63
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2371 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -56.5 · 80% CI -120.39 to 7.34
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0210 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -40.8 · 80% CI -62.30 to -19.35
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.7312 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 20.4 · 80% CI -68.17 to 108.94
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.0150 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 39.4 · 80% CI 19.88 to 58.83
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2559 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -53.3 · 80% CI -117.22 to 10.52
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0419 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -35.0 · 80% CI -56.21 to -13.72
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.7589 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 20.4 · 80% CI -78.95 to 119.74
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.0374 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 39.1 · 80% CI 15.97 to 62.31
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2463 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -54.9 · 80% CI -118.80 to 8.93
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0632 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -33.2 · 80% CI -55.56 to -10.90
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.7053 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 25.7 · 80% CI -75.41 to 126.78
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.0285 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 38.7 · 80% CI 17.09 to 60.34
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2236 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -64.6 · 80% CI -134.58 to 5.32
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0558 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -35.5 · 80% CI -58.65 to -12.41
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.7089 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 29.9 · 80% CI -89.41 to 149.24
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.0347 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 33.7 · 80% CI 14.08 to 53.35
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2835 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -60.9 · 80% CI -139.99 to 18.16
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0525 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -35.5 · 80% CI -58.31 to -12.77
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.7347 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 24.0 · 80% CI -81.68 to 129.66
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.0390 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 31.0 · 80% CI 12.50 to 49.60
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2299 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -60.6 · 80% CI -127.49 to 6.33
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0884 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -32.6 · 80% CI -56.70 to -8.53
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.8085 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 16.3 · 80% CI -84.37 to 116.87
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.2283 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 19.9 · 80% CI -1.33 to 41.14
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1625 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -69.9 · 80% CI -130.76 to -9.11
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0707 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -34.2 · 80% CI -57.87 to -10.52
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.9944 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 0.4 · 80% CI -81.79 to 82.55
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.1327 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 23.9 · 80% CI 3.71 to 44.05
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1777 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -69.2 · 80% CI -133.09 to -5.35
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.2796 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -23.9 · 80% CI -52.34 to 4.61
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.8999 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 7.6 · 80% CI -83.15 to 98.30
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.1867 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 22.0 · 80% CI 0.68 to 43.23
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1717 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -70.8 · 80% CI -134.68 to -6.94
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.2792 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -23.9 · 80% CI -52.50 to 4.61
SecondaryChange From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time

The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked "Over the last week, has your skin prevented you from working or studying?" If answered yes, score=3; If no, a second question will be asked: "Over the last week how much has your skin been a problem at work or studying?" If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 18
Reported as:
Mean · score on a scale
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
score on a scaleKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 4-5.8 ± 1.490.0 ± 0.00-3.4 ± 0.86-8.0 ± 1.96-4.7 ± 2.60—-4.5 ± 2.990.0 ± NA-10.0 ± 1.83-0.6 ± 3.12
Change at Week 8-6.5 ± 1.040.0 ± 0.00-3.6 ± 1.37-8.3 ± 2.01-4.7 ± 2.60—-3.0 ± 4.55-12.0 ± NA-11.2 ± 1.75-1.4 ± 3.33
Change at Week 12-6.5 ± 1.040.0 ± 0.00-4.3 ± 1.53-8.3 ± 2.01-7.0 ± 2.00—-3.0 ± 4.55-12.0 ± NA-10.7 ± 1.69-1.5 ± 3.76
Change at Week 16-7.3 ± 1.550.0 ± 0.00-4.8 ± 1.83-7.9 ± 2.25-10.0 ± 1.00—-6.3 ± 2.29-5.0 ± NA-10.0 ± 1.82-9.5 ± 2.46
Change at Week 18-6.0 ± 1.730.0 ± 0.00-4.4 ± 2.02-8.7 ± 2.28-17.5 ± 5.50—-6.5 ± 2.18-8.0 ± NA-9.9 ± 2.01-9.2 ± 2.04
SecondaryPercent Change From Baseline in DLQI Total Score Over Time

The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked "Over the last week, has your skin prevented you from working or studying?" If answered yes, score=3; If no, a second question will be asked: "Over the last week how much has your skin been a problem at work or studying?" If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect.

Time frame:
Baseline, Weeks 4, 8, 12, 16, 18
Reported as:
Mean · percent change
Percent Change From Baseline in DLQI Total Score Over Time
percent changeKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 4-51.0 ± 17.71-3.7 ± 25.35-32.8 ± 8.77-52.4 ± 10.95-24.2 ± 17.01—-53.5 ± 33.556.1 ± 94.72-68.2 ± 11.774.1 ± 16.65
Change at Week 8-54.5 ± 12.95-2.4 ± 18.53-41.1 ± 13.32-56.0 ± 16.63-24.2 ± 17.01—-32.5 ± 64.55-85.7 ± 182.21-72.2 ± 10.71-2.3 ± 15.15
Change at Week 12-54.5 ± 12.95-2.4 ± 18.53-48.1 ± 14.36-55.7 ± 16.59-36.4 ± 0.00—-32.5 ± 64.55-85.7 ± 182.21-72.9 ± 11.58-5.4 ± 17.75
Change at Week 16-60.5 ± 15.08-2.5 ± 21.57-51.0 ± 11.94-54.0 ± 13.79-61.4 ± 0.00—-71.9 ± 23.07-41.5 ± 65.13-69.6 ± 8.18-60.7 ± 12.54
Change at Week 18-52.5 ± 18.16-3.4 ± 25.99-44.0 ± 12.37-61.3 ± 14.29-89.7 ± 0.00—-75.0 ± 19.53-52.4 ± 55.14-68.7 ± 9.18-62.6 ± 14.08
Statistical analysis
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.2289 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -47.3 · 80% CI -98.77 to 4.10
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.1788 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 19.6 · 80% CI 0.96 to 38.27
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.6544 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -59.6 · 80% CI -275.19 to 156.06
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0023 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -72.2 · 80% CI -99.39 to -45.09
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.1081 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -52.1 · 80% CI -89.68 to -14.47
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.4926 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 14.9 · 80% CI -13.39 to 43.26
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.8315 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 53.2 · 80% CI -361.63 to 467.98
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0014 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -69.9 · 80% CI -94.61 to -45.22
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.1081 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -52.1 · 80% CI -89.68 to -14.47
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.7339 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 7.6 · 80% CI -21.65 to 36.82
  • Placebo: LSC Cohort vs KPL-716: PPs Cohort · ANCOVA · p = 0.8315 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 53.2 · 80% CI -361.63 to 467.98
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0055 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -67.6 · 80% CI -95.92 to -39.22
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.1188 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -57.9 · 80% CI -101.70 to -14.15
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.8697 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 3.0 · 80% CI -21.26 to 27.35
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.7368 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -30.3 · 80% CI -178.62 to 117.94
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.5571 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -9.0 · 80% CI -29.03 to 11.03
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.2251 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -49.1 · 80% CI -101.80 to 3.69
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.3733 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 17.3 · 80% CI -7.90 to 42.48
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.7662 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -22.6 · 80% CI -148.16 to 102.89
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.7241 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -6.1 · 80% CI -28.54 to 16.44
SecondaryChange From Baseline in ItchyQoL Total Score Over Time

ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110).

Time frame:
Baseline, Weeks 4, 8, 12, 16, 18
Reported as:
Mean · score on a scale
Change From Baseline in ItchyQoL Total Score Over Time
score on a scaleKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 4-17.0 ± 13.070.0 ± 0.00-10.9 ± 3.63-18.9 ± 6.25-27.3 ± 15.32—-31.5 ± 13.910.0 ± NA-29.0 ± 5.61-16.9 ± 7.04
Change at Week 8-23.3 ± 9.08-0.5 ± 0.50-17.8 ± 4.61-20.8 ± 8.66-27.3 ± 15.32—-38.8 ± 15.84-10.0 ± NA-35.8 ± 5.88-23.1 ± 7.31
Change at Week 12-22.8 ± 11.740.0 ± 0.00-22.0 ± 5.96-19.2 ± 5.78-47.0 ± 6.00—-41.5 ± 11.99-18.0 ± NA-35.5 ± 6.54-27.3 ± 4.62
Change at Week 16-33.3 ± 11.460.0 ± 0.00-19.9 ± 5.18-18.1 ± 6.93-50.0 ± 3.00—-41.5 ± 11.89-18.0 ± NA-38.1 ± 5.66-29.2 ± 8.15
Change at Week 18-29.3 ± 9.680.0 ± 0.00-25.1 ± 7.18-21.4 ± 6.82-64.5 ± 14.50—-46.8 ± 8.62-15.0 ± NA-32.9 ± 6.40-31.8 ± 8.46
SecondaryPercent Change From Baseline in ItchyQoL Total Score Over Time

ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110).

Time frame:
Baseline, Weeks 4, 8, 12, 16, 18
Reported as:
Least squares mean · percent change
Percent Change From Baseline in ItchyQoL Total Score Over Time
percent changeKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Change at Week 4-21.4 ± 16.56-0.2 ± 23.57-13.0 ± 5.15-24.3 ± 6.43-29.1 ± 7.02—-47.8 ± 17.3739.7 ± 46.22-34.8 ± 5.84-14.6 ± 8.32
Change at Week 8-29.2 ± 11.47-0.6 ± 16.32-23.7 ± 7.21-26.0 ± 9.01-29.1 ± 7.02—-56.3 ± 23.2327.3 ± 61.79-42.7 ± 6.29-21.9 ± 8.97
Change at Week 12-28.3 ± 14.700.2 ± 20.91-29.4 ± 6.30-25.0 ± 7.29-50.9 ± 0.00—-58.2 ± 15.8512.0 ± 42.18-42.7 ± 6.58-26.0 ± 10.25
Change at Week 16-41.7 ± 14.66-0.2 ± 20.86-26.5 ± 6.61-23.2 ± 7.65-54.6 ± 0.00—-59.8 ± 12.3419.8 ± 32.82-45.8 ± 6.06-29.4 ± 9.44
Change at Week 18-36.6 ± 12.160.0 ± 17.30-32.5 ± 7.93-27.6 ± 9.17-69.2 ± 0.00—-63.8 ± 7.4910.2 ± 19.94-39.6 ± 7.06-31.7 ± 11.00
Statistical analysis
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.5195 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -21.1 · 80% CI -68.69 to 26.43
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.1869 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 11.3 · 80% CI 0.34 to 22.26
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2545 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -87.5 · 80% CI -191.75 to 16.79
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0643 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -20.2 · 80% CI -33.88 to -6.57
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.2503 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -28.6 · 80% CI -61.52 to 4.35
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.8468 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: 2.3 · 80% CI -13.08 to 17.62
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.3755 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -83.6 · 80% CI -222.98 to 55.18
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0755 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -20.9 · 80% CI -35.58 to -6.15
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.3486 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -28.6 · 80% CI -70.76 to 13.65
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.6559 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -4.4 · 80% CI -17.28 to 8.50
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.2987 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -70.2 · 80% CI -165.35 to 24.94
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1966 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -16.7 · 80% CI -33.29 to -0.13
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.2051 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -41.5 · 80% CI -83.56 to 0.62
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.7511 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -3.3 · 80% CI -16.79 to 10.25
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.1797 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -79.6 · 80% CI -153.68 to -5.59
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.1715 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -16.3 · 80% CI -31.61 to -1.08
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.1850 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -36.5 · 80% CI -71.47 to -1.63
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.6907 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -4.9 · 80% CI -21.15 to 11.29
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0901 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -74.0 · 80% CI -118.97 to -29.02
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.5640 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -7.8 · 80% CI -25.64 to 9.94
PrimaryPercent Change From Baseline in Weekly Average WI-NRS at Week 8

WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.

Time frame:
Baseline, Week 8
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Weekly Average WI-NRS at Week 8
percent changeKPL-716: CIU CohortPlacebo: CIU CohortKPL-716: CIP CohortPlacebo: CIP CohortKPL-716: LP CohortPlacebo: LP CohortKPL-716: LSC CohortPlacebo: LSC CohortKPL-716: PPs CohortPlacebo: PPs Cohort
Percent Change From Baseline in Weekly Average WI-NRS at Week 8-50.7 ± 21.56-19.0 ± 31.07-52.4 ± 9.32-48.8 ± 11.63-39.4 ± 10.21—-85.0 ± 11.767.0 ± 26.80-66.5 ± 7.78-29.0 ± 11.00
Statistical analysis
  • KPL-716: CIU Cohort vs Placebo: CIU Cohort · ANCOVA · p = 0.4734 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -31.7 · 80% CI -95.11 to 31.76
  • KPL-716: CIP Cohort vs Placebo: CIP Cohort · ANCOVA · p = 0.8130 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -3.6 · 80% CI -23.33 to 16.18
  • KPL-716: LSC Cohort vs Placebo: LSC Cohort · ANCOVA · p = 0.0979 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -92.0 · 80% CI -150.60 to -33.32
  • KPL-716: PPs Cohort vs Placebo: PPs Cohort · ANCOVA · p = 0.0122 (Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.) · Ls mean difference: -37.5 · 80% CI -55.48 to -19.61

Adverse events

Collected over From first dose of study treatment through the end-of-study visit (Week 18).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
KPL-7160/39 (0%)1/39 (2.6%)15/39 (38.5%)
Placebo0/19 (0%)0/19 (0%)11/19 (57.9%)
Most frequent serious events
Most frequent serious events
EventKPL-716Placebo
AngioedemaSkin and subcutaneous tissue disorders1/390/19
Most frequent other events
Showing 10 of 44
Most frequent other events
EventKPL-716Placebo
Haemoglobin decreasedInvestigations0/392/19
FatigueGeneral disorders0/392/19
Upper respiratory tract infectionInfections and infestations2/391/19
InfluenzaInfections and infestations1/391/19
SinusitisInfections and infestations1/391/19
Urinary tract infectionInfections and infestations1/391/19
Pharyngitis streptococcalInfections and infestations0/391/19
Streptococcal infectionInfections and infestations0/391/19
Dermatitis contactSkin and subcutaneous tissue disorders1/391/19
Back painMusculoskeletal and connective tissue disorders1/391/19

Baseline characteristics

The baseline characteristics data are presented by combined cohorts for public reporting purposes because the low numbers of participants in the individual disease-specific cohorts may cause re-identification concerns if presented separately.

Age, Continuous
Age, Continuous(years)KPL-716PlaceboTotal
Mean53.1 ± 11.5153.3 ± 13.9453.2 ± 12.24
Sex: Female, Male
Sex: Female, Male(Participants)KPL-716PlaceboTotal
Female271441
Male12517
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)KPL-716PlaceboTotal
White341448
Black or African American448
Asian112
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)KPL-716PlaceboTotal
Hispanic or Latino20525
Not Hispanic or Latino191433
Weekly Average of Daily Worst Itch-Numeric Rating Scale (WI-NRS)
Weekly Average of Daily Worst Itch-Numeric Rating Scale (WI-NRS)(score on a scale)KPL-716PlaceboTotal
Mean8.1 ± 0.938.3 ± 1.148.2 ± 1.00
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Study locations

14 sites
  • Site 106
    Anniston, Alabama 36207, United States
  • Site 110
    Phoenix, Arizona 85032, United States
  • Site 114
    Hot Springs, Arkansas 71913, United States
  • Site 103
    Los Angeles, California 90045, United States
  • Site 113
    Sweetwater, Florida 33172, United States
  • Site 105
    Normal, Illinois 61761, United States
  • Site 112
    Plainfield, Indiana 46168, United States
  • Site 119
    New Orleans, Louisiana 70115, United States
  • Site 109
    Fort Gratiot, Michigan 48059, United States
  • Site 123
    New York, New York 10012, United States
  • Site 115
    Johnston, Rhode Island 02919, United States
  • Site 104
    Pflugerville, Texas 78660, United States
  • Site 101
    San Antonio, Texas 78213, United States
  • Site 122
    Spokane, Washington 99202, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03858634
Lead sponsor
Genentech, Inc.
Collaborators
Kiniksa Pharmaceuticals, Ltd.
Responsible party
Sponsor
First posted
Mar 1, 2019
Start date
May 29, 2019
Primary completion
Apr 1, 2020
Completion
Jun 8, 2020
Results posted
Dec 28, 2021
Last update
Mar 18, 2025

Study contacts

Clinical Trials
study director · Genentech, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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