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CompletedNCT04250337ADhereUpdated May 9, 2022Results posted

Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

A Phase 3 interventional study of Lebrikizumab and Placebo in Atopic Dermatitis, sponsored by Eli Lilly and Company. Completed at 63 sites in 4 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-05-09.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
228
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Eczema
  • Dermatitis
  • Dermatitis, Atopic
  • Skin Diseases
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 228 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

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

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female adult and adolescents (≥12 years to \<18 years, and weighing ≥40 kg).
  2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
  3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
  4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
  5. ≥10% body surface area (BSA) of AD involvement at the baseline visit.
  6. History of inadequate response to treatment with topical medications.

Exclusion criteria

Exclusion Criteria:

  1. Participation in a prior lebrikizumab clinical study.

  2. Treatment with the following prior to the baseline visit:

    1. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
    2. Dupilumab within 8 weeks.
    3. B-cell-depleting biologics, including to rituximab, within 6 months.
    4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
  3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
  4. Uncontrolled chronic disease that might require bursts of oral corticosteroids.
  5. Evidence of active acute or chronic hepatitis
  6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
  7. History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
  8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
228 participants (actual)

Study arms

  • Experimental
    Lebrikizumab + Topical Corticosteroid

    500 mg Lebrikizumab (2 x 250 mg) subcutaneous (SC) injections of lebrikizumab as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab every 2 weeks (Q2W) from Week 4 until Week 14. Topical corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.

    Biological: Lebrikizumab · Other: Topical Corticosteroid

  • Placebo comparator
    Placebo + Topical Corticosteroid

    Two placebo subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response

    Other: Placebo · Other: Topical Corticosteroid

Interventions

  • BiologicalLebrikizumab

    Subcutaneous injection

    Also known as: LY3650150, DRM06

  • OtherPlacebo

    Subcutaneous injection

  • OtherTopical Corticosteroid

    Topical Corticosteroid

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16.

    The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

    Time frame: Baseline to Week 16

  2. Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI Score) at Week 16

    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.

    Time frame: Baseline to Week 16

Secondary outcomes

  1. Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 16

    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.

    Time frame: Baseline to Week 16

  2. Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

    Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Least Squares (LS) Mean was calculated using analysis covariance (ANCOVA) model includes treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score as fixed factors.

    Time frame: Baseline, Week 16

  3. Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 16

    Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

    Time frame: Baseline to Week 16

  4. Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 16

    Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

    Time frame: Baseline to Week 16

  5. Percent Change in EASI Score From Baseline at Week 16

    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors.

    Time frame: Baseline, Week 16

  6. Change From Baseline to Week 16 in Percent Body Surface Area (BSA)

    The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.

    Time frame: Baseline, Week 16

  7. Percentage of Participants Achieving EASI-90 at Week 4

    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.

    Time frame: Baseline to Week 4

  8. Percent Change in Sleep-loss Score From Baseline to Week 16

    Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all)\]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. .

    Time frame: Baseline, Week 16

  9. Change From Baseline in Sleep-loss Score at Week 16

    Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all)\]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. APD: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

    Time frame: Baseline, Week 16

  10. Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

    The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.

    Time frame: Baseline to Week 4

  11. Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

    The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.

    Time frame: Baseline to Week 2

  12. Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

    The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.

    Time frame: Baseline to Week 1

  13. Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

    The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.

    Time frame: Baseline to Week 4

  14. Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

    The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.

    Time frame: Baseline to Week 2

  15. Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

    The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.

    Time frame: Baseline to Week 1

  16. Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16

    Number of the total TCS/TCI free days divided by total number of days during the treatment period. The mixed model repeated measures (MMRM) includes treatment, visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score.

    Time frame: Baseline to Week 16

  17. Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16

    Days from first study drug injection to the day participant stopped using all TCS/TCI (if a participant started and stopped using low or midpotency TCS/TCI multiple times, use the last stop date as the stop date for this participant).

    Time frame: Baseline to Week 16

  18. Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16

    The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Mean was calculated using the ANCOVA model with treatment group, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

    Time frame: Baseline, Week 16

  19. Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

    The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

    Time frame: Baseline, Week 16

  20. Percentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points

    The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

    Time frame: Baseline to Week 16

  21. Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Health State Index

    The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

    Time frame: Baseline, Week 16

  22. Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (VAS)

    The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

    Time frame: Baseline, Week 16

  23. Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

    POEM is a 7-item, validated, questionnaire used by the participant to assess disease symptoms over the last week. The participant is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1- 2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of a poor quality of life. POEM responses will be captured using an electronic diary and transferred into the clinical database. LS Mean was calculated using MMRM model using treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit as covariates, geographic region, age group, baseline IGA (3 versus 4) score as fixed.

    Time frame: Baseline, Week 16

  24. Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults

    PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

    Time frame: Baseline, Week 16

  25. Change From Baseline in PROMIS Depression at Week 16 - Adults

    PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

    Time frame: Baseline, Week 16

  26. Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics

    PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

    Time frame: Baseline, Week 16

  27. Change From Baseline in PROMIS Depression at Week 16 - Pediatrics

    PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS depression has 8 questions on Emotion Distress-Depression (or Pediatric Depressive Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

    Time frame: Baseline, Week 16

  28. Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma

    The ACQ-5 has been shown to reliably measure asthma control and distinguish participants with well-controlled asthma (score ≤0.75 points) from those with uncontrolled asthma (score ≥1.5 points). It consists of 5 questions that are scored on a 7- point Likert scale with a recall period of 1 week. The total ACQ-5 score is the mean score of all questions; a lower score represents better asthma control. LS Mean was calculated using ANCOVA with treatment, baseline value, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

    Time frame: Baseline, Week 16

  29. Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16

    The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms \& feelings, leisure, school or holidays, personal relationships, sleep, \& treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). LS Mean was calculated using MMRM model which includes treatment, baseline value, visit, the interaction of the baseline value-by-visit as covariates, the interaction of treatment by-visit, geographic region, age group, and baseline IGA (3 versus 4) score as fixed factors.

    Time frame: Baseline, Week 16

07

Results

Posted May 2, 2022
Limitations and caveats
One investigational site with seventeen participants was excluded from analysis due to GCP issues. Because of an error in the electronic data collection tool, the actual maximum score for each of the SCORAD symptoms was 9 instead of 10, resulting in a total maximum SCORAD score of 101 instead of 103. During the study, discussions with the SCORAD copyright owner resulted in a decision not to adjust the scale used or notify investigators as the altered scale was not expected to bias the results.

Participant flow

Participant flow — Overall Study
MilestonePlacebo + Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Started75153
Received at least one dose of study drug75153
Completed67142
Not completed811
Withdrew: Adverse event03
Withdrew: Lack of efficacy13
Withdrew: Physician decision10
Withdrew: Protocol deviation22
Withdrew: Withdrawal by subject43

Outcome measures

PrimaryPercentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16.

The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Time frame:
Baseline to Week 16
Reported as:
Number · percentage of participants
Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16.
percentage of participantsPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16.22.1 (11.6 to 32.7)41.2 (33.0 to 49.4)
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Cochran-Mantel-Haenszel · p = 0.011 · Risk difference (rd): 18.3 · 95% CI 5.1 to 31.5
PrimaryPercentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI Score) at Week 16

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.

Time frame:
Baseline to Week 16
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI Score) at Week 16
percentage of participantsPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI Score) at Week 1642.2 (30.1 to 54.4)69.5 (61.9 to 77.2)
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Cochran-Mantel-Haenszel · p = <.001 · Risk difference (rd): 26.4 · 95% CI 12.1 to 40.8
SecondaryPercentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 16

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.

Time frame:
Baseline to Week 16
Reported as:
Number · percentage of participants
Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 16
percentage of participantsPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 1621.7 (11.4 to 32.0)41.2 (33.0 to 49.3)
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Cochran-Mantel-Haenszel · p = 0.008 · Risk difference (rd): 18.9 · 95% CI 6.1 to 31.7
SecondaryPercent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Least Squares (LS) Mean was calculated using analysis covariance (ANCOVA) model includes treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score as fixed factors.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · Percent change
Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
Percent changePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16-35.47 ± 6.358-50.68 ± 4.546
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · ANCOVA · p = 0.017263 · Ls mean difference (final values): -15.21 · 95% CI -27.7 to -2.7
SecondaryPercentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 16

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

Time frame:
Baseline to Week 16
Reported as:
Number · percentage of participants
Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 16
percentage of participantsPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 1631.9 (19.3 to 44.4)50.6 (41.8 to 59.4)
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Cochran-Mantel-Haenszel · p = 0.017 · Risk difference (rd): 19.2 · 95% CI 4.3 to 34.1
SecondaryPercentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 16

Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

Time frame:
Baseline to Week 16
Reported as:
Number · percentage of participants
Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 16
percentage of participantsPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1626.4 (14.5 to 38.3)46.8 (38.0 to 55.6)
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Cochran-Mantel-Haenszel · p = 0.007 · Risk difference (rd): 21.6 · 95% CI 7.1 to 36.1
SecondaryPercent Change in EASI Score From Baseline at Week 16

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · Percent Change
Percent Change in EASI Score From Baseline at Week 16
Percent ChangePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percent Change in EASI Score From Baseline at Week 16-53.12 ± 5.097-76.76 ± 4.119
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · ANCOVA · p = 0.000003 · Ls mean difference (final values): -23.64 · 95% CI -33.6 to -13.7
SecondaryChange From Baseline to Week 16 in Percent Body Surface Area (BSA)

The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline to Week 16 in Percent Body Surface Area (BSA)
score on a scalePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Change From Baseline to Week 16 in Percent Body Surface Area (BSA)16.92 ± 2.287-29.19 ± 1.686
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Mixed Models Analysis · p = <0.001 · Ls mean difference (final values): -12.28 · 95% CI -17.07 to -7.49
SecondaryPercentage of Participants Achieving EASI-90 at Week 4

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.

Time frame:
Baseline to Week 4
Reported as:
Number · percentage of participants
Percentage of Participants Achieving EASI-90 at Week 4
percentage of participantsPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percentage of Participants Achieving EASI-90 at Week 47.2 (0.5 to 13.8)10.7 (5.6 to 15.8)
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Cochran-Mantel-Haenszel · p = 0.454 · Risk difference (rd): 3.5 · 95% CI -4.9 to 11.8
SecondaryPercent Change in Sleep-loss Score From Baseline to Week 16

Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all)\]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. .

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · percent change
Percent Change in Sleep-loss Score From Baseline to Week 16
percent changePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percent Change in Sleep-loss Score From Baseline to Week 16-36.89 ± 12.217-57.03 ± 7.939
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · ANCOVA · p = 0.117607 · Markov chain monte carlo (mcmc): -20.14 · 95% CI -45.4 to 5.1
SecondaryChange From Baseline in Sleep-loss Score at Week 16

Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all)\]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors. APD: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline in Sleep-loss Score at Week 16
score on a scalePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Change From Baseline in Sleep-loss Score at Week 16-0.80 ± 0.132-1.10 ± 0.102
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · ANCOVA · p = 0.025293 · Markov chain monte carlo (mcmc): -0.30 · 95% CI -0.6 to -0.0
SecondaryPercentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.

Time frame:
Baseline to Week 4
Reported as:
Number · percentage of participants
Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
percentage of participantsPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 49.3 (1.6 to 17.1)23.5 (16.2 to 30.9)
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Cochran-Mantel-Haenszel · p = 0.022 · Risk difference (rd): 14.2 · 95% CI 3.8 to 24.7
SecondaryPercentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.

Time frame:
Baseline to Week 2
Reported as:
Number · percentage of participants
Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2
percentage of participantsPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 27.1 (0.4 to 13.8)8.5 (3.7 to 13.3)
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Cochran-Mantel-Haenszel · p = 0.764 · Risk difference (rd): 1.2 · 95% CI -7.3 to 9.7
SecondaryPercentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.

Time frame:
Baseline to Week 1
Reported as:
Number · percentage of participants
Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1
percentage of participantsPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 11.8 (0.0 to 5.2)3.8 (0.5 to 7.2)
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Cochran-Mantel-Haenszel · p = 0.498 · Risk difference (rd): 1.9 · 95% CI -2.9 to 6.7
SecondaryPercentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4

The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.

Time frame:
Baseline to Week 4
Reported as:
Number · percentage of participants
Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4
percentage of participantsPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 47.5 (0.4 to 14.7)23.4 (15.9 to 30.8)
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Cochran-Mantel-Haenszel · p = 0.014 · Risk difference (rd): 15.6 · 95% CI 5.3 to 25.9
SecondaryPercentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2

The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.

Time frame:
Baseline to Week 2
Reported as:
Number · percentage of participants
Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2
percentage of participantsPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 27.5 (0.4 to 14.7)8.9 (3.9 to 13.9)
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Cochran-Mantel-Haenszel · p = 0.818 · Risk difference (rd): 1.1 · 95% CI -8.0 to 10.2
SecondaryPercentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1

The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable.

Time frame:
Baseline to Week 1
Reported as:
Number · percentage of participants
Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1
percentage of participantsPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 11.9 (0.0 to 5.5)4.0 (0.6 to 7.5)
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Cochran-Mantel-Haenszel · p = 0.499 · Risk difference (rd): 2.0 · 95% CI -3.1 to 7.1
SecondaryPercentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16

Number of the total TCS/TCI free days divided by total number of days during the treatment period. The mixed model repeated measures (MMRM) includes treatment, visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score.

Time frame:
Baseline to Week 16
Reported as:
Least squares mean · Percentage of Days
Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16
Percentage of DaysPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 1623.88 ± 4.82331.17 ± 3.512
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Mixed Models Analysis · p = 0.155 · Ls mean difference (final values): 7.29 · 95% CI -2.78 to 17.36
SecondaryMedian Time (Days) to TCS/TCI-free Use From Baseline to Week 16

Days from first study drug injection to the day participant stopped using all TCS/TCI (if a participant started and stopped using low or midpotency TCS/TCI multiple times, use the last stop date as the stop date for this participant).

Time frame:
Baseline to Week 16
Reported as:
Median · days
Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16
daysPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16NA (1 to 112)121.0 (2 to 121)
SecondaryPercent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16

The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Mean was calculated using the ANCOVA model with treatment group, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · percent change
Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16
percent changePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16-37.35 ± 4.415-55.04 ± 3.542
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · ANCOVA · p = <0.001 · Ls mean difference (final values): -17.69 · 95% CI -26.37 to -9.01
SecondaryChange From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
score on a scalePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16-6.46 ± 1.855-9.79 ± 1.815
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · ANCOVA · p = 0.001031 · Ls mean difference (final values): -3.33 · 95% CI -5.3 to -1.3
SecondaryPercentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points

The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Time frame:
Baseline to Week 16
Reported as:
Number · percentage of participants
Percentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points
percentage of participantsPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Percentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points58.7 (44.1 to 73.2)77.4 (69.3 to 85.5)
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Cochran-Mantel-Haenszel · p = 0.036 · Risk difference (rd): 17.2 · 95% CI 0.1 to 34.3
SecondaryChange From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Health State Index

The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Health State Index
score on a scalePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Health State Index UK0.05 ± 0.0250.15 ± 0.019
Health State Index US0.03 ± 0.0180.10 ± 0.014
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · ANCOVA · p = <0.001 · Ls mean difference (final values): 0.11 · 95% CI 0.06 to 0.16
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · ANCOVA · p = <0.001 · Ls mean difference (final values): 0.07 · 95% CI 0.04 to 0.11
SecondaryChange From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (VAS)

The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · millimeters (mm)
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (VAS)
millimeters (mm)Placebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (VAS)6.51 ± 2.36410.13 ± 1.831
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · ANCOVA · p = 0.131 · Ls mean difference (final values): 3.62 · 95% CI -1.08 to 8.32
SecondaryChange From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

POEM is a 7-item, validated, questionnaire used by the participant to assess disease symptoms over the last week. The participant is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1- 2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of a poor quality of life. POEM responses will be captured using an electronic diary and transferred into the clinical database. LS Mean was calculated using MMRM model using treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit as covariates, geographic region, age group, baseline IGA (3 versus 4) score as fixed.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16
score on a scalePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16-6.24 ± 1.038-10.23 ± 0.727
Statistical analysis
  • Placebo +Topical Corticosteroid · Mixed Models Analysis · p = <0.001 · Ls mean difference (final values): -4.00 · 95% CI -6.26 to -1.74
SecondaryChange From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults

PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults
score on a scalePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults-1.08 ± 1.367-1.88 ± 1.027
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · ANCOVA · p = 0.571 · Ls mean difference (final values): -0.80 · 95% CI -3.58 to 1.98
SecondaryChange From Baseline in PROMIS Depression at Week 16 - Adults

PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline in PROMIS Depression at Week 16 - Adults
score on a scalePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Change From Baseline in PROMIS Depression at Week 16 - Adults-1.21 ± 1.098-1.38 ± 0.834
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · ANCOVA · p = 0.882 · Ls mean difference (final values): -0.17 · 95% CI -2.40 to 2.06
SecondaryChange From Baseline in PROMIS Anxiety at Week 16 - Pediatrics

PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics
score on a scalePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics-4.92 ± 2.333-1.46 ± 1.732
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · ANCOVA · p = 0.171 · Ls mean difference (final values): 3.46 · 95% CI -1.56 to 8.48
SecondaryChange From Baseline in PROMIS Depression at Week 16 - Pediatrics

PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS depression has 8 questions on Emotion Distress-Depression (or Pediatric Depressive Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline in PROMIS Depression at Week 16 - Pediatrics
score on a scalePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Change From Baseline in PROMIS Depression at Week 16 - Pediatrics-6.43 ± 2.536-2.01 ± 1.916
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · ANCOVA · p = 0.109 · Ls mean difference (final values): 4.43 · 95% CI -1.03 to 9.89
SecondaryChange From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma

The ACQ-5 has been shown to reliably measure asthma control and distinguish participants with well-controlled asthma (score ≤0.75 points) from those with uncontrolled asthma (score ≥1.5 points). It consists of 5 questions that are scored on a 7- point Likert scale with a recall period of 1 week. The total ACQ-5 score is the mean score of all questions; a lower score represents better asthma control. LS Mean was calculated using ANCOVA with treatment, baseline value, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma
score on a scalePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma0.12 ± 0.1160.13 ± 0.076
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · ANCOVA · p = 0.922 · Ls mean difference (final values): 0.01 · 95% CI -0.22 to 0.24
SecondaryChange From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16

The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms \& feelings, leisure, school or holidays, personal relationships, sleep, \& treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). LS Mean was calculated using MMRM model which includes treatment, baseline value, visit, the interaction of the baseline value-by-visit as covariates, the interaction of treatment by-visit, geographic region, age group, and baseline IGA (3 versus 4) score as fixed factors.

Time frame:
Baseline, Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16
score on a scalePlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16-4.71 ± 1.170-9.33 ± 0.887
Statistical analysis
  • Placebo +Topical Corticosteroid vs Lebrikizumab + Topical Corticosteroid · Mixed Models Analysis · p = 0.001 · Ls mean difference (final values): -4.62 · 95% CI -7.22 to -2.03

Adverse events

Collected over Baseline up to Week 28. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo +Topical Corticosteroid0/75 (0%)1/75 (1.3%)26/75 (34.7%)
Lebrikizumab + Topical Corticosteroid0/153 (0%)2/153 (1.3%)66/153 (43.1%)
Most frequent serious events
Most frequent serious events
EventPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
DehydrationMetabolism and nutrition disorders1/750/153
Acute kidney injuryRenal and urinary disorders1/750/153
Sinus node dysfunctionCardiac disorders0/751/153
FallInjury, poisoning and procedural complications0/751/153
Most frequent other events
Showing 10 of 96
Most frequent other events
EventPlacebo +Topical CorticosteroidLebrikizumab + Topical Corticosteroid
NasopharyngitisInfections and infestations5/753/153
ConjunctivitisInfections and infestations0/757/153
HeadacheNervous system disorders1/757/153
Dermatitis atopicSkin and subcutaneous tissue disorders3/753/153
Upper respiratory tract infectionInfections and infestations2/751/153
HypertensionVascular disorders1/754/153
Dry eyeEye disorders0/753/153
Urinary tract infectionInfections and infestations0/753/153
LymphadenopathyBlood and lymphatic system disorders1/751/153
Conjunctival haemorrhageEye disorders1/750/153

Baseline characteristics

All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

Age, Customized
Age, Customized(Participants)Placebo + Topical CorticosteroidLebrikizumab + Topical CorticosteroidTotal
12 - <18183553
>= 18 - <6552103155
>=65 - <7551015
>=75055
Sex: Female, Male
Sex: Female, Male(Participants)Placebo + Topical CorticosteroidLebrikizumab + Topical CorticosteroidTotal
Female3775112
Male3878116
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo + Topical CorticosteroidLebrikizumab + Topical CorticosteroidTotal
American Indian or Alaska Native257
Asian131831
Native Hawaiian or Other Pacific Islander033
Black or African American92130
White4996145
More than one race189
Unknown or Not Reported123
Region of Enrollment
Region of Enrollment(Participants)Placebo + Topical CorticosteroidLebrikizumab + Topical CorticosteroidTotal
Canada81422
United States57111168
Poland81927
Germany2911
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Study locations

63 sites
  • Investigate MD
    Scottsdale, Arizona 85255, United States
  • Orange County Research Institute
    Anaheim, California 92801, United States
  • Bakersfield Dermatology and Skin Cancer Medical Group
    Bakersfield, California 93309, United States
  • Wallace Medical Group, Inc.
    Beverly Hills, California 90211, United States
  • First OC Dermatology
    Fountain Valley, California 92708, United States
  • Center For Dermatology Clinical Research, Inc.
    Fremont, California 94538, United States
  • California Allergy and Asthma Medical Group + Research Center
    Los Angeles, California 90025, United States
  • Keck School of Medicine University of Southern California
    Los Angeles, California 90033, United States
  • Dermatology Research Associates
    Los Angeles, California 90045, United States
  • LA Universal Research Center, INC
    Los Angeles, California 90057, United States
  • ACRC Studies
    San Diego, California 92119, United States
  • University Clinical Trials, Inc.
    San Diego, California 92123, United States
  • Southern California Dermatology, Inc.
    Santa Ana, California 92701, United States
  • Foxhall Dermatology
    Washington, District of Columbia 20016, United States
  • St. Francis Medical Institute
    Clearwater, Florida 33765, United States
  • University of Florida - Gainesville
    Gainesville, Florida 32606, United States
  • Direct Helpers Medical Center
    Hialeah, Florida 33012, United States
  • The Community Research of South Florida
    Hialeah, Florida 33016, United States
  • GSI Clinical Research, LLC
    Margate, Florida 33063, United States
  • Vitae Research Center, LLC
    Miami, Florida 33135, United States
  • Well Pharma Medical Research Corp.
    Miami, Florida 33143, United States
  • ForCare Clinical Research
    Tampa, Florida 33613-1244, United States
  • Advanced Medical Research
    Sandy Springs, Georgia 30328, United States
  • The Indiana Clinical Trials Center
    Plainfield, Indiana 46168, United States
  • Dermatology and Skin Cancer Specialists
    Rockville, Maryland 20850, United States
  • ActivMed Practices and Research
    Beverly, Massachusetts 01915, United States
  • Beacon Clinical Research LLC
    Quincy, Massachusetts 02169, United States
  • Fivenson Dermatology
    Ann Arbor, Michigan 48103, United States
  • Clarkston Skin Research
    Clarkston, Michigan 48346, United States
  • MediSearch Clinical Trials
    Saint Joseph, Missouri 64506, United States
  • ALLCUTIS Research
    Portsmouth, New Hampshire 03801, United States
  • Psoriasis Treatment Center of Central New Jersey
    East Windsor, New Jersey 08520, United States
  • Sadick Research Group
    New York, New York 10075, United States
  • OnSite Clinical Solutions
    Charlotte, North Carolina 28277, United States
  • Wilmington Dermatology Center
    Wilmington, North Carolina 28405, United States
  • Clinical Research Institute
    Medford, Oregon 97504, United States
  • Oregon Dermatology and Research Center
    Portland, Oregon 97210, United States
  • Oregon Medical Research Center
    Portland, Oregon 97223, United States
  • OHSU Center for Health and Healing
    Portland, Oregon 97239, United States
  • Clinical Partners, LLC
    Johnston, Rhode Island 02919, United States
  • Clinical Research Center of the Carolinas
    Charleston, South Carolina 29407, United States
  • Arlington Research Center, Inc
    Arlington, Texas 76011, United States
  • Dermatology Treatment and Research Center
    Dallas, Texas 75230, United States
  • CARe Clinic
    Red Deer, Alberta T4N 6V7, Canada
  • Dr. Chih-ho Hong Medical Inc.
    Surrey, British Columbia V3R 6A7, Canada
  • Enverus Medical Research
    Surrey, British Columbia V3V 0C6, Canada
  • Wiseman Dermatology Research Inc.
    Winnipeg, Manitoba R3M 3Z4, Canada
  • SKiN Centre for Dermatology
    Peterborough, Ontario K9J 5K2, Canada
  • International Dermatology Research
    Montreal, Quebec H3H1V4, Canada
  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
    Frankfurt am Main, Hessen 60590, Germany
  • Elbe Klinikum Buxtehude
    Buxtehude, Lower Saxony 21614, Germany
  • Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer
    Dresden, Saxony 01307, Germany
  • Praxis für Ganzheitliche Dermatologie im Ärztehaus
    Berlin, 13055, Germany
  • TFS Trial Form Support GmbH
    Hamburg, 20537, Germany
  • DermMEDICA Sp. z o.o.
    Wroclaw, Dolnoslaskie 51-318, Poland
  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
    Tarnow, Malopolska 33100, Poland
  • Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii
    Rzeszow, Podkarpackie 35-055, Poland
  • COPERNICUS Podmiot Leczniczy sp. z o.o.
    Gdansk, Pomorskie 80-219, Poland
  • Labderm s.c.
    Ossy, Slaskie 42-624, Poland
  • Gabinet Dermatlogiczny. Beata Krecisz
    Kielce, Swietokrzyskie 25-155, Poland
  • Clinica Vitae Sp. z o.o.
    Gdansk, Woj. Pomorskie 80-405, Poland
  • Clinical Research Group Sp. z o.o.
    Warszawa, 01-142, Poland
  • Centralny Szpital Kliniczny MSWiA
    Warszawa, 02-507, Poland
09

References and documents

Study documents

  • Study protocol · May 13, 2020
  • Statistical analysis plan · Oct 15, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04250337
Lead sponsor
Eli Lilly and Company
Collaborators
Dermira, Inc.
Responsible party
Sponsor
First posted
Jan 31, 2020
Start date
Feb 3, 2020
Primary completion
Aug 11, 2021
Completion
Sep 16, 2021
Results posted
May 2, 2022
Last update
May 9, 2022

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

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

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