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CompletedNCT03628924NOVAUpdated Feb 4, 2025Results posted

A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)

A Phase 2 interventional study of Guselkumab dose 1 and Guselkumab dose 2 in Hidradenitis Suppurativa, sponsored by Janssen Research & Development, LLC. Completed at 45 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).

02

Conditions studied

  • Hidradenitis Suppurativa
03

In context

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.

This study's enrollment of 184 is above the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

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

04

Who can participate

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

Inclusion criteria

  • Have moderate to severe Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the baseline visit as determined by the investigator through participant interview and/or review of the medical history
  • Have HS lesions present in at least 2 distinct anatomic areas (examples include but are not limited to left and right axilla; or left axilla and left inguinocrural fold)
  • Had an inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS (or demonstrated intolerance to, or had a contraindication to oral antibiotics for treatment of their HS) in the investigator's opinion
  • Have a total abscess and inflammatory nodule (AN) count of greater than or equal to (>=) 3 at the screening and baseline visit
  • Must agree to daily use (throughout the entirety of the study) of one of the following over-the-counter treatments to the body areas affected with HS lesions: either soap and water, or a topical antiseptic wash containing chlorhexidine gluconate, triclosan, or benzoyl peroxide, or a dilute bleach bath

Exclusion criteria

Exclusion Criteria:

  • Any other active skin disease or condition (example, bacterial, fungal or viral infection) that could have interfered with assessment of HS
  • Has a draining fistula count of greater than (>) 20 at the baseline visit
  • Receipt of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit
  • Receipt of systemic non-biologic therapies for the treatment of HS less than (\<) 4 Weeks prior to the baseline visit
  • Receipt of any oral antibiotic treatment for HS or inflammatory disorders within 4 Weeks prior to the baseline visit
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
184 participants (actual)

Study arms

  • Experimental
    Group 1: Guselkumab Regimen 1

    Participants will receive guselkumab dose 1 administered Intravenously (IV) followed by guselkumab dose 2 administered subcutaneously.

    Drug: Guselkumab dose 1 · Drug: Guselkumab dose 2 · Drug: Placebo

  • Experimental
    Group 2: Guselkumab Regimen 2

    Participants will receive guselkumab dose 2 subcutaneously.

    Drug: Guselkumab dose 2 · Drug: Placebo

  • Experimental
    Group 3: Placebo then Guselkumab

    Participants will receive placebo IV and SC and an additional SC placebo dose at Week 12 then cross over at Week 16 to receive guselkumab dose 2 and dose 3 SC and placebo SC.

    Drug: Guselkumab dose 2 · Drug: Guselkumab dose 3 · Drug: Placebo

Interventions

  • DrugGuselkumab dose 1

    Participants will receive guselkumab dose 1 IV.

    Also known as: CNTO 1959

  • DrugGuselkumab dose 2

    Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.

    Also known as: CNTO 1959

  • DrugGuselkumab dose 3

    Participants will receive guselkumab dose 3 SC in Group 3.

    Also known as: CNTO 1959

  • DrugPlacebo

    Participants will receive matched placebo SC and IV in group 1, 2 and 3 with an additional placebo SC dose in Group 3.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16

    HiSCR is defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.

    Time frame: Week 16

Secondary outcomes

  1. Change From Baseline in Participant's Total Abscess and Inflammatory Nodule (AN) Count at Week 16

    Change from baseline in total AN count at Week 16 was reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

    Time frame: Baseline and Week 16

  2. Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16

    DLQI is a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (that is, negative change score) indicates improvement in the Quality of Life.

    Time frame: Baseline and Week 16

  3. Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Week 16

    HSSD is a 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms have a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours with a score range from 0 (no symptom experience) to 10 (worst possible symptom experience). A total symptom score also ranged from 0 (no symptom) to 10 (worst possible symptom), was derived by averaging the 5 individual scale scores that utilize the past 7-day recall period. Change from baseline in HS-related pain symptom score based on HSSD was reported.

    Time frame: Baseline and Week 16

  4. Percentage of Participants Who Achieved at Least 50 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16

    Percentage of participants who achieved at least 50 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

    Time frame: Week 16

  5. Percentage of Participants Who Achieved at Least 75 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16

    Percentage of participants who achieved at least 75 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

    Time frame: Week 16

  6. Percentage of Participants Who Achieved at Least 90 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16

    Percentage of participants who achieved at least 90 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

    Time frame: Week 16

  7. Percentage of Participants Who Achieved 100 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16

    Percentage of participants who achieved 100 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

    Time frame: Week 16

  8. Percentage of Participants Who Achieved an Abscess and Inflammatory Nodule Count of 0/1 and AN Count of 0/1/2 at Week 16

    Percentage of participants who achieved an AN count of 0/1 and AN Count of 0/1/2 at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

    Time frame: Week 16

  9. Percentage of Participants Who Achieved Abscess Count of 0 at Week 16 For Participants With Baseline Abscess Count Greater Than 0

    Percentage of participants who achieved abscess count of 0 at Week 16 for participants with baseline abscess count greater than (\>) 0 were reported.

    Time frame: Week 16

  10. Change From Baseline in the Number of Abscesses at Week 16

    Change from baseline in number of abscesses at Week 16 was reported.

    Time frame: Baseline and Week 16

  11. Change From Baseline in HSSD Symptom Scale Total Score at Week 16

    HSSD is a 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms have a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours. A total symptom score, also ranged from 0 (no symptom) to 10 (worst possible symptom), was derived by averaging the 5 individual scale scores that utilize the past 7-day recall period.

    Time frame: Baseline and Week 16

  12. Change From Baseline in HSSD Symptom Scale Score (Other Than Pain in the Past 24 Hours) at Week 16

    HSSD is a 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms have a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours. Change from baseline in each individual HSSD component scale (other than pain in the past 24 hours) tenderness, hot skin feeling, odor and itchiness symptom, pain, and current pain score (rated on a scale of 0 \[no symptom experience\] to 10 \[worst possible symptom experience\]) were reported.

    Time frame: Baseline and Week 16

  13. Percentage of Participants Who Achieved Draining Fistula Count of 0 at Week 16 for Participants With Baseline Draining Fistula Count Greater Than 0

    Percentage of participants who achieved draining fistulas count of 0 at Week 16 for participants with baseline draining fistula count \>0 were reported. Draining fistula were defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.

    Time frame: Week 16

  14. Change From Baseline in Number of Draining Fistulas at Week 16

    Change from baseline in number of draining fistulas at Week 16 was reported. Draining fistula are defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.

    Time frame: Baseline and Week 16

  15. Percentage of Participants Who Achieved Inflammatory Nodules Count of 0 at Week 16 for Participants With Baseline Inflammatory Nodule Count Greater Than 0

    Percentage of participants who achieved inflammatory nodules count of 0 at Week 16 in participants with baseline inflammatory nodules count \>0 were reported.

    Time frame: Week 16

  16. Change From Baseline in Number of Inflammatory Nodules at Week 16

    Change from baseline in number of inflammatory nodules at Week 16 was reported.

    Time frame: Baseline and Week 16

  17. Percentage of Participants With Hidradenitis Suppurativa-investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-Grade Improvement Relative to Baseline at Week 16

    The HS-IGA documents the investigator's assessment of the participant's HS at a given timepoint. The anatomic region with the most severe HS activity at the baseline was evaluated for erythema, drainage, and pain and/or tenderness to palpation for each participant. The participant's HS is assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. Percentage of participants with HS-IGA score of inactive (0), almost inactive (1), or mild activity (2) and with at least 2-grade improvement relative to baseline at Week 16 were reported.

    Time frame: Week 16

  18. Percentage of Participants With HS-IGA Score of Inactive (0) or Almost Inactive (1) at Week 16 Among Participants With HS-IGA Score of Moderate Activity (3) or Severe Activity (4) at Baseline

    The HS-IGA documents the investigator's assessment of the participant's HS at a given timepoint. The anatomic region with the most severe HS activity at the baseline was evaluated for erythema, drainage, and pain and/or tenderness to palpation for each participant. Among participants with score of moderate activity (3) or severe activity (4) at baseline, the same anatomic site selected for evaluation at the baseline were re-evaluated at Week 16. The participant's HS is assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. Percentage of participants with HS-IGA score of inactive (0), almost inactive (1) at Week 16 among participants with HS-IGA score of moderate activity (3) or severe activity (4) at baseline were reported.

    Time frame: Week 16

  19. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 16

    The HADS has been developed to identify symptoms of anxiety and depression in hospitalized participants and in outpatients. It comprises 14 items, seven to assess anxiety (HADS-A), namely items 1, 3, 5, 7, 9, 11, and 13; and seven to assess depression (HADS-D), namely items 2, 4, 6, 8, 10, 12, and 14. Each item receives a score from 0 to 3 on a Likert Scale. The total score for each HADS-A and HADS-D scale is obtained by adding the individual scores for each item, with the maximum score 21. The presence or absence of depression and anxiety was defined, for each respective scale, based on the following cutoff values: HADS (anxiety): 0-8 equal to (=) no anxiety; greater than (\>) 9 = anxiety; HADS (depression): 0-8 = no depression; \>9 = depression.

    Time frame: Baseline and Week 16

  20. Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) at Week 16

    Change from baseline in hs-CRP at Week 16 was reported. Serum samples were collected and analyzed for hsCRP. Change from Baseline was calculated as: (\[hs-CRP value at Week 16 minus Baseline value\] divided by \[Baseline value\]).

    Time frame: Baseline and Week 16

  21. Number of Participants With Patient Global Impression of Change (PGIC) of Hidradenitis Suppurativa Severity Scale Score at Week 16

    The PGIC of HS Severity is a questionnaire that measures participants' perceived change (improvement or deterioration) in severity of their HS. Participants rated how his/her HS has changed since the beginning of the study using a 7-point scale ranging from 1 which indicates "a lot better now" to 7 which indicates "a lot worse now" with a neutral center point 4 which indicates ("neither better nor worse"). Participants' PGIC of HS Severity scale score at Week 16 were reported

    Time frame: Week 16

07

Results

Posted Jun 14, 2021

Participant flow

Placebo Controlled Period (Week 0 - 16)
Participant flow — Placebo Controlled Period (Week 0 - 16)
MilestonePlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)Placebo Crossover to Guselkumab 100 mg SC (Week 16 - 48)Placebo Crossover to Guselkumab 200 mg SC (Week 16 - 48)Guselkumab 200 mg SC (Week 16 - 48)Guselkumab 1200 mg IV Crossover to Guselkumab 200 mg SC (Week 16 - 48)
Started6259600000
Completed5656570000
Not completed6330000
Withdrew: Lost to follow-up2000000
Withdrew: Withdrawal by subject0010000
Withdrew: Protocol violation1210000
Withdrew: Adverse event0100000
Withdrew: Lack of efficacy3010000
Active Treatment Period (Week 16-48)
Participant flow — Active Treatment Period (Week 16-48)
MilestonePlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)Placebo Crossover to Guselkumab 100 mg SC (Week 16 - 48)Placebo Crossover to Guselkumab 200 mg SC (Week 16 - 48)Guselkumab 200 mg SC (Week 16 - 48)Guselkumab 1200 mg IV Crossover to Guselkumab 200 mg SC (Week 16 - 48)
Started00028285657
Completed00020244346
Not completed000841311
Withdrew: Lost to follow-up0001121
Withdrew: Adverse event0001024
Withdrew: Protocol violation0001101
Withdrew: Lack of efficacy0005142
Withdrew: Withdrawal by subject0000153

Outcome measures

PrimaryPercentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16

HiSCR is defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.

Time frame:
Week 16
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
percentage of participantsPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 1638.750.845.0
Statistical analysis
  • Placebo (Week 0 - 16) vs Guselkumab 200 Milligrams (mg) SC (Week 0 - 16) · Cochran-Mantel-Haenszel · p = = 0.166 · Treatment difference: 12.6 · 95% CI -4.6 to 29.8
  • Placebo (Week 0 - 16) vs Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16) · Cochran-Mantel-Haenszel · p = = 0.459 · Treatment difference: 6.6 · 95% CI -10.3 to 23.6
SecondaryChange From Baseline in Participant's Total Abscess and Inflammatory Nodule (AN) Count at Week 16

Change from baseline in total AN count at Week 16 was reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

Time frame:
Baseline and Week 16
Reported as:
Mean · count of abscess and inflammatory nodule
Change From Baseline in Participant's Total Abscess and Inflammatory Nodule (AN) Count at Week 16
count of abscess and inflammatory nodulePlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Change From Baseline in Participant's Total Abscess and Inflammatory Nodule (AN) Count at Week 16-3.2 ± 7.37-5.3 ± 9.29-5.3 ± 6.53
SecondaryChange From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16

DLQI is a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (that is, negative change score) indicates improvement in the Quality of Life.

Time frame:
Baseline and Week 16
Reported as:
Mean · units on a scale
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
units on a scalePlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16-0.7 ± 5.17-3.4 ± 6.81-2.5 ± 6.13
SecondaryChange From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Week 16

HSSD is a 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms have a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours with a score range from 0 (no symptom experience) to 10 (worst possible symptom experience). A total symptom score also ranged from 0 (no symptom) to 10 (worst possible symptom), was derived by averaging the 5 individual scale scores that utilize the past 7-day recall period. Change from baseline in HS-related pain symptom score based on HSSD was reported.

Time frame:
Baseline and Week 16
Reported as:
Mean · units on a scale
Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Week 16
units on a scalePlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Week 16-0.3 ± 3.17-1.6 ± 3.05-1.2 ± 2.93
SecondaryPercentage of Participants Who Achieved at Least 50 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16

Percentage of participants who achieved at least 50 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

Time frame:
Week 16
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved at Least 50 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16
percentage of participantsPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Percentage of Participants Who Achieved at Least 50 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 1645.255.951.7
SecondaryPercentage of Participants Who Achieved at Least 75 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16

Percentage of participants who achieved at least 75 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

Time frame:
Week 16
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved at Least 75 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16
percentage of participantsPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Percentage of Participants Who Achieved at Least 75 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 1630.640.726.7
SecondaryPercentage of Participants Who Achieved at Least 90 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16

Percentage of participants who achieved at least 90 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

Time frame:
Week 16
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved at Least 90 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16
percentage of participantsPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Percentage of Participants Who Achieved at Least 90 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 1617.722.015.0
SecondaryPercentage of Participants Who Achieved 100 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16

Percentage of participants who achieved 100 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

Time frame:
Week 16
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved 100 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16
percentage of participantsPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Percentage of Participants Who Achieved 100 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 1614.515.315.0
SecondaryPercentage of Participants Who Achieved an Abscess and Inflammatory Nodule Count of 0/1 and AN Count of 0/1/2 at Week 16

Percentage of participants who achieved an AN count of 0/1 and AN Count of 0/1/2 at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

Time frame:
Week 16
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved an Abscess and Inflammatory Nodule Count of 0/1 and AN Count of 0/1/2 at Week 16
percentage of participantsPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
AN Count of 0/127.430.523.3
AN Count of 0/1/233.939.031.7
SecondaryPercentage of Participants Who Achieved Abscess Count of 0 at Week 16 For Participants With Baseline Abscess Count Greater Than 0

Percentage of participants who achieved abscess count of 0 at Week 16 for participants with baseline abscess count greater than (\>) 0 were reported.

Time frame:
Week 16
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved Abscess Count of 0 at Week 16 For Participants With Baseline Abscess Count Greater Than 0
percentage of participantsPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Percentage of Participants Who Achieved Abscess Count of 0 at Week 16 For Participants With Baseline Abscess Count Greater Than 039.363.945.2
SecondaryChange From Baseline in the Number of Abscesses at Week 16

Change from baseline in number of abscesses at Week 16 was reported.

Time frame:
Baseline and Week 16
Reported as:
Mean · abscess
Change From Baseline in the Number of Abscesses at Week 16
abscessPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Change From Baseline in the Number of Abscesses at Week 16-0.4 ± 2.72-2.1 ± 4.56-1.6 ± 3.90
SecondaryChange From Baseline in HSSD Symptom Scale Total Score at Week 16

HSSD is a 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms have a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours. A total symptom score, also ranged from 0 (no symptom) to 10 (worst possible symptom), was derived by averaging the 5 individual scale scores that utilize the past 7-day recall period.

Time frame:
Baseline and Week 16
Reported as:
Mean · units on a scale
Change From Baseline in HSSD Symptom Scale Total Score at Week 16
units on a scalePlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Change From Baseline in HSSD Symptom Scale Total Score at Week 16-0.19 ± 2.124-1.71 ± 2.325-0.82 ± 2.148
SecondaryChange From Baseline in HSSD Symptom Scale Score (Other Than Pain in the Past 24 Hours) at Week 16

HSSD is a 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms have a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours. Change from baseline in each individual HSSD component scale (other than pain in the past 24 hours) tenderness, hot skin feeling, odor and itchiness symptom, pain, and current pain score (rated on a scale of 0 \[no symptom experience\] to 10 \[worst possible symptom experience\]) were reported.

Time frame:
Baseline and Week 16
Reported as:
Mean · units on a scale
Change From Baseline in HSSD Symptom Scale Score (Other Than Pain in the Past 24 Hours) at Week 16
units on a scalePlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Change in HSSD Tenderness Scale Score-0.4 ± 2.78-2.1 ± 2.93-1.3 ± 2.56
Change in HSSD Hot Skin Feeling Scale Score0.1 ± 2.85-1.6 ± 3.12-0.2 ± 3.16
Change in HSSD Odor Scale Score-0.4 ± 2.73-1.9 ± 2.58-1.2 ± 2.77
Change in HSSD Itchiness Scale Score0.1 ± 2.82-1.1 ± 3.28-0.5 ± 2.85
Change in HSSD Pain Scale Score-0.3 ± 2.64-1.8 ± 2.86-0.9 ± 2.34
Change in HSSD Current Pain Score-0.4 ± 2.71-1.5 ± 2.94-1.2 ± 2.76
SecondaryPercentage of Participants Who Achieved Draining Fistula Count of 0 at Week 16 for Participants With Baseline Draining Fistula Count Greater Than 0

Percentage of participants who achieved draining fistulas count of 0 at Week 16 for participants with baseline draining fistula count \>0 were reported. Draining fistula were defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.

Time frame:
Week 16
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved Draining Fistula Count of 0 at Week 16 for Participants With Baseline Draining Fistula Count Greater Than 0
percentage of participantsPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Percentage of Participants Who Achieved Draining Fistula Count of 0 at Week 16 for Participants With Baseline Draining Fistula Count Greater Than 036.631.020.5
SecondaryChange From Baseline in Number of Draining Fistulas at Week 16

Change from baseline in number of draining fistulas at Week 16 was reported. Draining fistula are defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.

Time frame:
Baseline and Week 16
Reported as:
Mean · fistulas
Change From Baseline in Number of Draining Fistulas at Week 16
fistulasPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Change From Baseline in Number of Draining Fistulas at Week 16-0.5 ± 2.87-1.7 ± 3.77-0.8 ± 2.08
SecondaryPercentage of Participants Who Achieved Inflammatory Nodules Count of 0 at Week 16 for Participants With Baseline Inflammatory Nodule Count Greater Than 0

Percentage of participants who achieved inflammatory nodules count of 0 at Week 16 in participants with baseline inflammatory nodules count \>0 were reported.

Time frame:
Week 16
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved Inflammatory Nodules Count of 0 at Week 16 for Participants With Baseline Inflammatory Nodule Count Greater Than 0
percentage of participantsPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Percentage of Participants Who Achieved Inflammatory Nodules Count of 0 at Week 16 for Participants With Baseline Inflammatory Nodule Count Greater Than 017.717.218.6
SecondaryChange From Baseline in Number of Inflammatory Nodules at Week 16

Change from baseline in number of inflammatory nodules at Week 16 was reported.

Time frame:
Baseline and Week 16
Reported as:
Mean · inflammatory nodule
Change From Baseline in Number of Inflammatory Nodules at Week 16
inflammatory nodulePlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Change From Baseline in Number of Inflammatory Nodules at Week 16-2.8 ± 6.96-3.2 ± 7.84-3.7 ± 4.91
SecondaryPercentage of Participants With Hidradenitis Suppurativa-investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-Grade Improvement Relative to Baseline at Week 16

The HS-IGA documents the investigator's assessment of the participant's HS at a given timepoint. The anatomic region with the most severe HS activity at the baseline was evaluated for erythema, drainage, and pain and/or tenderness to palpation for each participant. The participant's HS is assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. Percentage of participants with HS-IGA score of inactive (0), almost inactive (1), or mild activity (2) and with at least 2-grade improvement relative to baseline at Week 16 were reported.

Time frame:
Week 16
Reported as:
Number · percentage of participants
Percentage of Participants With Hidradenitis Suppurativa-investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-Grade Improvement Relative to Baseline at Week 16
percentage of participantsPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
HS-IGA scores of inactive (0)16.113.613.3
HS-IGA scores of inactive (0) or almost inactive (1)24.228.823.3
HS-IGA scores of inactive (0), almost inactive (1), or mild activity (2)24.235.631.7
SecondaryPercentage of Participants With HS-IGA Score of Inactive (0) or Almost Inactive (1) at Week 16 Among Participants With HS-IGA Score of Moderate Activity (3) or Severe Activity (4) at Baseline

The HS-IGA documents the investigator's assessment of the participant's HS at a given timepoint. The anatomic region with the most severe HS activity at the baseline was evaluated for erythema, drainage, and pain and/or tenderness to palpation for each participant. Among participants with score of moderate activity (3) or severe activity (4) at baseline, the same anatomic site selected for evaluation at the baseline were re-evaluated at Week 16. The participant's HS is assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. Percentage of participants with HS-IGA score of inactive (0), almost inactive (1) at Week 16 among participants with HS-IGA score of moderate activity (3) or severe activity (4) at baseline were reported.

Time frame:
Week 16
Reported as:
Number · percentage of participants
Percentage of Participants With HS-IGA Score of Inactive (0) or Almost Inactive (1) at Week 16 Among Participants With HS-IGA Score of Moderate Activity (3) or Severe Activity (4) at Baseline
percentage of participantsPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Percentage of Participants With HS-IGA Score of Inactive (0) or Almost Inactive (1) at Week 16 Among Participants With HS-IGA Score of Moderate Activity (3) or Severe Activity (4) at Baseline27.332.725.0
SecondaryChange From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 16

The HADS has been developed to identify symptoms of anxiety and depression in hospitalized participants and in outpatients. It comprises 14 items, seven to assess anxiety (HADS-A), namely items 1, 3, 5, 7, 9, 11, and 13; and seven to assess depression (HADS-D), namely items 2, 4, 6, 8, 10, 12, and 14. Each item receives a score from 0 to 3 on a Likert Scale. The total score for each HADS-A and HADS-D scale is obtained by adding the individual scores for each item, with the maximum score 21. The presence or absence of depression and anxiety was defined, for each respective scale, based on the following cutoff values: HADS (anxiety): 0-8 equal to (=) no anxiety; greater than (\>) 9 = anxiety; HADS (depression): 0-8 = no depression; \>9 = depression.

Time frame:
Baseline and Week 16
Reported as:
Mean · units on a scale
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 16
units on a scalePlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
HADS-A0.0 ± 2.600.0 ± 2.82-0.3 ± 2.56
HADS-D0.2 ± 2.48-0.6 ± 2.73-0.5 ± 2.69
SecondaryChange From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) at Week 16

Change from baseline in hs-CRP at Week 16 was reported. Serum samples were collected and analyzed for hsCRP. Change from Baseline was calculated as: (\[hs-CRP value at Week 16 minus Baseline value\] divided by \[Baseline value\]).

Time frame:
Baseline and Week 16
Reported as:
Mean · milligrams per deciliter
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) at Week 16
milligrams per deciliterPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) at Week 16-0.308 ± 8.08403.238 ± 19.0716-2.828 ± 11.1048
SecondaryNumber of Participants With Patient Global Impression of Change (PGIC) of Hidradenitis Suppurativa Severity Scale Score at Week 16

The PGIC of HS Severity is a questionnaire that measures participants' perceived change (improvement or deterioration) in severity of their HS. Participants rated how his/her HS has changed since the beginning of the study using a 7-point scale ranging from 1 which indicates "a lot better now" to 7 which indicates "a lot worse now" with a neutral center point 4 which indicates ("neither better nor worse"). Participants' PGIC of HS Severity scale score at Week 16 were reported

Time frame:
Week 16
Reported as:
Count of participants · Participants
Number of Participants With Patient Global Impression of Change (PGIC) of Hidradenitis Suppurativa Severity Scale Score at Week 16
ParticipantsPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
A lot better now41310
Moderately better now71411
A little better now161012
No change201218
A little worse now324
Moderately worse now511
A lot worse now140

Adverse events

Collected over Up to 48 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo (Week 0 - 16)0/62 (0%)3/62 (4.8%)22/62 (35.5%)
Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)0/59 (0%)1/59 (1.7%)28/59 (47.5%)
Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)0/60 (0%)1/60 (1.7%)31/60 (51.7%)
Placebo Crossover to Guselkumab 100 mg SC (Week 16 - 48)0/28 (0%)3/28 (10.7%)12/28 (42.9%)
Placebo Crossover to Guselkumab 200 mg SC (Week 16 - 48)0/28 (0%)0/28 (0%)9/28 (32.1%)
Guselkumab 200 mg SC (Week 16 - 48)0/56 (0%)3/56 (5.4%)19/56 (33.9%)
Guselkumab 1200 mg IV Crossover to Guselkumab 200 mg SC (Week 16 - 48)0/57 (0%)2/57 (3.5%)28/57 (49.1%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)Placebo Crossover to Guselkumab 100 mg SC (Week 16 - 48)Placebo Crossover to Guselkumab 200 mg SC (Week 16 - 48)Guselkumab 200 mg SC (Week 16 - 48)Guselkumab 1200 mg IV Crossover to Guselkumab 200 mg SC (Week 16 - 48)
HidradenitisSkin and subcutaneous tissue disorders0/620/590/602/280/280/560/57
PneumoniaInfections and infestations0/620/590/601/280/280/560/57
Depression SuicidalPsychiatric disorders0/620/590/601/280/280/560/57
Diabetes MellitusMetabolism and nutrition disorders0/620/590/600/280/281/560/57
Acute Kidney InjuryRenal and urinary disorders0/620/590/600/280/281/560/57
Aortic AneurysmVascular disorders0/620/590/600/280/281/560/57
DysphagiaGastrointestinal disorders0/620/590/600/280/280/561/57
PancreatitisGastrointestinal disorders0/620/590/600/280/280/561/57
Septic ShockInfections and infestations0/620/590/600/280/280/561/57
AnaemiaBlood and lymphatic system disorders0/621/590/600/280/280/560/57
Most frequent other events
Showing 10 of 19
Most frequent other events
EventPlacebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)Placebo Crossover to Guselkumab 100 mg SC (Week 16 - 48)Placebo Crossover to Guselkumab 200 mg SC (Week 16 - 48)Guselkumab 200 mg SC (Week 16 - 48)Guselkumab 1200 mg IV Crossover to Guselkumab 200 mg SC (Week 16 - 48)
NasopharyngitisInfections and infestations2/6212/599/604/288/2810/5612/57
HidradenitisSkin and subcutaneous tissue disorders1/623/597/602/284/286/564/57
FatigueGeneral disorders2/622/597/600/281/281/562/57
HeadacheNervous system disorders7/626/592/603/280/282/563/57
ArthralgiaMusculoskeletal and connective tissue disorders3/621/595/601/283/280/560/57
DiarrhoeaGastrointestinal disorders6/622/596/600/280/284/561/57
Upper Respiratory Tract InfectionInfections and infestations3/623/595/601/280/281/563/57
Oedema PeripheralGeneral disorders0/621/592/602/280/280/561/57
Urinary Tract InfectionInfections and infestations1/620/590/602/280/280/562/57
Skin PapillomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/620/590/602/280/280/560/57

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Placebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)Total
<=18 years0000
Between 18 and 65 years605760177
>=65 years2204
Age, Continuous
Age, Continuous(years)Placebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)Total
Mean38.2 ± 11.5539 ± 12.3737.2 ± 10.9238.1 ± 11.58
Sex: Female, Male
Sex: Female, Male(Participants)Placebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)Total
Female383245115
Male24271566
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)Total
American Indian or Alaska Native0000
Asian1001
Native Hawaiian or Other Pacific Islander0000
Black or African American74617
White464243131
More than one race2002
Unknown or Not Reported6131130
Region of Enrollment
Region of Enrollment(Participants)Placebo (Week 0 - 16)Guselkumab 200 Milligrams (mg) SC (Week 0 - 16)Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)Total
CANADA88622
DENMARK2024
FRANCE13182051
GERMANY13131036
NETHERLANDS3137
UNITED STATES23191961
08

Study locations

45 sites
  • University of Alabama Birmingham
    Birmingham, Alabama 35233, United States
  • Olympian Clinical Research
    Largo, Florida 33770, United States
  • Renstar Medical Research
    Ocala, Florida 34470, United States
  • Park Avenue Dermatology
    Orange Park, Florida 32073, United States
  • Olympian Clinical Research
    Tampa, Florida 33614, United States
  • Forcare Clinical Research Inc
    Tampa, Florida 33624, United States
  • Great Lakes Clinical Trials
    Chicago, Illinois 60640, United States
  • Indiana Clinical Trial Center
    Plainfield, Indiana 46168, United States
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Hamzavi Dermatology
    Fort Gratiot, Michigan 48059, United States
  • Central Dermatology
    Saint Louis, Missouri 63117, United States
  • Clinical Studies Group
    Henderson, Nevada 89052, United States
  • Ohio State University
    Columbus, Ohio 43215, United States
  • Oregon Medical Research Center
    Portland, Oregon 97223, United States
  • University of Pittsburgh Department of Dermatology
    Pittsburgh, Pennsylvania 15213, United States
  • Clinical Partners, LLC
    Johnston, Rhode Island 02919, United States
  • Progressive Clinical Research
    San Antonio, Texas 78213, United States
  • Dermatology Associates of Seattle
    Seattle, Washington 98101-1498, United States
  • Dr Wei Jing Loo Medicine Professional Corporation
    London, Ontario N6H 5L5, Canada
  • Skin Centre for Dermatology
    Peterborough, Ontario K9J 5K2, Canada
  • York Dermatology Clinic and Research Centre
    Richmond Hill, Ontario L4C 9M7, Canada
  • Alliance Clinical Trials
    Waterloo, Ontario N2J 1C4, Canada
  • Bispebjerg Hospital
    København NV, DK-2400, Denmark
  • Sjaellands University Hospital
    Roskilde, DK-4000, Denmark
  • Hopital Prive d'Antony
    Antony, 92160, France
  • Groupe Hospitalier La Rochelle - Re - Aunis
    La Rochelle, 17019, France
  • CHU de Nice
    Nice, 06200, France
  • Polyclinique de Courlancy
    Reims, 51100, France
  • Hopital Charles Nicolle
    Rouen, 76031, France
  • CHU Saint Etienne
    St Priest En Jarez, 42270, France
  • Hopital Larrey CHU de Toulouse
    Toulouse, 31000, France
  • Charite - Universitaetsmedizin Berlin (CCM)
    Berlin, 10117, Germany
  • Katholisches Klinikum Bochum gGmbH
    Bochum, 44791, Germany
  • Klinikum Darmstadt GmbH - Hautklinik
    Darmstadt, 64297, Germany
  • Stadtisches Klinikum Dresden
    Dresden, 01067, Germany
  • Universitaetsklinik Erlangen
    Erlangen, 91054, Germany
  • Universitatsklinikum Frankfurt
    Frankfurt, 60590, Germany
  • Haut- und Laserzentrum Freising
    Freising, 85354, Germany
  • Universitaetsklinikum Heidelberg
    Heidelberg, 69120, Germany
  • Universitaetsmedizin Mainz
    Mainz, 55131, Germany
  • University Medical Center Groningen
    Groningen, 9700 RB, Netherlands
  • Radboudumc
    Nijmegen, 6525GA, Netherlands
  • Erasmus Medisch Centrum
    Rotterdam, 3015 CE, Netherlands
09

References and documents

Study documents

  • Study protocol · May 2, 2019
  • Statistical analysis plan · May 31, 2019

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03628924
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Aug 14, 2018
Start date
Sep 4, 2018
Primary completion
May 22, 2020
Completion
May 22, 2020
Results posted
Jun 14, 2021
Last update
Feb 4, 2025

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

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

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