A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa

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• Hidradenitis Suppurativa 277
• Hidradenitis 160

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's enrollment of 151 is above the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.

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.

Study arms

• Placebo comparator
  Part 1 (Group 1): Placebo

  Participants will receive placebo subcutaneously (SC) at Week 0 through Week 15. At Week 16, participants will cross over to receive bermekimab dose 1 SC every week thereafter through Week 31.

  Drug: Bermekimab · Drug: Placebo

• Active comparator
  Part 1 (Group 2): Adalimumab

  Participants will receive adalimumab 160 milligrams (mg) SC at Week 0, placebo SC at Week 1, followed by adalimumab 80 mg SC and placebo SC at Weeks 2 and 3. Participants will then receive adalimumab 40 mg SC and placebo SC at Week 4 and every week thereafter through Week 31.

  Drug: Adalimumab · Drug: Placebo

• Experimental
  Part 1 (Group 3): Bermekimab Dose 1

  Participants will receive bermekimab dose 1 SC and placebo SC at Week 0, followed by bermekimab dose 1 SC at Week 1 and every week thereafter through Week 31.

  Drug: Bermekimab · Drug: Placebo

• Placebo comparator
  Part 2 (Group 1): Placebo

  Participants will receive placebo SC from Week 0 through Week 11. At Week 12, participants will cross over to receive bermekimab dose 1 SC weekly through Week 31.

  Drug: Bermekimab · Drug: Placebo

• Experimental
  Part 2 (Group 2): Bermekimab Dose 1

  Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 31.

  Drug: Bermekimab

• Experimental
  Part 2 (Group 3): Bermekimab Dose 1

  Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 11. From Week 12, participants will receive bermekimab dose 1 SC every other week thereafter through Week 30. During weeks in which bermekimab is not administered, participants will receive placebo SC through Week 31.

  Drug: Bermekimab · Drug: Placebo

• Experimental
  Part 2 (Group 4): Bermekimab Dose 2

  Participants will receive bermekimab dose 2 SC and placebo SC at Week 0 and every week thereafter through Week 11. From Week 12, participants will receive bermekimab dose 2 SC and placebo SC every other week thereafter through Week 30. During weeks in which bermekimab is not administered, participants will receive placebo SC through Week 31.

  Drug: Bermekimab · Drug: Placebo

Interventions

• DrugBermekimab

  Bermekimab will be administered subcutaneously.

  Also known as: JNJ-77474462

• DrugAdalimumab

  Adalimumab will be administered subcutaneously.

• DrugPlacebo

  Placebo will be administered subcutaneously.

Primary outcomes

1. Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16

   HiSCR50 was defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule counts (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. Part 1: Percentage of Participants Who Achieved HiSCR75 at Week 16

   HiSCR75 was defined as at least 75% reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline.

   Time frame: Week 16

2. Part 1: Percentage of Participants Who Achieved HiSCR90 at Week 16

   HiSCR90 was defined as at least 90% reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline.

   Time frame: Week 16

3. Part 1: Change From Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16

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

   Time frame: Baseline, Week 16

4. Part 1: Change From Baseline in Number of Abscess at Week 16

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

   Time frame: Baseline, Week 16

5. Part 1: Change From Baseline in Number of Draining Fistula at Week 16

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

   Time frame: Baseline, Week 16

6. Part 1: Change From Baseline in Number of Inflammatory Nodules at Week 16

   Change from baseline in number of inflammatory nodules at Week 16 was reported. Inflammatory nodules arise from inflamed blood vessels (vasculitis) or adipose tissue (panniculitis).

   Time frame: Baseline, Week 16

7. Part 1: Change From Baseline in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 16

   IHS4 was a dynamic severity assessment of HS. IHS4 score was arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. Higher scores indicate more severity.

   Time frame: Baseline up to Week 16

8. Part 1: 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 was 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: Baseline, Week 16

9. Part 1: 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 in the past 24 hours based on HSSD was reported.

   Time frame: Baseline, Week 16

10. Serum Concentration of Bermekimab

    Serum concentration of bermekimab was reported. As per planned analysis, this outcome measure was analyzed in a single arm for participants who received bermekimab from Week 0 to Week 36.

    Time frame: Weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36

11. Number of Participants With Antibodies to Bermekimab

    Number of participants with antibodies to bermekimab was reported. As per planned analysis, this outcome measure was analyzed in a single arm for participants who received bermekimab from Week 0 to Week 36.

    Time frame: From baseline up to Week 36

Baseline characteristics

Study documents

• Study protocol · Aug 12, 2022
• Statistical analysis plan · Nov 14, 2022

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

Individual participant data

Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu