A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Registration Number
- NCT04988308
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants with moderate to severe Hidradenitis Suppurativa (HS).
- Detailed Description
Hidradenitis suppurativa (HS) is a chronic skin disease of unclear etiology that affects 1 percent (%) to 4% of the general population. JNJ-77474462 (bermekimab) is a recombinant human immunoglobulin G1 kappa (IgG1k) monoclonal antibody (mAb) that binds with high affinity and selectivity for human interleukin-1 alpha (IL-1 alpha) and is an effective blocker of IL-1 alpha biological activity. IL-1 alpha is a key mediator of sterile inflammatory responses. Skin is a significant reservoir of preformed IL-1 alpha, and it has been postulated that IL-1 alpha may play a role in the pathophysiology of multiple inflammatory skin disorders, including HS. Part 1 of this study contains 4 study periods: up to 6 weeks screening period (Period 1), 16-week placebo-controlled period (Period 2), 16-week cross over period (Period 3), and 4-week safety follow-up (Period 4). Part 2 of this study also contains 4 study periods: up to 6 weeks screening period (Period 1), 12-week placebo-controlled period (Period 2), 20-week cross over period (Period 3), and 4-week safety follow up (Period 4). Safety will be assessed by adverse events (AEs), serious adverse event (SAEs), physical examinations, vital signs, electrocardiograms, clinical safety laboratory assessments, allergic reaction, injection-site reactions, and tuberculosis evaluations. The total duration of study participation will be up to 42 weeks.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 151
- Have 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 Hurley Stage II or Hurley Stage III HS as determined by the investigator at screening and baseline visits
- 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) at screening and baseline visits
- Have a total abscess and inflammatory nodule (AN) count of greater than or equal to (>=) 5 at the screening and baseline visit
- Agree not to receive a live virus or live bacterial vaccination during the study and for 90 days after the last administration of study intervention
- Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has unstable cardiovascular disease, defined as a recent clinical deterioration (that is, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
- Has or has had herpes zoster within the 2 months before screening
- Has a transplanted organ (with exception of a corneal transplant greater than [>] 3 months before the first administration of study intervention)
- Has known allergies, hypersensitivity, or intolerance to bermekimab or adalimumab or its excipients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 (Group 1): Placebo 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. Part 1 (Group 2): Adalimumab Placebo 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. Part 1 (Group 3): Bermekimab Dose 1 Bermekimab 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. Part 1 (Group 3): Bermekimab Dose 1 Placebo 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. Part 2 (Group 3): Bermekimab Dose 1 Placebo 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. Part 2 (Group 1): Placebo 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. Part 2 (Group 4): Bermekimab Dose 2 Placebo 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. Part 1 (Group 2): Adalimumab 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. Part 1 (Group 1): Placebo Bermekimab 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. Part 2 (Group 1): Placebo Bermekimab 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. Part 2 (Group 2): Bermekimab Dose 1 Bermekimab Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 31. Part 2 (Group 3): Bermekimab Dose 1 Bermekimab 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. Part 2 (Group 4): Bermekimab Dose 2 Bermekimab 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.
- Primary Outcome Measures
Name Time Method Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16 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.
- Secondary Outcome Measures
Name Time Method Part 1: Change From Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16 Baseline, 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.
Part 1: Change From Baseline in Number of Abscess at Week 16 Baseline, Week 16 Change from baseline in number of abscess at Week 16 was reported.
Part 1: Change From Baseline in Number of Draining Fistula at Week 16 Baseline, 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.
Part 1: Percentage of Participants Who Achieved HiSCR75 at Week 16 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.
Part 1: Percentage of Participants Who Achieved HiSCR90 at Week 16 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.
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 Baseline, 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.
Part 1: Change From Baseline in Number of Inflammatory Nodules at Week 16 Baseline, 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).
Part 1: Change From Baseline in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 16 Baseline up to 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.
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 Baseline, 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.
Serum Concentration of Bermekimab Weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 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.
Number of Participants With Antibodies to Bermekimab From baseline up to Week 36 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.
Trial Locations
- Locations (54)
Medical Dermatology Specialists
🇺🇸Phoenix, Arizona, United States
Forcare Clinical Research, Inc.
🇺🇸Tampa, Florida, United States
Allcutis Research
🇺🇸Beverly, Massachusetts, United States
JDR Dermatology Research
🇺🇸Las Vegas, Nevada, United States
First OC Dermatology
🇺🇸Fountain Valley, California, United States
Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
🇵🇱Wroclaw, Poland
Universitaets-Hautklinik Kiel
🇩🇪Kiel, Germany
Center for Dermatology Clinical Research
🇺🇸Fremont, California, United States
Clarkston Dermatology & Vein Center, PLLC
🇺🇸Clarkston, Michigan, United States
Minnesota Clinical Study Center
🇺🇸New Brighton, Minnesota, United States
Modern Research Associates
🇺🇸Dallas, Texas, United States
Universitaetsklinik Erlangen
🇩🇪Erlangen, Germany
Meiwa Hospital
🇯🇵Nishinomiya, Japan
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Sinclair Dermatology
🇦🇺East Melbourne, Australia
SimcoMed Health Ltd
🇨🇦Barrie, Ontario, Canada
York Dermatology Clinic and Research Centre
🇨🇦Richmond Hill, Ontario, Canada
Clinica Univ. de Navarra
🇪🇸Madrid, Spain
Penn State Milton S. Hershey Medical Ctr.
🇺🇸Hershey, Pennsylvania, United States
Clinical Partners
🇺🇸Johnston, Rhode Island, United States
Indiana Clinical Trial Center
🇺🇸Plainfield, Indiana, United States
Universitaetsmedizin Mainz
🇩🇪Mainz, Germany
Clinical Trials SA Pty Ltd
🇦🇺Campbelltown, Australia
Somerset Skin Centre
🇺🇸Troy, Michigan, United States
ActivMed Practices & Research
🇺🇸Portsmouth, New Hampshire, United States
Hosp. de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Wright State Physicians Health Center
🇺🇸Dayton, Ohio, United States
Katholisches Klinikum Bochum gGmbH
🇩🇪Bochum, Germany
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
Arlington Center for Dermatology
🇺🇸Arlington, Texas, United States
Centre De Recherche Dermatologique Du Quebec Metropolitan
🇨🇦Quebec, Canada
Takagi Dermatology Clinic
🇯🇵Obihiro-shi, Japan
Holdsworth House
🇦🇺Darlinghurst, Australia
Hosp. de Manises
🇪🇸Valencia, Spain
Universitatsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
University of the Ryukyus Hospital
🇯🇵Nakagami-gun, Japan
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Hosp. Univ. Germans Trias I Pujol
🇪🇸Badalona, Spain
Veracity Clinical Research
🇦🇺Woolloongabba, Australia
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Alliance Clinical Trials
🇨🇦Waterloo, Ontario, Canada
Wallace Medical Group, Inc.
🇺🇸Los Angeles, California, United States
Dawes Fretzin Clinical Research Group
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Center for Clinical Studies
🇺🇸Houston, Texas, United States
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Nagoya City University Hospital
🇯🇵Nagoya, Japan
Hosp. Gral. Univ. Gregorio Maranon
🇪🇸Madrid, Spain
Hosp. Univ. 12 de Octubre
🇪🇸Madrid, Spain
Centrum Medyczne Dermoklinika
🇵🇱Lódź, Poland
Royalderm Agnieszka Nawrocka
🇵🇱Warsaw, Poland
Wromedica
🇵🇱Wrocław, Poland
Hosp. Provincial de Pontevedra
🇪🇸Pontevedra, Spain