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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04988308
Other study ID # CR109063
Secondary ID 2020-002607-1977
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 12, 2021
Est. completion date November 23, 2022

Study information

Verified date October 2023
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants with moderate to severe Hidradenitis Suppurativa (HS).


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 information / eligibility

Status Terminated
Enrollment 151
Est. completion date November 23, 2022
Est. primary completion date October 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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


Related Conditions & MeSH terms


Intervention

Drug:
Bermekimab
Bermekimab will be administered subcutaneously.
Adalimumab
Adalimumab will be administered subcutaneously.
Placebo
Placebo will be administered subcutaneously.

Locations

Country Name City State
Australia Clinical Trials SA Pty Ltd Campbelltown
Australia Holdsworth House Darlinghurst
Australia Sinclair Dermatology East Melbourne
Australia Veracity Clinical Research Woolloongabba
Canada SimcoMed Health Ltd Barrie Ontario
Canada Centre De Recherche Dermatologique Du Quebec Metropolitan Quebec
Canada York Dermatology Clinic and Research Centre Richmond Hill Ontario
Canada Alliance Clinical Trials Waterloo Ontario
Germany Katholisches Klinikum Bochum gGmbH Bochum
Germany Universitaetsklinik Erlangen Erlangen
Germany Universitatsklinikum Frankfurt Frankfurt
Germany Universitaets-Hautklinik Kiel Kiel
Germany Universitaetsmedizin Mainz Mainz
Germany Universitätsklinikum Würzburg Würzburg
Japan Fukuoka University Hospital Fukuoka
Japan Nagoya City University Hospital Nagoya
Japan University of the Ryukyus Hospital Nakagami-gun
Japan Meiwa Hospital Nishinomiya
Japan Takagi Dermatology Clinic Obihiro-shi
Netherlands University Medical Center Groningen Groningen
Netherlands Erasmus Medisch Centrum Rotterdam
Poland Centrum Medyczne Dermoklinika Lódz
Poland Royalderm Agnieszka Nawrocka Warsaw
Poland Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spólka Partnerska Wroclaw
Poland Wromedica Wroclaw
Spain Hosp. Univ. Germans Trias I Pujol Badalona
Spain Hosp. de La Santa Creu I Sant Pau Barcelona
Spain Clinica Univ. de Navarra Madrid
Spain Hosp. Gral. Univ. Gregorio Maranon Madrid
Spain Hosp. Univ. 12 de Octubre Madrid
Spain Hosp. Provincial de Pontevedra Pontevedra
Spain Hosp. de Manises Valencia
United States Arlington Center for Dermatology Arlington Texas
United States Allcutis Research Beverly Massachusetts
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Clarkston Dermatology & Vein Center, PLLC Clarkston Michigan
United States Modern Research Associates Dallas Texas
United States Wright State Physicians Health Center Dayton Ohio
United States First OC Dermatology Fountain Valley California
United States Center for Dermatology Clinical Research Fremont California
United States Penn State Milton S. Hershey Medical Ctr. Hershey Pennsylvania
United States Center for Clinical Studies Houston Texas
United States Dawes Fretzin Clinical Research Group Indianapolis Indiana
United States Clinical Partners Johnston Rhode Island
United States JDR Dermatology Research Las Vegas Nevada
United States Wallace Medical Group, Inc. Los Angeles California
United States Minnesota Clinical Study Center New Brighton Minnesota
United States Renstar Medical Research Ocala Florida
United States Medical Dermatology Specialists Phoenix Arizona
United States Indiana Clinical Trial Center Plainfield Indiana
United States ActivMed Practices & Research Portsmouth New Hampshire
United States Progressive Clinical Research San Antonio Texas
United States Forcare Clinical Research, Inc. Tampa Florida
United States Somerset Skin Centre Troy Michigan

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Japan,  Netherlands,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Week 16
Secondary 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. Week 16
Secondary 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. Week 16
Secondary 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. Baseline, Week 16
Secondary Part 1: Change From Baseline in Number of Abscess at Week 16 Change from baseline in number of abscess at Week 16 was reported. Baseline, Week 16
Secondary 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. Baseline, Week 16
Secondary 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). Baseline, Week 16
Secondary 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. Baseline up to Week 16
Secondary 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. Baseline, Week 16
Secondary 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. Baseline, Week 16
Secondary 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. Weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36
Secondary 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. From baseline up to Week 36
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