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

NCT ID: NCT04988308

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2022-11-23

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.

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Bermekimab

Intervention Type: DRUG

Bermekimab will be administered subcutaneously.

Placebo

Intervention Type: DRUG

Placebo will be administered subcutaneously.

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.

Group Type: ACTIVE_COMPARATOR

Adalimumab

Intervention Type: DRUG

Adalimumab will be administered subcutaneously.

Placebo

Intervention Type: DRUG

Placebo will be administered subcutaneously.

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.

Group Type: EXPERIMENTAL

Bermekimab

Intervention Type: DRUG

Bermekimab will be administered subcutaneously.

Placebo

Intervention Type: DRUG

Placebo will be administered subcutaneously.

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.

Group Type: PLACEBO_COMPARATOR

Bermekimab

Intervention Type: DRUG

Bermekimab will be administered subcutaneously.

Placebo

Intervention Type: DRUG

Placebo will be administered subcutaneously.

Part 2 (Group 2): Bermekimab Dose 1

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

Group Type: EXPERIMENTAL

Bermekimab

Intervention Type: DRUG

Bermekimab will be administered subcutaneously.

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.

Group Type: EXPERIMENTAL

Bermekimab

Intervention Type: DRUG

Bermekimab will be administered subcutaneously.

Placebo

Intervention Type: DRUG

Placebo will be administered subcutaneously.

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.

Group Type: EXPERIMENTAL

Bermekimab

Intervention Type: DRUG

Bermekimab will be administered subcutaneously.

Placebo

Intervention Type: DRUG

Placebo will be administered subcutaneously.

Interventions

Bermekimab

Bermekimab will be administered subcutaneously.

Intervention Type: DRUG

Adalimumab

Adalimumab will be administered subcutaneously.

Intervention Type: DRUG

Placebo

Placebo will be administered subcutaneously.

Intervention Type: DRUG

Other Intervention Names

JNJ-77474462

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Medical Dermatology Specialists

Phoenix, Arizona, United States

First OC Dermatology

Fountain Valley, California, United States

Center for Dermatology Clinical Research

Fremont, California, United States

Wallace Medical Group, Inc.

Los Angeles, California, United States

Renstar Medical Research

Ocala, Florida, United States

Forcare Clinical Research, Inc.

Tampa, Florida, United States

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States

Indiana Clinical Trial Center

Plainfield, Indiana, 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

Somerset Skin Centre

Troy, Michigan, United States

Minnesota Clinical Study Center

New Brighton, Minnesota, United States

JDR Dermatology Research

Las Vegas, Nevada, United States

ActivMed Practices & Research

Portsmouth, New Hampshire, United States

Wright State Physicians Health Center

Dayton, Ohio, United States

Penn State Milton S. Hershey Medical Ctr.

Hershey, Pennsylvania, United States

Clinical Partners

Johnston, Rhode Island, United States

Arlington Center for Dermatology

Arlington, Texas, United States

Modern Research Associates

Dallas, Texas, United States

Center for Clinical Studies

Houston, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

Clinical Trials SA Pty Ltd

Campbelltown, , Australia

Holdsworth House

Darlinghurst, , Australia

Sinclair Dermatology

East Melbourne, , Australia

Veracity Clinical Research

Woolloongabba, , Australia

SimcoMed Health Ltd

Barrie, Ontario, Canada

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, Canada

Alliance Clinical Trials

Waterloo, Ontario, Canada

Centre De Recherche Dermatologique Du Quebec Metropolitan

Québec, Quebec, Canada

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, , Germany

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, , Japan

University Medical Center Groningen

Groningen, , Netherlands

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Centrum Medyczne Dermoklinika

Lódź, , Poland

Royalderm Agnieszka Nawrocka

Warsaw, , Poland

Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, , Poland

Wromedica

Wroclaw, , Poland

Hosp. Univ. Germans Trias I Pujol

Badalona, , Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, , Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, , Spain

Clinica Univ. de Navarra

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Provincial de Pontevedra

Pontevedra, , Spain

Hosp. de Manises

Valencia, , Spain

Countries

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

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-002607-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

77474462HDS2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR109063

Identifier Type: -

Identifier Source: org_study_id