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

NCT04988308 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR1090632020-002607-1977474462HDS2001
• Study Type: interventional
• Target: 151
• Locations: 8 countries
• Sites: 54

Brief Summary

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

Conditions

Hidradenitis Suppurativa

Outcome Measures

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.

  Week 16

Secondary Outcomes (11)

• Part 1: Percentage of Participants Who Achieved HiSCR75 at Week 16

  Week 16

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

  Week 16

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

  Baseline, Week 16

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

  Baseline, Week 16

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

  Baseline, Week 16

Study Arms (7)

Part 1 (Group 1): Placebo

PLACEBO COMPARATOR

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

Part 1 (Group 2): Adalimumab

ACTIVE COMPARATOR

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

Part 1 (Group 3): Bermekimab Dose 1

EXPERIMENTAL

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

Part 2 (Group 1): Placebo

PLACEBO COMPARATOR

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

Part 2 (Group 2): Bermekimab Dose 1

EXPERIMENTAL

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

Drug: Bermekimab

Part 2 (Group 3): Bermekimab Dose 1

EXPERIMENTAL

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

Part 2 (Group 4): Bermekimab Dose 2

EXPERIMENTAL

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

Bermekimab DRUG

Bermekimab will be administered subcutaneously.

Also known as: JNJ-77474462

Part 1 (Group 1): Placebo; Part 1 (Group 3): Bermekimab Dose 1; Part 2 (Group 1): Placebo; Part 2 (Group 2): Bermekimab Dose 1; Part 2 (Group 3): Bermekimab Dose 1; Part 2 (Group 4): Bermekimab Dose 2

Adalimumab DRUG

Adalimumab will be administered subcutaneously.

Part 1 (Group 2): Adalimumab

Placebo DRUG

Placebo will be administered subcutaneously.

Part 1 (Group 1): Placebo; Part 1 (Group 2): Adalimumab; Part 1 (Group 3): Bermekimab Dose 1; Part 2 (Group 1): Placebo; Part 2 (Group 3): Bermekimab Dose 1; Part 2 (Group 4): Bermekimab Dose 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (54)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

Wallace Medical Group, Inc.

Los Angeles, California, 90056, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Forcare Clinical Research, Inc.

Tampa, Florida, 33613, United States

Location

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46256, United States

Location

Indiana Clinical Trial Center

Plainfield, Indiana, 46168, United States

Location

Allcutis Research

Beverly, Massachusetts, 01915, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Clarkston Dermatology & Vein Center, PLLC

Clarkston, Michigan, 48346, United States

Location

Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

JDR Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

ActivMed Practices & Research

Portsmouth, New Hampshire, 03801, United States

Location

Wright State Physicians Health Center

Dayton, Ohio, 45324, United States

Location

Penn State Milton S. Hershey Medical Ctr.

Hershey, Pennsylvania, 17033, United States

Location

Clinical Partners

Johnston, Rhode Island, 02919, United States

Location

Arlington Center for Dermatology

Arlington, Texas, 76011, United States

Location

Modern Research Associates

Dallas, Texas, 75231, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Clinical Trials SA Pty Ltd

Campbelltown, 5074, Australia

Location

Holdsworth House

Darlinghurst, 2010, Australia

Location

Sinclair Dermatology

East Melbourne, 3002, Australia

Location

Veracity Clinical Research

Woolloongabba, 4102, Australia

Location

SimcoMed Health Ltd

Barrie, Ontario, L4M 7G1, Canada

Location

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Alliance Clinical Trials

Waterloo, Ontario, N2J 1C4, Canada

Location

Centre De Recherche Dermatologique Du Quebec Metropolitan

Québec, Quebec, G1V 4X7, Canada

Location

Katholisches Klinikum Bochum gGmbH

Bochum, 44791, Germany

Location

Universitaetsklinik Erlangen

Erlangen, 91054, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Universitaets-Hautklinik Kiel

Kiel, 24105, Germany

Location

Universitaetsmedizin Mainz

Mainz, 55131, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Location

Nagoya City University Hospital

Nagoya, 467-8602, Japan

Location

University of the Ryukyus Hospital

Nakagami-gun, 903-0215, Japan

Location

Meiwa Hospital

Nishinomiya, 663-8186, Japan

Location

Takagi Dermatology Clinic

Obihiro-shi, 080-0013, Japan

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 CE, Netherlands

Location

Centrum Medyczne Dermoklinika

Lódź, 90-436, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, 02-962, Poland

Location

Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, 50566, Poland

Location

Wromedica

Wroclaw, 51-685, Poland

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hosp. de La Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

Location

Clinica Univ. de Navarra

Madrid, 28027, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Provincial de Pontevedra

Pontevedra, 36003, Spain

Location

Hosp. de Manises

Valencia, 46940, Spain

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

bermekimab; Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

As per change in planned analysis, Part 2 and some secondary efficacy analysis of Part 1 in this study was not conducted due to early termination because interim analysis 1 efficacy results met the prespecified futility criteria related to the primary endpoint. Hence, data for Part 2 and some secondary efficacy outcome measures (Parts 1 and 2) were not collected in this results summary.

Results Point of Contact

• Title: Director Clinical Research Dermatology
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 3, 2021
• Study Start: October 12, 2021
• Primary Completion: October 14, 2022
• Study Completion: November 23, 2022
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

AU (4); NL (2); US (22); JP (5); ES (7); DE (6); CA (4); PL (4)