A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis
NCT ID: NCT04791319
Last Updated: 2023-03-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
199 participants
INTERVENTIONAL
2021-05-03
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1: Placebo
Participants will receive subcutaneous (SC) placebo once a week (qw) through Week 15. At Week 16, participants will crossover to receive SC bermekimab Dose 2 qw through Week 31.
Placebo
Placebo will be administered subcutaneously.
Bermekimab
Bermekimab will be administered subcutaneously.
Group 2: Bermekimab
Participant will receive SC bermekimab Dose 1 qw from Week 0 through Week 31.
Bermekimab
Bermekimab will be administered subcutaneously.
Group 3: Bermekimab
Participants will receive SC bermekimab Dose 2 qw from Week 0 through Week 15. At Week 16, participants who achieve an eczema area and severity index (EASI)-75 response (responders) will be rerandomized either to continue to receive bermekimab Dose 2 qw, or to receive bermekimab Dose 1 qw, through Week 31 and participants who do not achieve an EASI-75 response (non responders) will continue to receive bermekimab Dose 2 qw through Week 31.
Bermekimab
Bermekimab will be administered subcutaneously.
Group 4: Dupilumab
Participants will receive a loading dose of SC dupilumab Dose 1 at Week 0, SC placebo every two week (q2w) from Week 1 through Week 15 and then dupilumab Dose 2 q2w from Week 2 through Week 14. At Week 16, participants who achieve EASI-75 response (dupilumab responders) will continue on dupilumab Dose 2 q2w through Week 30 and placebo q2w from Week 17 through Week 31. Participants who do not achieve an EASI-75 response (dupilumab non-responders) will receive placebo qw from Week 16 through Week 18 (washout period) and bermekimab Dose 2 qw from Week 19 through Week 31.
Placebo
Placebo will be administered subcutaneously.
Bermekimab
Bermekimab will be administered subcutaneously.
Dupilumab
Dupilumab will be administered subcutaneously.
Interventions
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Placebo
Placebo will be administered subcutaneously.
Bermekimab
Bermekimab will be administered subcutaneously.
Dupilumab
Dupilumab will be administered subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have atopic dermatitis (AD) for at least 1 year (365 days) prior to the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history
* Have a history of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable (example \[eg\], due to important side effects or safety risks)
* Be considered, in the opinion of the investigator, a suitable candidate for dupilumab (DUPIXENT) therapy according to their country's approved DUPIXENT product labeling
* Have an eczema area and severity index (EASI) score greater than or equal (\>=) to 16 at screening and at baseline
* Have an investigator global assessment (IGA) score \>=3 and involved body surface area (BSA) \>=10 percent (%) at screening and baseline
Exclusion Criteria
* Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
* Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis), or has been hospitalized or received intravenous (IV) antibiotics for an infection during the 2 months before screening
* Has or has had herpes zoster within the 2 months before screening
* Has a history of being human immunodeficiency virus (HIV) antibody-positive, or tests positive for HIV at screening
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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California Allergy & Asthma Medical Group Inc.
Los Angeles, California, United States
Wolverine Clinical Trials
Santa Ana, California, United States
Park Avenue Dermatology
Orange Park, Florida, United States
Forcare Clinical Research, Inc.
Tampa, Florida, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States
Grekin Skin Institute
Warren, Michigan, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Ohio State University
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Clinical Partners
Johnston, Rhode Island, United States
Arlington Center for Dermatology
Arlington, Texas, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Virginia Clinical Research
Norfolk, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
Dermatology Research Institute Inc.
Calgary, Alberta, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
Allergy Research Canada Inc.
Niagara Falls, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Centre De Recherche Dermatologique Du Quebec Metropolitan
Québec, Quebec, Canada
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
ISA - Interdisciplinary Study Association GmbH
Berlin, , Germany
Goethe Universität Frankfurt
Frankfurt am Main, , Germany
TFS Trial Form Support GmbH
Hamburg, , Germany
MensingDerma research GmbH
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Praxis Dr. med. Beate Schwarz - Germany
Langenau, , Germany
Hautarztpraxis
Mahlow, , Germany
Takagi Clinic
Obihiro-shi, , Japan
Kume Clinic
Osaka Fu, , Japan
Sapporo Skin Clinic
Sapporo, , Japan
Nzoz Przychodnia Specjalistyczna Medica
Częstochowa, , Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, , Poland
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
Osielsko, , Poland
Klinika Ambroziak Estederm Sp. z o.o
Warsaw, , Poland
Royalderm Agnieszka Nawrocka
Warsaw, , Poland
Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wroclaw, , Poland
WroMedica I.Bielicka, A.Strzałkowska s.c.
Wroclaw, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-002587-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
77474462ADM2001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108932
Identifier Type: -
Identifier Source: org_study_id
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