A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants with Moderate to Severe Atopic Dermatitis

Last Updated   December 5, 2021 - 00:00

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 2
    The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety.
  • Sites
    51 sites
  • Status
    Recruiting

SUMMARY

The purpose of this study is to evaluate the efficacy and safety of bermekimab in participants with moderate to severe atopic dermatitis (AD).

CONDITIONS

  • Dermatitis, Atopic

ELIGIBILITY

Inclusion Criteria:

  • • Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ECGs) performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
  • • 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 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 (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

DETAILS

LOCATIONS

Locations in:
United States, Canada, Japan, Poland, Germany
City or Province (51) Country (5) Status
Plainfield, IN Indiana Clinical Trial Center United States
Withdrawn
Dallas, TX Modern Research Associates United States
Withdrawn
Portland, OR Oregon Dermatology and Research Center United States
Withdrawn
Memphis, TN Clinical NeuroScience Solutions, Inc United States
Withdrawn
Portland, OR Oregon Medical Research Center United States
Withdrawn
Ocala, FL Renstar Medical Research United States
Withdrawn
Tampa, FL FORCARE CLINICAL RESEARCH, INC. United States
Recruiting
San Antonio, TX Progressive Clinical Research United States
Recruiting
Indianapolis, IN Dawes Fretzin Clinical Research Group United States
Recruiting
East Windsor, NJ Psoriasis Treatment Center of Central New Jersey United States
Recruiting
Johnston, RI Clinical Partners United States
Recruiting
Warren, MI Grekin Skin Institute United States
Recruiting
Pittsburgh, PA University of Pittsburgh Medical Center United States
Recruiting
Mississauga, ON DermEdge Research Canada
Recruiting
Orange Park, FL Park Avenue Dermatology United States
Recruiting
Arlington, TX Arlington Center for Dermatology United States
Recruiting
Webster, TX Center for Clinical Studies United States
Recruiting
Norfolk, VA Virginia Clinical Research United States
Recruiting
Spokane, WA Premier Clinical Research United States
Recruiting
Obihiro-shi, 01 Takagi Clinic Japan
Recruiting
Wrocław WroMedica I.Bielicka, A.Strzałkowska s.c. Poland
Recruiting
Osielsko DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c. Poland
Recruiting
Warszawa Klinika Ambroziak Estederm Sp. z o.o Poland
Recruiting
Warszawa Royalderm Agnieszka Nawrocka Poland
Recruiting
Czestochowa Nzoz Przychodnia Specjalistyczna Medica Poland
Recruiting
Montreal, QC Innovaderm Research Inc. Canada
Recruiting
Sapporo, 01 Sapporo Skin Clinic Japan
Recruiting
Lodz Centrum Terapii Wspolczesnej J. M. Jasnorzewska J. M. Jasnorzewska Spolka Komandytowo-Akcyjna Poland
Recruiting
Osaka Fu, 27 Kume Clinic Japan
Recruiting
Wroclaw Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska Poland
Recruiting
Hamburg, HH MensingDerma research GmbH Germany
Recruiting
Langenau, BW Praxis Dr. med. Beate Schwarz - Germany Germany
Recruiting
Mahlow, BB Hautarztpraxis Germany
Recruiting
Berlin, BE ISA - Interdisciplinary Study Association GmbH Germany
Recruiting
Bad Bentheim Fachklinik Bad Bentheim Germany
Recruiting
New York, NY Icahn School of Medicine at Mount Sinai United States
Recruiting
Frankfurt/ Main, HE Goethe Universität Frankfurt Germany
Recruiting
Hannover Medizinische Hochschule Hannover Germany
Recruiting
Santa Ana, CA Wolverine Clinical Trials United States
Recruiting
Tampa, FL Avita Clinical Research United States
Withdrawn
Quebec, QC Centre De Recherche Dermatologique Du Quebec Metropolitan Canada
Recruiting
Calgary, AB Dermatology Research Institute Inc. Canada
Recruiting
Rolling Meadows, IL Arlington Dermatology United States
Completed
Hamburg, HH TFS Trial Form Support GmbH Germany
Recruiting
Pflugerville, TX Austin Institute for Clinical Research United States
Recruiting
Los Angeles, CA California Allergy & Asthma Medical Group Inc. United States
Completed
Niagara Falls, ON Allergy Research Canada Inc. Canada
Recruiting
Hialeah, FL Doral Medical Research United States
Withdrawn
Rockville, MD DermAssociates, PC United States
Not yet recruiting
Markham, ON Lynderm Research Inc. Canada
Recruiting
Columbus, OH Ohio State University United States
Recruiting
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5

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Corresponds to individual site.

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