Psoriasis Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

199

Study ID:

NCT04791319

Recruitment Status:

Terminated

Sponsor:

Janssen Research & Development, LLC

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There are 42 Locations for this study

See Locations Near You

California Allergy & Asthma Medical Group Inc.
Los Angeles California, 90025, United States
Wolverine Clinical Trials
Santa Ana California, 92705, United States
Park Avenue Dermatology
Orange Park Florida, 32073, United States
Forcare Clinical Research, Inc.
Tampa Florida, 33613, United States
Arlington Dermatology
Rolling Meadows Illinois, 60008, United States
Dawes Fretzin Clinical Research Group
Indianapolis Indiana, 46256, United States
Grekin Skin Institute
Warren Michigan, 48088, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Ohio State University
Columbus Ohio, 43215, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States
Clinical Partners
Johnston Rhode Island, 02919, United States
Arlington Center for Dermatology
Arlington Texas, 76011, United States
Austin Institute for Clinical Research
Pflugerville Texas, 78660, United States
Progressive Clinical Research
San Antonio Texas, 78213, United States
Center for Clinical Studies
Webster Texas, 77598, United States
Virginia Clinical Research
Norfolk Virginia, 23502, United States
Premier Clinical Research
Spokane Washington, 99202, United States
Dermatology Research Institute Inc.
Calgary Alberta, T2J 7, Canada
Lynderm Research Inc.
Markham Ontario, L3P 1, Canada
DermEdge Research
Mississauga Ontario, L4Y 4, Canada
Allergy Research Canada Inc.
Niagara Falls Ontario, L2H 1, Canada
Innovaderm Research Inc.
Montreal Quebec, H2H2B, Canada
Centre De Recherche Dermatologique Du Quebec Metropolitan
Quebec , G1V 4, Canada
Fachklinik Bad Bentheim
Bad Bentheim , 48455, Germany
ISA - Interdisciplinary Study Association GmbH
Berlin , 10789, Germany
Goethe Universität Frankfurt
Frankfurt/ Main , 60590, Germany
TFS Trial Form Support GmbH
Hamburg , 20537, Germany
MensingDerma research GmbH
Hamburg , 22391, Germany
Medizinische Hochschule Hannover
Hannover , 30625, Germany
Praxis Dr. med. Beate Schwarz - Germany
Langenau , 89129, Germany
Hautarztpraxis
Mahlow , 15831, Germany
Takagi Clinic
Obihiro-shi , 080-0, Japan
Kume Clinic
Osaka Fu , 593-8, Japan
Sapporo Skin Clinic
Sapporo , 060-0, Japan
Nzoz Przychodnia Specjalistyczna Medica
Czestochowa , 42-20, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz , 90-24, Poland
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
Osielsko , 86031, Poland
Klinika Ambroziak Estederm Sp. z o.o
Warszawa , 02-95, Poland
Royalderm Agnieszka Nawrocka
Warszawa , 02962, Poland
Centrum Medyczne Matusiak w CITYCLINICPrzychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wroclaw , 50566, Poland
WroMedica I.Bielicka, A.Strzałkowska s.c.
Wrocław , 51-68, Poland

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

199

Study ID:

NCT04791319

Recruitment Status:

Terminated

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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