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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Dermatitis, Atopic

In brief

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

Key facts

Study ID

NCT04791319

Run by

Janssen Research & Development, LLC

People needed

199

Starts

2021-05-03

Expected to finish

2022-03-31

Last updated by the study team

2023-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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 (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

Where it is running

• 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

Full record on ClinicalTrials.gov

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