A Study of Bermekimab for the Treatment of Adult 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 of Bermekimab, compared with placebo, in participants with moderate-to-severe atopic dermatitis (AD).

Key facts

Study ID

NCT04990440

Run by

Janssen Research & Development, LLC

People needed

6

Starts

2021-09-02

Expected to finish

2022-03-09

Last updated by the study team

2023-05-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, due to important side effects or safety risks)
• Have an Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at screening and at baseline
• Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
• Must be willing to undergo 4 skin biopsies
• Have an Investigator Global Assessment (IGA) score >=3 at screening and at baseline
• Have an involved body surface area (BSA) >=10 percent (%) at screening and at 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 ever received any Human interleukin-1 (IL-1) antagonist (example, including but not limited to anakinra, rilonacept)

Where it is running

• Dawes Fretzin Clinical Research Group — Indianapolis, Indiana, United States
• Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
• Vital Prospects Clinical Research Institute, PC — Tulsa, Oklahoma, United States
• Modern Research Associates — Dallas, Texas, United States
• Progressive Clinical Research — San Antonio, Texas, United States
• Texas Dermatology and Laser Specialists — San Antonio, Texas, United States
• CARE - Centro de Alergia y Enfermedades Respiratorias — Buenos Aires, Argentina
• Conexa Investigacion Clinica S.A. — CABA, Argentina
• STAT Research S.A. — CABA, Argentina
• Clínica Adventista Belgrano — CABA, Argentina
• CINME - Centro de Investigaciones Metabolicas — Ciudad de Buenos Aires, Argentina

Full record on ClinicalTrials.gov

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