A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: Placebo; Bermekimab; Dupilumab
Intervention description: Placebo will be administered subcutaneously.; Bermekimab will be administered subcutaneously.; Dupilumab will be administered subcutaneously.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 199.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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

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