A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 2

Conditions: Dermatitis, Atopic

Treatments: Drug: Placebo; Drug: Bermekimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04990440

2020-005900-21 (EudraCT Number)

77474462ADM2003 (Other Identifier)

CR109057

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of Bermekimab, compared with placebo, in participants with moderate-to-severe atopic dermatitis (AD).

Enrollment: 6 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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 ever received any Human interleukin-1 (IL-1) antagonist (example, including but not limited to anakinra, rilonacept)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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6 participants in 3 patient groups

Part A: Bermekimab Dose 1

Experimental group

Description:

Participants will receive bermekimab Dose 1 or placebo as an intravenous (IV) infusion weekly from Week 0 to Week 15.

Treatment:

Drug: Bermekimab

Drug: Placebo

Part B: Bermekimab Dose 2

Experimental group

Description:

Participants will receive bermekimab Dose 2 or placebo as an IV infusion weekly from Week 0 to Week 15.

Treatment:

Drug: Bermekimab

Drug: Placebo

Part C: Bermekimab Dose 3

Experimental group

Description:

Participants will receive bermekimab or placebo at a higher or lower dose (not less than \[\<\] Dose 1) than Part B, but with a maximum dose of Dose 3 IV weekly based on pharmacokinetic (PK), pharmacodynamic (PD), efficacy, and safety analysis.

Treatment:

Drug: Bermekimab

Drug: Placebo