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).

Timeline

Start

2021-05-03

Primary completion

2022-02-02

Completion

2022-03-31

Outcome

Missed primary endpoint

Stopped: “Premature Termination due to Interim Analysis (100 patients at Week 16) meeting futility.”

registry analysis (superiority test); Placebo vs Bermekimab 350 mg; p = 0.489; MH weights 7.1 (95% CI -12.1 to 26.2); Chi-squared; note: Threshold for significance at 0.05 level. NCT04791319 ↗

registry analysis (superiority test); Placebo vs Bermekimab 700 mg; p = 0.448; MH Weights 7.1 (95% CI -9.4 to 23.7); Chi-squared NCT04791319 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bermekimab	Monoclonal antibody	—	Subcutaneous
Comparator	Dupilumab	Monoclonal antibody	—	Subcutaneous

Indications