NCT04021862

A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis

Detailed description

This is a phase II, randomized, double-blind, placebo-controlled study of bermekimab in patients with moderate to severe atopic dermatitis. The primary objective of the study is to analyze the safety and efficacy of different dose regimens of bermekimab compared to placebo treatment in adult patients with moderate-to-severe AD. The study is multicenter and will consist of three groups: Treatment Arm 1: Bermekimab every week (qw) Treatment Arm 2: Bermekimab every other week (q2w) Arm 3 (Placebo): Placebo every week (qw)

Conditions

• Atopic Dermatitis
• Eczema

Interventions

Type	Name	Description
DRUG	Bermekimab Monoclonal Antibody	Bermekimab 400 mg or 800 mg will be administered subcutaneously.
DRUG	Placebo	Placebo will be administered subcutaneously.

Timeline

• Start date: 2019-10-16
• Primary completion: 2020-06-30
• Completion: 2020-11-19
• First posted: 2019-07-16
• Last updated: 2025-02-04
• Results posted: 2023-09-05

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study