NCT06727552

A Study of Barzolvolimab in Patients With Atopic Dermatitis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Moderate to Severe Atopic Dermatitis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Celldex Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis

Detailed description

This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of barzolvolimab (CDX-0159) in adult participants with Atopic Dermatitis. There is a screening period of up to 28 days, a 16-week double-blind, placebo-controlled treatment period, a 16-week double-blind, active treatment period, and a 16-week follow-up period. On Day 1, participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (CDX-0159) by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg \[Arm 1\], 300 mg Q4W after an initial loading dose of 450 mg \[Arm 2\], or placebo Q4W \[Arm 3\]. At Week 16, participants on placebo will be re-randomized on a 1:1 ratio to receive barzolvolimab by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg. Participants on Arms 1 and 2 will undergo a mock re-randomization at Week 16 to maintain the blind.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	Barzolvolimab	Subcutaneous Administration
DRUG	Matching placebo	Subcutaneous Administration

Timeline

• Start date: 2024-12-18
• Primary completion: 2026-10-01
• Completion: 2027-05-01
• First posted: 2024-12-11
• Last updated: 2026-03-27

Locations

33 sites across 1 country: United States

Regulatory

• FDA-regulated drug study