NCT06366750

A Study of Barzolvolimab in Patients With Prurigo Nodularis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Patients With Prurigo Nodularis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (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 prurigo nodularis.

Detailed description

The purpose of this study is to assess the efficacy and safety of barzolvolimab (CDX-0159) in adults with prurigo nodularis. There is a screening period of approximately 28 days, a 24-week double-blind treatment period and a 16-week follow-up period after treatment. 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, 300 mg Q4W after an initial loading dose of 450 mg, or placebo Q4W. Following the completion of the treatment period, participants may enter an open label extension portion of the study if they are eligible.

Conditions

• Prurigo Nodularis

Interventions

Type	Name	Description
BIOLOGICAL	barzolvolimab	subcutaneous administration
OTHER	Matching Placebo	subcutaneous administration

Timeline

• Start date: 2024-04-12
• Primary completion: 2026-06-01
• Completion: 2027-03-01
• First posted: 2024-04-16
• Last updated: 2026-01-30

Locations

72 sites across 6 countries: United States, Canada, Croatia, Germany, Poland, Spain

Regulatory

• FDA-regulated drug study