NCT05405660

A Study of CDX-0159 in Patients With Chronic Inducible Urticaria

: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-ranging Study to Assess the Efficacy and Safety of CDX-0159 in Patients With Chronic Inducible Urticaria

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Celldex Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.

Detailed description

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with Chronic Inducible Urticaria (Cold Urticaria \[ColdU\] or Symptomatic Dermographism \[SD\]) who remain symptomatic despite the use of H1-antihistamines. There is a screening period of up to 4 weeks, followed by a 20-week treatment period where patients will receive either barzolvolimab 150mg, 300mg or placebo, and then a 24-week follow up period where all patients are observed.

Conditions

• Chronic Inducible Urticaria

Interventions

Type	Name	Description
BIOLOGICAL	barzolvolimab	Subcutaneous Administration
DRUG	Matching Placebo	Subcutaneous Administration

Timeline

• Start date: 2022-06-28
• Primary completion: 2024-06-12
• Completion: 2025-09-12
• First posted: 2022-06-06
• Last updated: 2025-11-06

Locations

76 sites across 11 countries: United States, Bulgaria, Estonia, Georgia, Germany, Hungary, Latvia, Lithuania, Poland, South Africa, Spain

Regulatory

• FDA-regulated drug study