Clinical Trial

A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)

Recruiting Phase 3
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Summary
The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2025-11-25; most recent amendment 2026-06-30.
Status change: Not Yet Recruiting → Recruiting 2025-12-09
Trial Details
NCT Number NCT07266402
Lead Sponsor Celldex Therapeutics
Conditions Chronic Inducible Urticaria, Cold Urticaria, Cold-Induced Urticaria, Symptomatic Dermographism
Enrollment 240 participants
Start Date 2026-01-15
Primary Completion 2028-06 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-29