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Clinical Trial ● Currently Recruiting Phase III NCT07266402

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)

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…

📅 03 Jun 2026 ⏱ 1 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT07266402
Start
2026-01-15
Completion
2028-06
ClinicaliQ Trial Snapshot
  • 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 III • NCT07266402.
  • Barzolvolimab reduces symptoms of cold-induced urticaria and dermographism better than placebo in patients uncontrolled on antihistamines.

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What This Trial Is Studying

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. Conditions: Chronic Inducible Urticaria, Cold Urticaria, Cold-Induced Urticaria, Symptomatic Dermographism Interventions: Barzolvolimab, Matching Placebo Lead Sponsor: Celldex Therapeutics Planned Enrollment: 240 participants

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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