drugset / Trial / 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)

NCT07266402 ↗

Phase 3 Recruiting 240 enrolled Celldex Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-01-15
Primary completion
2028-06
Completion
2028-10

Drugs

EvaluationDrugModalityDoseRoute
Subject barzolvolimab Monoclonal antibody 300 mg Subcutaneous