Phase 3 Study of Barzolvolimab Compared to Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Not Fully Controlled by H1-Antihistamines

What this Trial Is About

Researchers are evaluating the activity and safety of barzolvolimab compared to placebo in adults with cold induced urticaria or symptomatic dermographism who continue to have symptoms despite using H1-antihistamines. This Phase 3, randomized, double-blind, placebo-controlled trial aims to understand how barzolvolimab works in these conditions that cause hives and itching triggered by cold or skin friction. Participants will first go through a screening period of up to 4 weeks to confirm eligibility. The treatment period lasts 52 weeks and has two parts for the first 24 weeks, patients receive either barzolvolimab or placebo by subcutaneous injection every 4 weeks, with an initial barzolvolimab dose of 450mg followed by 150mg doses. For the next 28 weeks, all patients receive 300mg barzolvolimab every 8 weeks. After treatment, there is a 16-week follow-up period during which participants are observed without receiving study drug. During the study, participants will have provocation testing to measure responses at various time points, including weeks 4, 12, and 24. Researchers will assess symptoms like itch and hives and measure thresholds related to cold and friction triggers. Participants will complete daily symptom diaries and attend regular visits for safety monitoring and assessments. The main outcome is a complete response to provocation testing at week 12. Overall participation lasts about 1 year including screening, treatment, and follow-up.

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)