Trials / Recruiting

RecruitingNCT07266402

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 Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study of Barzolvolimab in Participants With Cold Induced Urticaria and Symptomatic Dermographism (EMBARQ-COLDU and SD)

Status: Recruiting
Phase: Phase 3
Study type: Interventional
Enrollment: 240 (estimated)

Sponsor: Celldex Therapeutics · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

Detailed description

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 (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 24-week treatment period where patients will receive barzolvolimab or placebo. Patients receiving barzolvolimab will receive 450mg at the start of the treatment period and then 150mg. Then there is 16-week follow-up period where all patients are observed.

Conditions

Interventions

Type	Name	Description
DRUG	Barzolvolimab	Subcutaneous Administration
DRUG	Matching Placebo	Subcutaneous Administration

Timeline

Start date: 2026-01-15
Primary completion: 2028-06-01
Completion: 2028-10-01
First posted: 2025-12-05
Last updated: 2026-03-27

Locations

72 sites across 7 countries: United States, Germany, Lithuania, Poland, South Africa, Spain, United Kingdom

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07266402. Inclusion in this directory is not an endorsement.