Clinical Study for Cold-Induced Hives
Do you experience hives or itching when your skin is exposed to cold temperatures? You may be living with cold-induced urticaria, a type of chronic inducible urticaria that can cause uncomfortable and recurring symptoms.
Advanced ENT & Allergy is participating in a clinical research study evaluating an investigational treatment for adults with cold-induced urticaria. The EMBARQ-COLDU study is evaluating barzolvolimab to assess its safety and efficacy in adults whose symptoms remain inadequately controlled with H1-antihistamines.
Primary Investigator: Kali Gerace, M.D.
Study Sponsor: Celldex Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT07266402
What Is Cold-Induced Urticaria?
Cold-induced urticaria, sometimes called cold hives, is a condition in which exposure to cold temperatures can trigger hives, itching, redness, or swelling of the skin.
Symptoms may occur after exposure to cold air, cold water, cold objects, or other cold environments. For some people, symptoms can interfere with everyday activities and quality of life.
Learn More About Cold-Induced Urticaria
In this video, learn more about cold-induced urticaria, what can trigger symptoms, and when it may be time to talk with a specialist.
What Is the EMBARQ-COLDU Clinical Trial?
The EMBARQ-COLDU clinical trial is a Phase 3, randomized, double-blind, placebo-controlled study evaluating barzolvolimab in adults with cold-induced urticaria and symptomatic dermographism. The study is designed to assess the safety and efficacy of barzolvolimab compared with placebo.
The study includes adults who continue to experience symptoms despite treatment with H1-antihistamines. Additional eligibility requirements apply.
How Does Cold-Induced Urticaria Affect Daily Life?
Cold-induced hives can be triggered by situations that are part of everyday life, from cold weather to swimming or handling cold objects. This video provides more information about common triggers and how cold-induced urticaria can affect daily activities.
Who May Qualify?
You may be eligible for the EMBARQ-COLDU clinical trial if you:
- Are 18 years of age or older
- Have been diagnosed with cold-induced urticaria
- Have experienced symptoms for at least 3 months
- Continue to experience symptoms despite treatment with H1-antihistamines
- Meet additional study requirements
The study team will review your medical history and other eligibility criteria to determine whether you may qualify.
What Can I Expect From a Clinical Trial?
Participating in a clinical study involves regular visits with the research team and monitoring throughout the study. The study team will explain the clinical trial, answer your questions, review the requirements, and determine whether you qualify before you decide whether to participate.
Clinical trials are voluntary, and the study team can provide additional information about the potential benefits, risks, procedures, and time commitment involved.
Interested in Learning More?
If you have cold-induced urticaria and are interested in learning whether you may qualify for the EMBARQ-COLDU clinical trial at Advanced ENT & Allergy, contact our clinical research team.
Primary Investigator:
Kali Gerace, M.D.
Advanced ENT & Allergy
Rhonda Dase, Study Coordinator
(502) 399-1885 x 80071
rdase@advancedentandallergy.com
Learn More About the EMBARQ-COLDU Study
View the full study information on ClinicalTrials.gov, including the study's eligibility requirements and locations.
ClinicalTrials.gov Identifier: NCT07266402
Clinical trial participation is voluntary. Additional eligibility criteria apply. The study team will determine whether you qualify.
