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 now · Phase 3 · Has a placebo group
Conditions studied: Chronic Inducible Urticaria, Cold Urticaria, Cold-Induced Urticaria, Symptomatic Dermographism
In brief
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.
Key facts
- Study ID
- NCT07266402
- Run by
- Celldex Therapeutics
- People needed
- 240
- Starts
- 2026-01-15
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cahaba Dermatology & Skin Health Center, LLC — Birmingham, Alabama, United States (enrolling)
- Kern Research, Inc. — Bakersfield, California, United States (enrolling)
- One of a Kind Clinical Research Center — Napa, California, United States (enrolling)
- One of a Kind Clinical Research Center, LLC — Scottsdale, Arizona, United States (enrolling)
- Amicis Research Center — Sherman Oaks, California, United States (enrolling)
- FOMAT - Allergy, Asthma & Immunology Medical Group — Ventura, California, United States (enrolling)
- Direct Helpers Research Center — Hialeah, Florida, United States (enrolling)
- Well Pharma Medical Research, Corp. — Miami, Florida, United States (enrolling)
- Deluxe Health Center, LLC — Miami Lakes, Florida, United States (enrolling)
- Allergy & Asthma Consultants — Redwood City, California, United States (enrolling)
- Advanced Clinical Research Institute — Tampa, Florida, United States (enrolling)
- Centricity Research Columbus Dermatology — Columbus, Georgia, United States (enrolling)
- Treasure Valley Medical Research — Boise, Idaho, United States (enrolling)
- Endeavor Health Clinical Trials Center — Skokie, Illinois, United States (enrolling)
- Equity Medical, LLC — Bowling Green, Kentucky, United States (enrolling)
- Advanced ENT and Allergy, PLLC — Louisville, Kentucky, United States (enrolling)
- Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
- Revival Research Institute, LLC — Troy, Michigan, United States (enrolling)
- Equity Medical, LLC — New York, New York, United States (enrolling)
- Markowitz Medical PLLC dba OptiSkin Medical — New York, New York, United States (enrolling)
- GCP, Global Clinical Professionals — St. Petersburg, Florida, United States (enrolling)
- Allergy, Asthma & Clinical Research Center — Oklahoma City, Oklahoma, United States (enrolling)
- Advanced Dermatology and Cosmetic Surgery - Spartanburg — Spartanburg, South Carolina, United States (enrolling)
- RFSA Dermatology — San Antonio, Texas, United States (enrolling)
- Allergy Associates of Utah — Sandy City, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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