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) — Stella
Phase 3 — Large-scale testing across thousands of people, comparing the new treatment against current standard treatments.
(72 sites) United States
Cahaba Dermatology & Skin Health Center, LLC, Birmingham, Alabama One of a Kind Clinical Research Center, LLC, Scottsdale, Arizona Kern Research, Inc., Bakersfield, California One of a Kind Clinical Research Center, Napa, California Allergy & Asthma Consultants, Redwood City, California Amicis Research Center, Sherman Oaks, California FOMAT - Allergy, Asthma & Immunology Medical Group, Ventura, California Direct Helpers Research Center, Hialeah, Florida Well Pharma Medical Research, Corp., Miami, Florida Deluxe Health Center, LLC, Miami Lakes, Florida GCP, Global Clinical Professionals, St. Petersburg, Florida Advanced Clinical Research Institute, Tampa, Florida Centricity Research Columbus Dermatology, Columbus, Georgia Treasure Valley Medical Research, Boise, Idaho Endeavor Health Clinical Trials Center, Skokie, Illinois Equity Medical, LLC, Bowling Green, Kentucky Advanced ENT and Allergy, PLLC, Louisville, Kentucky Johns Hopkins University, Baltimore, Maryland Revival Research Institute, LLC, Troy, Michigan Equity Medical, LLC, New York, New York Markowitz Medical PLLC dba OptiSkin Medical, New York, New York University of Cincinnati, Cincinnati, Ohio Allergy, Asthma & Clinical Research Center, Oklahoma City, Oklahoma Advanced Dermatology and Cosmetic Surgery - Spartanburg, Spartanburg, South Carolina RFSA Dermatology, San Antonio, Texas Allergy Associates of Utah, Sandy City, Utah Germany
Universitätsklinikum Augsburg - III. Med. Klinik, Augsburg Institut für Allergieforschung (IFA) Charité - Universitätsmedizin Berlin, Berlin Elbekliniken Buxtehude, Buxtehude Rosenpark Research, Darmstadt University Hospital Dresden, Dresden University Hospital Düsseldorf, Düsseldorf Universitatsklinkum Erlangen-Ulmenweg 18, Erlangen Universitätsklinikum Göttingen, Göttingen Universitätsklinikum Heidelberg, Heidelberg Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Lübeck LMU Klinikum der Universität, München Universitätsklinikum Münster, Klinik u. Poliklinik f. Dermatologie, Münster
Lithuania
UAB Ausros Medicinos Centras, Kaunas Republic Klaipeda Hospital, Klaipėda Center of Allergy Diagnosis and Treatment, Vilnius Santaros KTC (klinikiniu tyrimu centras), Vilnius Poland
Centrum Medyczne ALL-MED Badania Kliniczne, Krakow Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o., Krakow "Oddzial Kliniczny Chorob Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Uniwersytecki Szpital Kliniczny nr 1 w Lodzi", Lodz Santa Familia PTG Lodz, Lodz Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. N. med. Dorota Krasowska, Lublin Uniwersytecki Szpital Kliniczny w Opolu, Opole Medicome Sp. z o.o., Oświęcim EMC Instytut Medyczny S.A.PL CERTUS Szpital i Ambulatorium, Poznan Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie, Rzeszów Alergo-med Ośrodek Badań Klinicznych Spólka z ograniczoną odpowiedzialnością, Tarnów MICS Centrum Medyczne Toruń, Torun Klinika Ambroziak Dermatologia, Warsaw South Africa
Worthwhile Clinical Trials, Benoni Allergy and Immunology Unit, University of Cape Town Lung Institute (UCTLI), Cape Town Infinity Dermatology Inc, Durban Synapta Clinical Research Centre, Durban Newtown Clinical Research Centre, Johannesburg Sandton Medical Research Centre, Johannesburg Global Clinical Trials (Pty) Ltd, Pretoria Allergy and Asthma Centre, Westville Spain
Hospital del Mar, Barcelona Clinica Universidad Navarra - Pamplona, Pamplona United Kingdom
Addenbrooke's Hospital, Cambridge Queen Elizabeth University Hospital, Glasgow Salford Care Organisation NCA NHS Trust, Manchester Key details Sponsor
Celldex Therapeutics
Enrollment target
~240 participants
Primary completion
June 2028
Age range
18 Years and older
Last updated March 2026
Interested in joining? Universitäts-Hautklinik Tübingen, Tübingen
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Sp. Partnerska, Wroclaw