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Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Sponsor: Celldex Therapeutics
Summary
The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials. This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.
Official title: A Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1370
Start Date
2025-11-25
Completion Date
2028-09
Last Updated
2026-06-29
Healthy Volunteers
No
Conditions
Interventions
barzolvolimab
Subcutaneous Administration
Standard of Care
Observational/Standard of Care
Locations (63)
Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama, United States
Medical Research of Arizona
Scottsdale, Arizona, United States
Center for Dermatology & Plastic Surgery - Avacare
Scottsdale, Arizona, United States
Kern Research
Bakersfield, California, United States
Allergy and Asthma Associates of Southern California - Laguna Niguel - CRN
Laguna Niguel, California, United States
Dermatology Research Associates
Los Angeles, California, United States
LA Universal Research Center, Inc.
Los Angeles, California, United States
Encore Medical Research of Boynton Beach LLC
Boynton Beach, Florida, United States
Dolphin Medical Research
Doral, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Deluxe Health Center
Miami Lakes, Florida, United States
Sarasota Clinical Research
Sarasota, Florida, United States
Advanced Clinical Research Institute (ACRI) - Florida
Tampa, Florida, United States
Centricity Research Columbus Dermatology
Columbus, Georgia, United States
Endeavor Health
Skokie, Illinois, United States
The South Bend Clinic - Avacare
South Bend, Indiana, United States
John Hopkins University
Baltimore, Maryland, United States
Institute for Asthma and Allergy
Wheaton, Maryland, United States
Michigan Center for Research Co., LLC
Clarkston, Michigan, United States
Respiratory Medicine Research Institute of Michigan PLC
Ypsilanti, Michigan, United States
Midwest Clinical Research
St Louis, Missouri, United States
Montana Medical Research, Inc.
Missoula, Montana, United States
Bexley Dermatology Research
Bexley, Ohio, United States
Toledo Institute for Clinical Research
Toledo, Ohio, United States
Portland Allergy and Asthma
Clackamas, Oregon, United States
Clinical Partners LLC
Johnston, Rhode Island, United States
Western Sky Medical Research
El Paso, Texas, United States
Rainey & Finklea San Antonio (RFSA) Dermatology
San Antonio, Texas, United States
Conexa Investigación Clínica S.A.
CABA, Buenos Aires F.D., Argentina
Aprillus Asistencia e Investigacion de Arcis Salud SRL
CABA, Buenos Aires F.D., Argentina
Instituto de Especialidades de la Salud Rosario - Clínica del Tórax
Rosario, Sante Fe, Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Sante Fe, Argentina
Clinica Mayo de Urgencias
San Miguel de Tucumán, Tucumán Province, Argentina
Cornerstone Dermatology
Coorparoo, QSL, Australia
The Alfred Hospital - Kern
Melbourne, Victoria, Australia
Outpatient Clinic for IP for Specialized Outpatient Medical Care in Allergology-Dr.Cholak
Razgrad, Bulgaria
Medical Center Iskar EOOD
Sofia, Bulgaria
Medical Center Hera EOOD
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
Sofia, Bulgaria
Medical Center Pulmovision
Sofia, Bulgaria
Lima's Excellence In Allergy And Dermatology Research (Leader) Inc.
Hamilton, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
Evidence Based Medical Educator Inc.
Toronto, Ontario, Canada
Joel Liem Medicine Professional Corporation
Windsor, Ontario, Canada
CHRU Nantes Hôtel Dieu
Nantes, France
Hospital A. Syggros
Athens, Greece
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Krakow, Poland
MICS Centrum Medyczne Toruń
Torun, Poland
Klinika Ambroziak Dermatologia
Warsaw, Poland
Ginemedica Sp. z o.o.
Wroclaw, Poland
EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu
Wroclaw, Poland
Worthwhile Clinical Trials
Benoni, Gauteng, South Africa
Global Clinical Trials (Pty) Ltd - Pretoria
Pretoria, Gauteng, South Africa
About Allergy
Pretoria, Gauteng, South Africa
Synapta Clinical Research Centre
Durban, KwaZulu-Natal, South Africa
University of Cape Town Lung Institute (UCTLI)
Mowbray, Western Cape, South Africa
Ajou University Hospital
Suwon, South Korea
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Clinico San Carlos - Lopez Bran
Madrid, Spain
Hospital Universitario de La Plana
Villarreal de Huerva, Spain
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan