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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
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
barzolvolimab
Subcutaneous Administration
Standard of Care
Observational/Standard of Care
Locations (201)
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
Asthma and Allergy Associates
Colorado Springs, Colorado, 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
GSI Clinical Research
Margate, Florida, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, United States
Deluxe Health Center
Miami Lakes, Florida, United States
Sarasota Clinical Research
Sarasota, Florida, United States
GCP, Global Clinical Professionals
St. Petersburg, 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
Allergy and Asthma Specialists PSC
Owensboro, Kentucky, United States
John Hopkins University
Baltimore, Maryland, United States
DermAssociates, LLC
Rockville, 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
The Derm Institute of West Michigan
Caledonia, Missouri, United States
Midwest Clinical Research
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Montana Medical Research, Inc.
Missoula, Montana, United States
Skin Specialists, PC dba Schlessinger MD
Omaha, Nebraska, United States
Allergy Partners of NJ, PC
Ocean City, New Jersey, United States
Markowitz Medical PLLC dba OptiSkin Medical
New York, New York, United States
Bexley Dermatology Research
Bexley, Ohio, United States
Auni Allergy
Findlay, 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
Alina Clinical Trials LLC
Dallas, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
Rainey & Finklea San Antonio (RFSA) Dermatology
San Antonio, Texas, United States
Allergy and Asthma Care of Waco
Waco, Texas, United States
University of Utah MidValley Dermatology
Murray, Utah, United States
Allergy Associates of Utah
Sandy City, Utah, United States
Kalo Clinical Research
West Valley City, Utah, United States
Fundación CIDEA
Buenos Aires, Buenos Aires, Argentina
CEMLO - Centro de Especialidades Médicas Lobos
Lobos, Buenos Aires, Argentina
Conexa Investigación Clínica S.A.
CABA, Buenos Aires F.D., Argentina
Aprillus Asistencia e Investigacion
CABA, Buenos Aires F.D., Argentina
Centro de Investigaciones Clinicas - Instituto Especialidades de la Salud Rosario
Rosario, Sante Fe, Argentina
Centro Respiratorio Infantil
Rosario, Sante Fe, Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Sante Fe, Argentina
Clinica Mayo de U.M.C.B.
San Miguel de Tucumán, Tucumán Province, Argentina
Sanatorio 9 de Julio
San Miguel de Tucumán, Tucumán Province, Argentina
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, Tucumán Province, Argentina
Novatrials
Charlestown, New South Wales, Australia
Cornerstone Dermatology
Coorparoo, QSL, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Cliniques Universitaires Saint-Luc - PPDS
Brussels, Belgium
Medical Centre Asklepii OOD
Dupnitsa, Bulgaria
Medical Center Pulmo - 2018 EOOD
Haskovo, Bulgaria
Medical Center Medtech Services EOOD
Haskovo, Bulgaria
Medical Center Medconsult Pleven OOD
Lovech, Bulgaria
Outpatient Clinic for IP for Specialized Outpatient Medical Care in Allergology-Dr.Cholak
Razgrad, Bulgaria
Medical Center Prolet EOOD
Rousse, Bulgaria
Medical Center Iskar EOOD
Sofia, Bulgaria
Diagnostic and Consultative Center Ascendent EOOD
Sofia, Bulgaria
Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia, Bulgaria
Diagnostic and Consultative Center Focus-5 - Medical Establishment for Outpatient care OOD
Sofia, Bulgaria
Medical Center Hera EOOD
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N. I. Pirogov" EAD, Multiprofile Emergency Department, Allergology room
Sofia, Bulgaria
Diagnostic-Consultative Center Convex EOOD
Sofia, Bulgaria
Medical Center Pulmovision
Sofia, Bulgaria
MBAL Sv. Panteleymon AD - Yambol
Yambol, Bulgaria
Alberta DermaSurgery Centre - Probity - PPDS
Edmonton, Alberta, Canada
Vida Clinical Research
Edmonton, Alberta, Canada
LEADER research
Hamilton, Ontario, Canada
Triple A Lab, Inc.
Hamilton, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
North York Research Inc.
Toronto, Ontario, Canada
Evidence Based Medical Educator Inc.
Toronto, Ontario, Canada
Joel Liem Medicine Professional Corporation
Windsor, Ontario, Canada
Kingston Health Science Centre
Kingston, Canada
Centre de Recherche Saint-Louis
Québec, Canada
Hospital Base San Jose de Osorno
Osorno, Chile
Enroll SpA
Providencia, Chile
Clinica Davila - Recoleta
Recoleta, Chile
Centro Internacional de Estudios Clinicos (CIEC)
Recoleta, Chile
Biocinetic Servicios Medicos Ltda
Santiago, Chile
Clínica Dermacross S.A.
Vitacura, Chile
Centro de Inmunologia y Genetica CIGE S.A.S.
Medellín, Colombia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Aarhus Universitetshospital
Aarhus N, Denmark
Gentofte Hospital, Department of Dermatology and Allergy
Hellerup, Denmark
CHRU Nantes Hôtel Dieu
Nantes, France
CHU de Nice-Hôpital L'Archet
Nice, France
CHU de Nice. Hôpital L'Archet 2
Nice, France
D. Abuladze Georgian-Italian Clinic
Tbilisi, Georgia