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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
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
barzolvolimab
Subcutaneous Administration
Standard of Care
Observational/Standard of Care
Locations (15)
Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama, United States
Center for Dermatology & Plastic Surgery - Avacare
Scottsdale, Arizona, United States
Dermatology Research Associates
Los Angeles, California, United States
Encore Medical Research of Boynton Beach LLC
Boynton Beach, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Deluxe Health Center
Miami Lakes, Florida, United States
Advanced Clinical Research Institute (ACRI) - Florida
Tampa, Florida, United States
Centricity Research Columbus Dermatology
Columbus, Georgia, United States
The South Bend Clinic - Avacare
South Bend, Indiana, United States
Institute for Asthma and Allergy
Wheaton, Maryland, United States
Respiratory Medicine Research Institute of Michigan PLC
Ypsilanti, Michigan, United States
Michigan Center for Research Co., LLC (or Profound Research LLC at Clarkson Medical Group as listed in Suvoda)
Clarkson, 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