Clinical Trial

Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Enrolling by Invitation Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 6 changes
notable Trial sites expanded: 63 -> 96 locations 2026-07-30
notable Trial sites expanded: 34 -> 63 locations 2026-06-30
critical Trial status changed: Recruiting → Enrolling by Invitation 2026-06-04
notable Trial sites expanded: 20 -> 34 locations 2026-05-27
notable Trial sites expanded: 15 -> 20 locations 2026-05-02
notable Trial sites expanded: 9 -> 15 locations 2026-04-01
Trial Details
NCT Number NCT07256392
Lead Sponsor Celldex Therapeutics
Conditions Chronic Spontaneous Urticaria
Enrollment 1,370 participants
Start Date 2025-11-25
Primary Completion 2028-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-29