drugset / Trial / NCT07256392

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

NCT07256392 ↗

Phase 3 Enrolling by invitation 1370 enrolled Celldex Therapeutics
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-11-25
Primary completion
2028-09
Completion
2028-09

Drugs

EvaluationDrugModalityDoseRoute
Subject barzolvolimab Monoclonal antibody 150 mg Subcutaneous