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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Time to disease worsening or treatment failure through Week 52 based on the occurrence of UAS7 (Urticaria Activity Score) of 16 or greater.
Timeframe: From Day 1 (baseline) to Week 52.
Time to disease worsening or treatment failure through Week 52 based on the occurrence of the discontinuation of barzolvolimab in Group 2 due to lack of efficacy or to a treatment related adverse event.
Timeframe: From Day 1 (baseline) to Week 52.
Time to disease worsening or treatment failure through Week 52 based on the occurrence of first use of strongly confounding prohibited medication (Group 1 or 2) or use of barzolvolimab in Group 1.
Timeframe: From Day 1 (baseline) to Week 52.