Celldex Therapeutics
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.
This is a global, multicenter, long-term extension phase 3b study to determine the time to disease worsening or treatment failure in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods the phase 3 clinical trials. The study will consist of 2 Groups: Group 1 (Observation Group), comprising participants whose UAS7 score is less than 16 at entry and Group 2 (Barzolvolimab Retreatment Group) comprising participants whose UAS7 score is 16 or greater. Participation in this trial will last for approximately 52 weeks for participants assigned…
Key Inclusion Criteria: 1. Written informed consent 2. Must have successfully completed the preceding phase 3 clinical trials (CDX0159-12 or CDX0159-13). 3. Both males and females of child-bearing potential must agree to use highly effective contraceptives when receiving barzolvolimab treatment and for 150 days after treatment. 4. Willing and able to comply with all study requirements and procedures, including completion of a daily symptom electronic diary. Key Exclusion Criteria: 1. Active pruritic skin condition in addition to CSU. 2. Medical condition that would cause additional risk or…
Subcutaneous Administration
Observational/Standard of Care