Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
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
Celldex Therapeutics
1,370 participants
Nov 25, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Written informed consent
- Must have successfully completed the preceding phase 3 clinical trials (CDX0159-12 or CDX0159-13).
- 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.
- Willing and able to comply with all study requirements and procedures, including completion of a daily symptom electronic diary.
Exclusion Criteria4
- Active pruritic skin condition in addition to CSU.
- Medical condition that would cause additional risk or interfere with study procedures.
- Participants without at least one documented UAS7 score from Weeks 64-68 of the CDX0159-12 or CDX0159-13 trials.
- There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
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Interventions
Subcutaneous Administration
Observational/Standard of Care
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT07256392