Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Key Inclusion Criteria:
- 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.
Key Exclusion Criteria:
- 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.
Join this Trial
Enrolling by Invitation
These studies are not open to everyone who meets the eligibility criteria, but
only to people in that particular population, who are specifically invited to participate.
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Study Stats
Protocol No.
26-0714
Category
Autoimmune Disorders
Principal Investigator
Contact
- Yvonne Nong
- Hamida Askaryar
Location
- UCLA Santa Monica
- UCLA Westwood