Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT07256392
Eligibility Criteria:
Key Inclusion Criteria:
1. Written informed consent
2. Must have completed 52 weeks of treatment and the 16-week follow up in either the CDX0159-12 or CDX0159-13successfully 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 interfere with study procedures.
3. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07256392
Study Brief:
Protocol Section:
NCT07256392