Open
Actively Recruiting
A Study of Barzolvolimab in Patients With Atopic Dermatitis
About
Brief Summary
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Male or female ≥ 18 years of age
- Diagnosis of chronic atopic dermatitis (AD) for at least 1 year
- Onset of symptoms at least 1 year prior and current symptoms consistent with moderate to severe AD as defined by:
- EASI ≥ 12 at Visit 1 and EASI ≥ 16 at Visit 2
- Body Surface Area of Involvement (BSA) ≥ 10% at Visit 1 and Visit 2
- IGA score ≥ 3 at Visit 1 and Visit 2
- Severe itch, defined by weekly average of daily PP-NRS score of ≥ 5, during the 7 days prior to treatment
- Documented history of inadequate response to treatment with topical medications or for whom topical medications are otherwise medically inadvisable.
- Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
Exclusion Criteria:
- Any other active pruritic skin diseases that would confound AD assessments based on the Investigator's clinical judgment.
- Phototherapy with ultraviolet (UV) A or UVB within 4 weeks of Visit 1.
- Planned or anticipated use of any prohibited medications at any time during the study.
- Prior receipt of barzolvolimab or other anti-KIT therapy. There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Join this Trial
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Study Stats
Protocol No.
24-6226
Category
Healthy Volunteers
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood