This is a clinical trial (study), to be conducted at multiple clinical sites, of an oral study drug (EP262) that will be investigated in adult participants with Chronic Spontaneous Urticaria (CSU) to assess if it is effective and safe.
Phase 1
Recruiting
- Conditions
- Chronic Spontaneous UrticariaMedDRA version: 20.0Level: PTClassification code: 10072757Term: Chronic spontaneous urticaria Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2023-504799-94-00
- Lead Sponsor
- Escient Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 114
Inclusion Criteria
Age 18 to 80 years, Documented history of chronic spontaneous urticaria (CSU) with a UAS7 greater than or equal to 16 despite stable treatment with H1 antihistamine consistent with standard of care, Must be on a stable dose of H1 antihistamine up to 4 times the approved dose per local treatment guidelines
Exclusion Criteria
Urticaria with a clear underlying etiology other than CSU, Urticaria with a clearly defined or sole trigger (chronic inducible urticaria), Other active skin diseases associated with chronic pruritus (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method