A Phase 3 Placebo-Controlled Study With Randomized Dose Up/Dose Down Extension Period Investigating the Efficacy, Safety, and Tolerability of Ritlecitinib 100 mg and 50 mg QD in Adult Participants with Nonsegmental Vitiligo
- Conditions
- nonsegmental vitiligoMedDRA version: 21.1Level: PTClassification code: 10047642Term: Vitiligo Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2022-502518-98-00
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1450
Participants must be =18 years of age at Screening., Eligible participants must have at both Screening and BL: •A clinical diagnosis of nonsegmental vitiligo for at least 3 months; and •Body surface area (BSA) involvement between 4%-60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet; and •BSA =0.5% involvement on the face (face is defined as including the area on the forehead to the original hairline, on the cheek vertically to the jawline, and laterally from the corner of the mouth to the tragus. The face will not include scalp, ears, neck, or surface area of the lips, but will include the nose and the eyelids); and •F-VASI =0.5 and T-VASI =3; and •Either active or stable nonsegmental vitiligo at both Screening and BL visits. All participants who do not have the features of active vitiligo (defined below) will be classified as having stable disease.
Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin, History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.
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