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Ritlecitinib in Nonsegmental Vitiligo
NCT06072183Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Nov 2023
- Primary completion
- Jul 2027
- Countries
- 18
- Sponsor
- Pfizer
- Modality
- Small Molecules
- Conditions
- nonsegmental vitiligo (NSV)
01
Overview
Phase 3, randomised, double-blind trial of ritlecitinib tosilate in nonsegmental vitiligo (NSV), sponsored by Pfizer. Primary endpoints: Facial Vitiligo Area Scoring Index 75 at 52 weeks, Total body Vitiligo Area Scoring Index 50 at 52 weeks and 2 more. Started Nov 2023; status: active, not recruiting.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Adults with active or stable nonsegmental vitiligo for at least 3 months, with 4% to 60% BSA involvement (excluding palms, soles, dorsal feet) and >=0.5% BSA involvement on the face. Must have F-VASI >=0.5 and T-VASI >=3. Excludes patients with other types of vitiligo, active inflammatory skin diseases, significant leukotrichia, active infections (including HBV, HCV, HIV, TB), and history of malignancies or severe medical conditions.
04
Endpoints
Primary
Facial Vitiligo Area Scoring Index 75
Total body Vitiligo Area Scoring Index 50
Treatment Emergent Adverse Events
Clinically significant laboratory abnormalities
Secondary
Facial Vitiligo Area Scoring Index 75
Total body Vitiligo Area Scoring Index 50
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