A Phase 2a, proof-of-concept, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial to assess the efficacy and safety of ACT-777991 in adults with non-segmental vitiligo

Non-segmental vitiligo

Main primary endpoint: Percentage change from baseline in F-VASI based on BICR at Week 24 VASI is a validated clinician-reported outcome measure that scores both the extent (surface area) and degree (level of depigmentation) of vitiligo lesions over time. The F-VASI describes involvement of the face, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement., Supplementary primary endpoint: Percentage change from baseline in F-VASI based on investigator assessment at Week 24, Supplementary primary endpoint: Percentage change from baseline in F-VASI at Week 4, 8, and 16 F-VASI will be assessed by the investigator and by BICR., Supplementary primary endpoint: Achievement of F-VASI50 at Week 4, 8, 16 and 24 Proportion of patients achieving at least a 50% improvement from baseline in F-VASI., Supplementary primary endpoint: Achievement of F-VASI75 at Week 4, 8, 16 and 24 Proportion of patients achieving at least a 75% improvement from baseline in F-VASI., Supplementary primary endpoint: Achievement of F-VASI90 at Week 4, 8, 16 and 24 Proportion of patients achieving at least a 90% improvement from baseline in F-VASI.

Percentage change from baseline in T-VASI at Week 4, 8, 16 and 24 T-VASI will be assessed by the investigator. The T-VASI is calculated using a formula that includes contributions from all body regions, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement., Achievement of T-VASI50 based on investigator assessment at Week 4, 8, 16 and 24 Proportion of patients achieving at least a 50% improvement from baseline in T-VASI., Adverse events (AEs) leading to premature discontinuation of trial intervention, Treatment-emergent AEs and serious AEs (SAEs), Treatment-emergent AEs of special interest (AESIs), Change from baseline to all assessed time points in vital signs, clinical laboratory variables, and ECG measurements, Treatment-emergent marked abnormalities for vital signs, clinical laboratory variables, and ECG measurements

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