NON SEGMENTAL VITILIGO
Conditions
Brief summary
Response based on F-VASI75 (defined as at least 75% improvement in F-VASI from BL) at Week 52; • Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation. • Incidence of clinically significant laboratory abnormalities
Detailed description
Response based on F-VASI75 at Weeks 24 and 36, Response based on T-VASI50 at Weeks 24, 36, and 52, % CFB in F-VASI at Weeks 24, 36, and 52., % CFB in T-VASI at Weeks 24, 36, and 52., Response based on improvement in PGIS-Fb at Weeks 24, 36, and 52, Response based on improvement in PGIS-Vc at Weeks 24, 36, and 52
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response based on F-VASI75 (defined as at least 75% improvement in F-VASI from BL) at Week 52; • Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation. • Incidence of clinically significant laboratory abnormalities | — |
Secondary
| Measure | Time frame |
|---|---|
| Response based on F-VASI75 at Weeks 24 and 36, Response based on T-VASI50 at Weeks 24, 36, and 52, % CFB in F-VASI at Weeks 24, 36, and 52., % CFB in T-VASI at Weeks 24, 36, and 52., Response based on improvement in PGIS-Fb at Weeks 24, 36, and 52, Response based on improvement in PGIS-Vc at Weeks 24, 36, and 52 | — |
Countries
Bulgaria, Germany, Italy, Poland, Spain