[Translation] A Phase III, Randomized, Double-Blind, 52-Week Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Ritlecitinib in Adult and Adolescent Subjects with Non-Segmental Vitiligo
主要目的是在患有非节段型白癜风的成人和(允许时)青少年受试者中,评估 Ritlecitinib 相较安慰剂的疗效和安全性。将以第 52 周时测量的 F-VASI75 和 T-VASI50 作为主要终点,评估 Ritlecitinib 的疗效。以第 24 和 36 周时的 F-VASI75、第 24 周时的 T-VASI50以及第 52 周时的 PGIS-F 和 PGIS-V 为关键次要终点。其他目的是评估安全性和证明对不同受试者的有利获益风险比,证明相关患者报告结局的改善,并提供短期和长期治疗数据。
[Translation] The primary objective was to assess the efficacy and safety of ritlecitinib compared with placebo in adult and (when permitted) adolescent subjects with non-segmental vitiligo. The efficacy of Ritlecitinib will be assessed using primary endpoints of F-VASI75 and T-VASI50 measured at week 52. Key secondary endpoints were F-VASI75 at weeks 24 and 36, T-VASI50 at week 24, and PGIS-F and PGIS-V at week 52. Additional objectives are to assess safety and demonstrate a favorable benefit-risk ratio for different subjects, demonstrate improvements in relevant patient-reported outcomes, and provide short- and long-term treatment data.