Vitiligo

Phase III Vitiligo Study

• Population: Participants aged 12 years or older
• Study Condition: Stable or active vitiligo diagnosed for at least three months
• Study Design: This is a double arm, open label, 20-week Phase III study with three and six-month follow up periods, in patients with a documented history of generalized vitiligo. Up to 200 eligible patients across study sites will be enrolled and randomised in equal numbers to one of the following treatment groups:
  • Group A will receive NB-UVB twice weekly from Day 0 (40 treatments in total), and SCENESSE® (one implant administered on Days 0, 21 (±4), 42 (±4), 63 (±4), 84 (±4), 105(±4) and 126 (±4) (seven implants in total));

  To determine eligibility for study participation, patients will undergo a screening evaluation within a 28-day period before receiving the first study treatment.

• Duration: Approximately 12 months
• Compensation may be provided for participation.

• Group B will receive NB-UVB light only (administered twice weekly for 20 weeks, 40 treatments in total).

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 50mg QD in Adult Participants with Nonsegmental Vitiligo

• Population: Adult participants 18 years of age and older
• Study Condition: Nonsegmental vitiligo, both active and stable, with a clinical diagnosis for at least 3 months
• Study Design: This is a Phase 3 randomized, double-blind, 52-week placebo-controlled multicenter study with a double-blind 52-week extension period with randomized dose-up/down titration investigating the efficacy, safety, and tolerability of ritlecitinib 100 mg QD and 50 mg QD compared to placebo in adult participants with nonsegmental vitiligo. After a screening period of up to 30 days, eligible participants will be randomized in a 3:1:1 ratio to ritlecitinib 100 mg QD, ritlecitinib 50 mg QD, and placebo in the 52-week placebo-controlled treatment period. At Week 52, based on their responder status participants will enter the 52-week double-blind extension period and will either be re-randomized to dose-up titration period, dose-down titration period, or dose-ranging period, or enter a nonrandomized extension period.
• Compensation may be provided for participation

A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Topical Cream in Pediatric Participants With Nonsegmental Vitiligo

• Population: Patients aged 2 to ≤ 11 years
• Study Condition: Nonsegmental Vitiligo
• Study Design: This study is a randomized, double-blind, vehicle-controlled phase 3 study with an open label, treatment-extension period to evaluate the safety and efficacy of an investigational topical cream in pediatric patients with nonsegmental vitiligo. Approximately 180 participants will be enrolled and randomized across study sites. There will be a 30-day screening period, a Double-Blind period for 24 weeks in which subjects will have been randomized to either the study cream BID or vehicle cream BID, followed by a 28 week open-label treatment extension period, and a safety follow-up period for 30 days.
• Duration: Approximately 14 months
• Compensation may be provided for participation.