Selective Treatment of Oral Povorcitinib in Vitiligo Study 2 (STOP-V2)
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo
IRAS ID
1009249
Contact name
Guillaume BEAUGÉ
Contact email
Sponsor organisation
Incyte Corporation
Clinicaltrials.gov Identifier
Research summary
The study is researching an experimental oral drug called povorcitinib. An unmet need remains for the treatment of patients with vitiligo (pigment cells in skin is destroyed causing it to be pale), and those for whom a treatment applied to skin is unsuitable.
Povorcitinib has previously been studied in a phase 2 study where it demonstrated efficacy in participants with vitiligo with ≥ 8% affected Body Surface Area (1% BSA is equal to skin area equal to one palm) and has been generally safe and well tolerated. This Phase 3 study is to confirm the efficacy and safety findings from the povorcitinib Phase 2 study in a larger participant population. Participants will be aged ≥ 18 years with vitiligo which affects their face amongst other areas on the body.
The trial will consist of a screening period, a 52-week treatment period and a 52-week extension period. Approximately 444 participants will receive either povorcitinib or placebo once daily. Half of the study participants will receive povorcitinib and half will receive placebo and it will be random who will receive povorcitinib or placebo. Participants completing both the placebo-controlled and extension periods may have the opportunity to participate in a separate rollover study.
The trials main aim is to look at the proportion of participants achieving a 75% or greater reduction (an improvement of at least 2/3 of vitiligo) in the face following 52 weeks of treatment.
The study is looking at several other research questions, including:
• The percentage change from baseline in the Total Vitiligo Area at Week 52
• The proportion of participants achieving a 50% or greater reduction in the Total Vitiligo Area at Week 52
• The proportion of participants achieving a 75% or greater reduction in the Total Vitiligo Area at Week 52.
• The proportion of participants achieving a Vitiligo Noticeability of "4 – A lot less noticeable" or "5 – No longer noticeable" at Week 52.
• The frequency and severity of side effects.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
24/NW/0040
Date of REC Opinion
22 Mar 2024
REC opinion
Further Information Favourable Opinion