This Phase 3 study will evaluate the efficacy and safety of oral povorcitinib phosphate compared with placebo in Chinese adults with nonsegmental vitiligo who are considered suitable for systemic therapy. Approximately 174 participants will be randomized 1:1 to povorcitinib phosphate 30 mg once daily or matching placebo for 52 weeks, followed by a 4-week safety follow-up. The primary efficacy assessment is proportion of participants achieving ≥75% improvement from baseline in face vitiligo area scoring index at Week 52.
Able to understand and willing to sign written informed consent.
Age ≥18 years at consent; any sex.
Clinical diagnosis of nonsegmental vitiligo, with all of the following at screening and baseline: T-BSA ≥5%; T-VASI ≥4; F-BSA ≥0.5%; F-VASI ≥0.5%; and Considered suitable for systemic therapy by the investigator.Note: When assessing body surface area (BSA) and the Vitiligo Area Scoring Index (VASI), a Wood's lamp must be used in a darkroom. 4. Agrees to discontinue all vitiligo treatments from screening through the last safety follow-up visit.
Men with fertility potential: use highly effective contraception within at least 90 days from screening to the last dose of medication; do not donate sperm.
Patients clinically diagnosed with other types of vitiligo (e.g., segmental vitiligo) or other hypopigmentary skin disorders (including but not limited to piebaldism, pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive patchy hypopigmentation, nevus anemicus, chemical leukoderma, and pityriasis versicolor).
Following screening evaluation, white hair appears on more than 33% of the facial body surface area affected by vitiligo lesions; or white hair appears on more than 33% of the total body surface area (including the face) affected by vitiligo lesions.
Spontaneous and pronounced repigmentation occurring within the 6 months prior to screening (e.g., evident repigmentation without any prior treatment, as determined by the investigator).
Current or prior use of decolorizing agents such as hydroquinone monobenzyl ether (including Benoquin® [Monohydroquinone]).
Parallel
Povorcitinib phosphate
DrugPovorcitinib phosphate tablets, 30 mg orally once daily for 52 weeks.
Placebo
DrugMatching placebo orally once daily for 52 weeks.
Proportion of participants achieving F-VASI 75 at Week 52
Proportion of participants achieving ≥75% improvement from baseline in face vitiligo area scoring index (F-VASI 75). F-VASI 75 is defined as at least a 75% improvement from baseline in Facial Vitiligo Area Scoring Index(F-VASI). F-VASI is measured by multiplying the vitiligo involvement value assessed on each facial area by the percentage of affected skin, then adding the values from all areas.
Change from baseline in T-VASI at Week 52
T-VASI uses a formula that considers all body parts (range: 0-100), as follows: VASI = Σ All body parts \[palm units\] × \[degree of decolorization\].
Proportion of participants achieving T-VASI 50/75/90 at Week 52
Proportion of participants achieving ≥50%/75%/90% improvement from baseline in total body vitiligo area scoring index（T-VASI 50/75/90）
Proportion of participants achieving F-VASI 50/90 at Week 52
Proportion of participants achieving ≥50%/90% improvement from baseline in face vitiligo area scoring index (F-VASI 50/90)
Proportion of participants with VNS significantly lower (4) or no longer obvious (5) at Week 52
Vitiligo noticeability scale(VNS) is a patient-reported scale measuring the success of vitiligo treatment, using a 5-point scale. Participants were shown baseline facial photos for reference and provided with mirrors to assess their facial vitiligo.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
