Clinical Trials in Japan / NCT06113445
Active, not recruiting
Phase 3
A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)
NCT06113445 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
NonSegmental Vitiligo
Investigational drug(s) / intervention(s)
Povorcitinib →Placebo
Povorcitinib: Oral, Tablet
Placebo: Oral, Tablet
Study summary
This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.
Eligibility
Inclusion Criteria:
* Aged ≥ 18 years.
* Clinical diagnosis of nonsegmental vitiligo and meet the following:
* T-BSA ≥ 5%
* T-VASI score ≥ 4
* F-BSA ≥ 0.5%
* F-VASI score ≥ 0.5
* Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
* Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
* Other forms of vitiligo or skin depigmentation disorders.
* Clinically significant abnormal TSH or free T4 at screening.
* Use of laser or phototherapy within 8 weeks and dihydroxyacetone within 4 weeks prior to Day 1.
* Current or past use of the depigmenting agent monobenzyl ether of hydroquinone including Benoquin®.
* History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.
* Spontaneous and significant repigmentation within 6 months prior to screening.
* Women who are pregnant, considering pregnancy, or breast feeding.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or recurrent dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
* Evidence of infection with TB, HBV, HCV or HIV.
* History of failure to JAK inhibitor treatment of any inflammatory disease.
* Laboratory values outside of the protocol-defined ranges.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Primary outcome measure(s)
- Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) — Week 52
≥75% improvement in facial Vitiligo Area Scoring Index.
Trial sites (100)
| Facility | City | Region | Status |
|---|---|---|---|
| Cahaba Dermatology | Hoover | Alabama | |
| University of California Irvine | Irvine | California | |
| Clinical Science Institute Clinical Research Specialists Inc | Santa Monica | California | |
| Cura Clinical Research | Sherman Oaks | California | |
| Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale Center | Sunnyvale | California | |
| Renaissance Research | Cape Coral | Florida | |
| Encore Medical Research, Llc | Hollywood | Florida | |
| Savin Medical Group, Rc | Miami | Florida | |
| Skin Research of South Florida, Llc | Miami | Florida | |
| San Marcus Research Clinic Inc. | Miami Lakes | Florida | |
| Olympian Clinical Research | Tampa | Florida | |
| Forcare Clinical Research | Tampa | Florida | |
| Cleaver Medical Group | Cumming | Georgia | |
| Dermatology and Surgery Specialists of North Atlanta | Marietta | Georgia | |
| Pivotal Research Solutions | Stonecrest | Georgia | |
| Options Research Group, Llc | Kokomo | Indiana | |
| Allcutis Research, Llc | Beverly | Massachusetts | |
| Metro Boston Clinical Partners | Brighton | Massachusetts | |
| Great Lakes Research Group Inc | Bay City | Michigan | |
| Wayne State University Physician Group Dermatology | Dearborn | Michigan | |
| Revival Research Institute, Llc Dermatology | Troy | Michigan | |
| Medisearch Clinical Trials | Saint Joseph | Missouri | |
| Jdr Dermatology Research | Las Vegas | Nevada | |
| Empire Dermatology | East Syracuse | New York | |
| Sadick Dermatology Sadick Research Group | New York | New York | |
| Derm Research Center of New York Inc | Stony Brook | New York | |
| Dermatology Associates of Plymouth Meeting | Plymouth Meeting | Pennsylvania | |
| International Clinical Research Tennessee Llc | Murfreesboro | Tennessee | |
| University of Texas Physicians - Bellaire Station | Bellaire | Texas | |
| Center For Clinical Studies | Houston | Texas | |
| Progressive Clinical Research | San Antonio | Texas | |
| Jordan Valley Dermatology Center | West Jordan | Utah | |
| Clinical Research Partners Llc Crp Richmond Forest Avenue Office Building Location | Richmond | Virginia | |
| Dermatology Specialists of Spokane | Spokane | Washington | |
| Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel | Brussel/ Brussels/bruxelles | Belgium | |
| Universitair Ziekenhuis Gent (Uz Gent) | Ghent | Belgium | |
| Centre Hospitalier Universitaire de Liege - Sart Tilman | Liège | Belgium | |
| Cliniques Universitaires Ucl Saint-Luc | Woluwe-Saint-Lambert | Belgium | |
| Dermatology Research Institute | Calgary | Alberta | |
| Enverus Medical Research | Surrey | British Columbia |
+ 60 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06113445 on ClinicalTrials.gov ↗ ← All trials in Japan