Clinical Trials in the UK / NCT06113471
Active, not recruiting
Phase 3
A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)
NCT06113471 · tracked via the Priya Life Science UK 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 (86)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama At Birmingham Hospital-Whitaker Clinic | Birmingham | Alabama | |
| C2 Research Center, Llc | Montgomery | Alabama | |
| First Oc Dermatology Research Inc | Fountain Valley | California | |
| Center For Dermatology Clinical Research, Inc | Fremont | California | |
| Marvel Clinical Research Llc | Huntington Beach | California | |
| Vitiligo & Pigmentation Institute of Southern California | Los Angeles | California | |
| Dermatology Research Associates | Los Angeles | California | |
| Clinical Trials Research Institute | Thousand Oaks | California | |
| Skin Care Research, Llc | Boca Raton | Florida | |
| Total Vein and Skin Llc | Boynton Beach | Florida | |
| Driven Research Llc | Coral Gables | Florida | |
| Florida Academic Centers Research and Education Llc | Coral Gables | Florida | |
| Pediatric Skin Research Llc | Coral Gables | Florida | |
| Metabolic Research Institute Inc | West Palm Beach | Florida | |
| Dermatology and Surgery Specialists of North Atlanta | Marietta | Georgia | |
| Advanced Medical Research Pc | Sandy Springs | Georgia | |
| Dundee Dermatology | West Dundee | Illinois | |
| Indiana University School of Medicine Iusm Indianapolis | Indianapolis | Indiana | |
| Delricht Research | Baton Rouge | Louisiana | |
| Callender Dermatology and Cosmetic Center | Glenn Dale | Maryland | |
| Aesthetic and Dermatology Center | Rockville | Maryland | |
| Henry Ford Health System | Detroit | Michigan | |
| Allcutis Research, Llc | Portsmouth | New Hampshire | |
| Weill Cornell Medical College | New York | New York | |
| Remington-Davis Clinical Research | Columbus | Ohio | |
| Oregon Medical Research Center, Pc | Portland | Oregon | |
| Dermatology Treatment and Research Center | Dallas | Texas | |
| Heights Dermatology and Aesthetic Center | Houston | Texas | |
| University of Texas, Md Anderson Cancer | Houston | Texas | |
| Innovative Dermatology: Legacy Medical Village | Plano | Texas | |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | |
| Premier Clinical Research | Spokane | Washington | |
| Medical Center Asklepii Ood | Dupnitsa | Bulgaria | |
| Medical Center Unimed Eood | Sliven | Bulgaria | |
| Ambulatory For Specialized Medical Care - Individual Practice For Specialized Medical Care - Skin An | Sofia | Bulgaria | |
| Aleksandrovska University Hospital | Sofia | Bulgaria | |
| 28 Diagnostic and Consultative Center | Sofia | Bulgaria | |
| British Columbia'S Centre For Dermatologic Science - the Skin Care Centre | Vancouver | British Columbia | |
| Lynderm Research Inc | Markham | Ontario |
+ 46 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 NCT06113471 on ClinicalTrials.gov ↗ ← All trials in the UK