Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)
Lead Sponsor:
Incyte Corporation
Conditions:
NonSegmental Vitiligo
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2027
Estimated Enrollment :
467 Patients enrolled
Trial Details
Trial ID
NCT06113445
Start Date
November 29 2023
End Date
February 24 2027
Last Update
September 9 2025
Active Locations (100)
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1
Cahaba Dermatology
Hoover, Alabama, United States, 35244
2
University of California Irvine
Irvine, California, United States, 92697
3
Clinical Science Institute Clinical Research Specialists Inc
Santa Monica, California, United States, 90404
4
Cura Clinical Research
Sherman Oaks, California, United States, 91403