A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)
Purpose
This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.
Condition
- NonSegmental Vitiligo
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Experimental: Povorcitinib Dose A |
Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks. |
|
|
Placebo Comparator Placebo |
Participants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks. |
|
Recruiting Locations
University of Alabama At Birmingham Hospital-Whitaker Clinic
Birmingham, Alabama 35294-0007
Birmingham, Alabama 35294-0007
More Details
- Status
- Recruiting
- Sponsor
- Incyte Corporation