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Active Not Recruiting
NCT06113445
A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)
Conditions: NonSegmental Vitiligo
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 467
Sponsor: Incyte Corporation
Location: Cahaba Dermatology Hoover Alabama
Summary
This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06113445). StuddyBuddy aggregates publicly available trial information.