A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)

Launched by INCYTE CORPORATION · Oct 27, 2023

Keywords

ClinConnect Summary

This clinical trial, called the STOP-V1 study, is looking at a new treatment called povorcitinib for people with nonsegmental vitiligo, a condition that causes patches of skin to lose their color. The researchers want to find out if this treatment is effective and safe for adults aged 18 and older who have a certain level of skin involvement from vitiligo. To participate, individuals must have a specific amount of skin affected by the condition and agree to stop using any other treatments for vitiligo during the study.

Participants in the trial will be monitored closely to see how well the treatment works and if there are any side effects. It's important to note that not everyone can join; people with other skin conditions, certain medical histories, or those currently pregnant or breastfeeding will not be eligible. If you or a loved one is considering joining this study, it may be a good opportunity to help researchers understand more about treating vitiligo while also receiving potential benefits from the new treatment.

Gender

ALL

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.