Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
completion around

Description

Summary

This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.

Official Title

A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo

Keywords

NonSegmental Vitiligo, Vitiligo, Povorcitinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California Irvine not yet accepting patients
    Irvine California 92697 United States
  • Clinical Science Institute Clinical Research Specialists Inc not yet accepting patients
    Santa Monica California 90404 United States
  • Jordan Valley Dermatology Center accepting new patients
    West Jordan Utah 84088 United States
  • Randall Dermatology accepting new patients
    Kokomo Indiana 46901 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT06113445
Phase
Phase 3 Vitiligo Research Study
Study Type
Interventional
Participants
Expecting 444 study participants
Last Updated