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A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy, and Safety Study

Anand Ganesan


A Study On:

  • Skin - Dermatologic

Status:

  • Open

Eligibility

NonSegmental Vitiligo
18 Years and older (Adult, Older Adult )

Official Title

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

Details

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


Eligibility

You can join if...

Inclusion Criteria:

  1. Aged greater than or equal to 18 years.
  2. Clinical diagnosis of nonsegmental vitiligo and meet the following:
    • T-BSA greater than or equal to 5%
    • T-VASI score greater than or equal to 4
    • F-BSA greater than or equal to 0.5%
    • F-VASI score greater than or equal to 0.5
  3. Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
  4. Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

  1. Other forms of vitiligo or skin depigmentation disorders.
  2. Clinically significant abnormal TSH or free T4 at screening.
  3. Use of laser or phototherapy within 8 weeks and dihydroxyacetone within 4 weeks prior to Day 1.
  4. Current or past use of the depigmenting agent monobenzyl ether of hydroquinone including Benoquin®.
  5. History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.
  6. Spontaneous and significant repigmentation within 6 months prior to screening.
  7. Women who are pregnant, considering pregnancy, or breast feeding.
  8. 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.
  9. Evidence of infection with TB, HBV, HCV or HIV.
  10. History of failure to JAK inhibitor treatment of any inflammatory disease.
  11. Laboratory values outside of the protocol-defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Get in touch with our study team