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The trial is taking place at:
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Centro De Dermatologia De Monterrey | Monterrey, Mexico

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

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Incyte

Status and phase

Enrolling
Phase 3

Conditions

NonSegmental Vitiligo

Treatments

Drug: Placebo
Drug: Povorcitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06113445
2023-505782-86-00 (Registry Identifier)
INCB54707-303

Details and patient eligibility

About

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

Enrollment

444 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

444 participants in 2 patient groups, including a placebo group

Experimental: Povorcitinib Dose A
Experimental group
Description:
Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Treatment:
Drug: Povorcitinib
Placebo
Placebo Comparator group
Description:
Participants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Treatment:
Drug: Placebo

Trial contacts and locations

104

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Central trial contact

Incyte Corporation Call Center (US); Incyte Corporation Call Center (ex-US)

Data sourced from clinicaltrials.gov

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