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

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

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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