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

Phase 3

Active, not recruiting

• Conditions: NonSegmental Vitiligo
• Interventions: Drug: Placebo; Drug: Povorcitinib

• Registration Number: NCT06113445
• Lead Sponsor: Incyte Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-02
• Study Start: 2023-11-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-05-09
• Study Completion: 2027-05-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 467

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Experimental: Povorcitinib Dose A	Povorcitinib	Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)	Week 52	≥75% improvement in facial Vitiligo Area Scoring Index.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants achieving a Vitiligo Noticeability Scale Score (VNS) of 4 or 5	Week 52 and Week 104	VNS is a participant reported outcome measure on a scale of 1-5, 1- more noticeable, 4 - a lot less noticeable, and 5- no longer noticeable.
Number of participants with Treatment-emergent Adverse Events (TEAEs)	Up to Week 104 and 30 days	Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Percentage change from Baseline in Total Body Vitiligo Area Scoring Index (T-VASI)	Week 52	Percentage change from Baseline in total body Vitiligo Area Scoring Index.
Proportion of participants achieving an Facial Static Investigator Global Assessment (FSIGA) of 0 or 1	Week 52 and Week 104	Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo).
Proportion of participants achieving a Static Investigator Global Assessment (SIGA) of 0 (clear) or 1 (almost clear)	Week 52 and Week 104	Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo).
Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)	Week 52	≥50% improvement in total body Vitiligo Area Scoring Index.
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75)	Week 52	≥75% improvement in total body Vitiligo Area Scoring Index
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)	Week 104	≥75% improvement in facial Vitiligo Area Scoring Index.
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)	Week 52 and Week 104	≥90% improvement in total body Vitiligo Area Scoring Index.
Proportion of participants in each Static Investigator Global Assessment (SIGA) category	Week 52 and Week 104	Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo).
Proportion of participants who report Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) of 1 or 2	Week 52 and Week 104	T-PaGIC-V is an assessment of improvement of vitiligo on the total body by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).
Proportion of participants in each Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) category	Week 52 and Week 104	T-PaGIC-V is an assessment of improvement of vitiligo on the total body by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)	Week 104	≥50% improvement in total body Vitiligo Area Scoring Index.
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)	Week 104	≥75% improvement in total body Vitiligo Area Scoring Index.
Proportion of participants who report Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) of 1 or 2	Week 52 and Week 104	F-PaGIC-V is an assessment of improvement of vitiligo on the face by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).
Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL)	Week 52 and Week 104	VitiQoL is a 15-item QoL assessment that asks participants to rate various aspects of their condition during the past month using a 7-point scale ("Not at all" to "All of the time").
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)	Week 52 and Week 104	≥50% improvement in facial Vitiligo Area Scoring Index.
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)	Week 52 and Week 104	≥90% improvement in facial Vitiligo Area Scoring Index.
Proportion of participants in each Facial Static Investigator Global Assessment (FSIGA) category	Week 52 and Week 104	Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo).
Proportion of participants in each Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) category	Week 52 and Week 104	F-PaGIC-V is an assessment of improvement of vitiligo on the face by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).
Proportion of participants in each category for the color-matching question	Week 52 and Week 104	Participants will answer how well the color of the treated skin matches the normal skin on a scale of 1-5, 1 being excellent to 5 being very poor.
Change from baseline in the Hospital Anxiety and Depression Scale (HADS) subscales	Week 52 and Week 104	HADS is a 14-item questionnaire that assesses the levels of anxiety and depression that a participant is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3).

Trial Locations

Locations (100)

Cahaba Dermatology; 🇺🇸 Hoover, Alabama, United States

University of California Irvine; 🇺🇸 Irvine, California, United States

Clinical Science Institute Clinical Research Specialists Inc; 🇺🇸 Santa Monica, California, United States

Cura Clinical Research; 🇺🇸 Sherman Oaks, California, United States

Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale Center; 🇺🇸 Sunnyvale, California, United States

Renaissance Research; 🇺🇸 Cape Coral, Florida, United States

Encore Medical Research, Llc; 🇺🇸 Hollywood, Florida, United States

San Marcus Research Clinic Inc.; 🇺🇸 Miami Lakes, Florida, United States

Savin Medical Group, Rc; 🇺🇸 Miami, Florida, United States

Skin Research of South Florida, Llc; 🇺🇸 Miami, Florida, United States

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