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

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

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

Conditions
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NonSegmental Vitiligo

Intervention / Treatment
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* Drug: Povorcitinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Povorcitinib Dose A<br>Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks. | Drug: Povorcitinib<br>* Oral, Tablet<br>* Other names: INCB054707;|
| Placebo Comparator: Placebo<br>Participants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks. | Drug: Placebo<br>* Oral, Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) | Percentage change from Baseline in total body Vitiligo Area Scoring Index. | Week 52 | 
| Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) | ≥50% improvement in total body Vitiligo Area Scoring Index. | Week 52 | 
| Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) | ≥75% improvement in total body Vitiligo Area Scoring Index | Week 52 | 
| Proportion of participants achieving a Vitiligo Noticeability Scale Score (VNS) of 4 or 5 | 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. | Week 52 and Week 104 | 
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to Week 104 and 30 days | 
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50) | ≥50% improvement in facial Vitiligo Area Scoring Index. | Week 52 and Week 104 | 
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75) | ≥75% improvement in facial Vitiligo Area Scoring Index. | Week 104 | 
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90) | ≥90% improvement in facial Vitiligo Area Scoring Index. | Week 52 and Week 104 | 
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50) | ≥50% improvement in total body Vitiligo Area Scoring Index. | Week 104 | 
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75) | ≥75% improvement in total body Vitiligo Area Scoring Index. | Week 104 | 
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90) | ≥90% improvement in total body Vitiligo Area Scoring Index. | Week 52 and Week 104 | 
| Proportion of participants achieving an Facial Static Investigator Global Assessment (FSIGA) of 0 or 1 | Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo). | Week 52 and Week 104 | 
| Proportion of participants in each Facial Static Investigator Global Assessment (FSIGA) category | Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo). | Week 52 and Week 104 | 
| Proportion of participants achieving a Static Investigator Global Assessment (SIGA) of 0 (clear) or 1 (almost clear) | Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo). | Week 52 and Week 104 | 
| Proportion of participants in each Static Investigator Global Assessment (SIGA) category | Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo). | Week 52 and Week 104 | 
| Proportion of participants who report Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) of 1 or 2 | 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). | Week 52 and Week 104 | 
| Proportion of participants in each Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) category | 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). | Week 52 and Week 104 | 
| Proportion of participants who report Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) of 1 or 2 | 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). | Week 52 and Week 104 | 
| Proportion of participants in each Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) category | 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). | Week 52 and Week 104 | 
| Proportion of participants in each category for the color-matching question | 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. | Week 52 and Week 104 | 
| Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL) | 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). | Week 52 and Week 104 | 
| Change from baseline in the Hospital Anxiety and Depression Scale (HADS) subscales | 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). | Week 52 and Week 104 |