A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)

Phase 3Active Not RecruitingNCT06113471

Incyte Corporation450 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

450

Conditions

NonSegmental Vitiligo

Interventions

PovorcitinibDRUG

Oral, Tablet

PlaceboDRUG

Oral, Tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (86)

Outcomes

Primary Outcomes

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.

Time frame: Week 52

Secondary Outcomes

Percentage change from Baseline in Total Body Vitiligo Area Scoring Index (T-VASI)

Percentage change from Baseline in total body Vitiligo Area Scoring Index.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to Week 104 and 30 days

Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)

Data from ClinicalTrials.gov

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University of Alabama At Birmingham Hospital-Whitaker Clinic

Birmingham, Alabama, United States

C2 Research Center, Llc

Montgomery, Alabama, United States

First Oc Dermatology Research Inc

Fountain Valley, California, United States

Center For Dermatology Clinical Research, Inc

Fremont, California, United States

Marvel Clinical Research Llc

Huntington Beach, California, United States

Vitiligo & Pigmentation Institute of Southern California

Los Angeles, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Clinical Trials Research Institute

Thousand Oaks, California, United States

Skin Care Research, Llc

Boca Raton, Florida, United States

Total Vein and Skin Llc

Boynton Beach, Florida, United States

...and 76 more locations

≥50% improvement in facial Vitiligo Area Scoring Index.

Time frame: Week 52 and Week 104

Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)

≥75% improvement in facial Vitiligo Area Scoring Index.

Time frame: Week 104

Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VAS190)

≥90% improvement in facial Vitiligo Area Scoring Index.

Time frame: 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.

Time frame: Week 104

Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)

≥75% improvement in total body Vitiligo Area Scoring Index.

Time frame: Week 104

Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)

≥90% improvement in total body Vitiligo Area Scoring Index.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: Week 52 and Week 104

Proportion of participants in each Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) category

Time frame: 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).

Time frame: Week 52 and Week 104

Proportion of participants in each Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) category

Time frame: 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.

Time frame: 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").

Time frame: 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).

Time frame: Week 52 and Week 104