A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of INCB054707 over a 24-week placebo-controlled double-blind treatment period, followed by a 28-week double-blind extension period in participants with nonsegmental vitiligo.

Official Title
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 Followed by an Extension Period in Participants With Vitiligo

Conditions
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NonSegmental Vitiligo

Intervention / Treatment
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* Drug: INCB054707
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of nonsegmental vitiligo. History of prior vitiligo treatment with a total duration of at least 3 months. 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 Further inclusion criteria apply. Exclusion Criteria: Other forms of vitiligo (eg, segmental) or other skin depigmentation disorders. Uncontrolled thyroid function at screening as determined by the investigator. Women who are pregnant (or who are considering pregnancy) or lactating. Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator. Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis. Participants known to be infected with HIV, Hepatitis B, or Hepatitis C. Laboratory values outside of the protocol-defined ranges. Further exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: INCB054707 Dose A followed by Dose C<br>Participants will receive INCB054707 Dose A for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2). | Drug: INCB054707<br>* INCB054707 will be administered once daily<br>* Other names: Povorcitinib;|
| Experimental: INCB054707 Dose B<br>Participants will receive INCB054707 Dose B for 52 weeks (Period 1 + Period 2). | Drug: INCB054707<br>* INCB054707 will be administered once daily<br>* Other names: Povorcitinib;|
| Experimental: INCB054707 Dose C<br>Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2). | Drug: INCB054707<br>* INCB054707 will be administered once daily<br>* Other names: Povorcitinib;|
| Placebo Comparator: Placebo followed by INCB054707 Dose C<br>Participants will receive placebo for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2). | Drug: Placebo<br>* Placebo or INCB054707 will be administered once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 | The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. Percent change was calculated as ([post-Baseline value minus the Baseline value] / Baseline value) x 100. | Baseline; Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving T-VASI50 at Week 24 | T-VASI50 was defined as a 50% or greater reduction from Baseline in T-VASI. The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive body regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. | Baseline; Week 24 | 
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period. | up to Week 24 |