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

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.

Time frame: Baseline; Week 24

Population: Intent-to-Treat Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at randomization. Mixed-effect model for repeated measures (MMRM) model: (percent change from Baseline = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\] + visit + treatment\*visit + Baseline measurement + Baseline measurement\*visit). Only participants with available data were analyzed.

An 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.

Time frame: from Week 25 up to Week 76

Population: Extension Evaluable Population: all participants who received at least 1 dose of povorcitinib during the double-blind extension period

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.

Time frame: Baseline; Week 24

Population: Intent-to-Treat Population. The 95% confidence interval was based on the Clopper-Pearson exact method. Only participants with available data were analyzed.

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.

Time frame: up to Week 24

Population: Safety Population: all participants who received at least 1 dose of study drug. Treatment groups for this population were to have been determined according to the actual treatment the participant received on Day 1.