Trial Outcomes & Findings for Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo (NCT NCT04530344)

NCT ID: NCT04530344

Last Updated: 2025-08-14

Results Overview

Relapse was defined as a loss of 75% improvement from Baseline in the Face Vitiligo Area Scoring Index score (F-VASI75) response, assessed as percentage improvement in the F-VASI score at Baseline (Day 1 of the parent study) to \<75%.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 458 participants
• Primary outcome timeframe: from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study)
• Results posted on: 2025-08-14

Participant Flow

This study was conducted at 87 study centers in North America and Europe.

This randomized withdrawal and treatment-extension study (extension of treatment received in 2 parent studies: NCT04052425 or NCT04057573) was comprised of a 52-week extension treatment period and a 4-week safety follow-up period, starting 4 weeks (30 days) after the last application of study treatment or the last study visit.

Participant milestones

Measure	Cohort A: Vehicle Cream BID Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Overall Study STARTED	58	58	118	224
Overall Study COMPLETED	41	50	92	173
Overall Study NOT COMPLETED	17	8	26	51

Reasons for withdrawal

Measure	Cohort A: Vehicle Cream BID Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Overall Study Lost to Follow-up	3	3	3	10
Overall Study Withdrawal by Subject	14	5	18	33
Overall Study Adverse Event	0	0	0	1
Overall Study Lack of Efficacy	0	0	0	1
Overall Study Physician Decision	0	0	1	1
Overall Study Pregnancy	0	0	2	1
Overall Study Protocol Violation	0	0	0	1
Overall Study Site Closed Due to Noncompliance	0	0	0	1
Overall Study Discontinued due to COVID-19 Pandemic	0	0	1	0
Overall Study Missed Safety Follow-up Visit	0	0	1	0
Overall Study Personal Reasons	0	0	0	1
Overall Study Not Compliant with Protocol-specific Visit Window	0	0	0	1

Baseline Characteristics

Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

Baseline characteristics by cohort

Measure	Cohort A: Vehicle Cream BID n=58 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=58 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=224 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Total n=458 Participants Total of all reporting groups
Age, Continuous	39.3 years STANDARD_DEVIATION 12.49 • n=5 Participants	42.9 years STANDARD_DEVIATION 15.95 • n=7 Participants	39.7 years STANDARD_DEVIATION 14.62 • n=5 Participants	39.3 years STANDARD_DEVIATION 16.45 • n=4 Participants	39.9 years STANDARD_DEVIATION 15.47 • n=21 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	33 Participants n=7 Participants	61 Participants n=5 Participants	129 Participants n=4 Participants	254 Participants n=21 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	25 Participants n=7 Participants	57 Participants n=5 Participants	95 Participants n=4 Participants	204 Participants n=21 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	18 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants	23 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants	17 Participants n=21 Participants
Race/Ethnicity, Customized White	42 Participants n=5 Participants	48 Participants n=7 Participants	107 Participants n=5 Participants	180 Participants n=4 Participants	377 Participants n=21 Participants
Race/Ethnicity, Customized Captured as Latino in Database	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Persian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Indo-Caribbean	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Jordanian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Brazilian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Guyana	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Cape Verdean	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Dominican Republic	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Captured as Hispanic or Latino in Database	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Iranian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Indian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized North African	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Middle Eastern	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Arab//North-African	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White/Black/Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Mexican	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	11 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants	53 Participants n=4 Participants	93 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	45 Participants n=5 Participants	43 Participants n=7 Participants	99 Participants n=5 Participants	157 Participants n=4 Participants	344 Participants n=21 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Captured as Other in Database	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study)

Population: Intent-to-Treat Long-term Extension (ITT-Ext) Population: randomized participants who achieved ≥90% improvement from Baseline in the F-VASI score (≥F-VASI90) at Week 52. Treatment groups were defined according to the treatment assignment at randomization regardless of the actual study medication the participant received. Week 52 was the first visit of this Treatment Extension study (visits were named to reflect continuation from the parent studies). Only participants in Cohort A were analyzed.

Relapse was defined as a loss of 75% improvement from Baseline in the Face Vitiligo Area Scoring Index score (F-VASI75) response, assessed as percentage improvement in the F-VASI score at Baseline (Day 1 of the parent study) to <75%.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=56 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=55 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Time to Relapse (Defined as <F-VASI75)	NA days Interval 238.0 to The median and the upper limit of the confidence interval were not estimable because there were too few events of loss of F-VASI75 response.	NA days The median and the upper and lower limits of the confidence interval were not estimable because there were too few events of loss of F-VASI75 response.	—	—	—

SECONDARY outcome

Timeframe: from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study)

Population: ITT-Ext Population. Week 52 was the first visit of this Treatment Extension study (visits were named to reflect continuation from the parent studies). Only participants in Cohort A were analyzed.

Loss of adequate response was defined as a loss of 90% improvement from Baseline in the F-VASI score (F-VASI90) response, assessed as percentage improvement in the F-VASI score at Baseline (Day 1 of the parent study) to <90%.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=56 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=55 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Time to Loss of Adequate Response	195.0 days Interval 113.0 to 372.0	NA days The median and the upper and lower limits of the confidence interval were not estimable because there were too few events of loss of F-VASI90 response.	—	—	—

SECONDARY outcome

Timeframe: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: Full Analysis Set (FAS) without non-compliant site: all participants who received at least 1 dose of study drug at or after Week 52 (Baseline of Treatment Extension study). For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area [BSA]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period Week 52	98.2 percentage of participants Interval 90.6 to 100.0	98.2 percentage of participants Interval 90.6 to 100.0	45.8 percentage of participants Interval 36.6 to 55.2	65.6 percentage of participants Interval 58.9 to 71.9	—
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period Week 56	98.2 percentage of participants Interval 90.4 to 100.0	96.4 percentage of participants Interval 87.5 to 99.6	50.0 percentage of participants Interval 40.2 to 59.8	69.4 percentage of participants Interval 62.8 to 75.5	—
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period Week 60	97.9 percentage of participants Interval 88.9 to 99.9	98.1 percentage of participants Interval 89.7 to 100.0	54.2 percentage of participants Interval 44.3 to 63.9	69.2 percentage of participants Interval 62.5 to 75.4	—
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period Week 64	97.7 percentage of participants Interval 87.7 to 99.9	100.0 percentage of participants Interval 92.1 to 100.0	58.3 percentage of participants Interval 48.5 to 67.7	72.0 percentage of participants Interval 65.3 to 78.0	—
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period Week 68	95.1 percentage of participants Interval 83.5 to 99.4	100.0 percentage of participants Interval 92.1 to 100.0	63.6 percentage of participants Interval 53.7 to 72.6	77.1 percentage of participants Interval 70.9 to 82.6	—
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period Week 80	96.7 percentage of participants Interval 82.8 to 99.9	100.0 percentage of participants Interval 92.1 to 100.0	65.7 percentage of participants Interval 55.4 to 74.9	78.9 percentage of participants Interval 72.4 to 84.4	—
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period Week 92	100.0 percentage of participants Interval 85.2 to 100.0	97.7 percentage of participants Interval 87.7 to 99.9	66.0 percentage of participants Interval 55.5 to 75.4	84.4 percentage of participants Interval 78.2 to 89.3	—
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period Week 104	95.7 percentage of participants Interval 78.1 to 99.9	100.0 percentage of participants Interval 90.7 to 100.0	69.9 percentage of participants Interval 59.5 to 79.0	86.4 percentage of participants Interval 80.5 to 91.1	—

SECONDARY outcome

Timeframe: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

An F-VASI75 responder achieved at least 75% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period Week 52	98.2 percentage of participants Interval 90.6 to 100.0	98.2 percentage of participants Interval 90.6 to 100.0	16.1 percentage of participants Interval 10.0 to 24.0	30.8 percentage of participants Interval 24.8 to 37.3	—
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period Week 56	96.4 percentage of participants Interval 87.7 to 99.6	96.4 percentage of participants Interval 87.5 to 99.6	23.1 percentage of participants Interval 15.6 to 32.2	34.7 percentage of participants Interval 28.4 to 41.5	—
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period Week 60	95.8 percentage of participants Interval 85.7 to 99.5	90.4 percentage of participants Interval 79.0 to 96.8	29.0 percentage of participants Interval 20.6 to 38.5	40.8 percentage of participants Interval 34.1 to 47.7	—
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period Week 64	95.3 percentage of participants Interval 84.2 to 99.4	97.8 percentage of participants Interval 88.2 to 99.9	30.6 percentage of participants Interval 22.1 to 40.2	43.5 percentage of participants Interval 36.6 to 50.5	—
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period Week 68	87.8 percentage of participants Interval 73.8 to 95.9	100.0 percentage of participants Interval 92.1 to 100.0	34.6 percentage of participants Interval 25.6 to 44.4	48.6 percentage of participants Interval 41.6 to 55.5	—
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period Week 80	90.0 percentage of participants Interval 73.5 to 97.9	100.0 percentage of participants Interval 92.1 to 100.0	43.4 percentage of participants Interval 33.5 to 53.8	54.6 percentage of participants Interval 47.4 to 61.8	—
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period Week 92	100.0 percentage of participants Interval 85.2 to 100.0	97.7 percentage of participants Interval 87.7 to 99.9	47.9 percentage of participants Interval 37.5 to 58.4	60.3 percentage of participants Interval 52.8 to 67.6	—
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period Week 104	95.7 percentage of participants Interval 78.1 to 99.9	97.4 percentage of participants Interval 86.2 to 99.9	47.3 percentage of participants Interval 36.9 to 57.9	66.1 percentage of participants Interval 58.6 to 73.0	—

SECONDARY outcome

Timeframe: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

An F-VASI90 responder achieved at least 90% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period Week 52	98.2 percentage of participants Interval 90.6 to 100.0	96.5 percentage of participants Interval 87.9 to 99.6	0.0 percentage of participants Interval 0.0 to 3.1	2.3 percentage of participants Interval 0.7 to 5.2	—
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period Week 56	89.3 percentage of participants Interval 78.1 to 96.0	94.5 percentage of participants Interval 84.9 to 98.9	3.7 percentage of participants Interval 1.0 to 9.2	8.3 percentage of participants Interval 5.0 to 12.9	—
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period Week 60	83.3 percentage of participants Interval 69.8 to 92.5	86.5 percentage of participants Interval 74.2 to 94.4	8.4 percentage of participants Interval 3.9 to 15.4	15.2 percentage of participants Interval 10.6 to 20.7	—
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period Week 64	72.1 percentage of participants Interval 56.3 to 84.7	93.3 percentage of participants Interval 81.7 to 98.6	11.1 percentage of participants Interval 5.9 to 18.6	15.5 percentage of participants Interval 10.8 to 21.1	—
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period Week 68	68.3 percentage of participants Interval 51.9 to 81.9	95.6 percentage of participants Interval 84.9 to 99.5	12.1 percentage of participants Interval 6.6 to 19.9	22.4 percentage of participants Interval 16.9 to 28.6	—
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period Week 80	80.0 percentage of participants Interval 61.4 to 92.3	97.8 percentage of participants Interval 88.2 to 99.9	22.2 percentage of participants Interval 14.5 to 31.7	30.4 percentage of participants Interval 24.0 to 37.4	—
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period Week 92	78.3 percentage of participants Interval 56.3 to 92.5	93.0 percentage of participants Interval 80.9 to 98.5	24.5 percentage of participants Interval 16.2 to 34.4	32.4 percentage of participants Interval 25.6 to 39.8	—
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period Week 104	69.6 percentage of participants Interval 47.1 to 86.8	92.1 percentage of participants Interval 78.6 to 98.3	28.0 percentage of participants Interval 19.1 to 38.2	33.9 percentage of participants Interval 27.0 to 41.4	—

SECONDARY outcome

Timeframe: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Mean F-VASI Scores During the Extension Treatment Period Baseline	0.86 scores on a scale Standard Deviation 0.492	0.99 scores on a scale Standard Deviation 0.644	0.88 scores on a scale Standard Deviation 0.543	0.91 scores on a scale Standard Deviation 0.550	—
Mean F-VASI Scores During the Extension Treatment Period Week 52	0.05 scores on a scale Standard Deviation 0.110	0.07 scores on a scale Standard Deviation 0.181	0.51 scores on a scale Standard Deviation 0.459	0.39 scores on a scale Standard Deviation 0.374	—
Mean F-VASI Scores During the Extension Treatment Period Week 56	0.05 scores on a scale Standard Deviation 0.108	0.07 scores on a scale Standard Deviation 0.186	0.50 scores on a scale Standard Deviation 0.475	0.38 scores on a scale Standard Deviation 0.372	—
Mean F-VASI Scores During the Extension Treatment Period Week 60	0.06 scores on a scale Standard Deviation 0.145	0.09 scores on a scale Standard Deviation 0.186	0.45 scores on a scale Standard Deviation 0.450	0.35 scores on a scale Standard Deviation 0.375	—
Mean F-VASI Scores During the Extension Treatment Period Week 64	0.08 scores on a scale Standard Deviation 0.131	0.08 scores on a scale Standard Deviation 0.230	0.43 scores on a scale Standard Deviation 0.456	0.33 scores on a scale Standard Deviation 0.350	—
Mean F-VASI Scores During the Extension Treatment Period Week 68	0.11 scores on a scale Standard Deviation 0.199	0.04 scores on a scale Standard Deviation 0.081	0.40 scores on a scale Standard Deviation 0.430	0.31 scores on a scale Standard Deviation 0.352	—
Mean F-VASI Scores During the Extension Treatment Period Week 80	0.05 scores on a scale Standard Deviation 0.082	0.04 scores on a scale Standard Deviation 0.108	0.36 scores on a scale Standard Deviation 0.426	0.27 scores on a scale Standard Deviation 0.345	—
Mean F-VASI Scores During the Extension Treatment Period Week 92	0.04 scores on a scale Standard Deviation 0.055	0.04 scores on a scale Standard Deviation 0.076	0.38 scores on a scale Standard Deviation 0.471	0.23 scores on a scale Standard Deviation 0.281	—
Mean F-VASI Scores During the Extension Treatment Period Week 104	0.06 scores on a scale Standard Deviation 0.109	0.04 scores on a scale Standard Deviation 0.083	0.37 scores on a scale Standard Deviation 0.493	0.21 scores on a scale Standard Deviation 0.280	—

SECONDARY outcome

Timeframe: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 52	-0.81 scores on a scale Standard Deviation 0.464	-0.92 scores on a scale Standard Deviation 0.591	-0.37 scores on a scale Standard Deviation 0.346	-0.51 scores on a scale Standard Deviation 0.448	—
Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 56	-0.82 scores on a scale Standard Deviation 0.492	-0.90 scores on a scale Standard Deviation 0.594	-0.39 scores on a scale Standard Deviation 0.370	-0.54 scores on a scale Standard Deviation 0.457	—
Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 60	-0.84 scores on a scale Standard Deviation 0.447	-0.87 scores on a scale Standard Deviation 0.570	-0.43 scores on a scale Standard Deviation 0.402	-0.55 scores on a scale Standard Deviation 0.457	—
Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 64	-0.80 scores on a scale Standard Deviation 0.442	-0.87 scores on a scale Standard Deviation 0.527	-0.44 scores on a scale Standard Deviation 0.423	-0.58 scores on a scale Standard Deviation 0.452	—
Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 68	-0.73 scores on a scale Standard Deviation 0.316	-0.86 scores on a scale Standard Deviation 0.518	-0.46 scores on a scale Standard Deviation 0.437	-0.61 scores on a scale Standard Deviation 0.476	—
Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 80	-0.75 scores on a scale Standard Deviation 0.360	-0.86 scores on a scale Standard Deviation 0.508	-0.49 scores on a scale Standard Deviation 0.471	-0.64 scores on a scale Standard Deviation 0.478	—
Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 92	-0.76 scores on a scale Standard Deviation 0.341	-0.87 scores on a scale Standard Deviation 0.548	-0.48 scores on a scale Standard Deviation 0.531	-0.69 scores on a scale Standard Deviation 0.488	—
Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 104	-0.72 scores on a scale Standard Deviation 0.380	-0.92 scores on a scale Standard Deviation 0.561	-0.50 scores on a scale Standard Deviation 0.557	-0.68 scores on a scale Standard Deviation 0.514	—

SECONDARY outcome

Timeframe: Baseline (BL); up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 52	-94.45 percentage change Standard Deviation 14.069	-94.50 percentage change Standard Deviation 8.990	-44.32 percentage change Standard Deviation 27.775	-54.72 percentage change Standard Deviation 31.006	—
Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 56	-93.79 percentage change Standard Deviation 14.981	-93.21 percentage change Standard Deviation 12.573	-46.19 percentage change Standard Deviation 30.728	-57.38 percentage change Standard Deviation 31.256	—
Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 60	-93.85 percentage change Standard Deviation 9.087	-92.04 percentage change Standard Deviation 13.198	-50.55 percentage change Standard Deviation 30.537	-60.17 percentage change Standard Deviation 30.147	—
Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 64	-89.64 percentage change Standard Deviation 23.562	-94.87 percentage change Standard Deviation 8.079	-52.32 percentage change Standard Deviation 32.826	-62.94 percentage change Standard Deviation 27.427	—
Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 68	-87.98 percentage change Standard Deviation 19.644	-96.25 percentage change Standard Deviation 4.633	-55.27 percentage change Standard Deviation 32.433	-65.55 percentage change Standard Deviation 30.388	—
Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 80	-93.24 percentage change Standard Deviation 13.062	-96.65 percentage change Standard Deviation 4.683	-58.60 percentage change Standard Deviation 34.839	-69.38 percentage change Standard Deviation 29.091	—
Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 92	-95.77 percentage change Standard Deviation 5.586	-94.95 percentage change Standard Deviation 10.366	-55.44 percentage change Standard Deviation 49.855	-73.77 percentage change Standard Deviation 25.490	—
Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period Week 104	-90.53 percentage change Standard Deviation 17.763	-95.86 percentage change Standard Deviation 7.213	-56.53 percentage change Standard Deviation 57.087	-73.84 percentage change Standard Deviation 31.780	—

SECONDARY outcome

Timeframe: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period Week 52	80.7 percentage of participants Interval 68.1 to 90.0	71.9 percentage of participants Interval 58.5 to 83.0	16.9 percentage of participants Interval 10.7 to 25.0	42.5 percentage of participants Interval 35.9 to 49.3	—
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period Week 56	76.8 percentage of participants Interval 63.6 to 87.0	72.7 percentage of participants Interval 59.0 to 83.9	16.7 percentage of participants Interval 10.2 to 25.1	45.8 percentage of participants Interval 39.1 to 52.7	—
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period Week 60	83.3 percentage of participants Interval 69.8 to 92.5	75.0 percentage of participants Interval 61.1 to 86.0	19.6 percentage of participants Interval 12.6 to 28.4	49.8 percentage of participants Interval 42.8 to 56.7	—
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period Week 64	74.4 percentage of participants Interval 58.8 to 86.5	82.2 percentage of participants Interval 67.9 to 92.0	21.3 percentage of participants Interval 14.0 to 30.2	50.7 percentage of participants Interval 43.7 to 57.7	—
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period Week 68	70.7 percentage of participants Interval 54.5 to 83.9	84.4 percentage of participants Interval 70.5 to 93.5	29.9 percentage of participants Interval 21.4 to 39.5	54.3 percentage of participants Interval 47.3 to 61.2	—
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period Week 80	80.0 percentage of participants Interval 61.4 to 92.3	86.7 percentage of participants Interval 73.2 to 94.9	39.4 percentage of participants Interval 29.7 to 49.7	57.7 percentage of participants Interval 50.4 to 64.8	—
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period Week 92	73.9 percentage of participants Interval 51.6 to 89.8	86.0 percentage of participants Interval 72.1 to 94.7	48.9 percentage of participants Interval 38.5 to 59.5	61.5 percentage of participants Interval 53.9 to 68.6	—
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period Week 104	60.9 percentage of participants Interval 38.5 to 80.3	89.5 percentage of participants Interval 75.2 to 97.1	54.8 percentage of participants Interval 44.2 to 65.2	63.8 percentage of participants Interval 56.3 to 70.9	—

SECONDARY outcome

Timeframe: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

A T-VASI75 responder achieved at least 75% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period Week 52	38.6 percentage of participants Interval 26.0 to 52.4	42.1 percentage of participants Interval 29.1 to 55.9	3.4 percentage of participants Interval 0.9 to 8.5	12.2 percentage of participants Interval 8.2 to 17.3	—
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period Week 56	42.9 percentage of participants Interval 29.7 to 56.8	43.6 percentage of participants Interval 30.3 to 57.7	4.6 percentage of participants Interval 1.5 to 10.5	13.4 percentage of participants Interval 9.2 to 18.7	—
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period Week 60	45.8 percentage of participants Interval 31.4 to 60.8	38.5 percentage of participants Interval 25.3 to 53.0	4.7 percentage of participants Interval 1.5 to 10.6	14.2 percentage of participants Interval 9.8 to 19.7	—
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period Week 64	39.5 percentage of participants Interval 25.0 to 55.6	48.9 percentage of participants Interval 33.7 to 64.2	3.7 percentage of participants Interval 1.0 to 9.2	16.9 percentage of participants Interval 12.1 to 22.7	—
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period Week 68	39.0 percentage of participants Interval 24.2 to 55.5	42.2 percentage of participants Interval 27.7 to 57.8	6.5 percentage of participants Interval 2.7 to 13.0	22.4 percentage of participants Interval 16.9 to 28.6	—
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period Week 80	53.3 percentage of participants Interval 34.3 to 71.7	48.9 percentage of participants Interval 33.7 to 64.2	10.1 percentage of participants Interval 5.0 to 17.8	23.7 percentage of participants Interval 17.9 to 30.3	—
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period Week 92	43.5 percentage of participants Interval 23.2 to 65.5	53.5 percentage of participants Interval 37.7 to 68.8	12.8 percentage of participants Interval 6.8 to 21.2	29.1 percentage of participants Interval 22.5 to 36.3	—
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period Week 104	39.1 percentage of participants Interval 19.7 to 61.5	55.3 percentage of participants Interval 38.3 to 71.4	18.3 percentage of participants Interval 11.0 to 27.6	30.5 percentage of participants Interval 23.8 to 37.9	—

SECONDARY outcome

Timeframe: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

A T-VASI90 responder achieved at least 90% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period Week 52	12.3 percentage of participants Interval 5.1 to 23.7	12.3 percentage of participants Interval 5.1 to 23.7	0.0 percentage of participants Interval 0.0 to 3.1	2.3 percentage of participants Interval 0.7 to 5.2	—
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period Week 56	12.5 percentage of participants Interval 5.2 to 24.1	14.5 percentage of participants Interval 6.5 to 26.7	0.0 percentage of participants Interval 0.0 to 3.4	3.2 percentage of participants Interval 1.3 to 6.6	—
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period Week 60	16.7 percentage of participants Interval 7.5 to 30.2	17.3 percentage of participants Interval 8.2 to 30.3	0.0 percentage of participants Interval 0.0 to 3.4	3.8 percentage of participants Interval 1.7 to 7.3	—
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period Week 64	20.9 percentage of participants Interval 10.0 to 36.0	20.0 percentage of participants Interval 9.6 to 34.6	0.0 percentage of participants Interval 0.0 to 3.4	2.9 percentage of participants Interval 1.1 to 6.2	—
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period Week 68	22.0 percentage of participants Interval 10.6 to 37.6	20.0 percentage of participants Interval 9.6 to 34.6	0.9 percentage of participants Interval 0.0 to 5.1	4.3 percentage of participants Interval 2.0 to 8.0	—
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period Week 80	20.0 percentage of participants Interval 7.7 to 38.6	20.0 percentage of participants Interval 9.6 to 34.6	1.0 percentage of participants Interval 0.0 to 5.5	6.7 percentage of participants Interval 3.6 to 11.2	—
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period Week 92	21.7 percentage of participants Interval 7.5 to 43.7	20.9 percentage of participants Interval 10.0 to 36.0	2.1 percentage of participants Interval 0.3 to 7.5	8.9 percentage of participants Interval 5.2 to 14.1	—
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period Week 104	21.7 percentage of participants Interval 7.5 to 43.7	23.7 percentage of participants Interval 11.4 to 40.2	3.2 percentage of participants Interval 0.7 to 9.1	9.6 percentage of participants Interval 5.7 to 14.9	—

SECONDARY outcome

Timeframe: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Mean T-VASI Scores During the Extension Treatment Period Baseline	6.06 scores on a scale Standard Deviation 2.056	6.27 scores on a scale Standard Deviation 2.030	6.69 scores on a scale Standard Deviation 2.150	6.74 scores on a scale Standard Deviation 2.006	—
Mean T-VASI Scores During the Extension Treatment Period Week 52	2.38 scores on a scale Standard Deviation 2.206	2.36 scores on a scale Standard Deviation 1.805	5.25 scores on a scale Standard Deviation 3.248	3.90 scores on a scale Standard Deviation 2.132	—
Mean T-VASI Scores During the Extension Treatment Period Week 56	2.39 scores on a scale Standard Deviation 2.253	2.31 scores on a scale Standard Deviation 1.843	5.06 scores on a scale Standard Deviation 3.151	3.80 scores on a scale Standard Deviation 2.213	—
Mean T-VASI Scores During the Extension Treatment Period Week 60	2.21 scores on a scale Standard Deviation 2.176	2.30 scores on a scale Standard Deviation 1.841	4.86 scores on a scale Standard Deviation 3.150	3.58 scores on a scale Standard Deviation 2.122	—
Mean T-VASI Scores During the Extension Treatment Period Week 64	2.33 scores on a scale Standard Deviation 2.210	1.94 scores on a scale Standard Deviation 1.717	4.85 scores on a scale Standard Deviation 3.317	3.57 scores on a scale Standard Deviation 2.051	—
Mean T-VASI Scores During the Extension Treatment Period Week 68	2.45 scores on a scale Standard Deviation 2.231	1.76 scores on a scale Standard Deviation 1.378	4.51 scores on a scale Standard Deviation 3.060	3.43 scores on a scale Standard Deviation 2.160	—
Mean T-VASI Scores During the Extension Treatment Period Week 80	2.05 scores on a scale Standard Deviation 2.233	1.73 scores on a scale Standard Deviation 1.331	4.18 scores on a scale Standard Deviation 3.036	3.18 scores on a scale Standard Deviation 2.017	—
Mean T-VASI Scores During the Extension Treatment Period Week 92	2.17 scores on a scale Standard Deviation 1.913	1.65 scores on a scale Standard Deviation 1.244	4.12 scores on a scale Standard Deviation 3.477	3.04 scores on a scale Standard Deviation 2.128	—
Mean T-VASI Scores During the Extension Treatment Period Week 104	2.86 scores on a scale Standard Deviation 3.269	1.54 scores on a scale Standard Deviation 1.227	4.00 scores on a scale Standard Deviation 4.208	2.92 scores on a scale Standard Deviation 2.061	—

SECONDARY outcome

Timeframe: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Change from Baseline=post-Baseline value minus the Baseline value.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 52	-3.68 scores on a scale Standard Deviation 1.564	-3.91 scores on a scale Standard Deviation 1.526	-1.45 scores on a scale Standard Deviation 2.271	-2.83 scores on a scale Standard Deviation 1.938	—
Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 56	-3.71 scores on a scale Standard Deviation 1.615	-3.91 scores on a scale Standard Deviation 1.503	-1.69 scores on a scale Standard Deviation 2.217	-2.97 scores on a scale Standard Deviation 2.086	—
Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 60	-3.79 scores on a scale Standard Deviation 1.692	-3.95 scores on a scale Standard Deviation 1.585	-1.83 scores on a scale Standard Deviation 2.161	-3.16 scores on a scale Standard Deviation 2.027	—
Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 64	-3.60 scores on a scale Standard Deviation 2.033	-4.20 scores on a scale Standard Deviation 1.569	-1.84 scores on a scale Standard Deviation 2.375	-3.21 scores on a scale Standard Deviation 2.060	—
Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 68	-3.44 scores on a scale Standard Deviation 1.789	-4.24 scores on a scale Standard Deviation 1.534	-2.21 scores on a scale Standard Deviation 2.273	-3.35 scores on a scale Standard Deviation 2.143	—
Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 80	-3.79 scores on a scale Standard Deviation 1.663	-4.26 scores on a scale Standard Deviation 1.519	-2.49 scores on a scale Standard Deviation 2.175	-3.55 scores on a scale Standard Deviation 2.109	—
Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 92	-3.85 scores on a scale Standard Deviation 1.545	-4.33 scores on a scale Standard Deviation 1.673	-2.61 scores on a scale Standard Deviation 2.624	-3.73 scores on a scale Standard Deviation 2.246	—
Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 104	-3.05 scores on a scale Standard Deviation 2.156	-4.48 scores on a scale Standard Deviation 1.702	-2.71 scores on a scale Standard Deviation 3.479	-3.84 scores on a scale Standard Deviation 2.151	—

SECONDARY outcome

Timeframe: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 52	-65.01 percentage change Standard Deviation 23.969	-64.95 percentage change Standard Deviation 21.547	-24.75 percentage change Standard Deviation 2.271	-42.14 percentage change Standard Deviation 25.783	—
Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 56	-65.16 percentage change Standard Deviation 24.916	-65.69 percentage change Standard Deviation 22.042	-28.05 percentage change Standard Deviation 30.487	-43.91 percentage change Standard Deviation 27.408	—
Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 60	-66.83 percentage change Standard Deviation 26.478	-65.58 percentage change Standard Deviation 22.910	-31.01 percentage change Standard Deviation 28.944	-47.00 percentage change Standard Deviation 26.089	—
Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 64	-62.82 percentage change Standard Deviation 33.328	-70.44 percentage change Standard Deviation 20.212	-30.85 percentage change Standard Deviation 32.898	-46.96 percentage change Standard Deviation 26.395	—
Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 68	-61.40 percentage change Standard Deviation 29.204	-71.89 percentage change Standard Deviation 17.942	-35.53 percentage change Standard Deviation 32.135	-49.41 percentage change Standard Deviation 27.629	—
Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 80	-68.99 percentage change Standard Deviation 26.870	-72.21 percentage change Standard Deviation 17.852	-40.97 percentage change Standard Deviation 30.033	-52.48 percentage change Standard Deviation 26.991	—
Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 92	-66.95 percentage change Standard Deviation 24.885	-72.55 percentage change Standard Deviation 19.152	-43.34 percentage change Standard Deviation 34.425	-55.00 percentage change Standard Deviation 28.995	—
Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period Week 104	-58.38 percentage change Standard Deviation 35.533	-74.66 percentage change Standard Deviation 17.727	-45.52 percentage change Standard Deviation 41.968	-56.96 percentage change Standard Deviation 27.409	—

SECONDARY outcome

Timeframe: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Data are presented as the percentage of BSA involvement in the face as compared to total BSA.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period Week 52	0.18 percentage BSA Standard Deviation 0.240	0.27 percentage BSA Standard Deviation 0.401	0.81 percentage BSA Standard Deviation 0.641	0.70 percentage BSA Standard Deviation 0.568	—
Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period Baseline	0.92 percentage BSA Standard Deviation 0.498	1.10 percentage BSA Standard Deviation 0.745	1.01 percentage BSA Standard Deviation 0.632	1.02 percentage BSA Standard Deviation 0.636	—
Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period Week 56	0.18 percentage BSA Standard Deviation 0.198	0.27 percentage BSA Standard Deviation 0.416	0.77 percentage BSA Standard Deviation 0.638	0.67 percentage BSA Standard Deviation 0.572	—
Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period Week 60	0.20 percentage BSA Standard Deviation 0.225	0.25 percentage BSA Standard Deviation 0.309	0.73 percentage BSA Standard Deviation 0.616	0.63 percentage BSA Standard Deviation 0.557	—
Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period Week 64	0.20 percentage BSA Standard Deviation 0.206	0.20 percentage BSA Standard Deviation 0.271	0.71 percentage BSA Standard Deviation 0.607	0.61 percentage BSA Standard Deviation 0.566	—
Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period Week 68	0.22 percentage BSA Standard Deviation 0.258	0.16 percentage BSA Standard Deviation 0.183	0.67 percentage BSA Standard Deviation 0.581	0.57 percentage BSA Standard Deviation 0.548	—
Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period Week 80	0.12 percentage BSA Standard Deviation 0.138	0.15 percentage BSA Standard Deviation 0.200	0.62 percentage BSA Standard Deviation 0.565	0.55 percentage BSA Standard Deviation 0.564	—
Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period Week 92	0.10 percentage BSA Standard Deviation 0.130	0.15 percentage BSA Standard Deviation 0.180	0.64 percentage BSA Standard Deviation 0.595	0.49 percentage BSA Standard Deviation 0.527	—
Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period Week 104	0.13 percentage BSA Standard Deviation 0.154	0.15 percentage BSA Standard Deviation 0.181	0.62 percentage BSA Standard Deviation 0.602	0.47 percentage BSA Standard Deviation 0.509	—

SECONDARY outcome

Timeframe: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented as the percentage of BSA involvement in the face as compared to total BSA.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Change From Baseline in F-BSA During the Extension Treatment Period Week 52	-0.74 percentage BSA Standard Deviation 0.402	-0.83 percentage BSA Standard Deviation 0.638	-0.20 percentage BSA Standard Deviation 0.313	-0.31 percentage BSA Standard Deviation 0.435	—
Change From Baseline in F-BSA During the Extension Treatment Period Week 56	-0.76 percentage BSA Standard Deviation 0.458	-0.82 percentage BSA Standard Deviation 0.672	-0.25 percentage BSA Standard Deviation 0.345	-0.35 percentage BSA Standard Deviation 0.433	—
Change From Baseline in F-BSA During the Extension Treatment Period Week 60	-0.77 percentage BSA Standard Deviation 0.441	-0.80 percentage BSA Standard Deviation 0.601	-0.28 percentage BSA Standard Deviation 0.364	-0.38 percentage BSA Standard Deviation 0.454	—
Change From Baseline in F-BSA During the Extension Treatment Period Week 64	-0.74 percentage BSA Standard Deviation 0.446	-0.83 percentage BSA Standard Deviation 0.625	-0.29 percentage BSA Standard Deviation 0.417	-0.41 percentage BSA Standard Deviation 0.457	—
Change From Baseline in F-BSA During the Extension Treatment Period Week 68	-0.69 percentage BSA Standard Deviation 0.345	-0.86 percentage BSA Standard Deviation 0.657	-0.31 percentage BSA Standard Deviation 0.425	-0.45 percentage BSA Standard Deviation 0.489	—
Change From Baseline in F-BSA During the Extension Treatment Period Week 80	-0.74 percentage BSA Standard Deviation 0.381	-0.87 percentage BSA Standard Deviation 0.637	-0.37 percentage BSA Standard Deviation 0.494	-0.48 percentage BSA Standard Deviation 0.521	—
Change From Baseline in F-BSA During the Extension Treatment Period Week 92	-0.76 percentage BSA Standard Deviation 0.374	-0.87 percentage BSA Standard Deviation 0.678	-0.36 percentage BSA Standard Deviation 0.558	-0.54 percentage BSA Standard Deviation 0.532	—
Change From Baseline in F-BSA During the Extension Treatment Period Week 104	-0.70 percentage BSA Standard Deviation 0.400	-0.93 percentage BSA Standard Deviation 0.716	-0.39 percentage BSA Standard Deviation 0.604	-0.54 percentage BSA Standard Deviation 0.548	—

SECONDARY outcome

Timeframe: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-Baseline (BL) value minus BL value]/BL value) X 100.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Percent Change From Baseline in F-BSA During the Extension Treatment Period Week 52	-80.75 percentage change Standard Deviation 18.726	-76.75 percentage change Standard Deviation 23.470	-22.15 percentage change Standard Deviation 28.268	-29.06 percentage change Standard Deviation 36.354	—
Percent Change From Baseline in F-BSA During the Extension Treatment Period Week 56	-80.23 percentage change Standard Deviation 21.828	-74.42 percentage change Standard Deviation 35.048	-26.20 percentage change Standard Deviation 30.604	-33.66 percentage change Standard Deviation 33.944	—
Percent Change From Baseline in F-BSA During the Extension Treatment Period Week 60	-79.20 percentage change Standard Deviation 19.463	-77.67 percentage change Standard Deviation 20.946	-30.04 percentage change Standard Deviation 30.751	-36.86 percentage change Standard Deviation 33.289	—
Percent Change From Baseline in F-BSA During the Extension Treatment Period Week 64	-75.92 percentage change Standard Deviation 32.175	-80.06 percentage change Standard Deviation 22.142	-30.67 percentage change Standard Deviation 33.473	-39.58 percentage change Standard Deviation 31.992	—
Percent Change From Baseline in F-BSA During the Extension Treatment Period Week 68	-77.11 percentage change Standard Deviation 23.565	-83.14 percentage change Standard Deviation 21.999	-32.60 percentage change Standard Deviation 34.575	-43.61 percentage change Standard Deviation 32.549	—
Percent Change From Baseline in F-BSA During the Extension Treatment Period Week 80	-84.55 percentage change Standard Deviation 18.730	-84.67 percentage change Standard Deviation 22.014	-36.79 percentage change Standard Deviation 36.826	-46.38 percentage change Standard Deviation 34.407	—
Percent Change From Baseline in F-BSA During the Extension Treatment Period Week 92	-87.81 percentage change Standard Deviation 15.738	-83.24 percentage change Standard Deviation 23.746	-34.05 percentage change Standard Deviation 50.762	-51.96 percentage change Standard Deviation 31.510	—
Percent Change From Baseline in F-BSA During the Extension Treatment Period Week 104	-82.87 percentage change Standard Deviation 23.245	-84.09 percentage change Standard Deviation 22.920	-35.82 percentage change Standard Deviation 52.646	-52.85 percentage change Standard Deviation 32.983	—

SECONDARY outcome

Timeframe: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Data are presented as the percentage of BSA involvement in the total body.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period Baseline	6.79 percentage BSA Standard Deviation 2.157	6.85 percentage BSA Standard Deviation 1.924	7.42 percentage BSA Standard Deviation 2.064	7.49 percentage BSA Standard Deviation 2.006	—
Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period Week 52	4.09 percentage BSA Standard Deviation 2.838	4.20 percentage BSA Standard Deviation 2.640	6.95 percentage BSA Standard Deviation 3.403	5.96 percentage BSA Standard Deviation 2.352	—
Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period Week 56	4.11 percentage BSA Standard Deviation 2.880	4.13 percentage BSA Standard Deviation 2.788	6.73 percentage BSA Standard Deviation 3.281	5.81 percentage BSA Standard Deviation 2.558	—
Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period Week 60	3.77 percentage BSA Standard Deviation 2.756	4.09 percentage BSA Standard Deviation 2.833	6.61 percentage BSA Standard Deviation 3.262	5.64 percentage BSA Standard Deviation 2.479	—
Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period Week 64	3.98 percentage BSA Standard Deviation 3.087	3.49 percentage BSA Standard Deviation 2.452	6.67 percentage BSA Standard Deviation 3.448	5.64 percentage BSA Standard Deviation 2.483	—
Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period Week 68	3.92 percentage BSA Standard Deviation 2.813	3.27 percentage BSA Standard Deviation 2.310	6.46 percentage BSA Standard Deviation 3.239	5.51 percentage BSA Standard Deviation 2.682	—
Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period Week 80	3.72 percentage BSA Standard Deviation 3.151	3.18 percentage BSA Standard Deviation 2.232	6.09 percentage BSA Standard Deviation 3.313	5.27 percentage BSA Standard Deviation 2.581	—
Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period Week 92	3.94 percentage BSA Standard Deviation 2.834	3.04 percentage BSA Standard Deviation 2.194	5.96 percentage BSA Standard Deviation 3.646	5.15 percentage BSA Standard Deviation 2.741	—
Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period Week 104	4.56 percentage BSA Standard Deviation 4.156	2.93 percentage BSA Standard Deviation 2.301	5.91 percentage BSA Standard Deviation 4.475	5.07 percentage BSA Standard Deviation 2.699	—

SECONDARY outcome

Timeframe: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented as the percentage of BSA involvement in the total body.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Change From Baseline in T-BSA During the Extension Treatment Period Week 52	-2.70 percentage BSA Standard Deviation 1.830	-2.64 percentage BSA Standard Deviation 1.906	-0.47 percentage BSA Standard Deviation 2.325	-1.52 percentage BSA Standard Deviation 1.711	—
Change From Baseline in T-BSA During the Extension Treatment Period Week 56	-2.74 percentage BSA Standard Deviation 1.918	-2.70 percentage BSA Standard Deviation 1.983	-0.73 percentage BSA Standard Deviation 2.238	-1.71 percentage BSA Standard Deviation 2.059	—
Change From Baseline in T-BSA During the Extension Treatment Period Week 60	-2.95 percentage BSA Standard Deviation 1.910	-2.75 percentage BSA Standard Deviation 2.195	-0.80 percentage BSA Standard Deviation 2.128	-1.86 percentage BSA Standard Deviation 1.978	—
Change From Baseline in T-BSA During the Extension Treatment Period Week 64	-2.73 percentage BSA Standard Deviation 2.528	-3.22 percentage BSA Standard Deviation 1.883	-0.73 percentage BSA Standard Deviation 2.432	-1.90 percentage BSA Standard Deviation 2.052	—
Change From Baseline in T-BSA During the Extension Treatment Period Week 68	-2.73 percentage BSA Standard Deviation 1.958	-3.34 percentage BSA Standard Deviation 1.922	-0.98 percentage BSA Standard Deviation 2.262	-2.03 percentage BSA Standard Deviation 2.180	—
Change From Baseline in T-BSA During the Extension Treatment Period Week 80	-3.05 percentage BSA Standard Deviation 2.083	-3.42 percentage BSA Standard Deviation 1.809	-1.31 percentage BSA Standard Deviation 2.341	-2.21 percentage BSA Standard Deviation 2.169	—
Change From Baseline in T-BSA During the Extension Treatment Period Week 92	-3.03 percentage BSA Standard Deviation 1.664	-3.58 percentage BSA Standard Deviation 1.938	-1.49 percentage BSA Standard Deviation 2.753	-2.36 percentage BSA Standard Deviation 2.380	—
Change From Baseline in T-BSA During the Extension Treatment Period Week 104	-2.18 percentage BSA Standard Deviation 2.723	-3.72 percentage BSA Standard Deviation 2.075	-1.52 percentage BSA Standard Deviation 3.672	-2.42 percentage BSA Standard Deviation 2.307	—

SECONDARY outcome

Timeframe: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-Baseline (BL) value minus BL value]/BL value) X 100.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Percent Change From Baseline in T-BSA During the Extension Treatment Period Week 52	-43.81 percentage change Standard Deviation 27.916	-41.50 percentage change Standard Deviation 28.747	-8.54 percentage change Standard Deviation 28.806	-20.57 percentage change Standard Deviation 23.042	—
Percent Change From Baseline in T-BSA During the Extension Treatment Period Week 56	-44.22 percentage change Standard Deviation 29.590	-43.12 percentage change Standard Deviation 29.489	-11.96 percentage change Standard Deviation 28.156	-22.98 percentage change Standard Deviation 26.032	—
Percent Change From Baseline in T-BSA During the Extension Treatment Period Week 60	-47.61 percentage change Standard Deviation 29.237	-43.09 percentage change Standard Deviation 31.608	-13.40 percentage change Standard Deviation 26.410	-25.12 percentage change Standard Deviation 25.564	—
Percent Change From Baseline in T-BSA During the Extension Treatment Period Week 64	-43.29 percentage change Standard Deviation 40.045	-50.59 percentage change Standard Deviation 27.166	-12.00 percentage change Standard Deviation 30.202	-25.15 percentage change Standard Deviation 26.860	—
Percent Change From Baseline in T-BSA During the Extension Treatment Period Week 68	-44.53 percentage change Standard Deviation 30.086	-52.51 percentage change Standard Deviation 26.921	-15.01 percentage change Standard Deviation 29.093	-27.59 percentage change Standard Deviation 28.476	—
Percent Change From Baseline in T-BSA During the Extension Treatment Period Week 80	-50.51 percentage change Standard Deviation 33.794	-53.98 percentage change Standard Deviation 25.682	-20.22 percentage change Standard Deviation 30.154	-29.92 percentage change Standard Deviation 27.996	—
Percent Change From Baseline in T-BSA During the Extension Treatment Period Week 92	-48.53 percentage change Standard Deviation 29.457	-55.56 percentage change Standard Deviation 26.401	-22.84 percentage change Standard Deviation 33.708	-31.98 percentage change Standard Deviation 30.805	—
Percent Change From Baseline in T-BSA During the Extension Treatment Period Week 104	-40.84 percentage change Standard Deviation 40.076	-57.40 percentage change Standard Deviation 27.898	-24.26 percentage change Standard Deviation 42.193	-32.96 percentage change Standard Deviation 29.907	—

SECONDARY outcome

Timeframe: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.

The VNS is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. The Baseline facial photograph was shown to the participants for reference, and a mirror was provided for the participants to assess the vitiligo on their face. The participant was asked to respond to the following query: Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, and (5) no longer noticeable.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=57 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=57 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=222 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period Week 52	49.1 percentage of participants Interval 35.6 to 62.7	42.1 percentage of participants Interval 29.1 to 55.9	11.9 percentage of participants Interval 6.6 to 19.1	35.3 percentage of participants Interval 29.0 to 42.0	—
Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period Week 56	48.2 percentage of participants Interval 34.7 to 62.0	34.5 percentage of participants Interval 22.2 to 48.6	20.4 percentage of participants Interval 13.2 to 29.2	30.1 percentage of participants Interval 24.1 to 36.7	—
Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period Week 60	46.9 percentage of participants Interval 32.5 to 61.7	28.8 percentage of participants Interval 17.1 to 43.1	19.6 percentage of participants Interval 12.6 to 28.4	27.6 percentage of participants Interval 21.7 to 34.2	—
Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period Week 64	53.5 percentage of participants Interval 37.7 to 68.8	37.8 percentage of participants Interval 23.8 to 53.5	23.1 percentage of participants Interval 15.6 to 32.2	28.2 percentage of participants Interval 22.1 to 34.8	—
Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period Week 68	46.3 percentage of participants Interval 30.7 to 62.6	46.7 percentage of participants Interval 31.7 to 62.1	20.6 percentage of participants Interval 13.4 to 29.5	33.8 percentage of participants Interval 27.4 to 40.6	—
Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period Week 80	38.7 percentage of participants Interval 21.8 to 57.8	42.2 percentage of participants Interval 27.7 to 57.8	28.3 percentage of participants Interval 19.7 to 38.2	32.8 percentage of participants Interval 26.3 to 39.9	—
Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period Week 92	39.1 percentage of participants Interval 19.7 to 61.5	37.2 percentage of participants Interval 23.0 to 53.3	28.4 percentage of participants Interval 19.6 to 38.6	41.1 percentage of participants Interval 33.8 to 48.7	—
Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period Week 104	56.5 percentage of participants Interval 34.5 to 76.8	50.0 percentage of participants Interval 33.4 to 66.6	30.1 percentage of participants Interval 21.0 to 40.5	43.3 percentage of participants Interval 35.9 to 50.9	—

SECONDARY outcome

Timeframe: Week 52; up to up to Week 104 of Extension Study (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants who were ≥16 years old with available data were analyzed.

The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Participants age ≥16 years answered the questionnaire with: (1) very much; (2) a lot; (3) a little; or (4) not at all. The questionnaire was analyzed under 6 headings: Symptoms and feelings (Questions 1 and 2); Daily activities (Questions 3 and 4); Leisure (Questions 5 and 6); Work and school (Question 7); Personal relations (Questions 8 and 9); and Treatment (Question 10). The scoring of each question is as follows: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0. For Question 7, "prevented work or studying"=3. The total score ranges from 0 to 30; higher scores indicate higher quality of life. Change from Week 52 was calculated as the post-Week 52 value minus the Week 52 value.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=54 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=51 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=114 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=200 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period Week 52	2.87 scores on a scale Standard Deviation 3.059	4.10 scores on a scale Standard Deviation 4.784	3.69 scores on a scale Standard Deviation 3.428	3.53 scores on a scale Standard Deviation 4.150	—
Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period Change from Week 52 at Week 56	0.11 scores on a scale Standard Deviation 2.054	-0.47 scores on a scale Standard Deviation 1.757	-0.05 scores on a scale Standard Deviation 2.138	-0.22 scores on a scale Standard Deviation 2.483	—
Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period Change from Week 52 at Week 60	0.37 scores on a scale Standard Deviation 2.388	0.13 scores on a scale Standard Deviation 2.227	0.28 scores on a scale Standard Deviation 2.491	0.24 scores on a scale Standard Deviation 2.929	—
Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period Change from Week 52 at Week 64	0.35 scores on a scale Standard Deviation 2.578	0.18 scores on a scale Standard Deviation 2.630	-0.06 scores on a scale Standard Deviation 2.712	-0.14 scores on a scale Standard Deviation 2.350	—
Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period Change from Week 52 at Week 68	-0.08 scores on a scale Standard Deviation 2.508	-0.15 scores on a scale Standard Deviation 2.202	-0.17 scores on a scale Standard Deviation 2.501	0.08 scores on a scale Standard Deviation 2.454	—
Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period Change from Week 52 at Week 80	0.03 scores on a scale Standard Deviation 3.006	-0.23 scores on a scale Standard Deviation 2.315	-0.77 scores on a scale Standard Deviation 2.871	-0.13 scores on a scale Standard Deviation 2.809	—
Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period Change from Week 52 at Week 92	0.27 scores on a scale Standard Deviation 2.354	-0.23 scores on a scale Standard Deviation 1.898	-0.89 scores on a scale Standard Deviation 2.383	-0.22 scores on a scale Standard Deviation 2.941	—
Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period Change from Week 52 at Week 104	0.57 scores on a scale Standard Deviation 2.135	-0.40 scores on a scale Standard Deviation 1.538	-0.48 scores on a scale Standard Deviation 2.277	-0.06 scores on a scale Standard Deviation 2.813	—

SECONDARY outcome

Timeframe: Week 52; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants who were \<16 years old with available data were analyzed.

The CDLQI is the youth/children's version of the DLQI. The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Participants age <16 years answered the questionnaire with: (1) very much; (2) a lot; (3) a little; or (4) not at all. The questionnaire was analyzed under 6 headings: Symptoms and feelings (Questions 1 and 2); Leisure (Questions 4, 5, and 6); School or holidays (Question 7); Personal relationships (Questions 3 and 8); Sleep (Question 9); and Treatment (Question 10). The scoring of each question is as follows: very much = 3; quite a lot = 2; only a little = 1; not at all = 0; question unanswered = 0. The total score ranges from 0 to 30; higher scores indicate higher quality of life. Change from Week 52 was calculated as the post-Week 52 value minus the Week 52 value.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=3 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=6 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=4 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=22 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period Change from Week 52 at Week 92	NA scores on a scale Standard Deviation NA The mean and standard deviation cannot be calculated for a single participant.	0.25 scores on a scale Standard Deviation 1.258	-0.25 scores on a scale Standard Deviation 0.957	0.70 scores on a scale Standard Deviation 3.614	—
Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period Change from Week 52 at Week 104	-0.50 scores on a scale Standard Deviation 0.707	-0.67 scores on a scale Standard Deviation 1.155	-1.25 scores on a scale Standard Deviation 1.893	-0.20 scores on a scale Standard Deviation 4.086	—
Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period Week 52	1.67 scores on a scale Standard Deviation 2.887	1.00 scores on a scale Standard Deviation 0.632	1.25 scores on a scale Standard Deviation 1.893	2.32 scores on a scale Standard Deviation 3.872	—
Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period Change from Week 52 at Week 56	-1.00 scores on a scale Standard Deviation 2.646	-0.17 scores on a scale Standard Deviation 0.753	0.00 scores on a scale Standard Deviation 0.816	0.36 scores on a scale Standard Deviation 1.989	—
Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period Change from Week 52 at Week 60	0.00 scores on a scale Standard Deviation 0.000	-0.50 scores on a scale Standard Deviation 0.548	-0.50 scores on a scale Standard Deviation 0.577	-0.41 scores on a scale Standard Deviation 2.108	—
Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period Change from Week 52 at Week 64	-1.33 scores on a scale Standard Deviation 2.309	0.00 scores on a scale Standard Deviation 0.707	-1.00 scores on a scale Standard Deviation 1.414	-0.36 scores on a scale Standard Deviation 1.399	—
Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period Change from Week 52 at Week 68	-0.67 scores on a scale Standard Deviation 1.155	0.40 scores on a scale Standard Deviation 1.140	0.50 scores on a scale Standard Deviation 0.577	-0.23 scores on a scale Standard Deviation 1.541	—
Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period Change from Week 52 at Week 80	-2.00 scores on a scale Standard Deviation 2.828	-0.40 scores on a scale Standard Deviation 0.548	-0.75 scores on a scale Standard Deviation 1.708	0.15 scores on a scale Standard Deviation 1.814	—

SECONDARY outcome

Timeframe: up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.)

Population: FAS

A TEAE was defined as any adverse event (AE) reported for the first time or the worsening of a pre-existing event after the first application of study drug in this study. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=58 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=23 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=58 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=118 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID n=224 Participants Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	21 Participants	3 Participants	32 Participants	59 Participants	114 Participants

SECONDARY outcome

Timeframe: Weeks 80 (predose); Week 104 (any time post-dose) (Week 52 was the first visit of this Treatment Extension study.)

Population: Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of ruxolitinib cream and provided at least 1 measurable post-dose PK sample/assessment. Only participants with available data were analyzed.

The steady-state plasma concentration was assessed. Pharmacokinetic blood samples could have been collected at any time prior to study drug application at the site at the Week 80 visit and at any time at the Week 104 (End of Trial) visit. Results from the two parent studies indicated that steady state was reached at or before Week 4, and that, hence, the use of vehicle or ruxolitinib 1.5% in the first 52 weeks of treatment had no impact on the ruxolitinib plasma concentration at the Week 80 and Week 104 (End of Treatment) visits. Thus, the two Cohort B cohorts were combined into a single arm for data analysis in this study.

Outcome measures

Measure	Cohort A: Vehicle Cream BID n=54 Participants Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort A: Ruxolitinib 1.5% Cream BID n=293 Participants Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID n=347 Participants Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.
Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 12 to <18 years	7.28 nanomolar Standard Deviation 11.7	5.56 nanomolar Standard Deviation 10.5	5.85 nanomolar Standard Deviation 10.6	—	—
Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 18 to <65 years	15.1 nanomolar Standard Deviation 19.5	12.7 nanomolar Standard Deviation 17.2	13.1 nanomolar Standard Deviation 17.6	—	—
Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 ≥65 years	13.0 nanomolar Standard Deviation 9.44	25.7 nanomolar Standard Deviation 20.9	24.3 nanomolar Standard Deviation 20.2	—	—
Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 Overall	13.8 nanomolar Standard Deviation 18.1	12.8 nanomolar Standard Deviation 17.4	12.9 nanomolar Standard Deviation 17.5	—	—

Adverse Events

Vehicle Cream BID

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Ruxolitinib 1.5% Cream BID

Serious events: 12 serious events

Other events: 55 other events

Deaths: 0 deaths

Total

Serious events: 12 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vehicle Cream BID n=58 participants at risk Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Ruxolitinib 1.5% Cream BID n=423 participants at risk Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks, or were randomized to receive vehicle cream BID but experienced relapse (\<F-VASI75) and received open-label ruxolitinib 1.5% cream BID for the duration of the study. Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks. Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Total n=458 participants at risk Total
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Cardiac disorders Angina pectoris	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Psychiatric disorders Bipolar I disorder	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Infections and infestations COVID-19 pneumonia	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Hepatobiliary disorders Cholelithiasis	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Reproductive system and breast disorders Cystocele	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Psychiatric disorders Mental status changes	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Ear and labyrinth disorders Otosclerosis	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Reproductive system and breast disorders Pelvic prolapse	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Reproductive system and breast disorders Rectocele	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 2 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 2 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/58 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.24% 1/423 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	0.22% 1/458 • Number of events 1 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.

Other adverse events

Measure	Vehicle Cream BID n=58 participants at risk Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study.	Ruxolitinib 1.5% Cream BID n=423 participants at risk Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks, or were randomized to receive vehicle cream BID but experienced relapse (\<F-VASI75) and received open-label ruxolitinib 1.5% cream BID for the duration of the study. Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks. Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks.	Total n=458 participants at risk Total
Infections and infestations COVID-19	10.3% 6/58 • Number of events 6 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	13.0% 55/423 • Number of events 57 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.	13.3% 61/458 • Number of events 63 • up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: medinfo@incyte.com

Results disclosure agreements

• Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
• Publication restrictions are in place

Restriction type: OTHER