Trial Outcomes & Findings for Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1) (NCT NCT04052425)

Results Overview

An F-VASI75 responder achieved at least 75% 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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

330 participants

Primary outcome timeframe

Baseline; Week 24

Results posted on

2025-08-22

Participant Flow

This study was conducted at 45 study centers in North America and Europe.

A total of 330 participants were randomized into the study. All randomized participants (Intent-to-Treat Population) applied study drug at least once (Safety Population), and 283 participants applied ruxolitinib cream at least once during the Treatment-Extension (TE) Period (TE Evaluable Population).

Participant milestones

Participant milestones
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
24-Week Double-blind Period STARTED	221	109	0	0
24-Week Double-blind Period COMPLETED	193	90	0	0
24-Week Double-blind Period NOT COMPLETED	28	19	0	0
28-Week Treatment-Extension Period STARTED	0	0	193	90
28-Week Treatment-Extension Period COMPLETED	0	0	174	80
28-Week Treatment-Extension Period NOT COMPLETED	0	0	19	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
24-Week Double-blind Period Adverse Event	0	1	0	0
24-Week Double-blind Period Lack of Efficacy	0	1	0	0
24-Week Double-blind Period Lost to Follow-up	14	7	0	0
24-Week Double-blind Period Physician Decision	1	0	0	0
24-Week Double-blind Period Protocol Violation	1	0	0	0
24-Week Double-blind Period Withdrawal by Subject	9	10	0	0
24-Week Double-blind Period Discontinued Treatment Due to COVID-19 Pandemic	3	0	0	0
28-Week Treatment-Extension Period Adverse Event	0	0	1	0
28-Week Treatment-Extension Period Lack of Efficacy	0	0	1	0
28-Week Treatment-Extension Period Lost to Follow-up	0	0	5	1
28-Week Treatment-Extension Period Physician Decision	0	0	0	1
28-Week Treatment-Extension Period Withdrawal by Subject	0	0	10	7
28-Week Treatment-Extension Period Sponsor Opinion Due to Safety Reason	0	0	1	0
28-Week Treatment-Extension Period Participant Moved	0	0	1	1

Baseline Characteristics

Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=221 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=109 Participants Participants applied matching vehicle cream BID for 24 weeks.	Total n=330 Participants Total of all reporting groups
Age, Continuous	40.5 years STANDARD_DEVIATION 15.44 • n=5 Participants	39.7 years STANDARD_DEVIATION 16.71 • n=7 Participants	40.2 years STANDARD_DEVIATION 15.85 • n=5 Participants
Sex: Female, Male Female	136 Participants n=5 Participants	50 Participants n=7 Participants	186 Participants n=5 Participants
Sex: Female, Male Male	85 Participants n=5 Participants	59 Participants n=7 Participants	144 Participants n=5 Participants
Race/Ethnicity, Customized White · White	180 Participants n=5 Participants	96 Participants n=7 Participants	276 Participants n=5 Participants
Race/Ethnicity, Customized White · Black/African American	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized White · Asian	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized White · American Indian/Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White · Not Reported	16 Participants n=5 Participants	3 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized White · Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White · Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White · Iranian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White · Indian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White · Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White · Black-Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	53 Participants n=5 Participants	20 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	151 Participants n=5 Participants	86 Participants n=7 Participants	237 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	15 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Captured as "Other"	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Face Vitiligo Area Scoring Index (F-VASI)	0.932 scores on a scale STANDARD_DEVIATION 0.5813 • n=5 Participants	0.999 scores on a scale STANDARD_DEVIATION 0.5942 • n=7 Participants	0.954 scores on a scale STANDARD_DEVIATION 0.5855 • n=5 Participants
Facial Body Surface Area (F-BSA) Involvement	1.05 percentage of facial surface area STANDARD_DEVIATION 0.692 • n=5 Participants	1.15 percentage of facial surface area STANDARD_DEVIATION 0.710 • n=7 Participants	1.09 percentage of facial surface area STANDARD_DEVIATION 0.698 • n=5 Participants
Total Body Vitiligo Area Scoring Index (T-VASI)	6.489 scores on a scale STANDARD_DEVIATION 2.0228 • n=5 Participants	6.424 scores on a scale STANDARD_DEVIATION 1.9241 • n=7 Participants	6.467 scores on a scale STANDARD_DEVIATION 1.9881 • n=5 Participants
Total Body Surface Area (T-BSA) Involvement	7.28 percentage of total body surface area STANDARD_DEVIATION 2.033 • n=5 Participants	7.22 percentage of total body surface area STANDARD_DEVIATION 2.008 • n=7 Participants	7.26 percentage of total body surface area STANDARD_DEVIATION 2.022 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline; Week 24

Population: Intent-to-Treat Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at the time of randomization. Missing F-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators.

An F-VASI75 responder achieved at least 75% 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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=221 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=109 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24	29.8 percentage of participants	7.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Population. Missing F-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators.

An F-VASI50 responder achieved at least 50% 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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=221 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=109 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Week 24	51.2 percentage of participants	16.9 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Population. Missing F-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators.

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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=221 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=109 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage of Participants Achieving a ≥ 90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Week 24	15.3 percentage of participants	2.2 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Population. Missing T-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators.

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 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 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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=221 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=109 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24	20.6 percentage of participants	5.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Population. Missing VNS scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators.

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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=221 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=109 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) of 4 or 5 at Week 24	24.5 percentage of participants	3.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Population. Missing F-BSA scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators.

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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=221 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=109 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage Change From Baseline in Facial Body Surface Area (F-BSA) at Week 24	-28.9 percentage change Standard Error 2.22	-9.5 percentage change Standard Error 3.25	—	—

SECONDARY outcome

Timeframe: from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 24)

Population: Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1.

An adverse event (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 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. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.

Outcome measures

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=221 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=109 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period	101 Participants	42 Participants	—	—

SECONDARY outcome

Timeframe: from the completion of the Week 24 assessments until at least 30 days after the last application of study drug (up to Week 52 + 30 days)

Population: Treatment-Extension (TE) Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period

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 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. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.

Outcome measures

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=193 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=90 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Treatment-Extension Period	65 Participants	31 Participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Population. Missing F-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators.

An F-VASI25 responder achieved at least 25% 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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=221 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=109 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage of Participants Achieving a ≥ 25% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25) Score at Week 24	69.8 percentage of participants	30.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: ITT Population. Only participants with available data were analyzed.

An F-VASI25/50/75/90 responder achieved at least 25/50/75/90% 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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=173 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=82 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage of Participants Achieving a ≥ %25, ≥ %50, ≥ 75%, and ≥ 90% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25/50/75/90) Score at Week 52 F-VASI25	89.6 percentage of participants	74.4 percentage of participants	—	—
Percentage of Participants Achieving a ≥ %25, ≥ %50, ≥ 75%, and ≥ 90% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25/50/75/90) Score at Week 52 F-VASI50	75.1 percentage of participants	56.1 percentage of participants	—	—
Percentage of Participants Achieving a ≥ %25, ≥ %50, ≥ 75%, and ≥ 90% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25/50/75/90) Score at Week 52 F-VASI75	52.6 percentage of participants	26.8 percentage of participants	—	—
Percentage of Participants Achieving a ≥ %25, ≥ %50, ≥ 75%, and ≥ 90% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25/50/75/90) Score at Week 52 F-VASI90	32.9 percentage of participants	12.2 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Population. Only participants with available data were analyzed. MMRM model: (Response Variable = Treatment + Stratification Factors \[Skin Type Fitzpatrick Scale Type I and II versus Type III, IV, V, and VI, Region North America/Europe\] + Visit + Treatment\*Visit).

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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=195 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=90 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage Change From Baseline in F-VASI at Week 24	-47.79 percentage change Standard Error 2.43	-17.18 percentage change Standard Error 3.53	—	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: ITT Population. 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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=173 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=82 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage Change From Baseline in F-VASI at Week 52	-67.24 percentage change Standard Deviation 33.660	-52.98 percentage change Standard Deviation 30.174	—	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: ITT Population. 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 = (\[post-BL value minus BL value\]/BL value) X 100.

Outcome measures

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=173 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=82 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage Change From Baseline in F-BSA at Week 52	-44.87 percentage change Standard Deviation 43.954	-32.40 percentage change Standard Deviation 30.068	—	—

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Population. Only participants with available data were analyzed. MMRM model: (Response Variable = Treatment + Stratification Factors \[Skin Type Fitzpatrick scale Type I and II vs Type III, IV, V, and VI, Region North America/Europe\] + Visit + Treatment\*Visit).

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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=195 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=90 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage Change From Baseline in T-VASI at Week 24	-27.60 percentage change Standard Error 1.81	-10.62 percentage change Standard Error 2.64	—	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: ITT Population. 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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=173 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=82 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage Change From Baseline in T-VASI at Week 52	-49.23 percentage change Standard Deviation 26.366	-29.85 percentage change Standard Deviation 37.832	—	—

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Population. Only participants with available data were analyzed. MMRM model: (Response Variable = Treatment + Stratification Factors \[Skin Type Fitzpatrick scale Type I and II vs Type III, IV, V, and VI, Region North America/Europe\] + Visit + Treatment\*Visit).

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 = (\[post-BL value minus BL value\]/BL value) X 100.

Outcome measures

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=195 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=90 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage Change From Baseline in T-BSA at Week 24	-13.08 percentage change Standard Error 1.40	-4.02 percentage change Standard Error 2.05	—	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: ITT Population. 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 = (\[post-BL value minus BL value\]/BL value) X 100.

Outcome measures

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=173 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=82 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage Change From Baseline in T-BSA at Week 52	-27.39 percentage change Standard Deviation 25.705	-11.83 percentage change Standard Deviation 34.654	—	—

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Population. Missing T-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators.

A T-VASI25/75/90 responder achieved at least 25/75/90% 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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=221 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=109 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage of Participants Achieving a ≥ 25%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/75/90) Score at Week 24 T-VASI25	48.8 percentage of participants	23.8 percentage of participants	—	—
Percentage of Participants Achieving a ≥ 25%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/75/90) Score at Week 24 T-VASI75	4.1 percentage of participants	1.8 percentage of participants	—	—
Percentage of Participants Achieving a ≥ 25%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/75/90) Score at Week 24 T-VASI90	0.5 percentage of participants	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: ITT Population. Only participants with available data were analyzed.

A T-VASI25/50/75/90 responder achieved ≥25/50/75/90% 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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=173 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=82 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage of Participants Achieving a ≥ 25%, ≥ 50%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/50/75/90) Score at Week 52 T-VASI25	77.5 percentage of participants	56.1 percentage of participants	—	—
Percentage of Participants Achieving a ≥ 25%, ≥ 50%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/50/75/90) Score at Week 52 T-VASI50	53.2 percentage of participants	31.7 percentage of participants	—	—
Percentage of Participants Achieving a ≥ 25%, ≥ 50%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/50/75/90) Score at Week 52 T-VASI75	20.2 percentage of participants	9.8 percentage of participants	—	—
Percentage of Participants Achieving a ≥ 25%, ≥ 50%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/50/75/90) Score at Week 52 T-VASI90	3.5 percentage of participants	2.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 24 and Week 52

Population: ITT Population. 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

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=195 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=90 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID n=173 Participants Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID n=82 Participants Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) Week 24, more noticeable	6.2 percentage of participants	14.4 percentage of participants	—	—
Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) Week 24, as noticeable	17.4 percentage of participants	46.7 percentage of participants	—	—
Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) Week 24, slightly less noticeable	51.3 percentage of participants	35.6 percentage of participants	—	—
Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) Week 24, a lot less noticeable	24.1 percentage of participants	3.3 percentage of participants	—	—
Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) Week 24, no longer noticeable	1.0 percentage of participants	0.0 percentage of participants	—	—
Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) Week 52, more noticeable	—	—	4.0 percentage of participants	4.9 percentage of participants
Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) Week 52, as noticeable	—	—	9.2 percentage of participants	15.9 percentage of participants
Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) Week 52, slightly less noticeable	—	—	46.8 percentage of participants	59.8 percentage of participants
Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) Week 52, a lot less noticeable	—	—	39.3 percentage of participants	19.5 percentage of participants
Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) Week 52, no longer noticeable	—	—	0.6 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: ITT Population: participants aged ≥ 16 years. Only participants with available data were analyzed. MMRM model: \[Response Variable = Treatment + Stratification Factors (Skin Type Fitzpatrick scale Type I and II vs Type III, IV, V, and VI, Region North America/Europe) + Visit + Treatment\*Visit\].

The DLQI is a 10-question validated questionnaire for use in participants aged 16 years and over to measure how much the skin problem has affected the participant over the previous 7 days. Each question is scored as: 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 DLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Outcome measures

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=178 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=87 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24	-1.17 scores on a scale Standard Error 0.27	-0.85 scores on a scale Standard Error 0.39	—	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: ITT Population: participants aged ≥ 16 years. Only participants with available data were analyzed.

The DLQI is a 10-question validated questionnaire for use in participants aged 16 years and over to measure how much the skin problem has affected the participant over the previous 7 days. Each question is scored as: 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 DLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Outcome measures

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=204 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=105 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Change From Baseline in DLQI at Week 52 Baseline	4.63 scores on a scale Standard Deviation 4.446	4.59 scores on a scale Standard Deviation 4.871	—	—
Change From Baseline in DLQI at Week 52 Week 52	-1.40 scores on a scale Standard Deviation 4.087	-1.37 scores on a scale Standard Deviation 3.617	—	—

SECONDARY outcome

Timeframe: Baseline; Week 24 and Week 52

Population: ITT Population: participants aged \< 16 years. Only participants with available data were analyzed.

The DLQI is a 10-question validated questionnaire for use in participants aged 16 years and over to measure how much the skin problem has affected the participant over the previous 7 days. The CDLQI is the youth/children's version of the DLQI and was completed by adolescents aged ≥ 12 years to \< 16 years. Each question is scored as: very much = 3; quite a lot = 2; only a little = 1; not at all = 0; question unanswered = 0. For Question 7: "Prevented school" = 3. The CDLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Outcome measures

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=17 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID n=4 Participants Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID n=17 Participants Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID n=4 Participants Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) During the Treatment Period (Double-Blind and Treatment-Extension Periods) Baseline	2.50 scores on a scale Standard Deviation 2.805	1.25 scores on a scale Standard Deviation 1.893	—	—
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) During the Treatment Period (Double-Blind and Treatment-Extension Periods) Week 24	-0.25 scores on a scale Standard Deviation 2.113	0.00 scores on a scale Standard Deviation 0.000	—	—
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) During the Treatment Period (Double-Blind and Treatment-Extension Periods) Week 52	—	—	-1.00 scores on a scale Standard Deviation 2.507	0.00 scores on a scale Standard Deviation 1.000

SECONDARY outcome

Timeframe: pre-dose at Weeks 4, 24, and 40

Population: Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluable Population: all participants who applied ruxolitinib cream at least once and provided at least 1 postdose blood sample that complied with the Protocol

Trough plasma concentration was defined as the measurement of the plasma concentration of ruxolitinib before drug application.

Outcome measures

Outcome measures
Measure	Double-Blind Period: Ruxolitinib Cream 1.5% BID n=206 Participants Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.	Double-Blind Period: Vehicle Cream BID Participants applied matching vehicle cream BID for 24 weeks.	Treatment-Extension Period: Ruxolitinib Cream 1.5% BID n=173 Participants Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.	Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID n=80 Participants Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Trough Plasma Concentrations of Ruxolitinib at Weeks 4, 24, and 40 Week 4	57.1 nanomoles Standard Deviation 61.4	—	—	—
Trough Plasma Concentrations of Ruxolitinib at Weeks 4, 24, and 40 Week 24	56.3 nanomoles Standard Deviation 69.4	—	—	—
Trough Plasma Concentrations of Ruxolitinib at Weeks 4, 24, and 40 Week 40	—	—	55.5 nanomoles Standard Deviation 63.6	50.1 nanomoles Standard Deviation 55.8

Adverse Events

Vehicle Cream BID

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Ruxolitinib Cream 1.5% BID

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vehicle Cream BID n=109 participants at risk Participants applied matching vehicle cream twice a day (BID) for 24 weeks in the Double-Blind Period.	Ruxolitinib Cream 1.5% BID n=311 participants at risk Participants applied ruxolitinib cream during the Double-Blind Treatment Period and the Treatment-Extension Period. Participants applied ruxolitinib 1.5% cream BID for 24 weeks. Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
Gastrointestinal disorders Anal fistula	0.00% 0/109 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.	0.32% 1/311 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
Infections and infestations Appendicitis	0.00% 0/109 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.	0.32% 1/311 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
Injury, poisoning and procedural complications Concussion	0.00% 0/109 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.	0.32% 1/311 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
Infections and infestations Hepatitis infectious mononucleosis	0.00% 0/109 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.	0.32% 1/311 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
Immune system disorders Hypersensitivity	0.00% 0/109 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.	0.32% 1/311 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
Injury, poisoning and procedural complications Kidney contusion	0.00% 0/109 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.	0.32% 1/311 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
Cardiac disorders Myocarditis	0.00% 0/109 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.	0.32% 1/311 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/109 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.	0.32% 1/311 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
Nervous system disorders Subacute combined cord degeneration	0.00% 0/109 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.	0.32% 1/311 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
Injury, poisoning and procedural complications Tibia fracture	0.92% 1/109 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.	0.00% 0/311 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days) Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: [email protected]

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