Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo (NCT NCT05247489)

NCT ID: NCT05247489

Last Updated: 2025-02-20

Results Overview

T-VASI was calculated with contributions from 6 body sites. The percentage of vitiligo involvement was estimated in hand units (percentage of body surface area \[BSA\] 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 body 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 body site and summing the values (range: 0-100; lower scores indicate increased improvement).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 55 participants
• Primary outcome timeframe: Baseline; Week 48
• Results posted on: 2025-02-20

Participant Flow

This study was conducted at 10 study centers in Canada and the United States.

Participant milestones

Measure	Ruxolitinib 1.5% Cream BID Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Overall Study STARTED	20	35
Overall Study COMPLETED	6	26
Overall Study NOT COMPLETED	14	9

Reasons for withdrawal

Measure	Ruxolitinib 1.5% Cream BID Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Overall Study Lost to Follow-up	5	1
Overall Study Withdrawal by Subject	6	7
Overall Study Withdrawn by Sponsor: Noncompliance	0	1
Overall Study Left Country	1	0
Overall Study Noncompliance with Investigational Product	1	0
Overall Study Withdrawn by Sponsor: Surgery to Remove Excess Skin	1	0

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo

Baseline characteristics by cohort

Measure	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.	Total n=55 Participants Total of all reporting groups
Age, Continuous	42.0 years STANDARD_DEVIATION 18.97 • n=5 Participants	52.5 years STANDARD_DEVIATION 14.25 • n=7 Participants	48.7 years STANDARD_DEVIATION 16.75 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	17 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	18 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	32 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	11 Participants n=5 Participants	25 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Black/African-American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized American-Indian/Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized East Indian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Arab	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline; Week 48

Population: Full Analysis Set: all participants enrolled in the study who applied study cream at least once. Only participants with available data were analyzed. Change from Baseline was calculated as the Week 48 value minus the Baseline value.

T-VASI was calculated with contributions from 6 body sites. The percentage of vitiligo involvement was estimated in hand units (percentage of body surface area [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 body 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 body site and summing the values (range: 0-100; lower scores indicate increased improvement).

Outcome measures

Measure	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48 Change from Baseline at Week 48	-3.43 scores on a scale Standard Deviation 1.219	-3.46 scores on a scale Standard Deviation 2.106
Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48 Baseline	6.58 scores on a scale Standard Deviation 2.163	6.87 scores on a scale Standard Deviation 2.103

SECONDARY outcome

Timeframe: up to approximately 52 weeks

Population: Full Analysis Set

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. 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

Measure	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	9 Participants	21 Participants

SECONDARY outcome

Timeframe: Baseline; up to Week 48

Population: Full Analysis Set. 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 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	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit Week 4	6.3 percentage of participants Interval 0.2 to 30.2	5.7 percentage of participants Interval 0.7 to 19.2
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit Week 16	85.7 percentage of participants Interval 42.1 to 99.6	45.7 percentage of participants Interval 28.8 to 63.4
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit Week 32	100.0 percentage of participants Interval 54.1 to 100.0	87.5 percentage of participants Interval 71.0 to 96.5
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit Week 40	100.0 percentage of participants Interval 54.1 to 100.0	92.9 percentage of participants Interval 76.5 to 99.1
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit Week 8	21.4 percentage of participants Interval 4.7 to 50.8	17.1 percentage of participants Interval 6.6 to 33.6
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit Week 12	63.6 percentage of participants Interval 30.8 to 89.1	31.4 percentage of participants Interval 16.9 to 49.3
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit Week 24	100.0 percentage of participants Interval 59.0 to 100.0	76.5 percentage of participants Interval 58.8 to 89.3
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit Week 48	100.0 percentage of participants Interval 54.1 to 100.0	96.2 percentage of participants Interval 80.4 to 99.9

SECONDARY outcome

Timeframe: Baseline; up to Week 48

Population: Full Analysis Set. 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	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit Week 48	100.0 percentage of participants Interval 54.1 to 100.0	84.6 percentage of participants Interval 65.1 to 95.6
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit Week 4	6.3 percentage of participants Interval 0.2 to 30.2	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit Week 8	7.1 percentage of participants Interval 0.2 to 33.9	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit Week 12	45.5 percentage of participants Interval 16.7 to 76.6	14.3 percentage of participants Interval 4.8 to 30.3
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit Week 16	57.1 percentage of participants Interval 18.4 to 90.1	20.0 percentage of participants Interval 8.4 to 36.9
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit Week 24	85.7 percentage of participants Interval 42.1 to 99.6	47.1 percentage of participants Interval 29.8 to 64.9
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit Week 32	83.3 percentage of participants Interval 35.9 to 99.6	59.4 percentage of participants Interval 40.6 to 76.3
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit Week 40	100.0 percentage of participants Interval 54.1 to 100.0	71.4 percentage of participants Interval 51.3 to 86.8

SECONDARY outcome

Timeframe: Baseline; up to Week 48

Population: Full Analysis Set. 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	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit Week 8	0.0 percentage of participants Interval 0.0 to 23.2	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit Week 12	9.1 percentage of participants Interval 0.2 to 41.3	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit Week 24	42.9 percentage of participants Interval 9.9 to 81.6	17.6 percentage of participants Interval 6.8 to 34.5
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit Week 32	50.0 percentage of participants Interval 11.8 to 88.2	34.4 percentage of participants Interval 18.6 to 53.2
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit Week 40	50.0 percentage of participants Interval 11.8 to 88.2	53.6 percentage of participants Interval 33.9 to 72.5
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit Week 48	66.7 percentage of participants Interval 22.3 to 95.7	53.8 percentage of participants Interval 33.4 to 73.4
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit Week 4	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit Week 16	42.9 percentage of participants Interval 9.9 to 81.6	2.9 percentage of participants Interval 0.1 to 14.9

SECONDARY outcome

Timeframe: Baseline; up to Week 48

Population: Full Analysis Set. Only participants with available data were analyzed.

A T-VASI50 responder achieved ≥50% improvement from Baseline in T-VASI, calculated with contributions from 6 body 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 body 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 body site and summing the values (range: 0-100; lower scores indicate increased improvement).

Outcome measures

Measure	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Each Post-Baseline Visit Week 16	42.9 percentage of participants Interval 9.9 to 81.6	2.9 percentage of participants Interval 0.1 to 14.9
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Each Post-Baseline Visit Week 4	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Each Post-Baseline Visit Week 8	0.0 percentage of participants Interval 0.0 to 23.2	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Each Post-Baseline Visit Week 12	18.2 percentage of participants Interval 2.3 to 51.8	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Each Post-Baseline Visit Week 24	71.4 percentage of participants Interval 29.0 to 96.3	23.5 percentage of participants Interval 10.7 to 41.2
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Each Post-Baseline Visit Week 32	66.7 percentage of participants Interval 22.3 to 95.7	34.4 percentage of participants Interval 18.6 to 53.2
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Each Post-Baseline Visit Week 40	83.3 percentage of participants Interval 35.9 to 99.6	46.4 percentage of participants Interval 27.5 to 66.1
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Each Post-Baseline Visit Week 48	83.3 percentage of participants Interval 35.9 to 99.6	57.7 percentage of participants Interval 36.9 to 76.6

SECONDARY outcome

Timeframe: Baseline; up to Week 48

Population: Full Analysis Set. Only participants with available data were analyzed.

A T-VASI75 responder achieved ≥75% improvement from Baseline in T-VASI, calculated with contributions from 6 body 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 body 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 body site and summing the values (range: 0-100; lower scores indicate increased improvement).

Outcome measures

Measure	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Each Post-Baseline Visit Week 8	0.0 percentage of participants Interval 0.0 to 23.2	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Each Post-Baseline Visit Week 12	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Each Post-Baseline Visit Week 16	0.0 percentage of participants Interval 0.0 to 41.0	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Each Post-Baseline Visit Week 40	50.0 percentage of participants Interval 11.8 to 88.2	7.1 percentage of participants Interval 0.9 to 23.5
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Each Post-Baseline Visit Week 4	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Each Post-Baseline Visit Week 24	28.6 percentage of participants Interval 3.7 to 71.0	5.9 percentage of participants Interval 0.7 to 19.7
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Each Post-Baseline Visit Week 32	50.0 percentage of participants Interval 11.8 to 88.2	6.3 percentage of participants Interval 0.8 to 20.8
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Each Post-Baseline Visit Week 48	50.0 percentage of participants Interval 11.8 to 88.2	19.2 percentage of participants Interval 6.6 to 39.4

SECONDARY outcome

Timeframe: Baseline; up to Week 48

Population: Full Analysis Set. Only participants with available data were analyzed.

A T-VASI90 responder achieved ≥90% improvement from Baseline in T-VASI, calculated with contributions from 6 body 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 body 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 body site and summing the values (range: 0-100; lower scores indicate increased improvement).

Outcome measures

Measure	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) Score at Each Post-Baseline Visit Week 32	16.7 percentage of participants Interval 0.4 to 64.1	3.1 percentage of participants Interval 0.1 to 16.2
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) Score at Each Post-Baseline Visit Week 40	16.7 percentage of participants Interval 0.4 to 64.1	7.1 percentage of participants Interval 0.9 to 23.5
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) Score at Each Post-Baseline Visit Week 4	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) Score at Each Post-Baseline Visit Week 8	0.0 percentage of participants Interval 0.0 to 23.2	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) Score at Each Post-Baseline Visit Week 12	0.0 percentage of participants Interval 0.0 to 28.5	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) Score at Each Post-Baseline Visit Week 16	0.0 percentage of participants Interval 0.0 to 41.0	0.0 percentage of participants Interval 0.0 to 10.0
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) Score at Each Post-Baseline Visit Week 24	14.3 percentage of participants Interval 0.4 to 57.9	2.9 percentage of participants Interval 0.1 to 15.3
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) Score at Each Post-Baseline Visit Week 48	16.7 percentage of participants Interval 0.4 to 64.1	7.7 percentage of participants Interval 0.9 to 25.1

SECONDARY outcome

Timeframe: Baseline; up to Week 48

Population: Full Analysis Set. 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	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Change From Baseline in F-VASI at Each Post-Baseline Visit Week 8	-0.26 scores on a scale Standard Deviation 0.302	-0.14 scores on a scale Standard Deviation 0.204
Change From Baseline in F-VASI at Each Post-Baseline Visit Week 40	-0.88 scores on a scale Standard Deviation 0.326	-0.79 scores on a scale Standard Deviation 0.582
Change From Baseline in F-VASI at Each Post-Baseline Visit Baseline	1.00 scores on a scale Standard Deviation 0.446	0.91 scores on a scale Standard Deviation 0.522
Change From Baseline in F-VASI at Each Post-Baseline Visit Week 4	-0.13 scores on a scale Standard Deviation 0.234	-0.05 scores on a scale Standard Deviation 0.114
Change From Baseline in F-VASI at Each Post-Baseline Visit Week 12	-0.51 scores on a scale Standard Deviation 0.382	-0.32 scores on a scale Standard Deviation 0.330
Change From Baseline in F-VASI at Each Post-Baseline Visit Week 16	-0.68 scores on a scale Standard Deviation 0.319	-0.41 scores on a scale Standard Deviation 0.428
Change From Baseline in F-VASI at Each Post-Baseline Visit Week 24	-0.83 scores on a scale Standard Deviation 0.276	-0.60 scores on a scale Standard Deviation 0.536
Change From Baseline in F-VASI at Each Post-Baseline Visit Week 32	-0.87 scores on a scale Standard Deviation 0.311	-0.70 scores on a scale Standard Deviation 0.514
Change From Baseline in F-VASI at Each Post-Baseline Visit Week 48	-0.88 scores on a scale Standard Deviation 0.322	-0.82 scores on a scale Standard Deviation 0.603

SECONDARY outcome

Timeframe: Baseline; up to Week 48

Population: Full Analysis Set. 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-Baseline (BL) value minus BL value]/BL value) X 100.

Outcome measures

Measure	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit Week 4	-11.69 percent change Standard Deviation 20.612	-6.24 percent change Standard Deviation 12.472
Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit Week 12	-54.62 percent change Standard Deviation 34.297	-32.43 percent change Standard Deviation 26.031
Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit Week 16	-73.31 percent change Standard Deviation 27.030	-40.64 percent change Standard Deviation 27.945
Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit Week 8	-25.57 percent change Standard Deviation 24.957	-14.62 percent change Standard Deviation 20.210
Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit Week 24	-87.02 percent change Standard Deviation 12.247	-61.31 percent change Standard Deviation 28.613
Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit Week 32	-89.37 percent change Standard Deviation 11.661	-72.69 percent change Standard Deviation 24.815
Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit Week 40	-90.44 percent change Standard Deviation 11.006	-80.70 percent change Standard Deviation 20.478
Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit Week 48	-90.73 percent change Standard Deviation 11.002	-85.55 percent change Standard Deviation 15.856

SECONDARY outcome

Timeframe: Baseline; up to Week 48

Population: Full Analysis Set. Only participants with available data were analyzed.

T-VASI was calculated with contributions from 6 body 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 body 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). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values (range: 0-100; lower scores indicate increased improvement). Change from BL was calculated as the post-BL value minus the BL value.

Outcome measures

Measure	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Change From Baseline in T-VASI at Each Post-Baseline Visit Baseline	6.58 scores on a scale Standard Deviation 2.163	6.87 scores on a scale Standard Deviation 2.103
Change From Baseline in T-VASI at Each Post-Baseline Visit Week 4	-0.40 scores on a scale Standard Deviation 0.711	-0.06 scores on a scale Standard Deviation 0.179
Change From Baseline in T-VASI at Each Post-Baseline Visit Week 8	-0.85 scores on a scale Standard Deviation 0.865	-0.17 scores on a scale Standard Deviation 0.480
Change From Baseline in T-VASI at Each Post-Baseline Visit Week 12	-1.61 scores on a scale Standard Deviation 1.320	-0.52 scores on a scale Standard Deviation 0.710
Change From Baseline in T-VASI at Each Post-Baseline Visit Week 16	-2.47 scores on a scale Standard Deviation 1.532	-0.94 scores on a scale Standard Deviation 0.949
Change From Baseline in T-VASI at Each Post-Baseline Visit Week 24	-3.21 scores on a scale Standard Deviation 1.686	-1.73 scores on a scale Standard Deviation 1.679
Change From Baseline in T-VASI at Each Post-Baseline Visit Week 32	-3.03 scores on a scale Standard Deviation 1.542	-2.34 scores on a scale Standard Deviation 1.746
Change From Baseline in T-VASI at Each Post-Baseline Visit Week 40	-3.42 scores on a scale Standard Deviation 1.235	-2.97 scores on a scale Standard Deviation 1.867
Change From Baseline in T-VASI at Each Post-Baseline Visit Week 48	-3.43 scores on a scale Standard Deviation 1.219	-3.46 scores on a scale Standard Deviation 2.106

SECONDARY outcome

Timeframe: Baseline; up to Week 48

Population: Full Analysis Set. Only participants with available data were analyzed.

T-VASI was calculated with contributions from 6 body 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 body 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). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body 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	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit Week 40	-69.63 percent change Standard Deviation 19.748	-43.76 percent change Standard Deviation 27.441
Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit Week 4	-6.12 percent change Standard Deviation 11.217	-1.02 percent change Standard Deviation 3.063
Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit Week 8	-15.21 percent change Standard Deviation 15.360	-2.79 percent change Standard Deviation 6.833
Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit Week 12	-29.76 percent change Standard Deviation 24.512	-7.88 percent change Standard Deviation 9.796
Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit Week 16	-42.28 percent change Standard Deviation 23.530	-14.82 percent change Standard Deviation 15.536
Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit Week 24	-57.31 percent change Standard Deviation 26.271	-27.54 percent change Standard Deviation 26.386
Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit Week 32	-61.19 percent change Standard Deviation 28.399	-35.51 percent change Standard Deviation 27.266
Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit Week 48	-69.76 percent change Standard Deviation 18.519	-50.39 percent change Standard Deviation 28.689

SECONDARY outcome

Timeframe: Baseline; up to Week 48

Population: Full Analysis Set. 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.

Outcome measures

Measure	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit Baseline	1.12 percentage of facial surface area Standard Deviation 0.524	0.96 percentage of facial surface area Standard Deviation 0.615
Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit Week 4	-0.04 percentage of facial surface area Standard Deviation 0.126	-0.02 percentage of facial surface area Standard Deviation 0.088
Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit Week 8	-0.08 percentage of facial surface area Standard Deviation 0.148	-0.06 percentage of facial surface area Standard Deviation 0.194
Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit Week 12	-0.25 percentage of facial surface area Standard Deviation 0.246	-0.17 percentage of facial surface area Standard Deviation 0.299
Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit Week 16	-0.40 percentage of facial surface area Standard Deviation 0.283	-0.22 percentage of facial surface area Standard Deviation 0.378
Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit Week 24	-0.63 percentage of facial surface area Standard Deviation 0.150	-0.34 percentage of facial surface area Standard Deviation 0.426
Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit Week 32	-0.70 percentage of facial surface area Standard Deviation 0.167	-0.44 percentage of facial surface area Standard Deviation 0.457
Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit Week 40	-0.75 percentage of facial surface area Standard Deviation 0.207	-0.58 percentage of facial surface area Standard Deviation 0.577
Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit Week 48	-0.77 percentage of facial surface area Standard Deviation 0.234	-0.67 percentage of facial surface area Standard Deviation 0.716

SECONDARY outcome

Timeframe: Baseline; up to Week 48

Population: Full Analysis Set. 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	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit Week 4	-4.02 percent change Standard Deviation 12.769	-1.50 percent change Standard Deviation 4.345
Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit Week 8	-7.25 percent change Standard Deviation 13.838	-4.37 percent change Standard Deviation 12.349
Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit Week 12	-24.12 percent change Standard Deviation 22.508	-14.83 percent change Standard Deviation 19.575
Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit Week 16	-39.37 percent change Standard Deviation 35.289	-19.34 percent change Standard Deviation 23.332
Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit Week 24	-65.36 percent change Standard Deviation 25.090	-34.37 percent change Standard Deviation 30.969
Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit Week 32	-72.67 percent change Standard Deviation 20.378	-45.42 percent change Standard Deviation 31.086
Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit Week 40	-77.02 percent change Standard Deviation 20.748	-56.25 percent change Standard Deviation 31.498
Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit Week 48	-78.06 percent change Standard Deviation 20.018	-60.51 percent change Standard Deviation 29.172

SECONDARY outcome

Timeframe: Baseline; up to Week 48

Population: Full Analysis Set. 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.

Outcome measures

Measure	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit Week 24	-2.14 percentage of total body surface area Standard Deviation 1.462	-0.80 percentage of total body surface area Standard Deviation 1.538
Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit Baseline	7.00 percentage of total body surface area Standard Deviation 2.301	7.22 percentage of total body surface area Standard Deviation 2.118
Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit Week 4	-0.19 percentage of total body surface area Standard Deviation 0.701	-0.02 percentage of total body surface area Standard Deviation 0.200
Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit Week 8	-0.48 percentage of total body surface area Standard Deviation 0.794	-0.01 percentage of total body surface area Standard Deviation 0.430
Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit Week 12	-0.96 percentage of total body surface area Standard Deviation 0.952	-0.17 percentage of total body surface area Standard Deviation 0.544
Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit Week 16	-1.43 percentage of total body surface area Standard Deviation 1.359	-0.34 percentage of total body surface area Standard Deviation 0.659
Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit Week 32	-2.13 percentage of total body surface area Standard Deviation 1.556	-1.12 percentage of total body surface area Standard Deviation 1.689
Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit Week 40	-2.33 percentage of total body surface area Standard Deviation 1.617	-1.50 percentage of total body surface area Standard Deviation 1.988
Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit Week 48	-2.37 percentage of total body surface area Standard Deviation 1.627	-1.93 percentage of total body surface area Standard Deviation 2.312

SECONDARY outcome

Timeframe: Baseline; up to Week 48

Population: Full Analysis Set. 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

Measure	Ruxolitinib 1.5% Cream BID n=20 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit Week 4	-2.65 percent change Standard Deviation 10.057	-0.36 percent change Standard Deviation 3.374
Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit Week 8	-7.71 percent change Standard Deviation 13.609	-0.24 percent change Standard Deviation 6.006
Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit Week 12	-16.92 percent change Standard Deviation 17.590	-2.60 percent change Standard Deviation 7.586
Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit Week 16	-23.09 percent change Standard Deviation 22.344	-5.45 percent change Standard Deviation 9.946
Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit Week 24	-38.02 percent change Standard Deviation 23.485	-12.50 percent change Standard Deviation 21.869
Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit Week 32	-42.86 percent change Standard Deviation 28.257	-16.91 percent change Standard Deviation 23.758
Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit Week 40	-46.61 percent change Standard Deviation 29.639	-21.92 percent change Standard Deviation 27.234
Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit Week 48	-47.03 percent change Standard Deviation 29.370	-27.30 percent change Standard Deviation 30.712

SECONDARY outcome

Timeframe: pre-application at Weeks 4, 12, and 16

Population: Pharmacokinetic (PK)-Evaluable Population: all participants who applied ruxolitinib 1.5% cream at least once and provided at least 1 post-dose blood sample. Only participants with available data were analyzed.

The concentration of ruxolitinib in the plasma was assessed.

Outcome measures

Measure	Ruxolitinib 1.5% Cream BID n=16 Participants Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=34 Participants Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.
Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16 Week 4	18.7 nanomolar Standard Deviation 19.0	51.1 nanomolar Standard Deviation 45.4
Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16 Week 12	23.3 nanomolar Standard Deviation 23.1	53.7 nanomolar Standard Deviation 55.0
Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16 Week 16	49.3 nanomolar Standard Deviation 38.8	55.4 nanomolar Standard Deviation 43.9

Adverse Events

Ruxolitinib 1.5% Cream BID

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Ruxolitinib 1.5% Cream BID + NB-UVB

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Total

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ruxolitinib 1.5% Cream BID n=20 participants at risk Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 participants at risk Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.	Total n=55 participants at risk Total
Nervous system disorders Generalised tonic-clonic seizure	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Gastrointestinal disorders Intestinal obstruction	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Gastrointestinal disorders Small intestinal perforation	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.

Other adverse events

Measure	Ruxolitinib 1.5% Cream BID n=20 participants at risk Participants who achieved ≥25% improvement in Total Body Vitiligo Scoring Index (T-VASI25) at Week 12 applied ruxolitinib 1.5% cream twice daily (BID) as monotherapy through Week 48.	Ruxolitinib 1.5% Cream BID + NB-UVB n=35 participants at risk Participants applied ruxolitinib 1.5% cream BID as monotherapy through Week 12. Participants did not achieve T-VASI25 at Week 12 and added narrow-band ultraviolet B (NB-UVB) phototherapy to their ruxolitinib 1.5% cream BID regimen. NB-UVB phototherapy was given 3 times per week through Week 48 (up to 36 weeks). Participants continued to receive ruxolitinib 1.5% cream BID through Week 48.	Total n=55 participants at risk Total
Skin and subcutaneous tissue disorders Acne	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	2.9% 1/35 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	3.6% 2/55 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Injury, poisoning and procedural complications Animal bite	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
General disorders Application site acne	10.0% 2/20 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	11.4% 4/35 • Number of events 4 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	10.9% 6/55 • Number of events 6 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Infections and infestations Bacterial vaginosis	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Infections and infestations Bronchitis	10.0% 2/20 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	3.6% 2/55 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Infections and infestations COVID-19	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	2.9% 1/35 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	3.6% 2/55 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Eye disorders Cataract	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	2.9% 1/35 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	3.6% 2/55 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Injury, poisoning and procedural complications Concussion	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Injury, poisoning and procedural complications Contusion	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Hepatobiliary disorders Gallbladder enlargement	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	2.9% 1/35 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	3.6% 2/55 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Metabolism and nutrition disorders Hyperkalaemia	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Metabolism and nutrition disorders Hypoglycaemia	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Psychiatric disorders Libido decreased	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Gastrointestinal disorders Nausea	5.0% 1/20 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Renal and urinary disorders Nephrolithiasis	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	2.9% 1/35 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	3.6% 2/55 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Infections and infestations Oral herpes	0.00% 0/20 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	8.6% 3/35 • Number of events 3 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	5.5% 3/55 • Number of events 3 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.0% 2/20 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	2.9% 1/35 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	5.5% 3/55 • Number of events 3 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Gastrointestinal disorders Pancreatic cyst	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Injury, poisoning and procedural complications Procedural site reaction	0.00% 0/20 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	11.4% 4/35 • Number of events 5 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	7.3% 4/55 • Number of events 5 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
General disorders Pyrexia	10.0% 2/20 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	3.6% 2/55 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Vascular disorders Scalp haematoma	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Immune system disorders Seasonal allergy	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/20 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	5.7% 2/35 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	3.6% 2/55 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Injury, poisoning and procedural complications Skin laceration	5.0% 1/20 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	0.00% 0/35 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	1.8% 1/55 • Number of events 1 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.
Infections and infestations Upper respiratory tract infection	5.0% 1/20 • Number of events 2 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	8.6% 3/35 • Number of events 4 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.	7.3% 4/55 • Number of events 6 • up to approximately 52 weeks After the 12-week run-in, in which all participants applied ruxolitinib 1.5% cream BID, participants received either ruxolitinib 1.5% cream BID alone or ruxolitinib 1.5% cream BID plus NB-UVB phototherapy for 36 weeks, based on their T-VASI score at Week 12. As pre-specified in the Statistical Analysis Plan, AE data were summarized based on the treatments that the participant received after run-in.

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