Vitiligo
Conditions
Keywords
Non-segmental, Vitiligo, hypopigmentation, Pigment Disorders, Skin Diseases, JAK inhibitor
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream with or without phototherapy in adolescent and adult participants with non-segmental vitiligo for whom vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
Interventions
Ruxolitinib cream 1.5% applied twice a day (BID).
DEVICENB-UVB phototherapy
NB-UVB (311-312 nm) phototherapy is an established treatment modality for vitiligo. Starting dose will be 200 mJ/cm2 and dose may be increased by 10% at each visit
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* A clinical diagnosis of nonsegmental vitiligo with depigmented area including all of the following: 1. ≥ 0.5 F-VASI on the face 2. ≥ 3.0 T-VASI (body areas not including the face) 3. Total body vitiligo area (facial and nonfacial) not exceeding 10% BSA. * Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
Exclusion criteria
* No pigmented hair within any of the vitiligo areas on the face. * Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders. * Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas. * Previous adverse reaction to NB-UVB phototherapy that caused discontinuation of therapy. * Lack of response (little or no repigmentation) to prior NB-UVB phototherapy. * History of thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke, myocardial infarction). * Any other skin disease that, in the opinion of the investigator, would interfere with the study cream application or study assessments. * Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox) within 1 week before baseline. * Any serious illness or medical, physical, or psychiatric condition(s) that pose a significant risk to the participant; or interfere with interpretation of study data. * Recent use of topical or systemic medications (including biologics or JAK inhibitors), or laser or phototherapy to treat vitiligo. Note: Recent may be defined differently for different treatments. * Specific protocol-defined chemistry, hematology, and serological lab values. * Those who are pregnant, lactating or considering pregnancy during the period of study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48 | Baseline; Week 48 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit | Baseline; up to Week 48 | 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). |
| Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit | Baseline; up to Week 48 | 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). |
| Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit | Baseline; up to Week 48 | 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). |
| 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 | Baseline; up to Week 48 | 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). |
| 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 | Baseline; up to Week 48 | 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). |
| 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 | Baseline; up to Week 48 | 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). |
| Change From Baseline in F-VASI at Each Post-Baseline Visit | Baseline; up to Week 48 | 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. |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to approximately 52 weeks | 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. |
| Change From Baseline in T-VASI at Each Post-Baseline Visit | Baseline; up to Week 48 | 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. |
| Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Baseline; up to Week 48 | 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. |
| Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit | Baseline; up to Week 48 | 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. |
| Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Baseline; up to Week 48 | 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. |
| Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit | Baseline; up to Week 48 | 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. |
| Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Baseline; up to Week 48 | 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. |
| Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16 | pre-application at Weeks 4, 12, and 16 | The concentration of ruxolitinib in the plasma was assessed. |
| Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Baseline; up to Week 48 | 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. |
Countries
Canada, United States
Participant flow
Pre-assignment details
This study was conducted at 10 study centers in Canada and the United States.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 35 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Left Country | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 1 |
| Overall Study | Noncompliance with Investigational Product | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 7 |
| Overall Study | Withdrawn by Sponsor: Noncompliance | 0 | 1 |
| Overall Study | Withdrawn by Sponsor: Surgery to Remove Excess Skin | 1 | 0 |
Baseline characteristics
| Characteristic | Ruxolitinib 1.5% Cream BID | Total | Ruxolitinib 1.5% Cream BID + NB-UVB |
|---|---|---|---|
| Age, Continuous | 42.0 years STANDARD_DEVIATION 18.97 | 48.7 years STANDARD_DEVIATION 16.75 | 52.5 years STANDARD_DEVIATION 14.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 50 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized American-Indian/Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Arab | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 12 Participants | 6 Participants |
| Race/Ethnicity, Customized Black/African-American | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized East Indian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 11 Participants | 36 Participants | 25 Participants |
| Sex: Female, Male Female | 10 Participants | 27 Participants | 17 Participants |
| Sex: Female, Male Male | 10 Participants | 28 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 35 | 0 / 55 |
| other Total, other adverse events | 9 / 20 | 15 / 35 | 24 / 55 |
| serious Total, serious adverse events | 2 / 20 | 0 / 35 | 2 / 55 |
Outcome results
Primary
Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48 | Baseline | 6.87 scores on a scale | Standard Deviation 2.103 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48 | Change from Baseline at Week 48 | -3.46 scores on a scale | Standard Deviation 2.106 |
Secondary
Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit
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.
Time frame: Baseline; up to Week 48
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 0.15 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit | Week 48 | -0.67 percentage of facial surface area | Standard Deviation 0.716 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit | Baseline | 0.96 percentage of facial surface area | Standard Deviation 0.615 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit | Week 4 | -0.02 percentage of facial surface area | Standard Deviation 0.088 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit | Week 8 | -0.06 percentage of facial surface area | Standard Deviation 0.194 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit | Week 12 | -0.17 percentage of facial surface area | Standard Deviation 0.299 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit | Week 16 | -0.22 percentage of facial surface area | Standard Deviation 0.378 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit | Week 24 | -0.34 percentage of facial surface area | Standard Deviation 0.426 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit | Week 32 | -0.44 percentage of facial surface area | Standard Deviation 0.457 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit | Week 40 | -0.58 percentage of facial surface area | Standard Deviation 0.577 |
Secondary
Change From Baseline in F-VASI at Each Post-Baseline Visit
F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; up to Week 48
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 4 | -0.13 scores on a scale | Standard Deviation 0.234 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 24 | -0.83 scores on a scale | Standard Deviation 0.276 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 12 | -0.51 scores on a scale | Standard Deviation 0.382 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 32 | -0.87 scores on a scale | Standard Deviation 0.311 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 8 | -0.26 scores on a scale | Standard Deviation 0.302 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 40 | -0.88 scores on a scale | Standard Deviation 0.326 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 16 | -0.68 scores on a scale | Standard Deviation 0.319 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 48 | -0.88 scores on a scale | Standard Deviation 0.322 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI at Each Post-Baseline Visit | Baseline | 1.00 scores on a scale | Standard Deviation 0.446 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 48 | -0.82 scores on a scale | Standard Deviation 0.603 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in F-VASI at Each Post-Baseline Visit | Baseline | 0.91 scores on a scale | Standard Deviation 0.522 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 4 | -0.05 scores on a scale | Standard Deviation 0.114 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 8 | -0.14 scores on a scale | Standard Deviation 0.204 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 12 | -0.32 scores on a scale | Standard Deviation 0.33 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 16 | -0.41 scores on a scale | Standard Deviation 0.428 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 24 | -0.60 scores on a scale | Standard Deviation 0.536 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 32 | -0.70 scores on a scale | Standard Deviation 0.514 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 40 | -0.79 scores on a scale | Standard Deviation 0.582 |
Secondary
Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit
T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; up to Week 48
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit | Week 48 | -1.93 percentage of total body surface area | Standard Deviation 2.312 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit | Baseline | 7.22 percentage of total body surface area | Standard Deviation 2.118 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit | Week 4 | -0.02 percentage of total body surface area | Standard Deviation 0.2 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit | Week 8 | -0.01 percentage of total body surface area | Standard Deviation 0.43 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit | Week 12 | -0.17 percentage of total body surface area | Standard Deviation 0.544 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit | Week 16 | -0.34 percentage of total body surface area | Standard Deviation 0.659 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit | Week 24 | -0.80 percentage of total body surface area | Standard Deviation 1.538 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit | Week 32 | -1.12 percentage of total body surface area | Standard Deviation 1.689 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit | Week 40 | -1.50 percentage of total body surface area | Standard Deviation 1.988 |
Secondary
Change From Baseline in T-VASI at Each Post-Baseline Visit
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.
Time frame: Baseline; up to Week 48
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 4 | -0.40 scores on a scale | Standard Deviation 0.711 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 24 | -3.21 scores on a scale | Standard Deviation 1.686 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 12 | -1.61 scores on a scale | Standard Deviation 1.32 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 32 | -3.03 scores on a scale | Standard Deviation 1.542 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 8 | -0.85 scores on a scale | Standard Deviation 0.865 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 40 | -3.42 scores on a scale | Standard Deviation 1.235 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 16 | -2.47 scores on a scale | Standard Deviation 1.532 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 48 | -3.43 scores on a scale | Standard Deviation 1.219 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI at Each Post-Baseline Visit | Baseline | 6.58 scores on a scale | Standard Deviation 2.163 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 48 | -3.46 scores on a scale | Standard Deviation 2.106 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in T-VASI at Each Post-Baseline Visit | Baseline | 6.87 scores on a scale | Standard Deviation 2.103 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 4 | -0.06 scores on a scale | Standard Deviation 0.179 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 8 | -0.17 scores on a scale | Standard Deviation 0.48 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 12 | -0.52 scores on a scale | Standard Deviation 0.71 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 16 | -0.94 scores on a scale | Standard Deviation 0.949 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 24 | -1.73 scores on a scale | Standard Deviation 1.679 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 32 | -2.34 scores on a scale | Standard Deviation 1.746 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 40 | -2.97 scores on a scale | Standard Deviation 1.867 |
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it 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.
Time frame: up to approximately 52 weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ruxolitinib 1.5% Cream BID | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 9 Participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 21 Participants |
Secondary
Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit
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.
Time frame: Baseline; up to Week 48
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 4 | -4.02 percent change | Standard Deviation 12.769 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 8 | -7.25 percent change | Standard Deviation 13.838 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 12 | -24.12 percent change | Standard Deviation 22.508 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 16 | -39.37 percent change | Standard Deviation 35.289 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 24 | -65.36 percent change | Standard Deviation 25.09 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 32 | -72.67 percent change | Standard Deviation 20.378 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 40 | -77.02 percent change | Standard Deviation 20.748 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 48 | -78.06 percent change | Standard Deviation 20.018 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 48 | -60.51 percent change | Standard Deviation 29.172 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 4 | -1.50 percent change | Standard Deviation 4.345 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 24 | -34.37 percent change | Standard Deviation 30.969 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 8 | -4.37 percent change | Standard Deviation 12.349 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 40 | -56.25 percent change | Standard Deviation 31.498 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 12 | -14.83 percent change | Standard Deviation 19.575 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 32 | -45.42 percent change | Standard Deviation 31.086 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit | Week 16 | -19.34 percent change | Standard Deviation 23.332 |
Secondary
Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit
F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = (\[post-Baseline (BL) value minus BL value\]/BL value) X 100.
Time frame: Baseline; up to Week 48
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 4 | -11.69 percent change | Standard Deviation 20.612 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 8 | -25.57 percent change | Standard Deviation 24.957 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 12 | -54.62 percent change | Standard Deviation 34.297 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 16 | -73.31 percent change | Standard Deviation 27.03 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 24 | -87.02 percent change | Standard Deviation 12.247 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 32 | -89.37 percent change | Standard Deviation 11.661 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 40 | -90.44 percent change | Standard Deviation 11.006 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 48 | -90.73 percent change | Standard Deviation 11.002 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 48 | -85.55 percent change | Standard Deviation 15.856 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 4 | -6.24 percent change | Standard Deviation 12.472 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 24 | -61.31 percent change | Standard Deviation 28.613 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 8 | -14.62 percent change | Standard Deviation 20.21 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 40 | -80.70 percent change | Standard Deviation 20.478 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 12 | -32.43 percent change | Standard Deviation 26.031 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 32 | -72.69 percent change | Standard Deviation 24.815 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit | Week 16 | -40.64 percent change | Standard Deviation 27.945 |
Secondary
Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit
T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = (\[post-BL value minus BL value\]/BL value) X 100.
Time frame: Baseline; up to Week 48
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 4 | -2.65 percent change | Standard Deviation 10.057 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 8 | -7.71 percent change | Standard Deviation 13.609 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 12 | -16.92 percent change | Standard Deviation 17.59 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 16 | -23.09 percent change | Standard Deviation 22.344 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 24 | -38.02 percent change | Standard Deviation 23.485 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 32 | -42.86 percent change | Standard Deviation 28.257 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 40 | -46.61 percent change | Standard Deviation 29.639 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 48 | -47.03 percent change | Standard Deviation 29.37 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 48 | -27.30 percent change | Standard Deviation 30.712 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 4 | -0.36 percent change | Standard Deviation 3.374 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 24 | -12.50 percent change | Standard Deviation 21.869 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 8 | -0.24 percent change | Standard Deviation 6.006 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 40 | -21.92 percent change | Standard Deviation 27.234 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 12 | -2.60 percent change | Standard Deviation 7.586 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 32 | -16.91 percent change | Standard Deviation 23.758 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit | Week 16 | -5.45 percent change | Standard Deviation 9.946 |
Secondary
Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit
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.
Time frame: Baseline; up to Week 48
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 4 | -6.12 percent change | Standard Deviation 11.217 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 8 | -15.21 percent change | Standard Deviation 15.36 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 12 | -29.76 percent change | Standard Deviation 24.512 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 16 | -42.28 percent change | Standard Deviation 23.53 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 24 | -57.31 percent change | Standard Deviation 26.271 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 32 | -61.19 percent change | Standard Deviation 28.399 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 40 | -69.63 percent change | Standard Deviation 19.748 |
| Ruxolitinib 1.5% Cream BID | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 48 | -69.76 percent change | Standard Deviation 18.519 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 48 | -50.39 percent change | Standard Deviation 28.689 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 4 | -1.02 percent change | Standard Deviation 3.063 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 24 | -27.54 percent change | Standard Deviation 26.386 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 8 | -2.79 percent change | Standard Deviation 6.833 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 40 | -43.76 percent change | Standard Deviation 27.441 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 12 | -7.88 percent change | Standard Deviation 9.796 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 32 | -35.51 percent change | Standard Deviation 27.266 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit | Week 16 | -14.82 percent change | Standard Deviation 15.536 |
Secondary
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit
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).
Time frame: Baseline; up to Week 48
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 92.9 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 96.2 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 45.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 5.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 87.5 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 17.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 76.5 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 31.4 percentage of participants |
Secondary
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
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).
Time frame: Baseline; up to Week 48
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 57.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 23.5 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 46.4 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 0.0 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 34.4 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 2.9 percentage of participants |
Secondary
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit
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).
Time frame: Baseline; up to Week 48
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 84.6 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 0.0 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 47.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 0.0 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 71.4 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 14.3 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 59.4 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 20.0 percentage of participants |
Secondary
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
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).
Time frame: Baseline; up to Week 48
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 19.2 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 5.9 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 7.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 6.3 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 |
Secondary
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit
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).
Time frame: Baseline; up to Week 48
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 53.8 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 17.6 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 53.6 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 0.0 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 34.4 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 2.9 percentage of participants |
Secondary
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
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).
Time frame: Baseline; up to Week 48
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 7.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 2.9 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 7.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 | 3.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID + NB-UVB | 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 |
Secondary
Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16
The concentration of ruxolitinib in the plasma was assessed.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16 | Week 4 | 18.7 nanomolar | Standard Deviation 19 |
| Ruxolitinib 1.5% Cream BID | Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16 | Week 12 | 23.3 nanomolar | Standard Deviation 23.1 |
| Ruxolitinib 1.5% Cream BID | Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16 | Week 16 | 49.3 nanomolar | Standard Deviation 38.8 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16 | Week 4 | 51.1 nanomolar | Standard Deviation 45.4 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16 | Week 12 | 53.7 nanomolar | Standard Deviation 55 |
| Ruxolitinib 1.5% Cream BID + NB-UVB | Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16 | Week 16 | 55.4 nanomolar | Standard Deviation 43.9 |