Vitiligo
Conditions
Keywords
INCB018424
Brief summary
The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either Study NCT04052425 or NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream BID for the previous 28 to 52 weeks depending on their initial randomization in the parent study.
Interventions
DRUGruxolitinib
ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.
DRUGVehicle
Vehicle cream is a topical formulation applied as a thin film to affected areas.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently enrolled and receiving treatment in INCB 18424-306 (NCT04052425) or INCB 18424-307 (NCT04057573) studies evaluating ruxolitinib cream in participants with vitiligo. * Currently tolerating ruxolitinib cream in the parent study and no safety concerns per investigators judgment. * Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. * Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol. * Male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child. * Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and written assent from the participant when possible.
Exclusion criteria
* Has been permanently discontinued from study treatment in the parent study for any reason. * Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol. * Pregnant or breastfeeding woman. * Participants who live with anyone participating in any current Incyte-sponsored ruxolitinib cream study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Relapse (Defined as <F-VASI75) | from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study) | Relapse was defined as a loss of 75% improvement from Baseline in the Face Vitiligo Area Scoring Index score (F-VASI75) response, assessed as percentage improvement in the F-VASI score at Baseline (Day 1 of the parent study) to \<75%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). |
| Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | 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 F-VASI (F-VASI90) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | 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). |
| Mean F-VASI Scores During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | 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 in F-VASI Scores During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | 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. |
| Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Baseline (BL); up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = (\[post-BL value minus BL value\]/BL value) X 100. |
| Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). |
| Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | A T-VASI75 responder achieved at least 75% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). |
| Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | A T-VASI90 responder achieved at least 90% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). |
| Mean T-VASI Scores During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). |
| Change From Baseline in T-VASI Scores During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Change from Baseline=post-Baseline value minus the Baseline value. |
| Time to Loss of Adequate Response | from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study) | Loss of adequate response was defined as a loss of 90% improvement from Baseline in the F-VASI score (F-VASI90) response, assessed as percentage improvement in the F-VASI score at Baseline (Day 1 of the parent study) to \<90%. |
| Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area Face was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area Face did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Data are presented as the percentage of BSA involvement in the face as compared to total BSA. |
| Change From Baseline in F-BSA During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area Face was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area Face did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented as the percentage of BSA involvement in the face as compared to total BSA. |
| Percent Change From Baseline in F-BSA During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | 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. |
| Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Data are presented as the percentage of BSA involvement in the total body. |
| Change From Baseline in T-BSA During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented as the percentage of BSA involvement in the total body. |
| Percent Change From Baseline in T-BSA During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = (\[post-Baseline (BL) value minus BL value\]/BL value) X 100. |
| Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | The VNS is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. The Baseline facial photograph was shown to the participants for reference, and a mirror was provided for the participants to assess the vitiligo on their face. The participant was asked to respond to the following query: Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, and (5) no longer noticeable. |
| Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Week 52; up to up to Week 104 of Extension Study (Week 52 was the first visit of this Treatment Extension study.) | The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Participants age ≥16 years answered the questionnaire with: (1) very much; (2) a lot; (3) a little; or (4) not at all. The questionnaire was analyzed under 6 headings: Symptoms and feelings (Questions 1 and 2); Daily activities (Questions 3 and 4); Leisure (Questions 5 and 6); Work and school (Question 7); Personal relations (Questions 8 and 9); and Treatment (Question 10). The scoring of each question is as follows: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0. For Question 7, prevented work or studying=3. The total score ranges from 0 to 30; higher scores indicate higher quality of life. Change from Week 52 was calculated as the post-Week 52 value minus the Week 52 value. |
| Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Week 52; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | The CDLQI is the youth/children's version of the DLQI. The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Participants age \<16 years answered the questionnaire with: (1) very much; (2) a lot; (3) a little; or (4) not at all. The questionnaire was analyzed under 6 headings: Symptoms and feelings (Questions 1 and 2); Leisure (Questions 4, 5, and 6); School or holidays (Question 7); Personal relationships (Questions 3 and 8); Sleep (Question 9); and Treatment (Question 10). The scoring of each question is as follows: very much = 3; quite a lot = 2; only a little = 1; not at all = 0; question unanswered = 0. The total score ranges from 0 to 30; higher scores indicate higher quality of life. Change from Week 52 was calculated as the post-Week 52 value minus the Week 52 value. |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) | A TEAE was defined as any adverse event (AE) reported for the first time or the worsening of a pre-existing event after the first application of study drug in this study. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. |
| Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 | Weeks 80 (predose); Week 104 (any time post-dose) (Week 52 was the first visit of this Treatment Extension study.) | The steady-state plasma concentration was assessed. Pharmacokinetic blood samples could have been collected at any time prior to study drug application at the site at the Week 80 visit and at any time at the Week 104 (End of Trial) visit. Results from the two parent studies indicated that steady state was reached at or before Week 4, and that, hence, the use of vehicle or ruxolitinib 1.5% in the first 52 weeks of treatment had no impact on the ruxolitinib plasma concentration at the Week 80 and Week 104 (End of Treatment) visits. Thus, the two Cohort B cohorts were combined into a single arm for data analysis in this study. |
| Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) | T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Percentage change = (\[post-BL value minus BL value\]/BL value) X 100. |
Countries
Bulgaria, Canada, France, Germany, Netherlands, Poland, Spain, United States
Participant flow
Recruitment details
This study was conducted at 87 study centers in North America and Europe.
Pre-assignment details
This randomized withdrawal and treatment-extension study (extension of treatment received in 2 parent studies: NCT04052425 or NCT04057573) was comprised of a 52-week extension treatment period and a 4-week safety follow-up period, starting 4 weeks (30 days) after the last application of study treatment or the last study visit.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A: Vehicle Cream BID Participants who completed treatment and achieved ≥90% improvement from Baseline in the Facial Vitiligo Area Scoring Index score (≥F-VASI90) at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive vehicle cream twice daily (BID) for 52 weeks. Participants who experienced relapse (\<75% improvement from Baseline in the F-VASI score \[\<F-VASI75\]) received open-label ruxolitinib 1.5% cream BID for the duration of the study. | 58 |
| Cohort A: Ruxolitinib 1.5% Cream BID Participants who completed treatment and achieved ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants were randomized to receive ruxolitinib 1.5% cream BID for 52 weeks. Participants who experienced relapse (\<F-VASI75) received open-label ruxolitinib 1.5% cream BID for the duration of the study. | 58 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks. | 118 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants who completed treatment (ruxolitinib 1.5% BID for 52 weeks) and did not achieve ≥F-VASI90 at Week 52 in either of 2 parent studies (NCT04052425 or NCT04057573). In this study, these participants applied ruxolitinib 1.5% cream BID for 52 weeks. | 224 |
| Total | 458 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
| Overall Study | Discontinued due to COVID-19 Pandemic | 0 | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 3 | 3 | 10 |
| Overall Study | Missed Safety Follow-up Visit | 0 | 0 | 1 | 0 |
| Overall Study | Not Compliant with Protocol-specific Visit Window | 0 | 0 | 0 | 1 |
| Overall Study | Personal Reasons | 0 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 1 |
| Overall Study | Pregnancy | 0 | 0 | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
| Overall Study | Site Closed Due to Noncompliance | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 14 | 5 | 18 | 33 |
Baseline characteristics
| Characteristic | Total | Cohort A: Vehicle Cream BID | Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Cohort A: Ruxolitinib 1.5% Cream BID |
|---|---|---|---|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 15.47 | 39.3 years STANDARD_DEVIATION 12.49 | 39.7 years STANDARD_DEVIATION 14.62 | 39.3 years STANDARD_DEVIATION 16.45 | 42.9 years STANDARD_DEVIATION 15.95 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Arab//North-African | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 18 Participants | 4 Participants | 3 Participants | 8 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 23 Participants | 5 Participants | 3 Participants | 11 Participants | 4 Participants |
| Race/Ethnicity, Customized Brazilian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Cape Verdean | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Captured as Hispanic or Latino in Database | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Captured as Latino in Database | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Captured as Other in Database | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Dominican Republic | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Guyana | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 93 Participants | 11 Participants | 16 Participants | 53 Participants | 13 Participants |
| Race/Ethnicity, Customized Indian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Indo-Caribbean | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Iranian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Jordanian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Mexican | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Middle Eastern | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized North African | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 344 Participants | 45 Participants | 99 Participants | 157 Participants | 43 Participants |
| Race/Ethnicity, Customized Not Reported | 17 Participants | 2 Participants | 3 Participants | 11 Participants | 1 Participants |
| Race/Ethnicity, Customized Persian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 377 Participants | 42 Participants | 107 Participants | 180 Participants | 48 Participants |
| Race/Ethnicity, Customized White/Black/Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 254 Participants | 31 Participants | 61 Participants | 129 Participants | 33 Participants |
| Sex: Female, Male Male | 204 Participants | 27 Participants | 57 Participants | 95 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 423 | 0 / 458 |
| other Total, other adverse events | 6 / 58 | 55 / 423 | 61 / 458 |
| serious Total, serious adverse events | 0 / 58 | 12 / 423 | 12 / 458 |
Outcome results
Primary
Time to Relapse (Defined as <F-VASI75)
Relapse was defined as a loss of 75% improvement from Baseline in the Face Vitiligo Area Scoring Index score (F-VASI75) response, assessed as percentage improvement in the F-VASI score at Baseline (Day 1 of the parent study) to \<75%.
Time frame: from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study)
Population: Intent-to-Treat Long-term Extension (ITT-Ext) Population: randomized participants who achieved ≥90% improvement from Baseline in the F-VASI score (≥F-VASI90) at Week 52. Treatment groups were defined according to the treatment assignment at randomization regardless of the actual study medication the participant received. Week 52 was the first visit of this Treatment Extension study (visits were named to reflect continuation from the parent studies). Only participants in Cohort A were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: Vehicle Cream BID | Time to Relapse (Defined as <F-VASI75) | NA days |
| Cohort A: Ruxolitinib 1.5% Cream BID | Time to Relapse (Defined as <F-VASI75) | NA days |
Comparison: Cox regression model stratified by stratification factor (treatment assignment in the parent studies) was conducted to compare the difference in hazard rate between treatment and vehicle.p-value: 0.041495% CI: [0.18, 0.99]Log Rank
Secondary
Change From Baseline in F-BSA During the Extension Treatment Period
F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area Face was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area Face did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented as the percentage of BSA involvement in the face as compared to total BSA.
Time frame: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 104 | -0.70 percentage BSA | Standard Deviation 0.4 |
| Cohort A: Vehicle Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 68 | -0.69 percentage BSA | Standard Deviation 0.345 |
| Cohort A: Vehicle Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 80 | -0.74 percentage BSA | Standard Deviation 0.381 |
| Cohort A: Vehicle Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 92 | -0.76 percentage BSA | Standard Deviation 0.374 |
| Cohort A: Vehicle Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 56 | -0.76 percentage BSA | Standard Deviation 0.458 |
| Cohort A: Vehicle Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 60 | -0.77 percentage BSA | Standard Deviation 0.441 |
| Cohort A: Vehicle Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 64 | -0.74 percentage BSA | Standard Deviation 0.446 |
| Cohort A: Vehicle Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 52 | -0.74 percentage BSA | Standard Deviation 0.402 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 60 | -0.80 percentage BSA | Standard Deviation 0.601 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 104 | -0.93 percentage BSA | Standard Deviation 0.716 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 68 | -0.86 percentage BSA | Standard Deviation 0.657 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 92 | -0.87 percentage BSA | Standard Deviation 0.678 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 52 | -0.83 percentage BSA | Standard Deviation 0.638 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 64 | -0.83 percentage BSA | Standard Deviation 0.625 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 80 | -0.87 percentage BSA | Standard Deviation 0.637 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 56 | -0.82 percentage BSA | Standard Deviation 0.672 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 80 | -0.37 percentage BSA | Standard Deviation 0.494 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 92 | -0.36 percentage BSA | Standard Deviation 0.558 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 104 | -0.39 percentage BSA | Standard Deviation 0.604 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 56 | -0.25 percentage BSA | Standard Deviation 0.345 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 60 | -0.28 percentage BSA | Standard Deviation 0.364 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 64 | -0.29 percentage BSA | Standard Deviation 0.417 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 68 | -0.31 percentage BSA | Standard Deviation 0.425 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 52 | -0.20 percentage BSA | Standard Deviation 0.313 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 104 | -0.54 percentage BSA | Standard Deviation 0.548 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 56 | -0.35 percentage BSA | Standard Deviation 0.433 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 60 | -0.38 percentage BSA | Standard Deviation 0.454 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 64 | -0.41 percentage BSA | Standard Deviation 0.457 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 68 | -0.45 percentage BSA | Standard Deviation 0.489 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 80 | -0.48 percentage BSA | Standard Deviation 0.521 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 92 | -0.54 percentage BSA | Standard Deviation 0.532 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-BSA During the Extension Treatment Period | Week 52 | -0.31 percentage BSA | Standard Deviation 0.435 |
Secondary
Change From Baseline in F-VASI Scores During the Extension Treatment Period
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 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 104 | -0.72 scores on a scale | Standard Deviation 0.38 |
| Cohort A: Vehicle Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 92 | -0.76 scores on a scale | Standard Deviation 0.341 |
| Cohort A: Vehicle Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 68 | -0.73 scores on a scale | Standard Deviation 0.316 |
| Cohort A: Vehicle Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 80 | -0.75 scores on a scale | Standard Deviation 0.36 |
| Cohort A: Vehicle Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 64 | -0.80 scores on a scale | Standard Deviation 0.442 |
| Cohort A: Vehicle Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 52 | -0.81 scores on a scale | Standard Deviation 0.464 |
| Cohort A: Vehicle Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 60 | -0.84 scores on a scale | Standard Deviation 0.447 |
| Cohort A: Vehicle Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 56 | -0.82 scores on a scale | Standard Deviation 0.492 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 52 | -0.92 scores on a scale | Standard Deviation 0.591 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 56 | -0.90 scores on a scale | Standard Deviation 0.594 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 60 | -0.87 scores on a scale | Standard Deviation 0.57 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 64 | -0.87 scores on a scale | Standard Deviation 0.527 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 68 | -0.86 scores on a scale | Standard Deviation 0.518 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 80 | -0.86 scores on a scale | Standard Deviation 0.508 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 92 | -0.87 scores on a scale | Standard Deviation 0.548 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 104 | -0.92 scores on a scale | Standard Deviation 0.561 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 64 | -0.44 scores on a scale | Standard Deviation 0.423 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 80 | -0.49 scores on a scale | Standard Deviation 0.471 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 60 | -0.43 scores on a scale | Standard Deviation 0.402 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 92 | -0.48 scores on a scale | Standard Deviation 0.531 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 104 | -0.50 scores on a scale | Standard Deviation 0.557 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 52 | -0.37 scores on a scale | Standard Deviation 0.346 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 56 | -0.39 scores on a scale | Standard Deviation 0.37 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 68 | -0.46 scores on a scale | Standard Deviation 0.437 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 64 | -0.58 scores on a scale | Standard Deviation 0.452 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 104 | -0.68 scores on a scale | Standard Deviation 0.514 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 80 | -0.64 scores on a scale | Standard Deviation 0.478 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 60 | -0.55 scores on a scale | Standard Deviation 0.457 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 68 | -0.61 scores on a scale | Standard Deviation 0.476 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 92 | -0.69 scores on a scale | Standard Deviation 0.488 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 56 | -0.54 scores on a scale | Standard Deviation 0.457 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 52 | -0.51 scores on a scale | Standard Deviation 0.448 |
Secondary
Change From Baseline in T-BSA During the Extension Treatment Period
T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented as the percentage of BSA involvement in the total body.
Time frame: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 92 | -3.03 percentage BSA | Standard Deviation 1.664 |
| Cohort A: Vehicle Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 104 | -2.18 percentage BSA | Standard Deviation 2.723 |
| Cohort A: Vehicle Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 60 | -2.95 percentage BSA | Standard Deviation 1.91 |
| Cohort A: Vehicle Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 64 | -2.73 percentage BSA | Standard Deviation 2.528 |
| Cohort A: Vehicle Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 68 | -2.73 percentage BSA | Standard Deviation 1.958 |
| Cohort A: Vehicle Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 52 | -2.70 percentage BSA | Standard Deviation 1.83 |
| Cohort A: Vehicle Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 80 | -3.05 percentage BSA | Standard Deviation 2.083 |
| Cohort A: Vehicle Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 56 | -2.74 percentage BSA | Standard Deviation 1.918 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 80 | -3.42 percentage BSA | Standard Deviation 1.809 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 92 | -3.58 percentage BSA | Standard Deviation 1.938 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 64 | -3.22 percentage BSA | Standard Deviation 1.883 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 56 | -2.70 percentage BSA | Standard Deviation 1.983 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 68 | -3.34 percentage BSA | Standard Deviation 1.922 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 104 | -3.72 percentage BSA | Standard Deviation 2.075 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 60 | -2.75 percentage BSA | Standard Deviation 2.195 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 52 | -2.64 percentage BSA | Standard Deviation 1.906 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 56 | -0.73 percentage BSA | Standard Deviation 2.238 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 68 | -0.98 percentage BSA | Standard Deviation 2.262 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 60 | -0.80 percentage BSA | Standard Deviation 2.128 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 52 | -0.47 percentage BSA | Standard Deviation 2.325 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 64 | -0.73 percentage BSA | Standard Deviation 2.432 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 80 | -1.31 percentage BSA | Standard Deviation 2.341 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 92 | -1.49 percentage BSA | Standard Deviation 2.753 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 104 | -1.52 percentage BSA | Standard Deviation 3.672 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 104 | -2.42 percentage BSA | Standard Deviation 2.307 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 52 | -1.52 percentage BSA | Standard Deviation 1.711 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 56 | -1.71 percentage BSA | Standard Deviation 2.059 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 60 | -1.86 percentage BSA | Standard Deviation 1.978 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 68 | -2.03 percentage BSA | Standard Deviation 2.18 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 80 | -2.21 percentage BSA | Standard Deviation 2.169 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 92 | -2.36 percentage BSA | Standard Deviation 2.38 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-BSA During the Extension Treatment Period | Week 64 | -1.90 percentage BSA | Standard Deviation 2.052 |
Secondary
Change From Baseline in T-VASI Scores During the Extension Treatment Period
T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Change from Baseline=post-Baseline value minus the Baseline value.
Time frame: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 60 | -3.79 scores on a scale | Standard Deviation 1.692 |
| Cohort A: Vehicle Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 80 | -3.79 scores on a scale | Standard Deviation 1.663 |
| Cohort A: Vehicle Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 92 | -3.85 scores on a scale | Standard Deviation 1.545 |
| Cohort A: Vehicle Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 64 | -3.60 scores on a scale | Standard Deviation 2.033 |
| Cohort A: Vehicle Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 56 | -3.71 scores on a scale | Standard Deviation 1.615 |
| Cohort A: Vehicle Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 52 | -3.68 scores on a scale | Standard Deviation 1.564 |
| Cohort A: Vehicle Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 68 | -3.44 scores on a scale | Standard Deviation 1.789 |
| Cohort A: Vehicle Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 104 | -3.05 scores on a scale | Standard Deviation 2.156 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 80 | -4.26 scores on a scale | Standard Deviation 1.519 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 52 | -3.91 scores on a scale | Standard Deviation 1.526 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 56 | -3.91 scores on a scale | Standard Deviation 1.503 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 60 | -3.95 scores on a scale | Standard Deviation 1.585 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 64 | -4.20 scores on a scale | Standard Deviation 1.569 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 92 | -4.33 scores on a scale | Standard Deviation 1.673 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 104 | -4.48 scores on a scale | Standard Deviation 1.702 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 68 | -4.24 scores on a scale | Standard Deviation 1.534 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 68 | -2.21 scores on a scale | Standard Deviation 2.273 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 52 | -1.45 scores on a scale | Standard Deviation 2.271 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 80 | -2.49 scores on a scale | Standard Deviation 2.175 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 60 | -1.83 scores on a scale | Standard Deviation 2.161 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 92 | -2.61 scores on a scale | Standard Deviation 2.624 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 104 | -2.71 scores on a scale | Standard Deviation 3.479 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 56 | -1.69 scores on a scale | Standard Deviation 2.217 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 64 | -1.84 scores on a scale | Standard Deviation 2.375 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 80 | -3.55 scores on a scale | Standard Deviation 2.109 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 104 | -3.84 scores on a scale | Standard Deviation 2.151 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 68 | -3.35 scores on a scale | Standard Deviation 2.143 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 64 | -3.21 scores on a scale | Standard Deviation 2.06 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 60 | -3.16 scores on a scale | Standard Deviation 2.027 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 92 | -3.73 scores on a scale | Standard Deviation 2.246 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 56 | -2.97 scores on a scale | Standard Deviation 2.086 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 52 | -2.83 scores on a scale | Standard Deviation 1.938 |
Secondary
Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period
The CDLQI is the youth/children's version of the DLQI. The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Participants age \<16 years answered the questionnaire with: (1) very much; (2) a lot; (3) a little; or (4) not at all. The questionnaire was analyzed under 6 headings: Symptoms and feelings (Questions 1 and 2); Leisure (Questions 4, 5, and 6); School or holidays (Question 7); Personal relationships (Questions 3 and 8); Sleep (Question 9); and Treatment (Question 10). The scoring of each question is as follows: very much = 3; quite a lot = 2; only a little = 1; not at all = 0; question unanswered = 0. The total score ranges from 0 to 30; higher scores indicate higher quality of life. Change from Week 52 was calculated as the post-Week 52 value minus the Week 52 value.
Time frame: Week 52; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants who were \<16 years old with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Week 52 | 1.67 scores on a scale | Standard Deviation 2.887 |
| Cohort A: Vehicle Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 80 | -2.00 scores on a scale | Standard Deviation 2.828 |
| Cohort A: Vehicle Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 104 | -0.50 scores on a scale | Standard Deviation 0.707 |
| Cohort A: Vehicle Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 64 | -1.33 scores on a scale | Standard Deviation 2.309 |
| Cohort A: Vehicle Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 60 | 0.00 scores on a scale | Standard Deviation 0 |
| Cohort A: Vehicle Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 56 | -1.00 scores on a scale | Standard Deviation 2.646 |
| Cohort A: Vehicle Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 92 | NA scores on a scale | — |
| Cohort A: Vehicle Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 68 | -0.67 scores on a scale | Standard Deviation 1.155 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 60 | -0.50 scores on a scale | Standard Deviation 0.548 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 56 | -0.17 scores on a scale | Standard Deviation 0.753 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Week 52 | 1.00 scores on a scale | Standard Deviation 0.632 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 80 | -0.40 scores on a scale | Standard Deviation 0.548 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 68 | 0.40 scores on a scale | Standard Deviation 1.14 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 104 | -0.67 scores on a scale | Standard Deviation 1.155 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 92 | 0.25 scores on a scale | Standard Deviation 1.258 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 64 | 0.00 scores on a scale | Standard Deviation 0.707 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Week 52 | 1.25 scores on a scale | Standard Deviation 1.893 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 56 | 0.00 scores on a scale | Standard Deviation 0.816 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 60 | -0.50 scores on a scale | Standard Deviation 0.577 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 64 | -1.00 scores on a scale | Standard Deviation 1.414 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 68 | 0.50 scores on a scale | Standard Deviation 0.577 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 80 | -0.75 scores on a scale | Standard Deviation 1.708 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 92 | -0.25 scores on a scale | Standard Deviation 0.957 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 104 | -1.25 scores on a scale | Standard Deviation 1.893 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 64 | -0.36 scores on a scale | Standard Deviation 1.399 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 60 | -0.41 scores on a scale | Standard Deviation 2.108 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 104 | -0.20 scores on a scale | Standard Deviation 4.086 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 92 | 0.70 scores on a scale | Standard Deviation 3.614 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 56 | 0.36 scores on a scale | Standard Deviation 1.989 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 68 | -0.23 scores on a scale | Standard Deviation 1.541 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Week 52 | 2.32 scores on a scale | Standard Deviation 3.872 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 80 | 0.15 scores on a scale | Standard Deviation 1.814 |
Secondary
Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period
The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Participants age ≥16 years answered the questionnaire with: (1) very much; (2) a lot; (3) a little; or (4) not at all. The questionnaire was analyzed under 6 headings: Symptoms and feelings (Questions 1 and 2); Daily activities (Questions 3 and 4); Leisure (Questions 5 and 6); Work and school (Question 7); Personal relations (Questions 8 and 9); and Treatment (Question 10). The scoring of each question is as follows: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0. For Question 7, prevented work or studying=3. The total score ranges from 0 to 30; higher scores indicate higher quality of life. Change from Week 52 was calculated as the post-Week 52 value minus the Week 52 value.
Time frame: Week 52; up to up to Week 104 of Extension Study (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants who were ≥16 years old with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Week 52 | 2.87 scores on a scale | Standard Deviation 3.059 |
| Cohort A: Vehicle Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 68 | -0.08 scores on a scale | Standard Deviation 2.508 |
| Cohort A: Vehicle Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 56 | 0.11 scores on a scale | Standard Deviation 2.054 |
| Cohort A: Vehicle Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 80 | 0.03 scores on a scale | Standard Deviation 3.006 |
| Cohort A: Vehicle Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 60 | 0.37 scores on a scale | Standard Deviation 2.388 |
| Cohort A: Vehicle Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 104 | 0.57 scores on a scale | Standard Deviation 2.135 |
| Cohort A: Vehicle Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 64 | 0.35 scores on a scale | Standard Deviation 2.578 |
| Cohort A: Vehicle Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 92 | 0.27 scores on a scale | Standard Deviation 2.354 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Week 52 | 4.10 scores on a scale | Standard Deviation 4.784 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 104 | -0.40 scores on a scale | Standard Deviation 1.538 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 68 | -0.15 scores on a scale | Standard Deviation 2.202 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 92 | -0.23 scores on a scale | Standard Deviation 1.898 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 60 | 0.13 scores on a scale | Standard Deviation 2.227 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 64 | 0.18 scores on a scale | Standard Deviation 2.63 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 80 | -0.23 scores on a scale | Standard Deviation 2.315 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 56 | -0.47 scores on a scale | Standard Deviation 1.757 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 80 | -0.77 scores on a scale | Standard Deviation 2.871 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 92 | -0.89 scores on a scale | Standard Deviation 2.383 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 56 | -0.05 scores on a scale | Standard Deviation 2.138 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 104 | -0.48 scores on a scale | Standard Deviation 2.277 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 60 | 0.28 scores on a scale | Standard Deviation 2.491 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Week 52 | 3.69 scores on a scale | Standard Deviation 3.428 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 64 | -0.06 scores on a scale | Standard Deviation 2.712 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 68 | -0.17 scores on a scale | Standard Deviation 2.501 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 104 | -0.06 scores on a scale | Standard Deviation 2.813 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Week 52 | 3.53 scores on a scale | Standard Deviation 4.15 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 56 | -0.22 scores on a scale | Standard Deviation 2.483 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 60 | 0.24 scores on a scale | Standard Deviation 2.929 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 64 | -0.14 scores on a scale | Standard Deviation 2.35 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 68 | 0.08 scores on a scale | Standard Deviation 2.454 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 80 | -0.13 scores on a scale | Standard Deviation 2.809 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period | Change from Week 52 at Week 92 | -0.22 scores on a scale | Standard Deviation 2.941 |
Secondary
Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period
F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area Face was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area Face did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Data are presented as the percentage of BSA involvement in the face as compared to total BSA.
Time frame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 52 | 0.18 percentage BSA | Standard Deviation 0.24 |
| Cohort A: Vehicle Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Baseline | 0.92 percentage BSA | Standard Deviation 0.498 |
| Cohort A: Vehicle Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 56 | 0.18 percentage BSA | Standard Deviation 0.198 |
| Cohort A: Vehicle Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 60 | 0.20 percentage BSA | Standard Deviation 0.225 |
| Cohort A: Vehicle Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 64 | 0.20 percentage BSA | Standard Deviation 0.206 |
| Cohort A: Vehicle Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 68 | 0.22 percentage BSA | Standard Deviation 0.258 |
| Cohort A: Vehicle Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 80 | 0.12 percentage BSA | Standard Deviation 0.138 |
| Cohort A: Vehicle Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 92 | 0.10 percentage BSA | Standard Deviation 0.13 |
| Cohort A: Vehicle Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 104 | 0.13 percentage BSA | Standard Deviation 0.154 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Baseline | 1.10 percentage BSA | Standard Deviation 0.745 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 64 | 0.20 percentage BSA | Standard Deviation 0.271 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 92 | 0.15 percentage BSA | Standard Deviation 0.18 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 56 | 0.27 percentage BSA | Standard Deviation 0.416 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 80 | 0.15 percentage BSA | Standard Deviation 0.2 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 68 | 0.16 percentage BSA | Standard Deviation 0.183 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 60 | 0.25 percentage BSA | Standard Deviation 0.309 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 52 | 0.27 percentage BSA | Standard Deviation 0.401 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 104 | 0.15 percentage BSA | Standard Deviation 0.181 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 52 | 0.81 percentage BSA | Standard Deviation 0.641 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 104 | 0.62 percentage BSA | Standard Deviation 0.602 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 56 | 0.77 percentage BSA | Standard Deviation 0.638 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 60 | 0.73 percentage BSA | Standard Deviation 0.616 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 92 | 0.64 percentage BSA | Standard Deviation 0.595 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 64 | 0.71 percentage BSA | Standard Deviation 0.607 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 68 | 0.67 percentage BSA | Standard Deviation 0.581 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 80 | 0.62 percentage BSA | Standard Deviation 0.565 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Baseline | 1.01 percentage BSA | Standard Deviation 0.632 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 92 | 0.49 percentage BSA | Standard Deviation 0.527 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 64 | 0.61 percentage BSA | Standard Deviation 0.566 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Baseline | 1.02 percentage BSA | Standard Deviation 0.636 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 60 | 0.63 percentage BSA | Standard Deviation 0.557 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 80 | 0.55 percentage BSA | Standard Deviation 0.564 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 56 | 0.67 percentage BSA | Standard Deviation 0.572 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 52 | 0.70 percentage BSA | Standard Deviation 0.568 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 68 | 0.57 percentage BSA | Standard Deviation 0.548 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period | Week 104 | 0.47 percentage BSA | Standard Deviation 0.509 |
Secondary
Mean F-VASI Scores During the Extension Treatment Period
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).
Time frame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Baseline | 0.86 scores on a scale | Standard Deviation 0.492 |
| Cohort A: Vehicle Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 64 | 0.08 scores on a scale | Standard Deviation 0.131 |
| Cohort A: Vehicle Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 56 | 0.05 scores on a scale | Standard Deviation 0.108 |
| Cohort A: Vehicle Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 80 | 0.05 scores on a scale | Standard Deviation 0.082 |
| Cohort A: Vehicle Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 60 | 0.06 scores on a scale | Standard Deviation 0.145 |
| Cohort A: Vehicle Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 92 | 0.04 scores on a scale | Standard Deviation 0.055 |
| Cohort A: Vehicle Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 52 | 0.05 scores on a scale | Standard Deviation 0.11 |
| Cohort A: Vehicle Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 68 | 0.11 scores on a scale | Standard Deviation 0.199 |
| Cohort A: Vehicle Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 104 | 0.06 scores on a scale | Standard Deviation 0.109 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 104 | 0.04 scores on a scale | Standard Deviation 0.083 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 92 | 0.04 scores on a scale | Standard Deviation 0.076 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Baseline | 0.99 scores on a scale | Standard Deviation 0.644 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 56 | 0.07 scores on a scale | Standard Deviation 0.186 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 64 | 0.08 scores on a scale | Standard Deviation 0.23 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 60 | 0.09 scores on a scale | Standard Deviation 0.186 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 52 | 0.07 scores on a scale | Standard Deviation 0.181 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 80 | 0.04 scores on a scale | Standard Deviation 0.108 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 68 | 0.04 scores on a scale | Standard Deviation 0.081 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 80 | 0.36 scores on a scale | Standard Deviation 0.426 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 52 | 0.51 scores on a scale | Standard Deviation 0.459 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 68 | 0.40 scores on a scale | Standard Deviation 0.43 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 92 | 0.38 scores on a scale | Standard Deviation 0.471 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 104 | 0.37 scores on a scale | Standard Deviation 0.493 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Baseline | 0.88 scores on a scale | Standard Deviation 0.543 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 56 | 0.50 scores on a scale | Standard Deviation 0.475 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 60 | 0.45 scores on a scale | Standard Deviation 0.45 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 64 | 0.43 scores on a scale | Standard Deviation 0.456 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 60 | 0.35 scores on a scale | Standard Deviation 0.375 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Baseline | 0.91 scores on a scale | Standard Deviation 0.55 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 104 | 0.21 scores on a scale | Standard Deviation 0.28 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 52 | 0.39 scores on a scale | Standard Deviation 0.374 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 64 | 0.33 scores on a scale | Standard Deviation 0.35 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 92 | 0.23 scores on a scale | Standard Deviation 0.281 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 80 | 0.27 scores on a scale | Standard Deviation 0.345 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 56 | 0.38 scores on a scale | Standard Deviation 0.372 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean F-VASI Scores During the Extension Treatment Period | Week 68 | 0.31 scores on a scale | Standard Deviation 0.352 |
Secondary
Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period
T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Data are presented as the percentage of BSA involvement in the total body.
Time frame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 80 | 3.72 percentage BSA | Standard Deviation 3.151 |
| Cohort A: Vehicle Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 68 | 3.92 percentage BSA | Standard Deviation 2.813 |
| Cohort A: Vehicle Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 104 | 4.56 percentage BSA | Standard Deviation 4.156 |
| Cohort A: Vehicle Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 60 | 3.77 percentage BSA | Standard Deviation 2.756 |
| Cohort A: Vehicle Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 56 | 4.11 percentage BSA | Standard Deviation 2.88 |
| Cohort A: Vehicle Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 52 | 4.09 percentage BSA | Standard Deviation 2.838 |
| Cohort A: Vehicle Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 92 | 3.94 percentage BSA | Standard Deviation 2.834 |
| Cohort A: Vehicle Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 64 | 3.98 percentage BSA | Standard Deviation 3.087 |
| Cohort A: Vehicle Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Baseline | 6.79 percentage BSA | Standard Deviation 2.157 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 64 | 3.49 percentage BSA | Standard Deviation 2.452 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 80 | 3.18 percentage BSA | Standard Deviation 2.232 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 68 | 3.27 percentage BSA | Standard Deviation 2.31 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 52 | 4.20 percentage BSA | Standard Deviation 2.64 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Baseline | 6.85 percentage BSA | Standard Deviation 1.924 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 56 | 4.13 percentage BSA | Standard Deviation 2.788 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 104 | 2.93 percentage BSA | Standard Deviation 2.301 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 92 | 3.04 percentage BSA | Standard Deviation 2.194 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 60 | 4.09 percentage BSA | Standard Deviation 2.833 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 64 | 6.67 percentage BSA | Standard Deviation 3.448 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Baseline | 7.42 percentage BSA | Standard Deviation 2.064 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 52 | 6.95 percentage BSA | Standard Deviation 3.403 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 56 | 6.73 percentage BSA | Standard Deviation 3.281 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 60 | 6.61 percentage BSA | Standard Deviation 3.262 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 68 | 6.46 percentage BSA | Standard Deviation 3.239 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 80 | 6.09 percentage BSA | Standard Deviation 3.313 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 92 | 5.96 percentage BSA | Standard Deviation 3.646 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 104 | 5.91 percentage BSA | Standard Deviation 4.475 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 80 | 5.27 percentage BSA | Standard Deviation 2.581 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 60 | 5.64 percentage BSA | Standard Deviation 2.479 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 56 | 5.81 percentage BSA | Standard Deviation 2.558 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 104 | 5.07 percentage BSA | Standard Deviation 2.699 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 92 | 5.15 percentage BSA | Standard Deviation 2.741 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 52 | 5.96 percentage BSA | Standard Deviation 2.352 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 68 | 5.51 percentage BSA | Standard Deviation 2.682 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Week 64 | 5.64 percentage BSA | Standard Deviation 2.483 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period | Baseline | 7.49 percentage BSA | Standard Deviation 2.006 |
Secondary
Mean T-VASI Scores During the Extension Treatment Period
T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).
Time frame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 56 | 2.39 scores on a scale | Standard Deviation 2.253 |
| Cohort A: Vehicle Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 64 | 2.33 scores on a scale | Standard Deviation 2.21 |
| Cohort A: Vehicle Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 92 | 2.17 scores on a scale | Standard Deviation 1.913 |
| Cohort A: Vehicle Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Baseline | 6.06 scores on a scale | Standard Deviation 2.056 |
| Cohort A: Vehicle Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 68 | 2.45 scores on a scale | Standard Deviation 2.231 |
| Cohort A: Vehicle Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 52 | 2.38 scores on a scale | Standard Deviation 2.206 |
| Cohort A: Vehicle Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 104 | 2.86 scores on a scale | Standard Deviation 3.269 |
| Cohort A: Vehicle Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 80 | 2.05 scores on a scale | Standard Deviation 2.233 |
| Cohort A: Vehicle Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 60 | 2.21 scores on a scale | Standard Deviation 2.176 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 80 | 1.73 scores on a scale | Standard Deviation 1.331 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 104 | 1.54 scores on a scale | Standard Deviation 1.227 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 92 | 1.65 scores on a scale | Standard Deviation 1.244 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 56 | 2.31 scores on a scale | Standard Deviation 1.843 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 60 | 2.30 scores on a scale | Standard Deviation 1.841 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 64 | 1.94 scores on a scale | Standard Deviation 1.717 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 68 | 1.76 scores on a scale | Standard Deviation 1.378 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 52 | 2.36 scores on a scale | Standard Deviation 1.805 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Baseline | 6.27 scores on a scale | Standard Deviation 2.03 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 104 | 4.00 scores on a scale | Standard Deviation 4.208 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 56 | 5.06 scores on a scale | Standard Deviation 3.151 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 68 | 4.51 scores on a scale | Standard Deviation 3.06 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 80 | 4.18 scores on a scale | Standard Deviation 3.036 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 92 | 4.12 scores on a scale | Standard Deviation 3.477 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Baseline | 6.69 scores on a scale | Standard Deviation 2.15 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 52 | 5.25 scores on a scale | Standard Deviation 3.248 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 60 | 4.86 scores on a scale | Standard Deviation 3.15 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 64 | 4.85 scores on a scale | Standard Deviation 3.317 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 52 | 3.90 scores on a scale | Standard Deviation 2.132 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Baseline | 6.74 scores on a scale | Standard Deviation 2.006 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 56 | 3.80 scores on a scale | Standard Deviation 2.213 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 68 | 3.43 scores on a scale | Standard Deviation 2.16 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 60 | 3.58 scores on a scale | Standard Deviation 2.122 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 92 | 3.04 scores on a scale | Standard Deviation 2.128 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 80 | 3.18 scores on a scale | Standard Deviation 2.017 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 104 | 2.92 scores on a scale | Standard Deviation 2.061 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Mean T-VASI Scores During the Extension Treatment Period | Week 64 | 3.57 scores on a scale | Standard Deviation 2.051 |
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
A TEAE was defined as any adverse event (AE) reported for the first time or the worsening of a pre-existing event after the first application of study drug in this study. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment.
Time frame: up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: Vehicle Cream BID | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 21 Participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 3 Participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 32 Participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 59 Participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 114 Participants |
Secondary
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period
An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
Time frame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: Full Analysis Set (FAS) without non-compliant site: all participants who received at least 1 dose of study drug at or after Week 52 (Baseline of Treatment Extension study). For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 60 | 97.9 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 56 | 98.2 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 92 | 100.0 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 104 | 95.7 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 80 | 96.7 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 52 | 98.2 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 64 | 97.7 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 68 | 95.1 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 52 | 98.2 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 92 | 97.7 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 80 | 100.0 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 56 | 96.4 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 60 | 98.1 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 104 | 100.0 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 64 | 100.0 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 68 | 100.0 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 52 | 45.8 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 104 | 69.9 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 68 | 63.6 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 64 | 58.3 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 56 | 50.0 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 80 | 65.7 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 92 | 66.0 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 60 | 54.2 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 104 | 86.4 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 92 | 84.4 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 52 | 65.6 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 56 | 69.4 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 60 | 69.2 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 64 | 72.0 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 68 | 77.1 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period | Week 80 | 78.9 percentage of participants |
Secondary
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period
A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).
Time frame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period | Week 80 | 80.0 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period | Week 52 | 80.7 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period | Week 104 | 60.9 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period | Week 64 | 74.4 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period | Week 92 | 73.9 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period | Week 56 | 76.8 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period | Week 68 | 70.7 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period | Week 60 | 83.3 percentage of participants |
| Cohort A: 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 During the Extension Treatment Period | Week 68 | 84.4 percentage of participants |
| Cohort A: 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 During the Extension Treatment Period | Week 80 | 86.7 percentage of participants |
| Cohort A: 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 During the Extension Treatment Period | Week 92 | 86.0 percentage of participants |
| Cohort A: 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 During the Extension Treatment Period | Week 52 | 71.9 percentage of participants |
| Cohort A: 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 During the Extension Treatment Period | Week 60 | 75.0 percentage of participants |
| Cohort A: 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 During the Extension Treatment Period | Week 104 | 89.5 percentage of participants |
| Cohort A: 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 During the Extension Treatment Period | Week 64 | 82.2 percentage of participants |
| Cohort A: 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 During the Extension Treatment Period | Week 56 | 72.7 percentage of participants |
| Cohort B: Vehicle Cream BID to 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 During the Extension Treatment Period | Week 92 | 48.9 percentage of participants |
| Cohort B: Vehicle Cream BID to 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 During the Extension Treatment Period | Week 56 | 16.7 percentage of participants |
| Cohort B: Vehicle Cream BID to 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 During the Extension Treatment Period | Week 60 | 19.6 percentage of participants |
| Cohort B: Vehicle Cream BID to 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 During the Extension Treatment Period | Week 64 | 21.3 percentage of participants |
| Cohort B: Vehicle Cream BID to 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 During the Extension Treatment Period | Week 68 | 29.9 percentage of participants |
| Cohort B: Vehicle Cream BID to 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 During the Extension Treatment Period | Week 104 | 54.8 percentage of participants |
| Cohort B: Vehicle Cream BID to 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 During the Extension Treatment Period | Week 52 | 16.9 percentage of participants |
| Cohort B: Vehicle Cream BID to 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 During the Extension Treatment Period | Week 80 | 39.4 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to 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 During the Extension Treatment Period | Week 52 | 42.5 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to 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 During the Extension Treatment Period | Week 104 | 63.8 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to 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 During the Extension Treatment Period | Week 56 | 45.8 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to 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 During the Extension Treatment Period | Week 64 | 50.7 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to 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 During the Extension Treatment Period | Week 68 | 54.3 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to 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 During the Extension Treatment Period | Week 92 | 61.5 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to 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 During the Extension Treatment Period | Week 80 | 57.7 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to 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 During the Extension Treatment Period | Week 60 | 49.8 percentage of participants |
Secondary
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period
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: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 64 | 95.3 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 60 | 95.8 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 52 | 98.2 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 92 | 100.0 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 80 | 90.0 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 56 | 96.4 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 68 | 87.8 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 104 | 95.7 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 60 | 90.4 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 68 | 100.0 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 104 | 97.4 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 56 | 96.4 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 52 | 98.2 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 64 | 97.8 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 80 | 100.0 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 92 | 97.7 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 92 | 47.9 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 80 | 43.4 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 60 | 29.0 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 52 | 16.1 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 104 | 47.3 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 68 | 34.6 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 64 | 30.6 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 56 | 23.1 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 104 | 66.1 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 64 | 43.5 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 68 | 48.6 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 92 | 60.3 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 80 | 54.6 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 52 | 30.8 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 60 | 40.8 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period | Week 56 | 34.7 percentage of participants |
Secondary
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period
A T-VASI75 responder achieved at least 75% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).
Time frame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 64 | 39.5 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 56 | 42.9 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 60 | 45.8 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 52 | 38.6 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 92 | 43.5 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 80 | 53.3 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 68 | 39.0 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 104 | 39.1 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 52 | 42.1 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 60 | 38.5 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 92 | 53.5 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 104 | 55.3 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 64 | 48.9 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 68 | 42.2 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 80 | 48.9 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 56 | 43.6 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 52 | 3.4 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 92 | 12.8 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 80 | 10.1 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 104 | 18.3 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 60 | 4.7 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 56 | 4.6 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 68 | 6.5 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 64 | 3.7 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 92 | 29.1 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 104 | 30.5 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 52 | 12.2 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 56 | 13.4 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 60 | 14.2 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 64 | 16.9 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 68 | 22.4 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period | Week 80 | 23.7 percentage of participants |
Secondary
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period
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: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 92 | 78.3 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 68 | 68.3 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 80 | 80.0 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 104 | 69.6 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 52 | 98.2 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 56 | 89.3 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 60 | 83.3 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 64 | 72.1 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 56 | 94.5 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 52 | 96.5 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 68 | 95.6 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 80 | 97.8 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 92 | 93.0 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 104 | 92.1 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 60 | 86.5 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 64 | 93.3 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 52 | 0.0 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 56 | 3.7 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 60 | 8.4 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 64 | 11.1 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 68 | 12.1 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 80 | 22.2 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 92 | 24.5 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 104 | 28.0 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 60 | 15.2 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 52 | 2.3 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 104 | 33.9 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 92 | 32.4 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 64 | 15.5 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 68 | 22.4 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 56 | 8.3 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period | Week 80 | 30.4 percentage of participants |
Secondary
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period
A T-VASI90 responder achieved at least 90% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).
Time frame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 52 | 12.3 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 56 | 12.5 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 60 | 16.7 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 64 | 20.9 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 68 | 22.0 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 80 | 20.0 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 104 | 21.7 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 92 | 21.7 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 104 | 23.7 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 60 | 17.3 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 68 | 20.0 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 64 | 20.0 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 80 | 20.0 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 92 | 20.9 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 52 | 12.3 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 56 | 14.5 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 80 | 1.0 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 56 | 0.0 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 60 | 0.0 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 68 | 0.9 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 104 | 3.2 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 64 | 0.0 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 92 | 2.1 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 52 | 0.0 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 104 | 9.6 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 68 | 4.3 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 52 | 2.3 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 80 | 6.7 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 56 | 3.2 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 92 | 8.9 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 60 | 3.8 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period | Week 64 | 2.9 percentage of participants |
Secondary
Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period
The VNS is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. The Baseline facial photograph was shown to the participants for reference, and a mirror was provided for the participants to assess the vitiligo on their face. The participant was asked to respond to the following query: Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, and (5) no longer noticeable.
Time frame: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 52 | 49.1 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 56 | 48.2 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 60 | 46.9 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 64 | 53.5 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 68 | 46.3 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 80 | 38.7 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 92 | 39.1 percentage of participants |
| Cohort A: Vehicle Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 104 | 56.5 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 80 | 42.2 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 68 | 46.7 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 56 | 34.5 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 104 | 50.0 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 92 | 37.2 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 64 | 37.8 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 60 | 28.8 percentage of participants |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 52 | 42.1 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 92 | 28.4 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 60 | 19.6 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 64 | 23.1 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 68 | 20.6 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 80 | 28.3 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 104 | 30.1 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 52 | 11.9 percentage of participants |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 56 | 20.4 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 60 | 27.6 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 64 | 28.2 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 56 | 30.1 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 52 | 35.3 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 68 | 33.8 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 104 | 43.3 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 92 | 41.1 percentage of participants |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period | Week 80 | 32.8 percentage of participants |
Secondary
Percent Change From Baseline in F-BSA During the Extension Treatment Period
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 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 92 | -87.81 percentage change | Standard Deviation 15.738 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 80 | -84.55 percentage change | Standard Deviation 18.73 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 60 | -79.20 percentage change | Standard Deviation 19.463 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 56 | -80.23 percentage change | Standard Deviation 21.828 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 52 | -80.75 percentage change | Standard Deviation 18.726 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 104 | -82.87 percentage change | Standard Deviation 23.245 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 64 | -75.92 percentage change | Standard Deviation 32.175 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 68 | -77.11 percentage change | Standard Deviation 23.565 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 64 | -80.06 percentage change | Standard Deviation 22.142 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 92 | -83.24 percentage change | Standard Deviation 23.746 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 68 | -83.14 percentage change | Standard Deviation 21.999 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 56 | -74.42 percentage change | Standard Deviation 35.048 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 80 | -84.67 percentage change | Standard Deviation 22.014 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 104 | -84.09 percentage change | Standard Deviation 22.92 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 60 | -77.67 percentage change | Standard Deviation 20.946 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 52 | -76.75 percentage change | Standard Deviation 23.47 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 104 | -35.82 percentage change | Standard Deviation 52.646 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 52 | -22.15 percentage change | Standard Deviation 28.268 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 56 | -26.20 percentage change | Standard Deviation 30.604 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 60 | -30.04 percentage change | Standard Deviation 30.751 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 64 | -30.67 percentage change | Standard Deviation 33.473 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 68 | -32.60 percentage change | Standard Deviation 34.575 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 80 | -36.79 percentage change | Standard Deviation 36.826 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 92 | -34.05 percentage change | Standard Deviation 50.762 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 68 | -43.61 percentage change | Standard Deviation 32.549 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 64 | -39.58 percentage change | Standard Deviation 31.992 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 52 | -29.06 percentage change | Standard Deviation 36.354 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 92 | -51.96 percentage change | Standard Deviation 31.51 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 60 | -36.86 percentage change | Standard Deviation 33.289 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 56 | -33.66 percentage change | Standard Deviation 33.944 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 104 | -52.85 percentage change | Standard Deviation 32.983 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-BSA During the Extension Treatment Period | Week 80 | -46.38 percentage change | Standard Deviation 34.407 |
Secondary
Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period
F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = (\[post-BL value minus BL value\]/BL value) X 100.
Time frame: Baseline (BL); up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 52 | -94.45 percentage change | Standard Deviation 14.069 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 56 | -93.79 percentage change | Standard Deviation 14.981 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 60 | -93.85 percentage change | Standard Deviation 9.087 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 64 | -89.64 percentage change | Standard Deviation 23.562 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 68 | -87.98 percentage change | Standard Deviation 19.644 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 104 | -90.53 percentage change | Standard Deviation 17.763 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 80 | -93.24 percentage change | Standard Deviation 13.062 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 92 | -95.77 percentage change | Standard Deviation 5.586 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 56 | -93.21 percentage change | Standard Deviation 12.573 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 64 | -94.87 percentage change | Standard Deviation 8.079 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 80 | -96.65 percentage change | Standard Deviation 4.683 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 60 | -92.04 percentage change | Standard Deviation 13.198 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 92 | -94.95 percentage change | Standard Deviation 10.366 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 104 | -95.86 percentage change | Standard Deviation 7.213 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 52 | -94.50 percentage change | Standard Deviation 8.99 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 68 | -96.25 percentage change | Standard Deviation 4.633 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 104 | -56.53 percentage change | Standard Deviation 57.087 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 60 | -50.55 percentage change | Standard Deviation 30.537 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 64 | -52.32 percentage change | Standard Deviation 32.826 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 68 | -55.27 percentage change | Standard Deviation 32.433 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 80 | -58.60 percentage change | Standard Deviation 34.839 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 92 | -55.44 percentage change | Standard Deviation 49.855 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 52 | -44.32 percentage change | Standard Deviation 27.775 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 56 | -46.19 percentage change | Standard Deviation 30.728 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 68 | -65.55 percentage change | Standard Deviation 30.388 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 56 | -57.38 percentage change | Standard Deviation 31.256 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 60 | -60.17 percentage change | Standard Deviation 30.147 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 52 | -54.72 percentage change | Standard Deviation 31.006 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 64 | -62.94 percentage change | Standard Deviation 27.427 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 80 | -69.38 percentage change | Standard Deviation 29.091 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 104 | -73.84 percentage change | Standard Deviation 31.78 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period | Week 92 | -73.77 percentage change | Standard Deviation 25.49 |
Secondary
Percent Change From Baseline in T-BSA During the Extension Treatment Period
T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = (\[post-Baseline (BL) value minus BL value\]/BL value) X 100.
Time frame: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 52 | -43.81 percentage change | Standard Deviation 27.916 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 56 | -44.22 percentage change | Standard Deviation 29.59 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 60 | -47.61 percentage change | Standard Deviation 29.237 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 64 | -43.29 percentage change | Standard Deviation 40.045 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 68 | -44.53 percentage change | Standard Deviation 30.086 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 80 | -50.51 percentage change | Standard Deviation 33.794 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 92 | -48.53 percentage change | Standard Deviation 29.457 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 104 | -40.84 percentage change | Standard Deviation 40.076 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 80 | -53.98 percentage change | Standard Deviation 25.682 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 68 | -52.51 percentage change | Standard Deviation 26.921 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 56 | -43.12 percentage change | Standard Deviation 29.489 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 104 | -57.40 percentage change | Standard Deviation 27.898 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 92 | -55.56 percentage change | Standard Deviation 26.401 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 64 | -50.59 percentage change | Standard Deviation 27.166 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 60 | -43.09 percentage change | Standard Deviation 31.608 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 52 | -41.50 percentage change | Standard Deviation 28.747 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 92 | -22.84 percentage change | Standard Deviation 33.708 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 60 | -13.40 percentage change | Standard Deviation 26.41 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 64 | -12.00 percentage change | Standard Deviation 30.202 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 68 | -15.01 percentage change | Standard Deviation 29.093 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 80 | -20.22 percentage change | Standard Deviation 30.154 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 104 | -24.26 percentage change | Standard Deviation 42.193 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 52 | -8.54 percentage change | Standard Deviation 28.806 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 56 | -11.96 percentage change | Standard Deviation 28.156 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 60 | -25.12 percentage change | Standard Deviation 25.564 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 64 | -25.15 percentage change | Standard Deviation 26.86 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 56 | -22.98 percentage change | Standard Deviation 26.032 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 52 | -20.57 percentage change | Standard Deviation 23.042 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 68 | -27.59 percentage change | Standard Deviation 28.476 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 104 | -32.96 percentage change | Standard Deviation 29.907 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 92 | -31.98 percentage change | Standard Deviation 30.805 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-BSA During the Extension Treatment Period | Week 80 | -29.92 percentage change | Standard Deviation 27.996 |
Secondary
Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period
T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Percentage change = (\[post-BL value minus BL value\]/BL value) X 100.
Time frame: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Population: FAS without non-compliant site. For participants who experienced relapse (\<F-VASI75) and received open-label rescue treatment, only results before receiving open-label rescue treatment have been included. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 52 | -65.01 percentage change | Standard Deviation 23.969 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 104 | -58.38 percentage change | Standard Deviation 35.533 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 60 | -66.83 percentage change | Standard Deviation 26.478 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 80 | -68.99 percentage change | Standard Deviation 26.87 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 56 | -65.16 percentage change | Standard Deviation 24.916 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 92 | -66.95 percentage change | Standard Deviation 24.885 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 64 | -62.82 percentage change | Standard Deviation 33.328 |
| Cohort A: Vehicle Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 68 | -61.40 percentage change | Standard Deviation 29.204 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 64 | -70.44 percentage change | Standard Deviation 20.212 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 80 | -72.21 percentage change | Standard Deviation 17.852 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 68 | -71.89 percentage change | Standard Deviation 17.942 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 56 | -65.69 percentage change | Standard Deviation 22.042 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 92 | -72.55 percentage change | Standard Deviation 19.152 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 60 | -65.58 percentage change | Standard Deviation 22.91 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 52 | -64.95 percentage change | Standard Deviation 21.547 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 104 | -74.66 percentage change | Standard Deviation 17.727 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 104 | -45.52 percentage change | Standard Deviation 41.968 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 52 | -24.75 percentage change | Standard Deviation 2.271 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 56 | -28.05 percentage change | Standard Deviation 30.487 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 60 | -31.01 percentage change | Standard Deviation 28.944 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 64 | -30.85 percentage change | Standard Deviation 32.898 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 68 | -35.53 percentage change | Standard Deviation 32.135 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 80 | -40.97 percentage change | Standard Deviation 30.033 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 92 | -43.34 percentage change | Standard Deviation 34.425 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 80 | -52.48 percentage change | Standard Deviation 26.991 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 60 | -47.00 percentage change | Standard Deviation 26.089 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 56 | -43.91 percentage change | Standard Deviation 27.408 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 68 | -49.41 percentage change | Standard Deviation 27.629 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 92 | -55.00 percentage change | Standard Deviation 28.995 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 52 | -42.14 percentage change | Standard Deviation 25.783 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 64 | -46.96 percentage change | Standard Deviation 26.395 |
| Cohort B: Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period | Week 104 | -56.96 percentage change | Standard Deviation 27.409 |
Secondary
Time to Loss of Adequate Response
Loss of adequate response was defined as a loss of 90% improvement from Baseline in the F-VASI score (F-VASI90) response, assessed as percentage improvement in the F-VASI score at Baseline (Day 1 of the parent study) to \<90%.
Time frame: from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study)
Population: ITT-Ext Population. Week 52 was the first visit of this Treatment Extension study (visits were named to reflect continuation from the parent studies). Only participants in Cohort A were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: Vehicle Cream BID | Time to Loss of Adequate Response | 195.0 days |
| Cohort A: Ruxolitinib 1.5% Cream BID | Time to Loss of Adequate Response | NA days |
Comparison: Cox regression model stratified by stratification factor (treatment assignment in the parent studies) was conducted to compare the difference in hazard rate between treatment and vehicle.p-value: 0.000395% CI: [0.165, 0.606]Log Rank
Secondary
Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104
The steady-state plasma concentration was assessed. Pharmacokinetic blood samples could have been collected at any time prior to study drug application at the site at the Week 80 visit and at any time at the Week 104 (End of Trial) visit. Results from the two parent studies indicated that steady state was reached at or before Week 4, and that, hence, the use of vehicle or ruxolitinib 1.5% in the first 52 weeks of treatment had no impact on the ruxolitinib plasma concentration at the Week 80 and Week 104 (End of Treatment) visits. Thus, the two Cohort B cohorts were combined into a single arm for data analysis in this study.
Time frame: Weeks 80 (predose); Week 104 (any time post-dose) (Week 52 was the first visit of this Treatment Extension study.)
Population: Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of ruxolitinib cream and provided at least 1 measurable post-dose PK sample/assessment. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Vehicle Cream BID | Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 | 18 to <65 years | 15.1 nanomolar | Standard Deviation 19.5 |
| Cohort A: Vehicle Cream BID | Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 | 12 to <18 years | 7.28 nanomolar | Standard Deviation 11.7 |
| Cohort A: Vehicle Cream BID | Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 | ≥65 years | 13.0 nanomolar | Standard Deviation 9.44 |
| Cohort A: Vehicle Cream BID | Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 | Overall | 13.8 nanomolar | Standard Deviation 18.1 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 | Overall | 12.8 nanomolar | Standard Deviation 17.4 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 | ≥65 years | 25.7 nanomolar | Standard Deviation 20.9 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 | 12 to <18 years | 5.56 nanomolar | Standard Deviation 10.5 |
| Cohort A: Ruxolitinib 1.5% Cream BID | Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 | 18 to <65 years | 12.7 nanomolar | Standard Deviation 17.2 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 | 12 to <18 years | 5.85 nanomolar | Standard Deviation 10.6 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 | 18 to <65 years | 13.1 nanomolar | Standard Deviation 17.6 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 | ≥65 years | 24.3 nanomolar | Standard Deviation 20.2 |
| Cohort B: Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104 | Overall | 12.9 nanomolar | Standard Deviation 17.5 |