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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000987-53 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A : ruxolitinib cream | Experimental | Participants who achieve complete or almost complete facial repigmentation (achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to ruxolitinib cream. |
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| Cohort A : Vehicle | Placebo Comparator | Participants who achieve complete or almost complete facial repigmentation (ie, achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to vehicle cream. |
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| Cohort B : roxolitinib cream | Experimental | Participants who did not achieve ≥ F-VASI90 at Week 52 of the parent studies will be assigned to Cohort B and will continue ruxolitinib cream. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ruxolitinib | Drug | ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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%. | from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study) |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Butler, MD | Incyte Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology | Hoover | Alabama | 35244 | United States | ||
| Desert Sky Dermatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41125994 | Derived | Rosmarin D, Pandya AG, Passeron T, Forman SB, Zdybski J, Amster M, Feser C, Papp KA, Nuara A, Kornacki D, Wei S, Ren H, Harris JE, Ezzedine K. Long-Term Integrated Safety Summary of Ruxolitinib Cream in Phase 3 Clinical Trials of Patients with Vitiligo. Dermatol Ther (Heidelb). 2025 Dec;15(12):3703-3716. doi: 10.1007/s13555-025-01555-3. Epub 2025 Oct 22. |
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Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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.
This study was conducted at 87 study centers in North America and Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 [](streamdown:incomplete-link) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 10, 2020 | May 25, 2023 |
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Double Blind
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| Vehicle | Drug | Vehicle cream is a topical formulation applied as a thin film to affected areas. |
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| 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). | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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). | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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). | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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). | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | Baseline (BL); up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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). | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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). | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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). | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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). | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | Week 52; up to up to Week 104 of Extension Study (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | Week 52; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) |
| 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. | Weeks 80 (predose); Week 104 (any time post-dose) (Week 52 was the first visit of this Treatment Extension study.) |
| Gilbert |
| Arizona |
| 85295 |
| United States |
| First Oc Dermatology | Fountain Valley | California | 92708 | United States |
| Center For Dermatology Cosmetic and Laser Surgery | Fremont | California | 94538 | United States |
| Marvel Clinical Research Llc | Huntington Beach | California | 92647 | United States |
| Vitiligo & Pigmentation Institute of Southern California | Los Angeles | California | 90036 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Acrc Studies | San Diego | California | 92119 | United States |
| University of California San Francisco | San Francisco | California | 94158 | United States |
| Colorado Medical Research Center Inc | Denver | Colorado | 80210 | United States |
| Harmony Medical Research Institute | Hialeah | Florida | 33016 | United States |
| Advanced Pharma | Miami | Florida | 33147 | United States |
| San Marcus Research Clinic Inc. | Miami Lakes | Florida | 33014 | United States |
| Leavitt Medical Associates of Florida | Ormond Beach | Florida | 32174 | United States |
| Avita Clinical Research | Tampa | Florida | 33613 | United States |
| Olympian Clinical Research | Tampa | Florida | 33614 | United States |
| Forcare Clinical Research Fcr Forward Clinical Trials, Inc | Tampa | Florida | 33624 | United States |
| Metabolic Research Institute Inc | West Palm Beach | Florida | 33401 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Randall Dermatology | West Lafayette | Indiana | 47906 | United States |
| Delricht Clinical Research - Clinedge - Ppds Baton Rouge | Baton Rouge | Louisiana | 70809 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02116 | United States |
| Metro Boston Clinical Partners | Brighton | Massachusetts | 02135 | United States |
| Great Lakes Research Group Inc | Bay City | Michigan | 48706 | United States |
| Henry Ford Medical Center | Detroit | Michigan | 48202 | United States |
| Minnesota Clinical Study Center | Minneapolis | Minnesota | 55432 | United States |
| Jdr Dermatology Research | Las Vegas | Nevada | 89148 | United States |
| Suny Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Forest Hills Dermatology Group | Kew Gardens | New York | 11415 | United States |
| The Dermatology Specialists Greenwich | New York | New York | 10012 | United States |
| Icahn School of Medicine At Mount Sinai | New York | New York | 10029 | United States |
| Derm Research Center of New York Inc | Stony Brook | New York | 11790 | United States |
| Wake Research Associates Llc | Raleigh | North Carolina | 27612 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27104 | United States |
| Central Sooner Research | Norman | Oklahoma | 73071 | United States |
| Kgl Skin Study Center | Broomall | Pennsylvania | 19008 | United States |
| Dermatology Associates of Plymouth Meeting | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Palmetto Clinical Trial Services | Anderson | South Carolina | 29621 | United States |
| International Clinical Research Tennessee Llc | Murfreesboro | Tennessee | 37130 | United States |
| Innovative Dermatology | Plano | Texas | 75024 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| The Dermatology and Laser Center of San Antonio | San Antonio | Texas | 78229 | United States |
| Clinical Research Partners Llc | Richmond | Virginia | 23226 | United States |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202 | United States |
| Medical Center Unimed Eood | Sevlievo | 05400 | Bulgaria |
| Diagnostic Consultative Center Ii Sofia Eood | Sofia | 01000 | Bulgaria |
| University Multiprofile Hospital For Active Treatment Aleksandrovska | Sofia | 01431 | Bulgaria |
| Diagnostic Consultative Center Xxviii - Sofia - Eood | Sofia | 01592 | Bulgaria |
| Medical Center Eurohealth | Sofia | 01606 | Bulgaria |
| Dermatology Research Institute | Calgary | Alberta | T1Y 0B4 | Canada |
| Simcoderm Medical and Surgical Dermatology Center | Barrie | Ontario | L4M 7G1 | Canada |
| Kingsway Clinical Research | Etobicoke | Ontario | M8X 1Y9 | Canada |
| Lynderm Research Inc | Markham | Ontario | L3P 1X2 | Canada |
| Skin Centre For Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| K. Papp Clinical Research | Waterloo | Ontario | N2J 1C4 | Canada |
| Xlr8 Medical Research | Windsor | Ontario | N8W 1E6 | Canada |
| Siena Medical Research Corporation | Westmount | Quebec | H3Z 2S6 | Canada |
| Le Bateau Blanc | Martigues | 13500 | France |
| Hopital Archet 2 Derm Dept | Nice | 06200 | France |
| Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque | Pessac | 33604 | France |
| Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume | Rouen | 76031 | France |
| Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol | Toulouse | 31059 | France |
| Universitaetsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Hautarztpraxis Mahlow | Mahlow | 15831 | Germany |
| Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii | Mainz | 55131 | Germany |
| Universitatsklinik Munster Dermatologie | Münster | 48149 | Germany |
| Amsterdam University Medical Centre | Amsterdam | 1100 DD | Netherlands |
| Synexus - Polska Sp Z Oo Oddzial W Gdansk | Gdansk | 80-382 | Poland |
| Synexus Polska Sp. Z O.O. Oddzial W Gdyni | Gdynia | 81-537 | Poland |
| Synexus - Sp Z Oo Oddzial W Katowice | Katowice | 40-040 | Poland |
| Synexus Affiliate - Krakowskie Centrum Medyczne | Krakow | 31-501 | Poland |
| Synexus Polska Sp Z Oo Oddzial W Lodzi | Lodz | 90-127 | Poland |
| Synexus Polska Sp Z Oo Oddzial W Czestochowie | Lublin | 20-081 | Poland |
| Dermedic Dr. Zdybski | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Synexus Polska Sp. Z O.O. Oddzial W Poznaniu | Poznan | 60-702 | Poland |
| Lubeskie Centrum Diagnostyczne | Świdnik | 21-040 | Poland |
| Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz | Torun | 87-100 | Poland |
| Synexus Polska Sp. Z O.O. Oddzial Warszawie | Warsaw | 01-192 | Poland |
| High-Med Przychodnia Specjalistycza | Warsaw | 01-817 | Poland |
| Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu | Wroclaw | 50-381 | Poland |
| Dermmedica Sp. Z O.O. | Wroclaw | 51-318 | Poland |
| Ico Hospital Germans Trias I Pujol | Badalona | 08916 | Spain |
| Dermomedic | Madrid | 28001 | Spain |
| Clinica Universidad de Navarra (Cun) | Pamplona | 31008 | Spain |
| FG001 | 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 (\ |
| FG002 | 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. |
| FG003 | 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. |
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| ID | Title | Description |
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| BG000 | 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 [](streamdown:incomplete-link) |
| BG001 | 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 (\ |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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%. | 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. | Posted | Median | 95% Confidence Interval | days | from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study) |
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| 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%. | 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. | Posted | Median | 95% Confidence Interval | days | from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study) |
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| 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). | 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 (\ | Posted | Number | 95% Confidence Interval | percentage of participants | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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). | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Number | 95% Confidence Interval | percentage of participants | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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). | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Number | 95% Confidence Interval | percentage of participants | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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). | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Mean | Standard Deviation | scores on a scale | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Mean | Standard Deviation | scores on a scale | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Mean | Standard Deviation | percentage change | Baseline (BL); up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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). | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Number | 95% Confidence Interval | percentage of participants | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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). | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Number | 95% Confidence Interval | percentage of participants | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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). | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Number | 95% Confidence Interval | percentage of participants | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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). | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Mean | Standard Deviation | scores on a scale | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Mean | Standard Deviation | scores on a scale | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Mean | Standard Deviation | percentage change | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Mean | Standard Deviation | percentage BSA | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Mean | Standard Deviation | percentage BSA | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Mean | Standard Deviation | percentage change | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Mean | Standard Deviation | percentage BSA | up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Mean | Standard Deviation | percentage BSA | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Mean | Standard Deviation | percentage change | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Mean | Standard Deviation | scores on a scale | Week 52; up to up to Week 104 of Extension Study (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | FAS without non-compliant site. For participants who experienced relapse (\ | Posted | Mean | Standard Deviation | scores on a scale | Week 52; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | FAS | Posted | Count of Participants | Participants | up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.) |
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| 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. | 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. | Posted | Mean | Standard Deviation | nanomolar | Weeks 80 (predose); Week 104 (any time post-dose) (Week 52 was the first visit of this Treatment Extension study.) |
|
up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.)
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 [](streamdown:incomplete-link) | 0 | 58 | 0 | 58 | 6 | 58 |
| EG001 | 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, or were randomized to receive vehicle cream BID but experienced relapse (\ | 0 | 423 | 12 | 423 | 55 | 423 |
| EG002 | Total | Total | 0 | 458 | 12 | 458 | 61 | 458 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Otosclerosis | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pelvic prolapse | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
Data from participants at a single site (N = 2) were removed from all efficacy analyses performed on the ITT-Ext Population and FAS Cohort A owing to noncompliance with the Protocol in the parent study resulting in serious concerns with data quality.
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2022 | May 25, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540383 | ruxolitinib |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| Not Reported |
|
| White |
|
| Captured as Latino in Database |
|
| Persian |
|
| Indo-Caribbean |
|
| Jordanian |
|
| Brazilian |
|
| Guyana |
|
| American Indian or Alaska Native |
|
| Cape Verdean |
|
| Dominican Republic |
|
| Captured as Hispanic or Latino in Database |
|
| Iranian |
|
| Indian |
|
| North African |
|
| Middle Eastern |
|
| Arab//North-African |
|
| White/Black/Asian |
|
| Mexican |
|
| Not Hispanic or Latino |
|
| Not Reported |
|
| Unknown |
|
| Captured as Other in Database |
|
| OG002 | 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. |
| OG003 | 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. |
|
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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 [](streamdown:incomplete-link)
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
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| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
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| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
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|
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 (\ |
| OG002 | 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. |
| OG003 | 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. |
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| 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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 (\ |
| OG002 | 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. |
| OG003 | 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. |
|
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| OG002 | 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 (\ |
| OG003 | 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. |
| OG004 | 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. |
|
|
Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks or 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. |
| OG002 | Cohorts A and B: 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). Participants who completed treatment (vehicle cream BID for 24 weeks and ruxolitinib 1.5% BID for 28 weeks or 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 (58 from Cohort A; 289 from Cohort B) applied ruxolitinib 1.5% cream BID for 52 weeks. |
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