Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000847-28 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-Blind Period: Ruxolitinib cream 1.5% BID | Experimental | Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks. |
|
| Double-Blind Period: Vehicle cream BID | Placebo Comparator | Participants applied matching vehicle cream BID for 24 weeks. |
|
| Treatment-Extension Period: Ruxolitinib cream 1.5% BID | Experimental | Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period. |
|
| Treatment-Extension Period: Vehicle cream to Ruxolitinib cream 1.5% BID | Experimental | Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib cream | Drug | Ruxolitinib cream is a topical formulation applied as a thin film to affected areas. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24 | An F-VASI75 responder achieved at least 75% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area [BSA]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). | Baseline; Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Week 24 | An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathleen Butler, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Sky Dermatology | Gilbert | Arizona | 85295 | United States | ||
| Center For Dermatology Cosmetic and Laser Surgery |
| 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. | |
| 40156697 |
| Label | URL |
|---|---|
| Plain Language Summary for Upload to Incyteclinicaltrials.com | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 344 participants were randomized into the study. Of the 344 randomized participants (Intent-to-Treat Population), 343 applied study drug at least once (Safety Population); 297 participants applied ruxolitinib cream at least once during the Treatment-Extension (TE) Period (TE Evaluable Population).
This study was conducted at 49 study centers in North America and Europe.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Double-Blind Period: Ruxolitinib Cream 1.5% BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks. |
| FG001 | Double-Blind Period: Vehicle Cream BID | Participants applied matching vehicle cream BID for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 24-Week Double-Blind Period |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 23, 2019 | Jul 20, 2022 |
Not provided
Not provided
Participants will receive ruxolitinib cream or vehicle for 24 weeks, after which they will be offered the opportunity to continue in the treatment extension period. Participants initially randomized to vehicle will be crossed over to active drug, and participants treated with ruxolitinib cream will receive an additional 28 weeks of treatment with ruxolitinib cream.
Not provided
Not provided
Not provided
|
| Vehicle | Drug | Vehicle cream is a topical formulation applied as a thin film to affected areas. |
|
| Baseline; Week 24 |
| Percentage of Participants Achieving a ≥ 90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Week 24 | 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). | Baseline; Week 24 |
| Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24 | A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). | Baseline; Week 24 |
| Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) of 4 or 5 at Week 24 | 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; Week 24 |
| Percentage Change From Baseline in Facial Body Surface Area (F-BSA) at Week 24 | 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; Week 24 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. | from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 24) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Treatment-Extension Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. | from the completion of the Week 24 assessments until at least 30 days after the last application of study drug (up to Week 52 + 30 days) |
| Percentage of Participants Achieving a ≥ 25% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25) Score at Week 24 | An F-VASI25 responder achieved at least 25% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). | Baseline; Week 24 |
| Percentage of Participants Achieving a ≥ %25, ≥ %50, ≥ 75%, and ≥ 90% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25/50/75/90) Score at Week 52 | An F-VASI25/50/75/90 responder achieved at least 25/50/75/90% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). | Baseline; Week 52 |
| Percentage Change From Baseline in F-VASI at Week 24 | 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; Week 24 |
| Percentage Change From Baseline in F-VASI at Week 52 | 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; Week 52 |
| Percentage Change From Baseline in F-BSA at Week 52 | F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-BL value minus BL value]/BL value) X 100. | Baseline; Week 52 |
| Percentage Change From Baseline in T-VASI at Week 24 | T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100. | Baseline; Week 24 |
| Percentage Change From Baseline in T-VASI at Week 52 | T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100. | Baseline; Week 52 |
| Percentage Change From Baseline in T-BSA at Week 24 | T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-BL value minus BL value]/BL value) X 100. | Baseline; Week 24 |
| Percentage Change From Baseline in T-BSA at Week 52 | T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-BL value minus BL value]/BL value) X 100. | Baseline; Week 52 |
| Percentage of Participants Achieving a ≥ 25%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/75/90) Score at Week 24 | A T-VASI25/75/90 responder achieved at least 25/75/90% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). | Baseline; Week 24 |
| Percentage of Participants Achieving a ≥ 25%, ≥ 50%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/50/75/90) Score at Week 52 | A T-VASI25/50/75/90 responder achieved ≥25/50/75/90% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). | Baseline; Week 52 |
| Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) | 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; Week 24 and Week 52 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24 | The DLQI is a 10-question validated questionnaire for use in participants aged 16 years and over to measure how much the skin problem has affected the participant over the previous 7 days. Each question is scored as: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0. For Question 7, "Prevented work or studying" = 3. The DLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. | Baseline; Week 24 |
| Change From Baseline in DLQI at Week 52 | The DLQI is a 10-question validated questionnaire for use in participants aged 16 years and over to measure how much the skin problem has affected the participant over the previous 7 days. Each question is scored as: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0. For Question 7, "Prevented work or studying" = 3. The DLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. | Baseline; Week 52 |
| Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) During the Treatment Period (Double-Blind and Treatment-Extension Periods) | The DLQI is a 10-question validated questionnaire for use in participants aged 16 years and over to measure how much the skin problem has affected the participant over the previous 7 days. The CDLQI is the youth/children's version of the DLQI and was completed by adolescents aged ≥ 12 years to < 16 years. Each question is scored as: very much = 3; quite a lot = 2; only a little = 1; not at all = 0; question unanswered = 0. For Question 7: "Prevented school" = 3. The CDLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. | Baseline; Week 24 and Week 52 |
| Trough Plasma Concentrations of Ruxolitinib at Weeks 4, 24, and 40 | Trough plasma concentration was defined as the measurement of the plasma concentration of ruxolitinib before drug application. | pre-dose at Weeks 4, 24, and 40 |
| Fremont |
| California |
| 94538 |
| United States |
| Uci Beckman Laser Institute and Medical Clinic | Irvine | California | 92617 | United States |
| UCI Health Beckman Laser Institute and Medical Center | Irvine | California | 92697 | United States |
| Vitiligo & Pigmentation Institute of Southern California | Los Angeles | California | 90036 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Dermatology Specialists Inc | Murrieta | California | 92562 | United States |
| Dermatology Specialists Inc | Oceanside | California | 92056 | United States |
| Integrative Skin Science and Research | Sacramento | California | 95815 | United States |
| Acrc Studies | San Diego | California | 92119 | United States |
| Central Sooner Research | San Diego | California | 92123 | United States |
| Colorado Medical Research Center Inc | Denver | Colorado | 80210 | United States |
| Advanced Pharma Cr | Miami | Florida | 33147 | 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 |
| Ashira Dermatology Llc | Gurnee | Illinois | 60031 | United States |
| Randall Dermatology of West Lafayette | West Lafayette | Indiana | 47096 | 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 | 02111 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02116 | United States |
| Metro Boston Clinical Partners | Brighton | Massachusetts | 02135 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01655 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | 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 |
| Northwell Physician Partners | New Hyde Park | New York | 11042 | 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 |
| Central Sooner Research | Norman | Oklahoma | 73071 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| Clinical Research Partners Llc | Richmond | Virginia | 23220 | United States |
| Medical Center Unimed Eood | Sevlievo | 05400 | Bulgaria |
| Medical Center Unimed EOOD | Sevlievo | 5300 | Bulgaria |
| Diagnostic Consultative Center Ii Sofia Eood | Sofia | 01000 | Bulgaria |
| University Multiprofile Hospital For Active Treatment Aleksandrovska | Sofia | 01431 | Bulgaria |
| Diagnostic Consultative Center II Sofia EOOD | Sofia | 1000 | Bulgaria |
| Diagnostic Consultative Center II Sofia EOOD | Sofia | 1407 | Bulgaria |
| University Hospital Prof Dr Stoyan Kirkovich | Stara Zagora | 06003 | Bulgaria |
| University Hospital " Prof. Dr Stoyan Kirkovich" | Stara Zagora | 6003 | Bulgaria |
| 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 |
| K. Papp Clinical Research | Waterloo | Ontario | N2J 1C4 | Canada |
| Xlr8 Medical Research | Windsor | Ontario | N8W 1E6 | Canada |
| Centre Hospitalier Universitaire de Besancon | Besançon | 25000 | France |
| CHU Besancon | Besançon | 25030 | France |
| Centre Hospitalier Universitaire de Bordeaux | Bordeaux | 33000 | France |
| CHU de Bordeaux, Hospital Saint Andre | Bordeaux | 33075 | France |
| University Hospital Henri Mondor | Créteil | 94000 | France |
| CENTRE HOSpITALIER UNIVERSITAIRE HENRI MONDOR | Créteil | 94010 | France |
| Le Bateau Blanc | Martigues | 13500 | France |
| Emovis GMBH | Berlin | 10629 | Germany |
| Universitatsklinikum Bonn Aoer | Bonn | 53127 | Germany |
| Hautarztpraxis Mahlow | Mahlow | 15831 | Germany |
| Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii | Mainz | 55131 | Germany |
| University Medical Center (Universitätsmedizin der Johannes Gutenberg-Universität Mainz) | Mainz | 55131 | Germany |
| Policlinico S. Orsola Malpighi | Bologna | 40138 | Italy |
| Istituto Dermatologico San Gallicano | Rome | 00163 | Italy |
| Amsterdam University Medical Centre | Amsterdam | 1105 AZ | Netherlands |
| Synexus Polska Sp. Z o.o. Oddział w Częstochowie | Częstochowa | 42-202 | 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 |
| Lubeskie Centrum Diagnostyczne | Świdnik | 21-040 | Poland |
| Synexus Polska Sp. Z O.O. Oddzial Warszawie | Warsaw | 01-192 | Poland |
| High-Med Przychodnia Specjalistycza | Warsaw | 01-817 | Poland |
| Dermmedica Sp. Z O.O. | Wroclaw | 51-318 | Poland |
| Ico Hospital Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hospital Universitari Germans Trias i Pujol | Barcelona | 8916 | Spain |
| Dermomedic | Madrid | 28001 | Spain |
| IDEI (Instituto de Dermatología Integral). | Madrid | 28010 | Spain |
| Hospital La Paz (Hospital Universitario La Paz ) | Madrid | 28046 | Spain |
| Hospital Universitario de La Paz | Madrid | 28046 | Spain |
| Seneschal J, Wolkerstorfer A, Desai SR, Grimes P, Ezzedine K, Pandya AG, Kornacki D, Wei S, Passeron T, Rosmarin D. Efficacy and Safety of Ruxolitinib Cream in Vitiligo by Patient Characteristic Subgroups: Descriptive Pooled Analysis From Two Phase 3 Studies. Dermatol Ther (Heidelb). 2025 May;15(5):1227-1238. doi: 10.1007/s13555-025-01381-7. Epub 2025 Mar 29. |
| 39078582 | Derived | Bibeau K, Butler K, Wang M, Skaltsa K, Hamzavi IH. Psychometric Evaluation of the Facial and Total Vitiligo Area Scoring Index Instruments in the TRuE-V Phase 3 Studies. Dermatol Ther (Heidelb). 2024 Aug;14(8):2223-2234. doi: 10.1007/s13555-024-01223-y. Epub 2024 Jul 30. |
| 36260792 | Derived | Rosmarin D, Passeron T, Pandya AG, Grimes P, Harris JE, Desai SR, Lebwohl M, Ruer-Mulard M, Seneschal J, Wolkerstorfer A, Kornacki D, Sun K, Butler K, Ezzedine K; TRuE-V Study Group. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo. N Engl J Med. 2022 Oct 20;387(16):1445-1455. doi: 10.1056/NEJMoa2118828. |
| FG002 | Treatment-Extension Period: Ruxolitinib Cream 1.5% BID | Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period. |
| FG003 | Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period. |
| ITT Population |
|
| ITT Population, Excluding Non-compliant Site |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 28-Week Treatment Extension Period |
|
|
Baseline data are reported for members of the Safety Population, comprised of all participants who applied ruxolitinib cream or vehicle cream at least once. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Double-Blind Period: Ruxolitinib Cream 1.5% BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks. |
| BG001 | Double-Blind Period: Vehicle Cream BID | Participants applied matching vehicle cream BID for 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Face Vitiligo Area Scoring Index (F-VASI) | F-VASI was measured by the percentage of vitiligo involvement (percentage of body surface area [BSA]; assessed by the Investigator) and the degree of depigmentation: 0% (no depigmentation), 10% (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), 100% (no pigment). F-VASI was derived by multiplying the vitiligo involvement values by the percentage of affected skin for each facial site and summing all values (range: 0-3; higher values=worse outcome). | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Facial Body Surface Area (F-BSA) Involvement | 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. | Mean | Standard Deviation | percentage of facial surface area |
| ||||||||||||||
| Total Body Vitiligo Area Scoring Index (T-VASI) | T-VASI was measured by the percentage of vitiligo involvement from all body regions (percentage of BSA; Investigator assessed) and the degree of depigmentation: 0% (no depigmentation), 10% (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), 100% (no pigment). T-VASI was derived by multiplying the vitiligo involvement values by the percentage of affected skin for each site and summing all values (possible range: 0-100; higher values=worse outcome). | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Total Body Surface Area (T-BSA) Involvement | T-BSA involvement was the proportion of the body surface area with vitiligo. The body was divided into the following 6 separate and mutually exclusive sites: (1) head/neck, (2) hands, (3) upper extremities (excluding hands), (4) trunk, (5) lower extremities (excluding feet), and (6) feet. | Mean | Standard Deviation | percentage of total body surface area |
| ||||||||||||||
| Age Continuous, without Noncompliant Site | Baseline data are reported for members of the Intent-to-Treat (ITT) Population (all randomized participants), minus those participants enrolled at the noncompliant site. Treatment groups for this population were defined according to the treatment assignment at the time of randomization). | Mean | Standard Deviation | years |
| ||||||||||||||
| Gender, without Noncompliant Site | Baseline data are reported for members of the ITT Population, minus those participants enrolled at the noncompliant site. | Count of Participants | Participants |
| |||||||||||||||
| Race, without Noncompliant Site | Baseline data are reported for members of the ITT Population, minus those participants enrolled at the noncompliant site. | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity, without Noncompliant Site | Baseline data are reported for members of the ITT Population, minus those participants enrolled at the noncompliant site. | Count of Participants | Participants |
| |||||||||||||||
| F-VASI, without Noncompliant Site | F-VASI was measured by the percentage of vitiligo involvement (percentage of body surface area [BSA]; assessed by the Investigator) and the degree of depigmentation: 0% (no depigmentation), 10% (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), 100% (no pigment). F-VASI was derived by multiplying the vitiligo involvement values by the percentage of affected skin for each facial site and summing all values (range: 0-3; higher values=worse outcome). | Baseline data are reported for members of the ITT Population, minus those participants enrolled at the noncompliant site. | Mean | Standard Deviation | scores on a scale |
| |||||||||||||
| F-BSA Involvement, without Noncompliant Site | 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. | Baseline data are reported for members of the ITT Population, minus those participants enrolled at the noncompliant site. | Mean | Standard Deviation | percentage of facial surface area |
| |||||||||||||
| T-VASI, without Noncompliant Site | T-VASI was measured by the percentage of vitiligo involvement from all body regions (percentage of BSA; Investigator assessed) and the degree of depigmentation: 0% (no depigmentation), 10% (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), 100% (no pigment). T-VASI was derived by multiplying the vitiligo involvement values by the percentage of affected skin for each site and summing all values (possible range: 0-100; higher values=worse outcome). | Baseline data are reported for members of the ITT Population, minus those participants enrolled at the noncompliant site. | Mean | Standard Deviation | scores on a scale |
| |||||||||||||
| T-BSA Involvement, without Noncompliant Site | T-BSA involvement was the proportion of the body surface area with vitiligo. The body was divided into the following 6 separate and mutually exclusive sites: (1) head/neck, (2) hands, (3) upper extremities (excluding hands), (4) trunk, (5) lower extremities (excluding feet), and (6) feet. | Baseline data are reported for members of the ITT Population, minus those participants enrolled at the noncompliant site. | Mean | Standard Deviation | percentage of total body surface area |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24 | An F-VASI75 responder achieved at least 75% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area [BSA]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). | Intent-to-Treat Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at the time of randomization. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing F-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | Posted | Number | percentage of participants | Baseline; Week 24 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Week 24 | An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing F-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | Posted | Number | percentage of participants | Baseline; Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a ≥ 90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Week 24 | 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). | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing F-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | Posted | Number | percentage of participants | Baseline; Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24 | A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing T-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | Posted | Number | percentage of participants | Baseline; Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) of 4 or 5 at Week 24 | 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. | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing VNS scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | Posted | Number | percentage of participants | Baseline; Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in Facial Body Surface Area (F-BSA) at Week 24 | 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. | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing F-BSA scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline; Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. | Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1. | Posted | Count of Participants | Participants | from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 24) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Treatment-Extension Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. | Treatment-Extension (TE) Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period | Posted | Count of Participants | Participants | from the completion of the Week 24 assessments until at least 30 days after the last application of study drug (up to Week 52 + 30 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a ≥ 25% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25) Score at Week 24 | An F-VASI25 responder achieved at least 25% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing F-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | Posted | Number | percentage of participants | Baseline; Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a ≥ %25, ≥ %50, ≥ 75%, and ≥ 90% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25/50/75/90) Score at Week 52 | An F-VASI25/50/75/90 responder achieved at least 25/50/75/90% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Only participants with available data were analyzed. | Posted | Number | percentage of participants | Baseline; Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in F-VASI at Week 24 | 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. | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Only participants with available data were analyzed. MMRM model: (Response Variable = Treatment + Stratification Factors [Skin Type Fitzpatrick Scale Type I and II versus Type III, IV, V, and VI, Region North America/Europe] + Visit + Treatment*Visit). | Posted | Least Squares Mean | Standard Error | percentage change | Baseline; Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in F-VASI at Week 52 | 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. | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline; Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in F-BSA at Week 52 | F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-BL value minus BL value]/BL value) X 100. | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline; Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in T-VASI at Week 24 | T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100. | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Only participants with available data were analyzed. MMRM model: (Response Variable = Treatment + Stratification Factors [Skin Type Fitzpatrick scale Type I and II vs Type III, IV, V, and VI, Region North America/Europe] + Visit + Treatment*Visit). | Posted | Least Squares Mean | Standard Error | percentage change | Baseline; Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in T-VASI at Week 52 | T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100. | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline; Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in T-BSA at Week 24 | T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-BL value minus BL value]/BL value) X 100. | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Only participants with available data were analyzed. MMRM model: (Response Variable = Treatment + Stratification Factors [Skin Type Fitzpatrick scale Type I and II vs Type III, IV, V, and VI, Region North America/Europe] + Visit + Treatment*Visit). | Posted | Least Squares Mean | Standard Error | percentage change | Baseline; Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in T-BSA at Week 52 | T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-BL value minus BL value]/BL value) X 100. | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline; Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a ≥ 25%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/75/90) Score at Week 24 | A T-VASI25/75/90 responder achieved at least 25/75/90% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing T-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | Posted | Number | percentage of participants | Baseline; Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a ≥ 25%, ≥ 50%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/50/75/90) Score at Week 52 | A T-VASI25/50/75/90 responder achieved ≥25/50/75/90% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Only participants with available data were analyzed. | Posted | Number | percentage of participants | Baseline; Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) | 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. | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Only participants with available data were analyzed. | Posted | Number | percentage of participants | Baseline; Week 24 and Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24 | The DLQI is a 10-question validated questionnaire for use in participants aged 16 years and over to measure how much the skin problem has affected the participant over the previous 7 days. Each question is scored as: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0. For Question 7, "Prevented work or studying" = 3. The DLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. | ITT Population: participants aged ≥ 16 years. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Only participants with available data were analyzed. MMRM model: (Response Variable = Treatment + Stratification Factors [Skin Type Fitzpatrick scale Type I and II vs Type III, IV, V, and VI, Region North America/Europe] + Visit + Treatment*Visit). | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline; Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in DLQI at Week 52 | The DLQI is a 10-question validated questionnaire for use in participants aged 16 years and over to measure how much the skin problem has affected the participant over the previous 7 days. Each question is scored as: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0. For Question 7, "Prevented work or studying" = 3. The DLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. | ITT Population: participants aged ≥ 16 years. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) During the Treatment Period (Double-Blind and Treatment-Extension Periods) | The DLQI is a 10-question validated questionnaire for use in participants aged 16 years and over to measure how much the skin problem has affected the participant over the previous 7 days. The CDLQI is the youth/children's version of the DLQI and was completed by adolescents aged ≥ 12 years to < 16 years. Each question is scored as: very much = 3; quite a lot = 2; only a little = 1; not at all = 0; question unanswered = 0. For Question 7: "Prevented school" = 3. The CDLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. | ITT Population: participants aged < 16 years. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; Week 24 and Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Plasma Concentrations of Ruxolitinib at Weeks 4, 24, and 40 | Trough plasma concentration was defined as the measurement of the plasma concentration of ruxolitinib before drug application. | Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluable Population: all participants who applied ruxolitinib cream at least once and provided at least 1 postdose blood sample that complied with the Protocol | Posted | Mean | Standard Deviation | nanomoles | pre-dose at Weeks 4, 24, and 40 |
|
from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
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 applied matching vehicle cream twice a day (BID) for 24 weeks in the Double-Blind Period. | 0 | 115 | 0 | 115 | 6 | 115 |
| EG001 | Ruxolitinib Cream 1.5% BID | Participants applied ruxolitinib cream during the Double-Blind Treatment Period and the Treatment-Extension Period. Participants applied ruxolitinib 1.5% cream BID for 24 weeks. Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period. | 0 | 326 | 6 | 326 | 56 | 326 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendiceal abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site acne | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
Data from participants at a single site were excluded from all efficacy analyses done on the Intent-to-Treat Population owing to serious noncompliance with the protocol resulting in serious concerns with the 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 | Mar 9, 2021 | Jul 20, 2022 | 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
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Unable to Perform Safety Follow-up Visit |
|
|
|
|
|
|
|
|
|
|
| Male |
|
|
|
| Black/African American |
|
|
| Asian |
|
|
| American Indian/Alaska Native |
|
|
| Native Hawaiian/Pacific Islander |
|
|
| Not Reported |
|
|
| North African |
|
|
| White/Caucasian and Asian |
|
|
| Guyana |
|
|
| Cape Verdean |
|
|
| Persian |
|
|
| Middle Eastern |
|
|
| Arab/North-African |
|
|
| White/Black/Asian |
|
|
| Mexican |
|
|
| Jordanian |
|
|
| Arabic |
|
|
| Argentinian |
|
|
| Brazilian |
|
|
| Dominican Republic |
|
|
| Indo-Caribbean |
|
|
| Multi-National |
|
|
|
| Not Hispanic or Latino |
|
|
| Not Reported |
|
|
| Captured as "Other" |
|
|
|
|
|
|
| OG001 |
| Double-Blind Period: Vehicle Cream BID |
Participants applied matching vehicle cream BID for 24 weeks. |
|
|
|
| OG001 |
| Double-Blind Period: Vehicle Cream BID |
Participants applied matching vehicle cream BID for 24 weeks. |
|
|
|
| OG001 | Double-Blind Period: Vehicle Cream BID | Participants applied matching vehicle cream BID for 24 weeks. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants applied matching vehicle cream BID for 24 weeks.
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| OG001 |
| Double-Blind Period: Vehicle Cream BID |
Participants applied matching vehicle cream BID for 24 weeks. |
|
|
|
| OG001 | Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period. |
|
|
| OG001 |
| Double-Blind Period: Vehicle Cream BID |
Participants applied matching vehicle cream BID for 24 weeks. |
|
|
|
| OG001 | Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period. |
|
|
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period. |
|
|
| OG001 | Double-Blind Period: Vehicle Cream BID | Participants applied matching vehicle cream BID for 24 weeks. |
|
|
|
| OG001 | Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
| OG001 | Double-Blind Period: Vehicle Cream BID | Participants applied matching vehicle cream BID for 24 weeks. |
|
|
|
| OG001 | Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period. |
|
|
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.
| OG003 | Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| OG002 |
| Treatment-Extension Period: Ruxolitinib Cream 1.5% BID |
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period. |
| OG003 | Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period. |
|
|
| OG003 | Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period. |
|
|
| Title | Measurements |
|---|---|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|