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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000361-32 | EudraCT Number |
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The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib cream | Experimental | Ruxolitinib cream will be administered twice a day (BID) for 24 weeks |
|
| Vehicle Cream | Placebo Comparator | Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream. |
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| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24 | Baseline was defined as the last non-missing measurement obtained on or before the first application of study drug. Percentage change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value)*100. | Baseline; Week 4, Week 12, and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Key Skin Inflammatory Biomarkers of Vitiligo in Target Lesions to Efficacy Readouts | Clinical scores (facial Vitiligo Area Scoring Index [F-VASI] and total body Vitiligo Area Scoring Index [T-VASI]) were evaluated for correlation with skin CXCL10 levels. | Baseline, Week 12, and Week 24 |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Oc Dermatology | Fountain Valley | California | 92708 | United States | ||
| UC Irvine |
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 study was conducted at a total of 11 sites in Canada, France, and the United States.
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| 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 |
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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 | Mar 3, 2021 | Nov 16, 2023 |
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Randomized, double-blind, vehicle-controlled, with an open-label treatment extension.
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Double-blind
| Vehicle Cream | Drug | Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream. |
|
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| 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 or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. 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 the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days) |
| Number of Participants With 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 or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. 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 at Week 52 + 30 days |
| Number of Participants With a Grade 3 or Higher TEAE During the Double-Blind 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. 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. AE severity was assessed per the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated; Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal. | from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days) |
| Number of Participants With a Grade 3 or Higher TEAE 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. 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. AE severity was assessed per the CTCAE, version 5.0: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated; Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal. | from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days |
| Irvine |
| California |
| 92697 |
| United States |
| George Washington Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| Suny Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202 | United States |
| Dermatology Research Institute | Calgary | Alberta | T1Y 0B4 | Canada |
| Simcoderm Medical and Surgical Dermatology Center | Barrie | Ontario | L4M 7G1 | Canada |
| Lynderm Research Inc | Markham | Ontario | L3P 1X2 | Canada |
| JRB Research Inc | Ottawa | Ontario | K1H 7X8 | Canada |
| Hopital Saint Andre | Bordeaux | 33000 | France |
| Centre Hospitalier Universitaire Henri Mondor | Créteil | 94010 | France |
| Hopital Archet 2 Derm Dept | Nice | 06200 | France |
| 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% BID for 28 weeks in the Treatment-Extension Period. |
| COMPLETED |
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| NOT COMPLETED |
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| 28-Week Treatment-Extension Period |
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| 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 |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an immune biomarker | Baseline was defined as the last non-missing measurement obtained on or before the first application of study drug. | Only participants with available data were analyzed. | Mean | Standard Deviation | nanograms per Liter (ng/L) |
|
| 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 Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24 | Baseline was defined as the last non-missing measurement obtained on or before the first application of study drug. Percentage change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value)*100. | Safety Population: all participants who applied at least 1 dose of study drug. Treatment groups for this population were to be determined according to the actual treatment the participant received on Day 1. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 4, Week 12, and Week 24 |
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| Secondary | Correlation of Key Skin Inflammatory Biomarkers of Vitiligo in Target Lesions to Efficacy Readouts | Clinical scores (facial Vitiligo Area Scoring Index [F-VASI] and total body Vitiligo Area Scoring Index [T-VASI]) were evaluated for correlation with skin CXCL10 levels. | Safety Population. Repeated measures correlation (Crm) takes into account that measures were taken from the same individual across multiple timepoints. Included in the analysis were only those participants with values at each of 3 timepoints: Baseline, Week 12, and Week 24. | Posted | Number | correlation coefficient | Baseline, Week 12, and Week 24 |
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| 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 or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. 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. | Double-Blind Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once during the Double-Blind Period. 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 the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days) |
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| Secondary | Number of Participants With 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 or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. 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 Evaluable Population: all participants who applied ruxolitinib cream at least once during the Treatment-Extension 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 at Week 52 + 30 days |
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| Secondary | Number of Participants With a Grade 3 or Higher TEAE During the Double-Blind 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. 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. AE severity was assessed per the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated; Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal. | Double-Blind Safety Population. 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 the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days) |
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| Secondary | Number of Participants With a Grade 3 or Higher TEAE 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. 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. AE severity was assessed per the CTCAE, version 5.0: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated; Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal. | Treatment-Extension Evaluable Population | 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 at Week 52 + 30 days |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 55 | 1 | 55 | 10 | 55 |
| EG001 | Vehicle Cream BID | Participants applied matching vehicle cream twice a day (BID) for 24 weeks in the Double-Blind Period. | 0 | 19 | 0 | 19 | 7 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 26 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site exfoliation | General disorders | MedDRA 26 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| Hydrocele | Congenital, familial and genetic disorders | MedDRA 26 | Systematic Assessment |
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| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
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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 14, 2022 | Nov 16, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Withdrawal by Subject |
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| Participant Refused Safety Follow-up |
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| Pregnancy |
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| Black/African-American |
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| Asian |
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| Native Hawaiian/Pacific Islander |
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| Not Reported |
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| South Asian |
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| Middle Eastern |
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| Week 12 |
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| Week 24 |
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| Units | Counts |
|---|---|
| Participants |
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Participants applied matching vehicle cream BID for 24 weeks. |
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| 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% BID for 28 weeks in the Treatment-Extension Period. |
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