A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)
- Registration Number
- NCT04896385
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Vehicle Cream Vehicle Cream Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream. Ruxolitinib cream Ruxolitinib cream Ruxolitinib cream will be administered twice a day (BID) for 24 weeks
- Primary Outcome Measures
Name Time Method 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; 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With a Grade 3 or Higher TEAE During the Double-Blind Period 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) 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period 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) 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.
Correlation of Key Skin Inflammatory Biomarkers of Vitiligo in Target Lesions to Efficacy Readouts Baseline, Week 12, and Week 24 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.
Number of Participants With TEAEs During the Treatment-Extension Period 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 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.
Number of Participants With a Grade 3 or Higher TEAE During the Treatment-Extension Period 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 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.
Trial Locations
- Locations (13)
George Washington Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Suny Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Dermatology Specialists of Spokane
🇺🇸Spokane, Washington, United States
Simcoderm Medical and Surgical Dermatology Center
🇨🇦Barrie, Ontario, Canada
JRB Research Inc
🇨🇦Ottawa, Ontario, Canada
Hopital Saint Andre
🇫🇷Bordeaux, France
Dermatology Research Institute
🇨🇦Calgary, Alberta, Canada
Hopital Archet 2 Derm Dept
🇫🇷Nice, France
Centre Hospitalier Universitaire Henri Mondor
🇫🇷Creteil, France
First Oc Dermatology
🇺🇸Fountain Valley, California, United States
Lynderm Research Inc
🇨🇦Markham, Ontario, Canada
UC Irvine
🇺🇸Irvine, California, United States