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Janus Kinase (JAK) Inhibitor
Ruxolitinib cream for Vitiligo
Phase 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
Summary
This trial will study how well ruxolitinib cream works to treat vitiligo by measuring changes in biomarkers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24
Secondary outcome measures
Correlation of Key Skin Inflammatory Biomarkers of Vitiligo in Target Lesions to Efficacy Readouts
Number of Participants With TEAEs During the Treatment-Extension Period
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ruxolitinib creamExperimental Treatment1 Intervention
Ruxolitinib cream will be administered twice a day (BID) for 24 weeks
Group II: Vehicle CreamPlacebo Group1 Intervention
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib cream
2022
Completed Phase 3
~1850
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Who is running the clinical trial?
Incyte CorporationLead Sponsor
373 Previous Clinical Trials
55,719 Total Patients Enrolled
9 Trials studying Vitiligo
2,452 Patients Enrolled for Vitiligo
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