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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

Summary

This trial is testing a skin cream called ruxolitinib on people with vitiligo, a condition that causes skin to lose its color. The study aims to understand how the cream works by looking at changes in specific biological signals in the skin. Ruxolitinib cream has shown promise in previous studies for repigmentation in vitiligo patients.

Eligible Conditions
  • Vitiligo

Timeline

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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 more

Side effects data

From 2021 Phase 3 trial • 330 Patients • NCT04052425
1%
Tibia fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle Cream BID
Ruxolitinib Cream 1.5% BID

Trial 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

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
391 Previous Clinical Trials
63,864 Total Patients Enrolled
10 Trials studying Vitiligo
2,632 Patients Enrolled for Vitiligo
~14 spots leftby Nov 2025
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