Your session is about to expire
← Back to Search
Janus Kinase (JAK) Inhibitor
Ruxolitinib Cream for Vitiligo
Phase 3
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI.
* Total body vitiligo area does not exceed 10% BSA.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 6, 24, 30 and 52
Awards & highlights
Pivotal Trial
Summary
This trial aims to test if a cream called ruxolitinib is safe and effective for treating nonsegmental vitiligo in children.
Who is the study for?
This trial is for children with a type of skin condition called nonsegmental vitiligo, which causes loss of skin color in patches. They should have it on at least 0.5% of their face or 3% on other body parts but not more than 10% overall. Participants must stop using other vitiligo treatments during the study and if sexually active, avoid pregnancy.
What is being tested?
The study tests Ruxolitinib cream to see if it's safe and effective for treating pediatric nonsegmental vitiligo compared to a placebo (Vehicle Cream). It will involve applying these creams to see if they can restore skin color in affected areas.
What are the potential side effects?
Possible side effects are not detailed here, but like any topical treatment, Ruxolitinib cream may cause local reactions such as redness, itching or irritation where applied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have vitiligo with significant skin depigmentation on my face and body.
Select...
Less than 10% of my body is affected by vitiligo.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 6, 24, 30 and 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 6, 24, 30 and 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
Secondary study objectives
Number of Treatment Emergent Adverse Events (TEAEs)
Percentage change from baseline in F-BSA
Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations
+8 moreSide effects data
From 2020 Phase 3 trial • 631 Patients • NCT037456389%
Upper respiratory tract infection
6%
Nasopharyngitis
4%
Headache
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib 0.75% Cream BID
Vehicle Cream BID
Ruxolitinib 1.5% Cream BID
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ruxolitinib 1.5 % CreamExperimental Treatment1 Intervention
Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
Group II: Vehicle CreamPlacebo Group1 Intervention
Participants received vehicle cream, applied topically to the affected area as defined by the protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib Cream
2018
Completed Phase 3
~740
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
393 Previous Clinical Trials
63,664 Total Patients Enrolled
10 Trials studying Vitiligo
2,512 Patients Enrolled for Vitiligo
Incyte Medical MonitorStudy DirectorIncyte Corporation
34 Previous Clinical Trials
12,089 Total Patients Enrolled
2 Trials studying Vitiligo
888 Patients Enrolled for Vitiligo