Study Summary
This trial will study whether Ruxolitinib cream, with or without phototherapy, can help treat vitiligo in people for whom the affected area does not exceed 10% of their body.
Eligible Conditions
- Vitiligo
- JAK Inhibitor
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: Approximately 14 months
Approximately 14 months
Number of treatment-related adverse events
Week 48
Change from Baseline in T-VASI
Week 4
Population-based (trough) plasma concentrations of ruxolitinib
Week 4
Percentage change from baseline in F-BSA at each post-baseline visit
Percentage change from baseline in F-VASI at each post-baseline visit
Percentage change from baseline in T-BSA at each post-baseline visit
Percentage change from baseline in T-VASI at each post-baseline visit
Percentage of participants achieving F-VASI50/75/90 at each post-baseline visit
Percentage of participants achieving T-VASI50/75/90 at each post-baseline visit
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Adalimumab (Humira)
9%upper respiratory infection
6%joint range of motion decrease
6%vasovagal syncope
3%headache
3%nasal congestion
Trial Design
2 Treatment Groups
Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)
1 of 2
Group B: Ruxolitinib Monotherapy
1 of 2
Experimental Treatment
50 Total Participants · 2 Treatment Groups
Primary Treatment: NB-UVB phototherapy · No Placebo Group · Phase 2
Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)Experimental Group · 2 Interventions: NB-UVB phototherapy, Ruxolitinib 1.5% cream · Intervention Types: Device, Drug
Group B: Ruxolitinib Monotherapy
Drug
Experimental Group · 1 Intervention: Ruxolitinib 1.5% cream · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NB-UVB phototherapy
2017
Completed Phase 4
~150
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 14 months
Who is running the clinical trial?
Incyte CorporationLead Sponsor
315 Previous Clinical Trials
46,520 Total Patients Enrolled
6 Trials studying Vitiligo
1,520 Patients Enrolled for Vitiligo
Haq Nawaz, MDStudy DirectorIncyte Corporation
5 Previous Clinical Trials
195 Total Patients Enrolled
Eligibility Criteria
Age 12 - 99 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The patient must have a facial VASI score of at least 0.5 on the face.
You have a T-VASI score of at least 3.0.
Who else is applying?
What state do they live in?
| Washington | 33.3% |
| Georgia | 22.2% |
| Massachusetts | 22.2% |
| Other | 22.2% |
How old are they?
| 18 - 65 | 87.5% |
| 65+ | 12.5% |
What site did they apply to?
| UC Davis Health | 33.3% |
| Delricht Clinical Research - Clinedge - Ppds Baton Rouge | 16.7% |
| Principle Research Solutions | 33.3% |
| Other | 16.7% |
What portion of applicants met pre-screening criteria?
| Met criteria | 55.6% |
| Did not meet criteria | 44.4% |
Why did patients apply to this trial?
- "I'm hoping this clinical trial can help my condition vitiligo"
How many prior treatments have patients received?
| 0 | 100.0% |
How responsive is this trial?
Most responsive sites:
- Tufts Medical Center: < 24 hours
Average response time
- < 1 Day
Typically responds via
| Phone Call | 100.0% |
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Conditions
Cancer Related
Treatments