NB-UVB phototherapy for Vitiligo

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Vitiligo+1 MoreNB-UVB phototherapy - Device
Eligibility
12 - 99
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
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
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT01553058) in the Adalimumab (Humira) ARM group. Side effects include: upper respiratory infection with 9%, joint range of motion decrease with 6%, vasovagal syncope with 6%, headache with 3%, nasal congestion with 3%.

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: Drug
Treatment
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?
Washington33.3%
Georgia22.2%
Massachusetts22.2%
Other22.2%
How old are they?
18 - 6587.5%
65+12.5%
What site did they apply to?
UC Davis Health33.3%
Delricht Clinical Research - Clinedge - Ppds Baton Rouge16.7%
Principle Research Solutions33.3%
Other16.7%
What portion of applicants met pre-screening criteria?
Met criteria55.6%
Did not meet criteria44.4%
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?
0100.0%

How responsive is this trial?

Most responsive sites:
  1. Tufts Medical Center: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Phone Call100.0%