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Janus Kinase (JAK) Inhibitor
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With 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 week 25 up to week 76
Summary
This trial is testing a medication called INCB054707 to see if it can help people with nonsegmental vitiligo, a condition where the skin loses its color in patches. The study will check if the medication can safely and effectively bring back the natural color to their skin.
Eligible Conditions
- Vitiligo
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from week 25 up to week 76
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 25 up to week 76
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
Secondary study objectives
Extension Period: Number of Participants With Any TEAE
Percentage of Participants Achieving T-VASI50 at Week 24
Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Side effects data
From 2019 Phase 2 trial • 10 Patients • NCT0356937130%
Upper respiratory tract infection
10%
Nausea
10%
Headache
10%
Fibromyalgia
10%
Anxiety
10%
Rash
10%
Night sweats
100%
80%
60%
40%
20%
0%
Study treatment Arm
INCB054707
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: INCB054707 Dose CExperimental Treatment1 Intervention
Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2).
Group II: INCB054707 Dose BExperimental Treatment1 Intervention
Participants will receive INCB054707 Dose B for 52 weeks (Period 1 + Period 2).
Group III: INCB054707 Dose A followed by Dose CExperimental Treatment1 Intervention
Participants will receive INCB054707 Dose A for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).
Group IV: Placebo followed by INCB054707 Dose CPlacebo Group1 Intervention
Participants will receive placebo for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB054707
2018
Completed Phase 2
~670
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
393 Previous Clinical Trials
63,795 Total Patients Enrolled
10 Trials studying Vitiligo
2,521 Patients Enrolled for Vitiligo