INCB054707 for Vitiligo

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
VitiligoINCB054707 - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new drug to see if it works better than a placebo at treating vitiligo over a 24-week period, followed by a 28-week extension.

Eligible Conditions
  • Vitiligo

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to Week 74

Up to Week 74
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Week 24
Percentage change in Total Vitiligo Area Scoring Index (T-VASI)
Proportion of participants achieving Total Vitiligo Area Scoring Index 50 (T-VASI50)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

INCB054707
30%Upper respiratory tract infection
10%Rash
10%Night sweats
10%Headache
10%Nausea
10%Fibromyalgia
10%Anxiety
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03569371) in the INCB054707 ARM group. Side effects include: Upper respiratory tract infection with 30%, Rash with 10%, Night sweats with 10%, Headache with 10%, Nausea with 10%.

Trial Design

4 Treatment Groups

INCB054707 Dose C
1 of 4
INCB054707 Dose B
1 of 4
INCB054707 Dose A followed by Dose C
1 of 4
Placebo followed by INCB054707 Dose C
1 of 4

Experimental Treatment

Non-Treatment Group

171 Total Participants · 4 Treatment Groups

Primary Treatment: INCB054707 · Has Placebo Group · Phase 2

INCB054707 Dose C
Drug
Experimental Group · 1 Intervention: INCB054707 · Intervention Types: Drug
INCB054707 Dose B
Drug
Experimental Group · 1 Intervention: INCB054707 · Intervention Types: Drug
INCB054707 Dose A followed by Dose C
Drug
Experimental Group · 1 Intervention: INCB054707 · Intervention Types: Drug
Placebo followed by INCB054707 Dose C
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB054707
2018
Completed Phase 2
~80

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 74

Who is running the clinical trial?

Incyte CorporationLead Sponsor
313 Previous Clinical Trials
46,275 Total Patients Enrolled
6 Trials studying Vitiligo
1,399 Patients Enrolled for Vitiligo

Eligibility Criteria

Age 18 - 75 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a history of prior vitiligo treatment with a total duration of at least 3 months.

Who else is applying?

What state do they live in?
Pennsylvania25.0%
Tennessee25.0%
Arizona25.0%
Other25.0%
How old are they?
18 - 6575.0%
< 1825.0%
What site did they apply to?
Investigative Site 01025.0%
Investigative Site 01525.0%
Investigative Site 02125.0%
Other25.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%