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A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo

Sponsor
Incyte Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04818346
Collaborator
(none)
171
Enrollment
31
Locations
4
Arms
20
Anticipated Duration (Months)
5.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of INCB054707 over a 24-week placebo-controlled double-blind treatment period, followed by a 28-week double-blind extension period in participants with nonsegmental vitiligo.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
171 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Double blinded
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 Followed by an Extension Period in Participants With Vitiligo
Actual Study Start Date :
May 6, 2021
Actual Primary Completion Date :
May 24, 2022
Anticipated Study Completion Date :
Jan 6, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: INCB054707 Dose A followed by Dose C

Participants will receive INCB054707 Dose A for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).

Drug: INCB054707
INCB054707 will be administered once daily
Experimental: INCB054707 Dose B

Participants will receive INCB054707 Dose B for 52 weeks (Period 1 + Period 2).

Drug: INCB054707
INCB054707 will be administered once daily
Experimental: INCB054707 Dose C

Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2).

Drug: INCB054707
INCB054707 will be administered once daily
Placebo Comparator: Placebo followed by INCB054707 Dose C

Participants will receive placebo for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).

Drug: Placebo
Placebo or INCB054707 will be administered once daily

Outcome Measures

Primary Outcome Measures

  1. Percentage change in Total Vitiligo Area Scoring Index (T-VASI) [Week 24]

    Defined as Percent change from baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24.

Secondary Outcome Measures

  1. Proportion of participants achieving Total Vitiligo Area Scoring Index 50 (T-VASI50) [Week 24]

    Defined as 50% or greater reduction in the Total Vitiligo Area Scoring Index.

  2. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Up to Week 74]

    A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Clinical diagnosis of nonsegmental vitiligo.

  • History of prior vitiligo treatment with a total duration of at least 3 months.

  • Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.

  • Willingness to avoid pregnancy or fathering children

  • Further inclusion criteria apply.

Exclusion Criteria:

  • Other forms of vitiligo (eg, segmental) or other skin depigmentation disorders.

  • Uncontrolled thyroid function at screening as determined by the investigator.

  • Women who are pregnant (or who are considering pregnancy) or lactating.

  • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.

  • Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.

  • Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.

  • Laboratory values outside of the protocol-defined ranges.

  • Further exclusion criteria apply.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigative Site 010 Hoover Alabama United States 35244
2 Investigative Site 015 Gilbert Arizona United States 85295
3 Investigative Site 028 Scottsdale Arizona United States 85260
4 Investigative Site 006 Irvine California United States 92697
5 Investigative Site 009 Los Angeles California United States 90036
6 Investigative Site 018 Los Angeles California United States 90045
7 Investigative Site 017 Sacramento California United States 95815
8 Investigative Site 032 Orange Park Florida United States 32073
9 Investigative Site 005 Tampa Florida United States 33613
10 Investigative Site 022 Tampa Florida United States 33614
11 Investigative Site 011 West Palm Beach Florida United States 33401
12 Investigative Site 024 Covington Louisiana United States 70433
13 Investigative Site 002 Brighton Massachusetts United States 02135
14 Investigative Site 023 Saint Paul Minnesota United States 55112
15 Investigative Site 027 Verona New Jersey United States 07044
16 Investigative Site 003 Columbus Ohio United States 43215
17 Investigative Site 007 Norman Oklahoma United States 73071
18 Investigative Site 001 Portland Oregon United States 97223
19 Investigative Site 021 Plymouth Meeting Pennsylvania United States 19462
20 Investigative Site 004 Murfreesboro Tennessee United States 37130
21 Investigative Site 033 Dallas Texas United States 75230
22 Investigative Site 012 San Antonio Texas United States 78213
23 Investigative Site 030 Spokane Washington United States 99202
24 Investigative Site 020 Winnipeg Manitoba Canada R3M 3Z4
25 Investigative Site 014 Etobicoke Ontario Canada M8X 1Y9
26 Investigative Site 034 London Ontario Canada N6H 5LR
27 Investigative Site 025 Mississauga Ontario Canada L5H 1G9
28 Investigative Site 026 North York Ontario Canada M2M4J5
29 Investigative Site 031 Oakville Ontario Canada L6J 7W5
30 Investigative Site 008 Peterborough Ontario Canada K9J 5K2
31 Investigative Site 029 Quebec Canada Q1V 4X7

Sponsors and Collaborators

  • Incyte Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT04818346
Other Study ID Numbers:
  • INCB 54707-205
First Posted:
Mar 26, 2021
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vitiligo

Study Results

No Results Posted as of Jul 21, 2022