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

Primary Purpose

NonSegmental Vitiligo

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
INCB054707
Placebo
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NonSegmental Vitiligo

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigative Site 010
  • Investigative Site 015
  • Investigative Site 028
  • Investigative Site 006
  • Investigative Site 009
  • Investigative Site 018
  • Investigative Site 017
  • Investigative Site 032
  • Investigative Site 005
  • Investigative Site 022
  • Investigative Site 011
  • Investigative Site 024
  • Investigative Site 002
  • Investigative Site 023
  • Investigative Site 027
  • Investigative Site 003
  • Investigative Site 007
  • Investigative Site 001
  • Investigative Site 021
  • Investigative Site 004
  • Investigative Site 033
  • Investigative Site 012
  • Investigative Site 030
  • Investigative Site 020
  • Investigative Site 014
  • Investigative Site 034
  • Investigative Site 025
  • Investigative Site 026
  • Investigative Site 031
  • Investigative Site 008
  • Investigative Site 029

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

INCB054707 Dose A followed by Dose C

INCB054707 Dose B

INCB054707 Dose C

Placebo followed by INCB054707 Dose C

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. Percent change was calculated as ([post-Baseline value minus the Baseline value] / Baseline value) x 100.

Secondary Outcome Measures

Percentage of Participants Achieving T-VASI50 at Week 24
T-VASI50 was defined as a 50% or greater reduction from Baseline in T-VASI. The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive body regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period.

Full Information

First Posted
March 25, 2021
Last Updated
June 15, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04818346
Brief Title
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
May 24, 2022 (Actual)
Study Completion Date
May 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NonSegmental Vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blinded
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INCB054707 Dose A followed by Dose C
Arm Type
Experimental
Arm Description
Participants will receive INCB054707 Dose A for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).
Arm Title
INCB054707 Dose B
Arm Type
Experimental
Arm Description
Participants will receive INCB054707 Dose B for 52 weeks (Period 1 + Period 2).
Arm Title
INCB054707 Dose C
Arm Type
Experimental
Arm Description
Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2).
Arm Title
Placebo followed by INCB054707 Dose C
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo for 24 weeks (Period 1) followed by INCB054707 Dose C for 28 weeks (Period 2).
Intervention Type
Drug
Intervention Name(s)
INCB054707
Other Intervention Name(s)
Povorcitinib
Intervention Description
INCB054707 will be administered once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo or INCB054707 will be administered once daily
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
Description
The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites. Percent change was calculated as ([post-Baseline value minus the Baseline value] / Baseline value) x 100.
Time Frame
Baseline; Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving T-VASI50 at Week 24
Description
T-VASI50 was defined as a 50% or greater reduction from Baseline in T-VASI. The T-VASI was calculated based on values from the whole body, which was split into 6 separate and mutually exclusive body regions (possible range: 0-100; higher values=worse outcome). The percentage of vitiligo involvement was estimated in hand units (% body surface area [BSA]; investigator assessed), based on the participant's hand size. The degree of depigmentation for each body site was determined and estimated to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. The T-VASI was derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values of all body sites.
Time Frame
Baseline; Week 24
Title
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Description
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up period.
Time Frame
up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Investigative Site 010
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Investigative Site 015
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85295
Country
United States
Facility Name
Investigative Site 028
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Investigative Site 006
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Investigative Site 009
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Investigative Site 018
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Investigative Site 017
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Investigative Site 032
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Investigative Site 005
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Investigative Site 022
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Investigative Site 011
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Investigative Site 024
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Investigative Site 002
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Investigative Site 023
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Investigative Site 027
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Investigative Site 003
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Investigative Site 007
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Investigative Site 001
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Investigative Site 021
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
Investigative Site 004
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Investigative Site 033
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Investigative Site 012
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Investigative Site 030
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Investigative Site 020
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Investigative Site 014
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M8X 1Y9
Country
Canada
Facility Name
Investigative Site 034
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5LR
Country
Canada
Facility Name
Investigative Site 025
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Investigative Site 026
City
North York
State/Province
Ontario
ZIP/Postal Code
M2M4J5
Country
Canada
Facility Name
Investigative Site 031
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
Investigative Site 008
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Investigative Site 029
City
Quebec
ZIP/Postal Code
Q1V 4X7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

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

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