A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo
NCT ID: NCT04818346
Last Updated: 2024-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
171 participants
INTERVENTIONAL
2021-05-06
2023-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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).
INCB054707
INCB054707 will be administered once daily
INCB054707 Dose B
Participants will receive INCB054707 Dose B for 52 weeks (Period 1 + Period 2).
INCB054707
INCB054707 will be administered once daily
INCB054707 Dose C
Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2).
INCB054707
INCB054707 will be administered once daily
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).
Placebo
Placebo or INCB054707 will be administered once daily
Interventions
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INCB054707
INCB054707 will be administered once daily
Placebo
Placebo or INCB054707 will be administered once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Locations
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Investigative Site 010
Hoover, Alabama, United States
Investigative Site 015
Gilbert, Arizona, United States
Investigative Site 028
Scottsdale, Arizona, United States
Investigative Site 006
Irvine, California, United States
Investigative Site 009
Los Angeles, California, United States
Investigative Site 018
Los Angeles, California, United States
Investigative Site 017
Sacramento, California, United States
Investigative Site 032
Orange Park, Florida, United States
Investigative Site 005
Tampa, Florida, United States
Investigative Site 022
Tampa, Florida, United States
Investigative Site 011
West Palm Beach, Florida, United States
Investigative Site 024
Covington, Louisiana, United States
Investigative Site 002
Brighton, Massachusetts, United States
Investigative Site 023
Saint Paul, Minnesota, United States
Investigative Site 027
Verona, New Jersey, United States
Investigative Site 003
Columbus, Ohio, United States
Investigative Site 007
Norman, Oklahoma, United States
Investigative Site 001
Portland, Oregon, United States
Investigative Site 021
Plymouth Meeting, Pennsylvania, United States
Investigative Site 004
Murfreesboro, Tennessee, United States
Investigative Site 033
Dallas, Texas, United States
Investigative Site 012
San Antonio, Texas, United States
Investigative Site 030
Spokane, Washington, United States
Investigative Site 020
Winnipeg, Manitoba, Canada
Investigative Site 014
Etobicoke, Ontario, Canada
Investigative Site 034
London, Ontario, Canada
Investigative Site 025
Mississauga, Ontario, Canada
Investigative Site 026
North YORK, Ontario, Canada
Investigative Site 031
Oakville, Ontario, Canada
Investigative Site 008
Peterborough, Ontario, Canada
Investigative Site 029
Québec, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INCB 54707-205
Identifier Type: -
Identifier Source: org_study_id
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