To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
NCT ID: NCT04476043
Last Updated: 2025-08-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
209 participants
INTERVENTIONAL
2020-08-25
2023-08-16
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 15 mg
Participants will receive INCB054707 15 milligrams (mg) for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.
INCB054707
Oral; Tablet
INCB054707 45 mg
Participants will receive INCB054707 45 mg for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.
INCB054707
Oral; Tablet
INCB054707 75 mg
Participants will receive INCB054707 75 mg for 52 weeks in the Placebo-controlled Treatment Period (16 weeks) plus the Open-label Extension Period (36 weeks). Participants will have the option to continue open-label treatment for an additional 48 weeks.
INCB054707
Oral; Tablet
Placebo followed by INCB054707 75 mg
Participants will receive placebo for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks.
Placebo
Oral; Tablet
Interventions
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INCB054707
Oral; Tablet
Placebo
Oral; Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willingness to avoid pregnancy or fathering children.
* Active HS in at least 2 distinct anatomical areas.
* Participants agree NOT to use topical antiseptics on the areas affected by HS lesions during the placebo-controlled 16-week treatment period
Exclusion Criteria
* 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.
* History of failure to treatment of inflammatory diseases with JAK inhibitors.
* 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 005
Hoover, Alabama, United States
Investigative Site 003
Gilbert, Arizona, United States
Investigative Site 011
Phoenix, Arizona, United States
Investigative Site 014
Fountain Valley, California, United States
Investigative Site 010
Fremont, California, United States
Investigative Site 012
Huntington Beach, California, United States
Investigative Site 022
Newbury Park, California, United States
Investigative Site 009
Sacramento, California, United States
Investigative Site 025
Cromwell, Connecticut, United States
Investigative Site 015
Coral Gables, Florida, United States
Investigative Site 021
Miami, Florida, United States
Investigative Site 006
Tampa, Florida, United States
Investigative Site 001
Tampa, Florida, United States
Investigative Site 016
Atlanta, Georgia, United States
Investigative Site 002
West Lafayette, Indiana, United States
Investigative Site 027
Baton Rouge, Louisiana, United States
Investigative Site 023
New Orleans, Louisiana, United States
Investigative Site 013
Boston, Massachusetts, United States
Investigative Site 004
Fort Gratiot, Michigan, United States
Investigative Site 019
St Louis, Missouri, United States
Investigative Site 026
The Bronx, New York, United States
Investigative Site 008
Chapel Hill, North Carolina, United States
Investigative Site 017
Winston-Salem, North Carolina, United States
Investigative Site 007
Hershey, Pennsylvania, United States
Investigative Site 018
Bellaire, Texas, United States
Investigative Site 101
Calgary, Alberta, Canada
Investigative Site 102
Calgary, Alberta, Canada
Investigative Site 304
Nantes, , France
Investigative Site 403
Berlin, , Germany
Investigative Site 401
Bochum, , Germany
Investigative Site 405
Dessau, , Germany
Investigative Site 406
Dresden, , Germany
Investigative Site 404
Erlangen, , Germany
Investigative Site 402
Frankfurt am Main, , Germany
Investigative Site 552
Rzeszów, , Poland
Investigative Site 551
Wroclaw, , Poland
Investigative Site 553
Wroclaw, , Poland
Investigative Site 703
Granada, , Spain
Investigative Site 702
Madrid, , Spain
Investigative Site 701
Valencia, , Spain
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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2020-001981-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 54707-204
Identifier Type: -
Identifier Source: org_study_id
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