Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)
NCT ID: NCT06959225
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2025-06-23
2027-07-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ruxolitinib 1.5 % Cream
Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Vehicle Cream
Participants received vehicle cream, applied topically to the affected area as defined by the protocol.
Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mild to moderate HS (Hurley I or II) with the following at both screening and baseline visits:
* A total AN count of at least 4, with no draining tunnels AND
* Affecting at least 2 distinct anatomical areas
* Agreement to NOT use topical and systemic antibiotics for treatment of HS during the vehicle-controlled period.
* Agreement to NOT use topical antiseptics, including washes and leave-on products on the areas affected by HS lesions during the vehicle-controlled period and Weeks 16 to 20 of the extension period.
Exclusion Criteria
* Presence of draining tunnels at screening or baseline.
* Medical history including current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
* Laboratory values outside of the protocol-defined criteria.
* Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Incyte Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Incyte Study Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigative Site US020
Phoenix, Arizona, United States
Investigative Site US033
Scottsdale, Arizona, United States
Investigative Site US054
Tempe, Arizona, United States
Investigative Site US002
Fayetteville, Arkansas, United States
Investigative Site US055
Brea, California, United States
Investigative Site US004
Laguna Niguel, California, United States
Investigative Site US007
Los Angeles, California, United States
Investigative Site US013
San Diego, California, United States
Investigative Site US060
San Diego, California, United States
Investigative Site US038
San Diego, California, United States
Investigative Site US059
Aurora, Colorado, United States
Investigative Site US045
Boynton Beach, Florida, United States
Investigative Site US028
Fort Myers, Florida, United States
Investigative Site US016
Miami, Florida, United States
Investigative Site US027
Sanford, Florida, United States
Investigative Site US057
Sweetwater, Florida, United States
Investigative Site US029
Tampa, Florida, United States
Investigative Site US061
Atlanta, Georgia, United States
Investigative Site US053
Atlanta, Georgia, United States
Investigative Site US019
Marietta, Georgia, United States
Investigative Site US026
Chicago, Illinois, United States
Investigative Site US042
Libertyville, Illinois, United States
Investigative Site US049
Clarksville, Indiana, United States
Investigative Site US052
West Lafayette, Indiana, United States
Investigative Site US001
Bowling Green, Kentucky, United States
Investigative Site US022
Louisville, Kentucky, United States
Investigative Site US050
Baton Rouge, Louisiana, United States
Investigative Site US046
Glenn Dale, Maryland, United States
Investigative Site US003
Boston, Massachusetts, United States
Investigative Site US030
Boston, Massachusetts, United States
Investigative Site US010
Quincy, Massachusetts, United States
Investigative Site US051
Detroit, Michigan, United States
Investigative Site US006
Minneapolis, Minnesota, United States
Investigative Site US021
New Brighton, Minnesota, United States
Investigative Site US036
Saint Joseph, Missouri, United States
Investigative Site US034
New City, New York, United States
Investigative Site US018
New York, New York, United States
Investigative Site US017
New York, New York, United States
Investigative Site US023
Rochester, New York, United States
Investigative Site US014
Chapel Hill, North Carolina, United States
Investigative Site US025
Fargo, North Dakota, United States
Investigative Site US015
Bexley, Ohio, United States
Investigative Site US044
Cincinnati, Ohio, United States
Investigative Site US008
Columbus, Ohio, United States
Investigative Site US031
Mason, Ohio, United States
Investigative Site US048
Oklahoma City, Oklahoma, United States
Investigative Site US043
Danville, Pennsylvania, United States
Investigative Site US056
Philadelphia, Pennsylvania, United States
Investigative Site US024
Charleston, South Carolina, United States
Investigative Site US041
Myrtle Beach, South Carolina, United States
Investigative Site US005
Murfreesboro, Tennessee, United States
Investigative Site US047
Nashville, Tennessee, United States
Investigative Site US062
Dallas, Texas, United States
Investigative Site US035
El Paso, Texas, United States
Investigative Site US032
Frisco, Texas, United States
Investigative Site US012
Plano, Texas, United States
Investigative Site US011
San Antonio, Texas, United States
Investigative Site US040
Layton, Utah, United States
Investigative Site US037
Murray, Utah, United States
Investigative Site US039
Ogden, Utah, United States
Investigative Site US058
Seattle, Washington, United States
Investigative Site BG002
Sofia, , Bulgaria
Investigative Site BG003
Sofia, , Bulgaria
Investigative Site BG001
Stara Zagora, , Bulgaria
Investigative Site CA004
Calgary, Alberta, Canada
Investigative Site CA003
Calgary, Alberta, Canada
Investigative Site CA009
Ottawa, Ontario, Canada
Investigative Site CA002
Peterborough, Ontario, Canada
Investigative Site CA001
Richmond Hill, Ontario, Canada
Investigative Site CA007
Toronto, Ontario, Canada
Investigative Site CA005
Toronto, Ontario, Canada
Investigative Site CA006
Waterloo, Ontario, Canada
Investigative Site CA008
Sherbrooke, Quebec, Canada
Investigative Site FR002
Bordeaux, , France
Investigative Site FR005
Brest, , France
Investigative Site FR004
Nantes, , France
Investigative Site FR003
Nice, , France
Investigative Site FR001
Paris, , France
Investigative Site DE006
Berlin, , Germany
Investigative Site DE005
Berlin, , Germany
Investigative Site DE002
Bochum, , Germany
Investigative Site DE004
Darmstadt, , Germany
Investigative Site DE001
Dresden, , Germany
Investigative Site DE003
Erlangen, , Germany
Investigative Site DE007
Hamburg, , Germany
Investigative Site DE008
Lübeck, , Germany
Investigative Site IT001
Catania, , Italy
Investigative Site IT005
Cona, , Italy
Investigative Site IT009
Florence, , Italy
Investigative Site IT003
Milan, , Italy
Investigative Site IT007
Naples, , Italy
Investigative Site IT006
Roma, , Italy
Investigative Site IT004
Roma, , Italy
Investigative Site IT002
Rozzano, , Italy
Investigative Site IT008
Torino, , Italy
Investigative Site PL002
Lodz, , Poland
Investigative Site PL003
Torun, , Poland
Investigative Site PL001
Warsaw, , Poland
Investigative Site PL004
Wroclaw, , Poland
Investigative Site ES004
Alicante, , Spain
Investigative Site ES005
Badalona, , Spain
Investigative Site ES003
Barcelona, , Spain
Investigative Site ES001
Madrid, , Spain
Investigative Site ES002
Madrid, , Spain
Investigative Site GB001
Cardiff, , United Kingdom
Investigative Site GB004
Harrogate, , United Kingdom
Investigative Site GB002
Ipswich, , United Kingdom
Investigative Site GB006
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-517632-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCB018424-324
Identifier Type: -
Identifier Source: org_study_id