Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)
NCT ID: NCT06958211
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
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RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2025-06-12
2027-07-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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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
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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
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Incyte Study Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Investigative Site US257
Birmingham, Alabama, United States
Investigative Site US218
Birmingham, Alabama, United States
Investigative Site US239
Montgomery, Alabama, United States
Investigative Site US215
Phoenix, Arizona, United States
Investigative Site US261
Phoenix, Arizona, United States
Investigative Site US221
Scottsdale, Arizona, United States
Investigative Site US240
Tucson, Arizona, United States
Investigative Site US262
Encino, California, United States
Investigative Site US222
Fountain Valley, California, United States
Investigative Site US211
Los Angeles, California, United States
Investigative Site US237
Los Angeles, California, United States
Investigative Site US234
Northridge, California, United States
Investigative Site US250
Santa Ana, California, United States
Investigative Site US244
Castle Rock, Colorado, United States
Investigative Site US252
Cromwell, Connecticut, United States
Investigative Site US208
Boca Raton, Florida, United States
Investigative Site US203
Hialeah, Florida, United States
Investigative Site US258
Jacksonville, Florida, United States
Investigative Site US206
Maitland, Florida, United States
Investigative Site US223
Miami, Florida, United States
Investigative Site US241
Miami, Florida, United States
Investigative Site US202
Miami, Florida, United States
Investigative Site US214
Tampa, Florida, United States
Investigative Site US247
Tampa, Florida, United States
Investigative Site US231
Columbus, Georgia, United States
Investigative Site US225
Sandy Springs, Georgia, United States
Investigative Site US233
Ketchum, Idaho, United States
Investigative Site US207
Skokie, Illinois, United States
Investigative Site US205
Plainfield, Indiana, United States
Investigative Site US264
Lake Charles, Louisiana, United States
Investigative Site US236
New Orleans, Louisiana, United States
Investigative Site US326
New Orleans, Louisiana, United States
Investigative Site US266
New Orleans, Louisiana, United States
Investigative Site US254
Gambrills, Maryland, United States
Investigative Site US201
Marriottsville, Maryland, United States
Investigative Site US253
Milford, Massachusetts, United States
Investigative Site US227
Needham, Massachusetts, United States
Investigative Site US268
Worcester, Massachusetts, United States
Investigative Site US238
Ann Arbor, Michigan, United States
Investigative Site US230
Auburn Hills, Michigan, United States
Investigative Site US251
St Louis, Missouri, United States
Investigative Site US271
Wildwood, Missouri, United States
Investigative Site US212
Missoula, Montana, United States
Investigative Site US216
Las Vegas, Nevada, United States
Investigative Site US235
Hoboken, New Jersey, United States
Investigative Site US217
Albuquerque, New Mexico, United States
Investigative Site US219
Brooklyn, New York, United States
Investigative Site US246
Elmhurst, New York, United States
Investigative Site US269
Fairport, New York, United States
Investigative Site US213
Kew Gardens, New York, United States
Investigative Site US242
New York, New York, United States
Investigative Site US245
Rochester, New York, United States
Investigative Site US259
Huntersville, North Carolina, United States
Investigative Site US263
Winston-Salem, North Carolina, United States
Investigative Site US228
Cleveland, Ohio, United States
Investigative Site US243
Columbus, Ohio, United States
Investigative Site US249
Columbus, Ohio, United States
Investigative Site US204
Portland, Oregon, United States
Investigative Site US226
Plymouth Meeting, Pennsylvania, United States
Investigative Site US256
Bluffton, South Carolina, United States
Investigative Site US267
Mt. Pleasant, South Carolina, United States
Investigative Site US255
Austin, Texas, United States
Investigative Site US260
Cypress, Texas, United States
Investigative Site US270
Prosper, Texas, United States
Investigative Site US232
Sugar Land, Texas, United States
Investigative Site US248
Arlington, Virginia, United States
Investigative Site US209
Danville, Virginia, United States
Investigative Site US229
Norfolk, Virginia, United States
Investigative Site US265
Seattle, Washington, United States
Investigative Site US224
Spokane, Washington, United States
Investigative Site US210
Milwaukee, Wisconsin, United States
Investigative Site BE204
Brussels, , Belgium
Investigative Site BE201
Ghent, , Belgium
Investigative Site BE203
Ghent, , Belgium
Investigative Site BE202
Leuven, , Belgium
Investigative Site BG201
Sevlievo, , Bulgaria
Investigative Site BG202
Sofia, , Bulgaria
Investigative Site BG203
Sofia, , Bulgaria
Investigative Site CA209
Edmonton, Alberta, Canada
Investigative Site CA201
Winnipeg, Manitoba, Canada
Investigative Site CA207
Fredericton, New Brunswick, Canada
Investigative Site CA202
Hamilton, Ontario, Canada
Investigative Site CA203
London, Ontario, Canada
Investigative Site CA204
Markham, Ontario, Canada
Investigative Site CA205
Mississauga, Ontario, Canada
Investigative Site CA208
Saskatoon, Saskatchewan, Canada
Investigative Site CA206
St. John's, , Canada
Investigative Site FR201
Reims, , France
Investigative Site FR203
Rouen, , France
Investigative Site FR204
Saint-Etienne, , France
Investigative Site FR202
Toulouse, , France
Investigative Site DE207
Bad Bentheim, , Germany
Investigative Site DE206
Göttingen, , Germany
Investigative Site DE202
Hanover, , Germany
Investigative Site DE203
Kiel, , Germany
Investigative Site DE205
Langenau, , Germany
Investigative Site DE204
Merzig, , Germany
Investigative Site NL203
AZ Amsterdam-zuidoost, , Netherlands
Investigative Site NL201
Rotterdam, , Netherlands
Investigative Site PL202
Lublin, , Poland
Investigative Site LP204
Poznan, , Poland
Investigative Site PL201
Rzeszów, , Poland
Investigative Site PL203
Wroclaw, , Poland
Investigative Site ES205
Barcelona, , Spain
Investigative Site ES208
Esplugues de Llobregat, , Spain
Investigative Site ES201
Granada, , Spain
Investigative Site ES206
Granollers, , Spain
Investigative Site ES202
Las Palmas de Gran Canaria, , Spain
Investigative Site ES203
Madrid, , Spain
Investigative Site ES207
Manises, , Spain
Investigative Site ES204
Santiago de Compostela, , Spain
Countries
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Central Contacts
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Related Links
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Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)
Other Identifiers
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2024-517633-40-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCB018424-325
Identifier Type: -
Identifier Source: org_study_id