Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)
Launched by INCYTE CORPORATION · Apr 25, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new cream called ruxolitinib to see how well it works and how safe it is for people with hidradenitis suppurativa (HS). HS is a chronic skin condition that causes painful lumps and sores, usually in areas like the armpits or groin. The trial is looking for participants aged 18 and older who have had HS for at least six months and have mild to moderate symptoms. To participate, individuals must have a certain number of skin lesions but no draining tunnels, and they need to agree not to use certain treatments during the study.
Participants in this trial will apply ruxolitinib cream to their affected areas and will be monitored for its effects over time. It’s important for potential participants to know that they cannot have large areas of skin affected or certain medical conditions that could affect their safety in the trial. The study is not yet recruiting, so if you or someone you know is interested, keep an eye out for when it opens up.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of HS for at least 6 months prior to screening visit.
- * 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.
- • Further inclusion criteria apply.
- Exclusion Criteria:
- • Body surface areas to be treated exceed 20% BSA at screening or baseline
- • 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.
- • Further exclusion criteria apply.
About Incyte Corporation
Incyte Corporation is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for oncology and other serious diseases. With a commitment to advancing precision medicine, Incyte leverages its expertise in molecular biology and clinical research to develop targeted treatments that address unmet medical needs. The company is dedicated to improving patient outcomes through rigorous clinical trials and collaborations with healthcare professionals and research institutions. Incyte's robust pipeline includes a range of investigational therapies aimed at various cancers, showcasing its dedication to transforming the landscape of cancer treatment.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Las Palmas De Gran Canaria, , Spain
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Encino, California, United States
Fountain Valley, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Northridge, California, United States
Castle Rock, Colorado, United States
Farmington, Connecticut, United States
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Maitland, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Ketchum, Idaho, United States
Skokie, Illinois, United States
Plainfield, Indiana, United States
Lake Charles, Louisiana, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Gambrills, Maryland, United States
Marriottsville, Maryland, United States
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Marlborough, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
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Saint Louis, Missouri, United States
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Brooklyn, New York, United States
Fairport, New York, United States
Kew Gardens, New York, United States
New York, New York, United States
Rochester, New York, United States
Huntersville, North Carolina, United States
Winston Salem, North Carolina, United States
Columbus, Ohio, United States
Dublin, Ohio, United States
Mayfield Heights, Ohio, United States
Portland, Oregon, United States
Plymouth Meeting, Pennsylvania, United States
Bluffton, South Carolina, United States
Mount Pleasant, South Carolina, United States
Cypress, Texas, United States
Sugar Land, Texas, United States
Arlington, Virginia, United States
Danville, Virginia, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Brussels, , Belgium
Gent, , Belgium
Gent, , Belgium
Leuven, , Belgium
Sevlievo, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Edmonton, Alberta, Canada
Winnipeg, Manitoba, Canada
Fredericton, New Brunswick, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Markham, Ontario, Canada
Mississauga, Ontario, Canada
Saskatoon, Saskatchewan, Canada
St. John's, , Canada
Reims, , France
Rouen Cedex, , France
Saint Etienne Cedex 2, , France
Toulouse Cedex 9, , France
Bad Bentheim, , Germany
Frankfurt Am Main, , Germany
Gottingen, , Germany
Hannover, , Germany
Kiel, , Germany
Langenau, , Germany
Mainz, , Germany
Amsterdam, , Netherlands
Bergen Op Zoom, , Netherlands
Rotterdam, , Netherlands
Ostrowiec Swietokrzyski, , Poland
Poznan, , Poland
Rzeszow, , Poland
Wrocaw, , Poland
Barcelona, , Spain
Barcelona, , Spain
Esplugues De Llobregat, , Spain
Granada, , Spain
Madrid, , Spain
Manises, , Spain
Santiago De Compostela, , Spain
Montgomery, Alabama, United States
Tucson, Arizona, United States
Tustin, California, United States
Miami, Florida, United States
New Hyde Park, New York, United States
Prosper, Texas, United States
Amsterdam, , Netherlands
Patients applied
Trial Officials
Incyte Study Monitor
Study Director
Incyte Corporation
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported