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Active, not recruitingPhase 3

Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)

Key facts

Where
Albuquerque, Ann Arbor, Arlington, Auburn Hills, Austin, Birmingham, Bluffton, Boca Raton, Brooklyn, Castle Rock, Cleveland, Columbus, Cromwell, Cypress, Danville, Elmhurst, Encino, Fairport, Fountain Valley, Gambrills, Hialeah, Hoboken, Huntersville, Jacksonville, Kew Gardens, Lake Charles, Las Vegas, Los Angeles, Maitland, Marriottsville, Miami, Milford, Milwaukee, Missoula, Montgomery, Mt. Pleasant, Needham, New Orleans, New York, Norfolk, Northridge, Phoenix, Plainfield, Plymouth Meeting, Portland, Prosper, Rochester, Sandy Springs, Santa Ana, Seattle, Skokie, Spokane, St Louis, Sugar Land, Tampa, Tucson, Wildwood, Winston-Salem, and Worcester, United StatesSee the 67 sites
Phase
Phase 3

Where in United States

  • Albuquerque, New MexicoHospital not named in the registryNo longer taking part
  • Ann Arbor, MichiganHospital not named in the registryNo longer taking part
  • Arlington, VirginiaHospital not named in the registryNo longer taking part
  • Auburn Hills, MichiganHospital not named in the registryNo longer taking part
  • Austin, TexasHospital not named in the registryNo longer taking part
  • Birmingham, AlabamaHospital not named in the registryNo longer taking part
  • Birmingham, AlabamaHospital not named in the registryNo longer taking part
  • Bluffton, South CarolinaHospital not named in the registryNo longer taking part
  • Boca Raton, FloridaHospital not named in the registryNo longer taking part
  • Brooklyn, New YorkHospital not named in the registryNo longer taking part
  • Castle Rock, ColoradoHospital not named in the registryNo longer taking part
  • Cleveland, OhioHospital not named in the registryNo longer taking part
  • Columbus, OhioHospital not named in the registryNo longer taking part
  • Columbus, GeorgiaHospital not named in the registryNo longer taking part
  • Columbus, OhioHospital not named in the registryNo longer taking part
  • Cromwell, ConnecticutHospital not named in the registryNo longer taking part
  • Cypress, TexasHospital not named in the registryNo longer taking part
  • Danville, VirginiaHospital not named in the registryNo longer taking part
  • Elmhurst, New YorkHospital not named in the registryNo longer taking part
  • Encino, CaliforniaHospital not named in the registryNo longer taking part
  • Fairport, New YorkHospital not named in the registryNo longer taking part
  • Fountain Valley, CaliforniaHospital not named in the registryNo longer taking part
  • Gambrills, MarylandHospital not named in the registryNo longer taking part
  • Hialeah, FloridaHospital not named in the registryNo longer taking part
  • Hoboken, New JerseyHospital not named in the registryNo longer taking part
  • Huntersville, North CarolinaHospital not named in the registryNo longer taking part
  • Jacksonville, FloridaHospital not named in the registryNo longer taking part
  • Kew Gardens, New YorkHospital not named in the registryNo longer taking part
  • Lake Charles, LouisianaHospital not named in the registryNo longer taking part
  • Las Vegas, NevadaHospital not named in the registryNo longer taking part
  • Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
  • Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
  • Maitland, FloridaHospital not named in the registryNo longer taking part
  • Marriottsville, MarylandHospital not named in the registryNo longer taking part
  • Miami, FloridaHospital not named in the registryNo longer taking part
  • Miami, FloridaHospital not named in the registryNo longer taking part
  • Miami, FloridaHospital not named in the registryNo longer taking part
  • Milford, MassachusettsHospital not named in the registryNo longer taking part
  • Milwaukee, WisconsinHospital not named in the registryNo longer taking part
  • Missoula, MontanaHospital not named in the registryNo longer taking part
  • Montgomery, AlabamaHospital not named in the registryNo longer taking part
  • Mt. Pleasant, South CarolinaHospital not named in the registryNo longer taking part
  • Needham, MassachusettsHospital not named in the registryNo longer taking part
  • New Orleans, LouisianaHospital not named in the registryNo longer taking part
  • New YorkHospital not named in the registryNo longer taking part
  • Norfolk, VirginiaHospital not named in the registryNo longer taking part
  • Northridge, CaliforniaHospital not named in the registryNo longer taking part
  • Phoenix, ArizonaHospital not named in the registryNo longer taking part
  • Phoenix, ArizonaHospital not named in the registryNo longer taking part
  • Plainfield, IndianaHospital not named in the registryNo longer taking part
  • Plymouth Meeting, PennsylvaniaHospital not named in the registryNo longer taking part
  • Portland, OregonHospital not named in the registryNo longer taking part
  • Prosper, TexasHospital not named in the registryNo longer taking part
  • Rochester, New YorkHospital not named in the registryNo longer taking part
  • Sandy Springs, GeorgiaHospital not named in the registryNo longer taking part
  • Santa Ana, CaliforniaHospital not named in the registryNo longer taking part
  • Seattle, WashingtonHospital not named in the registryNo longer taking part
  • Skokie, IllinoisHospital not named in the registryNo longer taking part
  • Spokane, WashingtonHospital not named in the registryNo longer taking part
  • St Louis, MissouriHospital not named in the registryNo longer taking part
  • Sugar Land, TexasHospital not named in the registryNo longer taking part
  • Tampa, FloridaHospital not named in the registryNo longer taking part
  • Tampa, FloridaHospital not named in the registryNo longer taking part
  • Tucson, ArizonaHospital not named in the registryNo longer taking part
  • Wildwood, MissouriHospital not named in the registryNo longer taking part
  • Winston-Salem, North CarolinaHospital not named in the registryNo longer taking part
  • Worcester, MassachusettsHospital not named in the registryNo longer taking part

Trial details

Who runs it
Incyte Corporation
Trial code
NCT06958211EU 2024-517633-40-00
Record updated
9 November 2026
Original description
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.Read full original descriptionShow less

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.

Inclusion: 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: 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; Body surface areas to be treated exceed 20% BSA at screening or baseline; Presence of draining tunnels at screening or baseline; Pregnant or lactating participants, or those considering pregnancy during the period of their study participation; Further exclusion criteria apply.

ClinicalTrials.gov NCT06958211 · EU CTIS 2024-517633-40-00