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Active, not recruitingPhase 3

Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)

Key facts

Where
Atlanta, Aurora, Baton Rouge, Bexley, Boston, Bowling Green, Boynton Beach, Brea, Chapel Hill, Charleston, Chicago, Cincinnati, Clarksville, Columbus, Dallas, Danville, El Paso, Fargo, Fayetteville, Fort Myers, Frisco, Glenn Dale, Laguna Niguel, Layton, Los Angeles, Louisville, Marietta, Mason, Miami, Minneapolis, Murray, Myrtle Beach, Nashville, New Brighton, New City, New York, Novi, Ogden, Oklahoma City, Philadelphia, Phoenix, Plano, Quincy, Rochester, Saint Joseph, San Antonio, San Diego, Sanford, Scottsdale, Seattle, Sweetwater, Tampa, Tempe, and West Lafayette, United StatesSee the 59 sites
Phase
Phase 3

Where in United States

  • Atlanta, GeorgiaHospital not named in the registryNo longer taking part
  • Atlanta, GeorgiaHospital not named in the registryNo longer taking part
  • Aurora, ColoradoHospital not named in the registryNo longer taking part
  • Baton Rouge, LouisianaHospital not named in the registryNo longer taking part
  • Bexley, OhioHospital not named in the registryNo longer taking part
  • Boston, MassachusettsHospital not named in the registryNo longer taking part
  • Boston, MassachusettsHospital not named in the registryNo longer taking part
  • Bowling Green, KentuckyHospital not named in the registryNo longer taking part
  • Boynton Beach, FloridaHospital not named in the registryNo longer taking part
  • Brea, CaliforniaHospital not named in the registryNo longer taking part
  • Chapel Hill, North CarolinaHospital not named in the registryNo longer taking part
  • Charleston, South CarolinaHospital not named in the registryNo longer taking part
  • Chicago, IllinoisHospital not named in the registryNo longer taking part
  • Cincinnati, OhioHospital not named in the registryNo longer taking part
  • Clarksville, IndianaHospital not named in the registryNo longer taking part
  • Columbus, OhioHospital not named in the registryNo longer taking part
  • Dallas, TexasHospital not named in the registryNo longer taking part
  • Danville, PennsylvaniaHospital not named in the registryNo longer taking part
  • El Paso, TexasHospital not named in the registryNo longer taking part
  • Fargo, North DakotaHospital not named in the registryNo longer taking part
  • Fayetteville, ArkansasHospital not named in the registryNo longer taking part
  • Fort Myers, FloridaHospital not named in the registryNo longer taking part
  • Frisco, TexasHospital not named in the registryNo longer taking part
  • Glenn Dale, MarylandHospital not named in the registryNo longer taking part
  • Laguna Niguel, CaliforniaHospital not named in the registryNo longer taking part
  • Layton, UtahHospital not named in the registryNo longer taking part
  • Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
  • Louisville, KentuckyHospital not named in the registryNo longer taking part
  • Marietta, GeorgiaHospital not named in the registryNo longer taking part
  • Mason, OhioHospital not named in the registryNo longer taking part
  • Miami, FloridaHospital not named in the registryNo longer taking part
  • Minneapolis, MinnesotaHospital not named in the registryNo longer taking part
  • Murray, UtahHospital not named in the registryNo longer taking part
  • Myrtle Beach, South CarolinaHospital not named in the registryNo longer taking part
  • Nashville, TennesseeHospital not named in the registryNo longer taking part
  • New Brighton, MinnesotaHospital not named in the registryNo longer taking part
  • New City, New YorkHospital not named in the registryNo longer taking part
  • New YorkHospital not named in the registryNo longer taking part
  • New YorkHospital not named in the registryNo longer taking part
  • Novi, MichiganHospital not named in the registryNo longer taking part
  • Ogden, UtahHospital not named in the registryNo longer taking part
  • Oklahoma City, OklahomaHospital not named in the registryNo longer taking part
  • Philadelphia, PennsylvaniaHospital not named in the registryNo longer taking part
  • Phoenix, ArizonaHospital not named in the registryNo longer taking part
  • Plano, TexasHospital not named in the registryNo longer taking part
  • Quincy, MassachusettsHospital not named in the registryNo longer taking part
  • Rochester, New YorkHospital not named in the registryNo longer taking part
  • Saint Joseph, MissouriHospital not named in the registryNo longer taking part
  • San Antonio, TexasHospital not named in the registryNo longer taking part
  • San Diego, CaliforniaHospital not named in the registryNo longer taking part
  • San Diego, CaliforniaHospital not named in the registryNo longer taking part
  • San Diego, CaliforniaHospital not named in the registryNo longer taking part
  • Sanford, FloridaHospital not named in the registryNo longer taking part
  • Scottsdale, ArizonaHospital not named in the registryNo longer taking part
  • Seattle, WashingtonHospital not named in the registryNo longer taking part
  • Sweetwater, FloridaHospital not named in the registryNo longer taking part
  • Tampa, FloridaHospital not named in the registryNo longer taking part
  • Tempe, ArizonaHospital not named in the registryNo longer taking part
  • West Lafayette, IndianaHospital not named in the registryNo longer taking part

Trial details

Who runs it
Incyte Corporation
Trial code
NCT06959225EU 2024-517632-22-00
Record updated
12 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 NCT06959225 · EU CTIS 2024-517632-22-00