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

NCT06959225

Active Not RecruitingPhase 3

Sponsor: Incyte Corporation

Conditions: Hidradenitis Suppurativa

Interventions: Ruxolitinib Cream, Vehicle Cream

Countries: United States, Bulgaria, Canada, France, Germany, Italy, Poland, Spain

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

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (101)
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Tempe, Arizona, United States
  • Fayetteville, Arkansas, United States
  • Brea, California, United States
  • Laguna Niguel, California, United States
  • Los Angeles, California, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • Aurora, Colorado, United States
  • Boynton Beach, Florida, United States
  • Fort Myers, Florida, United States
  • Miami, Florida, United States
  • Sanford, Florida, United States
  • Sweetwater, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Marietta, Georgia, United States
  • Chicago, Illinois, United States
  • Clarksville, Indiana, United States
  • West Lafayette, Indiana, United States
  • Bowling Green, Kentucky, United States
  • Louisville, Kentucky, United States
  • Baton Rouge, Louisiana, United States
  • Glenn Dale, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Quincy, Massachusetts, United States
  • + 71 more on CT.gov