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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)

Recruiting
12 years and older
All
Phase 3

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Overview

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

Eligibility

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.

Study details
    Hidradenitis Suppurativa

NCT06959225

Incyte Corporation

1 November 2025

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