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

Incyte

Status and phase: Begins enrollment this month; Phase 3

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Ruxolitinib Cream; Drug: Vehicle Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT06959225

INCB018424-324

2024-517632-22-00 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Ruxolitinib 1.5 % Cream

Experimental group

Description:

Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.

Treatment:

Drug: Ruxolitinib Cream

Vehicle Cream

Placebo Comparator group

Description:

Participants received vehicle cream, applied topically to the affected area as defined by the protocol.

Treatment:

Drug: Vehicle Cream