RecruitingPhase 3NCT06958211
Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)
A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
Sponsor
Incyte Corporation
Enrollment
550 participants
Start Date
Jun 12, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.
Eligibility
Min Age: 12 Years
Inclusion Criteria6
- 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.
Exclusion Criteria5
- 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.
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Interventions
DRUGRuxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
DRUGVehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Locations(107)
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NCT06958211
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