A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.
Condition or Disease
Hidradenitis Suppruativa
Study Design
| Study Type: | Interventional (Clinical Trial) |
| Estimated Enrollment: | 450 |
| Primary Outcome Measures |
1. Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline
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| Actual Study Start Date: | June 2025 |
| Estimated Primary Completion Date: | October 2026 |
Eligibility Criteria
| Ages Eligible for Study: | 12 & Older |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Study Population
Hidradenitis Supurativa
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: 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 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