Oregon Health and Science University
This is a single-center, open-label, single-arm pilot study evaluating topical ruxolitinib (OPZELURA) as a treatment for adults with Pyoderma Gangrenosum (PG), a chronic inflammatory skin condition that causes painful ulcers. Approximately 12 participants will apply ruxolitinib cream twice daily for 24 weeks while continuing standard wound care, with the goal of determining whether the drug helps target ulcers heal completely without the need for systemic immunosuppressive therapy. Participants will be followed for a total of 28 weeks, with the option to continue treatment in a 48-week open-label extension if they respond well and remain safe on the drug. The study is sponsored by Oregon Health \& Science University and funded by Incyte Corporation.
Pyoderma Gangrenosum is a rare, ulcerative inflammatory skin condition most commonly treated with systemic corticosteroids or cyclosporine, both of which carry significant long-term toxicity risks. Topical therapy has shown effectiveness for smaller lesions, but existing topical options (corticosteroids, calcineurin inhibitors) also carry risks with prolonged use and lack robust long-term safety data. Emerging evidence implicates the JAK-STAT signaling pathway in PG pathogenesis, with JAK1/2/3 and TYK2 found to be overexpressed in PG lesions and several PG-associated inflammatory cytokines (IF…
Inclusion Criteria: * Willingness to comply with study procedures/requirements * Capable of giving informed consent * Diagnosis of at least one PG ulcer by clinical, histological and laboratory assessments with a maximum wound size of 10 cm2. * Male age 18-99 who agree to not father a child or donate sperm while on study and at least 1 week following last dose of the study drug. If subject is a sexually active male and could cause a pregnancy, subject must be sure that female partner(s) are using birth control that works well or not have sex. * Female age 18-99; either of non-childbearing pot…
topical ruxolitinib 1.5% cream applied to wound bed twice daily for 24 weeks.
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