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Topical Ruxolitinib in the Treatment of Adults With Pyoderma Gangrenosum

Study acronym: TRIUMPH
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Notable Recruitment opened Show 5 more changesShow less
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 6 of 10 entries
    • Study description revised
    • Publications: details revised at 16 of 16 entries
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07783412
Lead Sponsor Oregon Health and Science University
Collaborators: Incyte Corporation
Conditions
(from sponsor)
Pyoderma Gangrenosum
Related terms Pyoderma Gangrenosum, Wounds and Injuries
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov