Actively Recruiting
Phase 2 Open-Label Study of Guselkumab with Prednisone for Adults with Pyoderma Gangrenosum
Led by Oregon Health and Science University · Updated on 2026-03-06
17
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the short-term and long-term effects of guselkumab treatment in adults with pyoderma gangrenosum PG, a skin condition characterized by painful ulcers. This Phase II open-label study involves 17 adult participants diagnosed with PG through clinical, histological, and laboratory assessments. The study aims to understand how guselkumab works alongside prednisone in managing PG over several months. Participants will receive 100 mg of guselkumab injected under the skin every 4 weeks for 28 weeks. Alongside this, they will take a stable daily dose of prednisone starting at 20 mg, which will be gradually reduced based on a specific plan. The study includes follow-up visits lasting until week 40, allowing researchers to observe both immediate and lasting treatment effects. During the study, participants will undergo skin biopsies at the beginning and at week 32, with an option for additional biopsies at week 16. They will be monitored through clinical assessments, laboratory tests, and various measures including ulcer healing, ulcer size reduction, skin pain levels, physical function, and quality of life. Researchers will also track any treatment failures and ulcer recurrence up to week 40, ensuring thorough evaluation of safety and effectiveness over time.
CONDITIONS
Brief Title
Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
Research Team
A
Alex G Ortega-Loayza, MD, MCR
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