A Single-arm Open-label Study Assessing Short-term (Week 6, 16) and Long-term (Week 32) Efficacy of Guselkumab in Adult Participants With Pyoderma Gangrenosum
A single-arm open-label study assessing short-term (week 6, 16) and long-term (week 32) efficacy of guselkumab in adult participants with pyoderma gangrenosum (PG)
• 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 minimum wound size of 4 cm2.
• Undergoing at least once a week standard of care wound care at home or at a wound care facility
• Are candidate for systemic therapy. Must be on a stable dose of prednisone of 20 mg/day for at least two weeks prior to first drug administration.
• Males ages 18-99 who agree to not father a child or donate sperm while on study and at least 12 weeks following last dose of the study drug. If subject is sexually active male and could cause pregnancy, subject much be sure that female partner(s) are using birth control that works well or not have sex.
• Females ages 18-99; either of non-childbearing potential or of childbearing potential who test negative for pregnancy and agree to use at least two reliable methods of birth control or remain abstinent during the study for at least 12 weeks following the last dose of guselkumab.
• Willingness to travel to study site for all study visits or living \>30 miles from study site and willing/able to participate in remote videoconferencing visits with access to a computer with internet and webcam capabilities.
• Be willing to undergo perilesional and non-lesional skin biopsy at week 0 and week 32 resulting in 4 biopsies during the course of the study. Participants can choose if they are willing to provide 2 additional biopsies at week 16. Refusal to give consent for any of the optional research samples does not exclude participant from participation in the study.