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
Oregon Health and Science University
Summary
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)
Description
This is a Phase II study that will be open label and include a total of 17 patients who will receive the investigational product. PG will be defined by the investigator on the basis of results from clinical, histological and laboratory assessments. These patients will undergo 28 weeks of guselkumab dosed every 4 weeks and a stable dose of prednisone dosed daily with follow-up until week 40.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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 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 follow…
Interventions
- DrugGuselkumab
Subjects with PG will be treated with 100 mg in a pre-filled syringe to be injected subcutaneously every 4 weeks for 28 weeks.
Locations (2)
- Ohio State DermatologyColumbus, Ohio
- Oregon Health and Science UniversityPortland, Oregon