A Single-arm Open-label Study Assessing Efficacy of Bimekizumab in Adult Participants With Pyoderma Gangrenosum Over 24 Weeks
Oregon Health and Science University
Summary
The purpose of the study is to learn more about an experimental drug bimekizumab that may be helpful for Pyoderma Gangrenosum (PG). Bimekizumab will be referred to as the study drug throughout this form. The investigators are hoping to find out if bimekizumab helps in healing PG wounds. The study drug is experimental. It has been approved by the FDA for use in adults with psoriatic conditions but not for Pyoderma Gangrenosum (PG).
Description
This is a single-arm, open-label, interventional Phase 2 study evaluating the efficacy and safety of bimekizumab in adult participants with pyoderma gangrenosum (PG). Bimekizumab is a monoclonal antibody that inhibits IL-17A, IL-17F, and the IL-17AF heterodimer. It is FDA-approved for psoriatic conditions but is not currently approved for the treatment of PG. Approximately 17 participants will be enrolled, with an anticipated 15 participants completing screening and initiating study treatment at Oregon Health \& Science University (OHSU), accounting for an estimated 10% dropout rate. Eligibl…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * At least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) * Have a diagnosis of at least one PG ulcer defined by the investigator on the basis of results from clinical and/or histological and/or laboratory assessments: Classic PG defined as deep ulceration with undermining violaceous borders and PARACELSUS score \>10. If multiple ulcers are present, the largest ulcer (defined by greatest surface area) will be designated the target ulcer and followed throughout the study. * Subject has a minimum of 1 evaluable ulcer (4cm…
Interventions
- DrugBimekizumab
Participants will receive bimekizumab 320 mg administered subcutaneously every 2 weeks for the first 16 weeks, followed by 320 mg every 4 weeks through Week 24
Location
- Oregon Health & Science University, Department of DermatologyPortland, Oregon