Efficacy of Bimekizumab in Adults With Pyoderma Gangrenosum
ConditionPyoderma Gangrenosum
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOregon Health and Science University
About this trial
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).
Eligibility criteria
Qualifiers
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 (4cm2 - 225cm2) at screening.
Be a candidate for systemic therapy.
Disqualifiers
4 weeks for any therapeutic agent directly targeted to IL-17 including, but not limited to, secukinumab, brodalumab, ixekizumab
8 weeks for infliximab;
6 weeks for adalimumab;
4 weeks for cyclosporine A, etanercept, inhibitors of the JAK/TYK pathway and PD4 inhibitors;
Trial design
Treatments tested in this trial
- Bimekizumab
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Oregon Health and Science University
Lead sponsor
UCB Pharma
Collaborator
Source ClinicalTrials.gov