Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorOregon Health and Science University
About this trial
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)
Eligibility criteria
Qualifiers
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
Disqualifiers
Has previously received at any time any therapeutic agent directly targeted to IL-23 including, but not limited to, guselkumab, risankizumab, tildrakuzumab, or mirikizumab
12 weeks for ustekinumab, ixekizumab, secukinumab, brodalumab;
8 weeks for infliximab;
6 weeks for adalimumab;
Trial design
Treatments tested in this trial
- Guselkumab
Treatment groups
17 Participants
are divided into 1 treatment groupSponsors and collaborators
Oregon Health and Science University
Lead sponsor
Janssen Scientific Affairs, LLC
Collaborator
Ohio State University
Collaborator
Source ClinicalTrials.gov