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About
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)
Full 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.
Enrollment
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Inclusion criteria
Exclusion criteria
Has previously received at any time any therapeutic agent directly targeted to IL-23 including, but not limited to, guselkumab, risankizumab, tildrakuzumab, or mirikizumab
Any drug treatment specifically for PG including but not limited to biologics (or biosimilar of), experimental antibodies, small molecules and oral immunosuppressives used within washout periods specified below, prior to first dose of study drug:
If not specified specifically, a time of 4 weeks or 5 half-lives of the drug (whichever is longer) prior to first drug administration.
Primary purpose
Allocation
Interventional model
Masking
17 participants in 1 patient group
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Central trial contact
Alex G Ortega-Loayza, MD, MCR
Data sourced from clinicaltrials.gov
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