Guselkumab for Skin Ulcers
(GEORGE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAlex G Ortega-Loayza, MD, MCR

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Oregon Health and Science University

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of 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)

Research Team

Alex G Ortega-Loayza, MD, MCR

Principal Investigator

Oregon Health and Science University, Department of Dermatology

Eligibility Criteria

This trial is for adults with Pyoderma Gangrenosum (PG), a rare skin condition that causes painful ulcers. Participants should have an active PG ulcer and be in generally stable health to join the study.

Inclusion Criteria

Willingness to comply with study procedures/requirements

I receive wound care at least weekly.

I am eligible for systemic therapy and have been on a stable dose of 20 mg/day of prednisone for at least two weeks.

See 6 more

Exclusion Criteria

I have not had, nor plan to have, major surgery within the study period.

Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients

Individuals who are pregnant, lactating or breastfeeding

See 22 more

Treatment Details

Interventions

Guselkumab (Monoclonal Antibodies)

Trial OverviewThe trial is testing Guselkumab, a medication, to see how effective it is at treating PG. It's an open-label study, meaning everyone knows they're getting the drug, and it looks at results after 6 weeks, then again at 16 and 32 weeks.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Guselkumab for PGExperimental Treatment1 Intervention

Subjects with PG will be treated with 100 mg every 4 weeks of guselkumab for 28 weeks in addition to starting stable dose (at least 2 weeks) of prednisone at 20 mg daily. Prednisone will be tapered based on a pre-established algorithm assessed by investigator.