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Monoclonal Antibodies

Guselkumab for Skin Ulcers (GEORGE Trial)

Phase 2
Waitlist Available
Led By Alex G Ortega-Loayza, MD, MCR
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing at least once a week standard of care wound care at home or at a wound care facility
Diagnosis of at least one PG ulcer by clinical, histological and laboratory assessments with a minimum wound size of 4 cm2
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 40
Awards & highlights

Summary

This trial will investigate the effectiveness of guselkumab in adults with pyoderma gangrenosum (PG) at weeks 6, 16, and 32.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Possible side effects of Guselkumab include reactions at the injection site like redness or pain, headaches, joint pain, stomach issues like diarrhea or gas, and potentially serious infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I receive wound care at least weekly.
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I have been diagnosed with a PG ulcer that is at least 4 cm2 in size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with drugs targeting IL-23.
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I haven't taken any medication for PG, including new or experimental drugs, within the specified washout period.
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I have a skin condition that could affect ulcer evaluation.
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I haven't had a stroke, heart attack, or heart procedure in the last 6 months and my blood pressure is controlled.
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I have had a shingles outbreak within the last 3 months or have had recurrent or widespread shingles.
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I have symptoms of herpes simplex or had a spread of herpes simplex at the start of the study.
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I have had serious infections like listeriosis or histoplasmosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 40
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 40 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Healing
Secondary study objectives
Change in physical function
Decrease in ulcer area size long-term
Decrease in ulcer area size short-term
+10 more
Other study objectives
Evaluation of cytokine gene expression

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323
1%
Nasopharyngitis
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab Post-Treatment Follow Up
Ixekizumab
Guselkumab
Guselkumab Post-Treatment Follow Up

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5990

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
994 Previous Clinical Trials
7,386,931 Total Patients Enrolled
1 Trials studying Pyoderma Gangrenosum
10 Patients Enrolled for Pyoderma Gangrenosum
Janssen Scientific Affairs, LLCIndustry Sponsor
161 Previous Clinical Trials
579,924 Total Patients Enrolled
Ohio State UniversityOTHER
859 Previous Clinical Trials
642,748 Total Patients Enrolled
2 Trials studying Pyoderma Gangrenosum
14 Patients Enrolled for Pyoderma Gangrenosum
~11 spots leftby Aug 2027
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