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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 40

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

Nasopharyngitis

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Ixekizumab Post-Treatment Follow Up

Ixekizumab

Guselkumab

Guselkumab Post-Treatment Follow Up

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6080

0 / 9Eligibility criteria met