Guselkumab for Skin Ulcers

(GEORGE Trial)

Overseen By Alex G Ortega-Loayza, MD, MCR

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Oregon Health and Science University

Must be taking: Prednisone

Must not be taking: Biologics, Immunosuppressives

Disqualifiers: Infections, Cancer, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

17 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications for pyoderma gangrenosum (PG) before starting the study drug, with specific 'washout' periods (time without taking certain medications) ranging from 2 to 12 weeks depending on the medication. However, you can continue taking medications for other conditions, except for Methotrexate and Leflunomide, which cannot be taken together.

How does the drug Guselkumab differ from other treatments for skin ulcers?

Guselkumab is unique because it is a biologic drug that targets specific proteins involved in inflammation, which may help in treating skin ulcers by reducing inflammation and promoting healing, unlike traditional treatments that focus on wound care and pressure relief. ^{1 2 3 4 5}

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guselkumab 100 mg every 4 weeks for 28 weeks and a stable dose of prednisone daily

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Guselkumab

Trial Overview 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.

Participant Groups

Group I: Guselkumab for PG Experimental Treatment 1 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.

Guselkumab is already approved in United States, European Union for the following indications:

Approved in United States as Tremfya for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Moderately to severely active ulcerative colitis

Approved in European Union as Tremfya for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Moderately to severely active ulcerative colitis

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2023

MD

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Findings from Research

In a study involving 5 patients with neurotrophic keratopathy, treatment with topical recombinant human nerve growth factor cenegermin 0.02% led to significant healing of corneal ulcers and improved corneal sensitivity after 8 weeks of use, with no adverse events reported.

Cenegermin is recommended as an effective treatment for advanced neurotrophic keratopathy, particularly when used alongside conventional therapies, as it promotes corneal healing and helps maintain corneal surface health without the need for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurotrophic Keratopathy Treated with Topical Recombinant Human Nerve Growth Factor (Cenegermin): Case Series Study with Long-Term Follow-Up. García-Delpech, S., Udaondo, P., Fernández-Santodomingo, AS., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Neurotrophic Keratopathy Treated with Topical Recombinant Human Nerve Growth Factor (Cenegermin): Case Series Study with Long-Term Follow-Up. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Pressure ulcers: a role for thymosin beta4. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Use of Becaplermin for nondiabetic ulcers: pyoderma gangrenosum and calciphylaxis. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Topical Application of CHF6467, a Mutated Form of Human Nerve Growth Factor, on Skin Wound Healing in Diabetic Mice. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The effect of thymosin treatment of venous ulcers. [2016]