Actively Recruiting

Phase 2
Age: 18Years - 99Years
All Genders
ID06563323

A Single-arm Open-label Study Assessing Short-term and Long-term Efficacy of Guselkumab in Adults With Pyoderma Gangrenosum

Led by Oregon Health and Science University · Updated on 2026-03-06

17

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

O

Oregon Health and Science University

Lead Sponsor

J

Janssen Scientific Affairs, LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the short-term and long-term effects of guselkumab treatment in adults with pyoderma gangrenosum (PG), a skin condition characterized by painful ulcers. This Phase II open-label study involves 17 adult participants diagnosed with PG through clinical, histological, and laboratory assessments. The study aims to understand how guselkumab works alongside prednisone in managing PG over several months. Participants will receive 100 mg of guselkumab injected under the skin every 4 weeks for 28 weeks. Alongside this, they will take a stable daily dose of prednisone starting at 20 mg, which will be gradually reduced based on a specific plan. The study includes follow-up visits lasting until week 40, allowing researchers to observe both immediate and lasting treatment effects. During the study, participants will undergo skin biopsies at the beginning and at week 32, with an option for additional biopsies at week 16. They will be monitored through clinical assessments, laboratory tests, and various measures including ulcer healing, ulcer size reduction, skin pain levels, physical function, and quality of life. Researchers will also track any treatment failures and ulcer recurrence up to week 40, ensuring thorough evaluation of safety and effectiveness over time.

CONDITIONS

Brief Title

Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willingness to comply with study procedures and requirements
  • Able to give informed consent
  • Diagnosed with at least one pyoderma gangrenosum ulcer by clinical, histological, and laboratory assessments with minimum wound size of 4 cm2
  • Receiving standard wound care at home or a facility at least once a week
  • Candidate for systemic therapy and on stable prednisone dose of 20 mg/day for at least two weeks prior to first dose
  • Males aged 18-99 agreeing to use birth control or abstain from fathering a child during and 12 weeks after study
  • Females aged 18-99 who are non-childbearing or test negative for pregnancy and agree to use two reliable birth control methods or abstain during and 12 weeks after study
  • Willing to travel to study site or able to participate remotely with internet and webcam access
  • Willing to undergo required skin biopsies at specified study weeks
Not Eligible

You will not qualify if you...

  • Previous treatment with IL-23 targeting agents such as guselkumab, risankizumab, tildrakuzumab, or mirikizumab
  • Recent use of specific PG treatments including biologics, experimental antibodies, or immunosuppressives within specified washout periods
  • Intralesional corticosteroids within 4 weeks before screening
  • Active infected ulcers until infection is resolved
  • Concurrent skin diseases interfering with ulcer assessment
  • Signs or history of lymphoproliferative disease or recent malignancy except treated nonmelanoma skin cancer or cervical carcinoma in situ
  • Recent serious cardiovascular events or uncontrolled hypertension
  • Significant drug or alcohol abuse within 6 months before baseline
  • Recent major surgery or planned surgery during study participation
  • Significant uncontrolled medical disorders or abnormal labs posing risk or affecting data
  • Known allergy or intolerance to guselkumab or its ingredients
  • Pregnancy, lactation, or breastfeeding
  • History of severe infections or immunocompromised status posing risk
  • Recent serious infections or symptomatic herpes infections
  • Recent live vaccines or planned live vaccination during or shortly after study
  • Other conditions or circumstances preventing study compliance as judged by investigator
  • Study site personnel or immediate family members
  • Recent participation in other clinical trials incompatible with this study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 28 weeks

Participants receive guselkumab injections every 4 weeks for 28 weeks along with a stable daily dose of prednisone that is tapered based on clinical assessment.

7 visits (in-person) every 4 weeks

Follow-up

Duration - 12 weeks

Participants are followed for safety and assessment of healing outcomes after treatment ends until week 40.

Approximately 3 visits (in-person) after treatment completion

Trial Site Locations

Total: 2 locations

1

Ohio State Dermatology

Columbus, Ohio, United States, 43215

Actively Recruiting

2

Oregon Health and Science University

Portland, Oregon, United States, 97239

Not Yet Recruiting

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Research Team

A

Alex G Ortega-Loayza, MD, MCR

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Comparison of the two most commonly used treatments for pyoderma gangrenosum: results of the STOP GAP randomised controlled trial.

Anthony D Ormerod, Kim S Thomas, Fiona E Craig...

https://pubmed.ncbi.nlm.nih.gov/26071094

Ustekinumab for Extra-intestinal Manifestations of Inflammatory Bowel Disease: A Systematic Literature Review.

Lucas Guillo, Ferdinando D'Amico, Silvio Danese...

https://pubmed.ncbi.nlm.nih.gov/33367674

Dysregulation of inflammatory gene expression in lesional and nonlesional skin of patients with pyoderma gangrenosum.

A G Ortega-Loayza, W H Nugent, O M Lucero...

https://pubmed.ncbi.nlm.nih.gov/28734003