Actively Recruiting
Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
Led by Oregon Health and Science University · Updated on 2026-03-06
17
Participants Needed
2
Research Sites
131 weeks
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
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)
CONDITIONS
Official Title
Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to follow all study procedures and requirements
- Ability to give informed consent
- Diagnosis of at least one pyoderma gangrenosum ulcer confirmed by clinical, histological, and laboratory assessments with a minimum wound size of 4 cm2
- Receiving standard wound care at least once a week at home or a wound care facility
- Candidate for systemic therapy and on a stable prednisone dose of 20 mg/day for at least two weeks before first drug administration
- Males aged 18-99 who agree not to father a child or donate sperm during the study and for 12 weeks after last dose; sexually active males must ensure female partners use effective birth control or abstain
- Females aged 18-99 either not of childbearing potential or who test negative for pregnancy and agree to use at least two reliable birth control methods or remain abstinent during the study and for 12 weeks after last dose
- Willingness to travel to the study site for all visits or live more than 30 miles away and be willing and able to participate in remote video visits with a computer, internet, and webcam
- Willingness to undergo perilesional and non-lesional skin biopsies at week 0 and week 32, with optional biopsies at week 16
You will not qualify if you...
- Previous treatment targeting IL-23 including guselkumab, risankizumab, tildrakizumab, or mirikizumab
- Recent use of certain drugs for pyoderma gangrenosum within specified washout periods prior to first drug dose
- Intralesional corticosteroids within 4 weeks of screening
- Active infected ulcers (until infection resolved)
- Use of methotrexate and leflunomide combination therapy prohibited; other immunomodulating medications for comorbidities allowed
- Concurrent skin disease interfering with ulcer assessment
- Signs or history of lymphoproliferative disease or malignancy within 5 years, except certain treated skin cancers
- Recent stroke, heart attack, coronary stenting or uncontrolled high blood pressure
- Significant drug or alcohol abuse within 6 months
- Not fully recovered from major surgery within 8 weeks or planned surgery during study
- Significant uncontrolled organ system disorders or abnormal lab results posing risk
- Known allergies or intolerance to guselkumab
- Pregnant, lactating, or breastfeeding individuals
- History of serious infections, immunocompromised status posing risk
- Recent serious infection or intravenous antibiotics within 8 weeks
- Signs of active tuberculosis unless treated latent TB prior to study
- Positive HIV, active hepatitis B or C infection
- Symptomatic herpes zoster or herpes simplex infections near study start
- History of disseminated opportunistic infections
- Recent live vaccines or planned live vaccines during and shortly after study
- Any condition or factor that would prevent following or completing the study
- Investigator site personnel or immediate family members
- Enrollment in conflicting clinical trials within 4 weeks or longer than 5 half-lives of prior drug use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
A
Alex G Ortega-Loayza, MD, MCR
CONTACT
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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