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New treatment option for Pyoderma Gangrenosum
Official title Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
ClinicalTrials.gov ID: NCT06563323
What this study is testing
What is Guselkumab?
Guselkumab is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for pyoderma gangrenosum.
Also referred to as Tremfya.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Willingness to comply with study procedures/requirements
- Capable of giving informed consent
- Diagnosis of at least one PG ulcer by clinical, histological and laboratory assessments with a minimum wound size of 4 cm2.
- Undergoing at least once a week standard of care wound care at home or at a wound care facility
- Are candidate for systemic therapy. Must be on a stable dose of prednisone of 20 mg/day for at least two weeks prior to first drug administration.
You likely can't join if
- Has previously received at any time any therapeutic agent directly targeted to IL-23 including, but not limited to, guselkumab, risankizumab...
- Any drug treatment specifically for PG including but not limited to biologics (or biosimilar of), experimental antibodies, small molecules and oral...
- 12 weeks for ustekinumab, ixekizumab, secukinumab, brodalumab;
- 8 weeks for infliximab;
- 6 weeks for adalimumab;
- 4 weeks for cyclosporine A, etanercept, inhibitors of the JAK/TYK pathway and PD4 inhibitors;
See the full eligibility criteria
Who can join
- Willingness to comply with study procedures/requirements
- Capable of giving informed consent
- Diagnosis of at least one PG ulcer by clinical, histological and laboratory assessments with a minimum wound size of 4 cm2.
- Undergoing at least once a week standard of care wound care at home or at a wound care facility
- Are candidate for systemic therapy. Must be on a stable dose of prednisone of 20 mg/day for at least two weeks prior to first drug administration.
- Males ages 18-99 who agree to not father a child or donate sperm while on study and at least 12 weeks following last dose of the study drug. If subject is sexually active male and could cause pregnancy, subject much be...
- Females ages 18-99; either of non-childbearing potential or of childbearing potential who test negative for pregnancy and agree to use at least two reliable methods of birth control or remain abstinent during the study...
- Willingness to travel to study site for all study visits or living \>30 miles from study site and willing/able to participate in remote videoconferencing visits with access to a computer with internet and webcam...
- Be willing to undergo perilesional and non-lesional skin biopsy at week 0 and week 32 resulting in 4 biopsies during the course of the study. Participants can choose if they are willing to provide 2 additional biopsies...
What rules you out
- 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...
- 12 weeks for ustekinumab, ixekizumab, secukinumab, brodalumab;
- 8 weeks for infliximab;
- 6 weeks for adalimumab;
- 4 weeks for cyclosporine A, etanercept, inhibitors of the JAK/TYK pathway and PD4 inhibitors;
- 2 weeks for Calcineurin inhibitor topicals (including but not limited to pimecrolimus and tacrolimus) and other advanced topicals (including but not limited to roflumilast and tapinarof). If not specified specifically...
- Intralesional corticosteroids within 4 weeks of screening.
- Active clinically infected ulcers. Individuals will be eligible for enrollment following completed treatment and resolution of infection. Antibiotics for wound superinfection are allowed.
- Immunomodulating medications for managing underlying comorbidities associated with PG, but not PG itself (e.g., for irritable bowel disease (IBD) or rheumatoid arthritis), are allowed as combination therapy except for...
- Concurrent skin disease that is deemed to interfere with assessment of ulcer.
- Have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly or a history of lymphoproliferative disease within 5 years before screening; or currently has a known...
- Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting. Uncontrolled hypertension - confirmed systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mm Hg.
- Clinically significant (per investigator's judgement) drug or alcohol abuse within the last 6 months preceding the Baseline Visit.
- Has not fully recovered from major surgery (e.g., requiring general anesthesia and hospitalization) within 8 weeks before screening, or has such surgery planned during the time the participant is expected to participate...
- Presence of significant uncontrolled respiratory, hepatic, renal, endocrine, hematologic, neurologic, or neuropsychiatric disorders, or abnormal laboratory screening values that, in the opinion of the investigator, pose...
- Have clinical laboratory test results at screening that are outside the normal reference range of the population and are considered clinically significant, or have any of the following specific abnormalities: Neutrophil...
- Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients.
- Individuals who are pregnant, lactating or breastfeeding.
- History of chronic or recurrent infections, or active, untreated, acute infection, or immunocompromised to an extent that participation in the study would pose an unacceptable risk to the subject based on the...
- Clinically serious infection or received intravenous antibiotics for an infection, within 8 weeks before first dose.
- Have signs or symptoms suggestive of active Tuberculosis (TB) upon medical history and/or physical examination. An exception is made for participants who are currently receiving treatment or will initiate treatment for...
- Positive for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C virus. A positive Hepatitis B surface antibody test with a corresponding negative hepatitis B surface antigen test indicates...
- Symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster.
- Symptomatic herpes simplex or disseminated (even a single episode) herpes simplex at the Week 0 (baseline) visit.
- History of disseminated opportunistic infections (e.g., listeriosis and histoplasmosis).
- Have received a live vaccine within 12 weeks prior to baseline or intend to have a live vaccine during the course of the study or 4 weeks after last study drug administration or 12 weeks after last study drug...
- Have any other condition that precludes the subject from following and completing the protocol, in the opinion of the investigator.
- Are investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling).
- Are currently enrolled in, or discontinued from a clinical trial involving an investigational product or non-approved use of a drug or device within the last 4 weeks or a period of at least 5 half-lives of the last...
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States; Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.