Multi-Center PAMPA Study

What this study is about

This is a multi-center (North-America), randomized, double-blind, placebo-controlled, wait-list, interventional, preventive trial of guselkumab in high-risk psoriasis patients compared to non-biologic standard of care. The primary objective of the proposed trial will be to test the hypothesis that a prolonged, unresolved skin inflammation coupled with musculoskeletal power-doppler ultrasound (MSKPDUS) abnormalities driven by IL-23 increase the risk for transition into PsA and that an intervention that targets one of these pivotal molecules (i.e., Guselkumab) will: 1. Diminish MSKPDUS findings at 24 weeks, and 2. Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2.

Who can join (things the study team will check)

✅ You may be able to join if…

• 18 years old or older;
• Both male \& female;
• Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants);
• Willing and able to provide informed consent;
• Fulfillment of HR-PsO criteria (Psoriasis (PsO) patients will meet the definition of HR if they fulfill the following criteria: a) PsO duration >2 years and Psoriasis Body Surface Area (BSA) >3% and positive imaging findings in MSKPDUS defined as a RM-PsASon score of >3.36

🚫 You may not be able to join if…

• Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam;
• Current systemic immunosuppressive medication use (i.e., methotrexate, apremilast) at the time of enrollment or biologic therapy (ever);
• RA seropositivity (mid-high RF/ACPA titers);
• Current active malignancy;
• History of symptomatic polyarticular OA or other joint conditions (such as RA, gout, etc) that may impair the ability to assess for PsA development
• Conditions where initiation of guselkumab is prohibited in the prescribing information, including clinically important active infection and untreated latent tuberculosis;
• Known hypersensitivity to the study agent.

Where this trial is running

• Brigham and Women's Hospital, Boston, Massachusetts, United States
• NYU Langone Health, New York, New York, United States
• University of Rochester Medical Center (URMC), Rochester, New York, United States
• Memorial University, St. John's, Newfoundland and Labrador, Canada
• Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada

Who to contact

Jose Scher, MD · 6465017400 · Jose.Scher@nyulangone.org

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05004727.