Multi-Center PAMPA Study
Recruiting · NCT05004727 · Interventional (participants receive a specific treatment) · Lead sponsor: NYU Langone Health
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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 take part
Inclusion criteria
- 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
Exclusion criteria
- 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 it is running
5 locations listed across 2 US states.
- 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