Multi-Center PAMPA Study
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: NYU Langone Health
You may qualify if…
- ✓ 1. 18 years old or older;
- ✓ 2. Both male \& female;
- ✓ 3. Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants);
- ✓ 4. Willing and able to provide informed consent;
- ✓ 5. 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 qualify if…
- ✕ 1. Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam;
- ✕ 2. Current systemic immunosuppressive medication use (i.e., methotrexate, apremilast) at the time of enrollment or biologic therapy (ever);
- ✕ 3. RA seropositivity (mid-high RF/ACPA titers);
- ✕ 4. Current active malignancy;
- ✕ 5. History of symptomatic polyarticular OA or other joint conditions (such as RA, gout, etc) that may impair the ability to assess for PsA development
- ✕ 6. Conditions where initiation of guselkumab is prohibited in the prescribing information, including clinically important active infection and untreated latent tuberculosis;
- ✕ 7. Known hypersensitivity to the study agent.
Where it's recruiting
Boston
New York · Rochester
Source: ClinicalTrials.gov · NCT05004727 · last updated 2026-03-30