Multi-Center PAMPA Study

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID: NCT05004727
Run by: NYU Langone Health
People needed: 176
Starts: 2022-02-16
Expected to finish: 2028-11-02
Last updated by the study team: 2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

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

Full record on ClinicalTrials.gov

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