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Multi-Center PAMPA Study

NCT05004727 · NYU Langone Health
In plain English

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Official title
Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort
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.
Eligibility criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Study design
Enrollment target: 176 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2022-02-16
Estimated completion: 2028-11-02
Last updated: 2026-03-30
Interventions
Drug: GuselkumabDrug: Placebo
Primary outcomes
  • Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score (Baseline, Week 24)
Sponsor
NYU Langone Health · other
With: Janssen Scientific Affairs, LLC
Contacts & investigators
ContactJose Scher, MD · contact · Jose.Scher@nyulangone.org · 6465017400
ContactStephanie Eichman · contact · Stephanie.Eichman@nyulangone.org
InvestigatorJose Scher, MD · principal_investigator, NYU Langone Health
All locations (5)
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
NYU Langone HealthRecruiting
New York, New York, United States
University of Rochester Medical Center (URMC)Recruiting
Rochester, New York, United States
Memorial UniversityRecruiting
St. John's, Newfoundland and Labrador, Canada
Women's College Research Institute, University of TorontoRecruiting
Toronto, Ontario, Canada