RecruitingPhase 4NCT05004727

Multi-Center PAMPA Study

Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort

Sponsor

NYU Langone Health

Enrollment

176 participants

Start Date

Feb 16, 2022

Study Type

INTERVENTIONAL

Conditions

Psoriasis

Summary

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria7

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.

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Interventions

DRUGGuselkumab

Guselkumab 100 mg 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (month 0 to month 24 for arm 1; week 24 to month 24 for arm 2).

DRUGPlacebo

• Placebo to Guselkumab 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (Month 0 to Week 20 for Arm 2).