Multi-Center PAMPA 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 our 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.
Conditions:
🦠 Psoriasis
🗓️ Study Start (Actual) 16 February 2022
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 1 March 2026
👥 Enrollment (Estimated) 350
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Boston, Massachusetts, United States
📍 New York, New York, United States
📍 Rochester, New York, United States
📍 Saint John's, Newfoundland and Labrador, Canada
📍 Toronto, Ontario, Canada

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 August 2021
  • First Submitted that Met QC Criteria 6 August 2021
  • First Posted 13 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 January 2024
  • Last Update Posted 5 January 2024
  • Last Verified January 2024