Multi-Center PAMPA Study

Last updated: May 27, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

4

Condition

Warts

Skin Wounds

Rash

Treatment

Guselkumab

Placebo

Clinical Study ID

NCT05004727
20-01158
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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% ofparticipants);

  4. Willing and able to provide informed consent;

  5. Fulfillment of HR-PsO criteria (Psoriasis (PsO) patients will meet the definition ofHR if they fulfill the following criteria: a) PsO duration >2 years and PsoriasisBody Surface Area (BSA) >3% and positive imaging findings in MSKPDUS defined as aRM-PsASon score of >3.36

Exclusion

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 prescribinginformation, including clinically important active infection and untreated latenttuberculosis;

  7. Known hypersensitivity to the study agent.

Study Design

Total Participants: 176
Treatment Group(s): 2
Primary Treatment: Guselkumab
Phase: 4
Study Start date:
February 16, 2022
Estimated Completion Date:
July 31, 2028

Connect with a study center

  • Memorial University

    Saint John's, Newfoundland and Labrador A1C 5B8
    Canada

    Active - Recruiting

  • Women's College Research Institute, University of Toronto

    Toronto, Ontario M5S 1B2
    Canada

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • University of Rochester Medical Center (URMC)

    Rochester, New York 14623
    United States

    Active - Recruiting

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