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NCT05004727 | RECRUITING | Psoriasis

Multi-Center PAMPA Study
Sponsor:

NYU Langone Health

Brief 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 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.

Condition or disease

Psoriasis

Intervention/treatment

Guselkumab

Placebo

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 350 participants
Masking : TRIPLE
Masking Description : Participants, investigator staff, persons performing the assessments, and the CTT will remain blind to the identity of the treatment from the time of randomization until database lock.
Primary Purpose : TREATMENT
Official Title : Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort
Actual Study Start Date : 2022-02-16
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Multi-Center PAMPA Study

Location Details

NCT05004727

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

RECRUITING

United States, New York

NYU Langone Health

New York, New York, United States, 10016

RECRUITING

United States, New York

University of Rochester Medical Center (URMC)

Rochester, New York, United States, 14623

RECRUITING

Canada, Newfoundland and Labrador

Memorial University

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

RECRUITING

Canada, Ontario

Women's College Research Institute, University of Toronto

Toronto, Ontario, Canada, M5S 1B2