Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05004727

Multi-Center PAMPA Study

Led by NYU Langone Health · Updated on 2026-03-30

176

Participants Needed

5

Research Sites

350 weeks

Total Duration

On this page

Sponsors

N

NYU Langone Health

Lead Sponsor

J

Janssen Scientific Affairs, LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Multi-Center PAMPA Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Male or female participants
  • Psoriasis diagnosis by dermatologist for at least 2 years (at least 30% of participants)
  • Willing and able to provide informed consent
  • Meet high-risk psoriasis criteria: psoriasis duration over 2 years, body surface area affected greater than 3%, and positive musculoskeletal power Doppler ultrasound findings with RM-PsASon score over 3.36
Not Eligible

You will not qualify if you...

  • Evidence of inflammatory joint pain, enthesitis, or dactylitis on exam
  • Current use of systemic immunosuppressive medications or any biologic therapy
  • Rheumatoid arthritis seropositivity with mid to high RF/ACPA titers
  • Active malignancy
  • History of symptomatic polyarticular osteoarthritis or other joint diseases that impair assessment for psoriatic arthritis development
  • Conditions prohibiting guselkumab use including active infection or untreated latent tuberculosis
  • Known hypersensitivity to guselkumab or study agent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

2

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

3

University of Rochester Medical Center (URMC)

Rochester, New York, United States, 14623

Actively Recruiting

4

Memorial University

St. John's, Newfoundland and Labrador, Canada, A1C 5B8

Actively Recruiting

5

Women's College Research Institute, University of Toronto

Toronto, Ontario, Canada, M5S 1B2

Actively Recruiting

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Research Team

J

Jose Scher, MD

CONTACT

S

Stephanie Eichman

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Multi-Center PAMPA Study | DecenTrialz