Multi-Center PAMPA Study

NCT05004727 · tracked via the Priya Life Science Canada tracker

Sponsor

NYU Langone Health

Phase

Phase 4

Started

2022-02-16

Last updated

2026-03-30

Condition(s) studied

Psoriasis

Investigational drug(s) / intervention(s)

Guselkumab →Placebo

Guselkumab: 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).

Placebo: • 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).

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 2.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score — Baseline, Week 24
Score is defined by the ultrasound (General Electric Logiq E9 or E10) equipment, not calculated through a scale.

Trial sites (5)

Facility	City	Region	Status
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
NYU Langone Health	New York	New York	Recruiting
University of Rochester Medical Center (URMC)	Rochester	New York	Recruiting
Memorial University	St. John's	Newfoundland and Labrador	Recruiting
Women's College Research Institute, University of Toronto	Toronto	Ontario	Recruiting

On this site

📄 Tremfya (guselkumab) drug profile →

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Other trials for the same condition

Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity Active, not recruiting

Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoriasis Treated With Subcutaneous (SC) Injection of Risankizumab Who Have Completed Participation in Study M19-977 Active, not recruiting

Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis Active, not recruiting

Psoriasis Longitudinal Assessment and Registry Active, not recruiting

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05004727 on ClinicalTrials.gov ↗ ← All trials in Canada