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RECRUITING
NCT05004727
PHASE4

Multi-Center PAMPA Study

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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.

Official title: Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

176

Start Date

2022-02-16

Completion Date

2028-11-02

Last Updated

2026-03-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

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).

DRUG

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).

Locations (5)

Brigham and Women's Hospital

Boston, Massachusetts, United States

NYU Langone Health

New York, New York, United States

University of Rochester Medical Center (URMC)

Rochester, New York, United States

Memorial University

St. John's, Newfoundland and Labrador, Canada

Women's College Research Institute, University of Toronto

Toronto, Ontario, Canada