NCT05004727

Multi-Center PAMPA Study

Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-02-16
• Primary completion: 2026-12-31
• Completion: 2028-11-02
• First posted: 2021-08-13
• Last updated: 2026-03-30

Locations

5 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study