Preventing Psoriatic Arthritis in High-Risk Psoriasis Patients

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

This study is testing whether a medication called guselkumab can help prevent people with long-term psoriasis from developing psoriatic arthritis.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 176 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NYU Langone Health (other)
• Drugs / interventions: guselkumab, methotrexate
• Locations: 5 sites (Boston, Massachusetts and 4 other locations)
• Trial ID: NCT05004727 on ClinicalTrials.gov

What this trial studies

This multi-center, randomized, double-blind, placebo-controlled trial aims to evaluate the effectiveness of guselkumab in preventing the transition from psoriasis to psoriatic arthritis (PsA) in high-risk patients. Participants will be monitored for changes in musculoskeletal power-doppler ultrasound (MSKPDUS) findings over 24 weeks and the emergence of synovio-enthesial phenotype over two years. The study will compare the effects of guselkumab against a non-biologic standard of care in patients with a history of psoriasis lasting more than two years. The trial is designed to provide insights into the role of IL-23 in skin inflammation and joint health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a psoriasis diagnosis of at least two years and specific imaging findings indicating high risk for PsA.

Not a fit: Patients with existing inflammatory joint pain or those currently on systemic immunosuppressive medications will not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could significantly reduce the risk of developing psoriatic arthritis in patients with psoriasis.

How similar studies have performed: Other studies targeting IL-23 have shown promise in treating psoriasis, suggesting potential success for this approach in preventing PsA.

Eligibility 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.

Where this trial is running

Boston, Massachusetts and 4 other locations

• Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
• NYU Langone Health — New York, New York, United States (RECRUITING)
• University of Rochester Medical Center (URMC) — Rochester, New York, United States (RECRUITING)
• Memorial University — St. John's, Newfoundland and Labrador, Canada (RECRUITING)
• Women's College Research Institute, University of Toronto — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Jose Scher, MD — NYU Langone Health
• Study coordinator: Jose Scher, MD

Conditions: Psoriasis