RECRUITINGPhase 4INTERVENTIONAL

Multi-Center PAMPA Study

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form; 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 Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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