Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort (Multi-Center PAMPA Study)

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Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort (Multi-Center PAMPA Study)

Brief description of study

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. Population: High-risk (HR) psoriasis patients based on clinical and imaging data. Estimated sample size: 350 HR psoriasis patients. Arm 1: 100 High Risk PsC patients will receive Guselkimab 100mg x 24 months Arm 2: 100 High Risk PsC patients will receive PBO (plus non-biologic standard of care) for 6 months followed by Guselkimab 100mg x 18 months. SOC will include topicals and/or UVB. No biologics/csDMARDs will be allowed during the treatment phase. Arm 3: 150 High Risk psoriasis patients who are not being treated with biologics/csDMARDs/small molecules will serve as controls for 2 years.

Clinical Study Identifier: s20-01158

ClinicalTrials.gov Identifier: NCT05004727

Principal Investigator: Jose U Scher.

Other Investigators: Andrea L. Neimann, Michael Toprover, Jonathan Samuels, Jessica Lindsay Garelik, Rebecca Barbara Blank, Rebecca Haberman, Catherine R Howe.

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