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Recruiting NCT07683065

A Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD

Conditions: Plaque Psoriasis, Metabolic Dysfunction-Associated Steatotic Liver Disease

Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Enrollment: 150
Sponsor: Novartis Pharmaceuticals

Location: Novartis Investigative Site Badalona Barcelona

Summary

This study aims to examine the retention rate of secukinumab in adult patients with plaque psoriasis (with or without psoriatic arthritis \[PsA\]) and metabolic dysfunction-associated steatotic liver disease (MASLD) in routine clinical practice in Spain, as well as hepatic biomarker trajectories. The study will use electronic medical record (EMR) data from multiple Spanish hospitals.

Eligibility Criteria

Inclusion criteria: * Patients with a first recorded secukinumab prescription between 01 January 2021 and 31 December 2023. * Patients aged ≥18 years at index date. * Patients with no prior secukinumab exposure in available EMR history. * Secukinumab must be patient's first-, second-, or third-line biologic therapy for psoriasis/psoriatic arthritis (PsA). * Patients with documented administration per Summary of Product Characteristics dosing recommendations (SmPC). * Patients with confirmed plaque psoriasis with or without PsA. * Patients with at least one cardiometabolic risk factor. * Patients with a confirmed MASLD diagnosis. * Patients with baseline laboratory data available. Exclusion criteria: * Patients with evidence of MASLD absence. * Patients with malignant liver disease. * Patients with a history of liver transplantation. * Patients with alcohol use disorder. * Patients with other chronic liver diseases. * Patients with diseases or treatments which cause thrombocytopenia. * Patients with decompensated cirrhosis. Other protocol-defined inclusion/exclusion criteria may apply.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07683065). StuddyBuddy aggregates publicly available trial information.