Secukinumab retention in adults with plaque psoriasis and MASLD in Spain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses electronic medical records from multiple Spanish hospitals to describe the retention rate of secukinumab in adults with plaque psoriasis (with or without PsA) and MASLD. It aims to characterize hepatic biomarker trajectories over time while patients remain on therapy. Eligible participants are adults initiating secukinumab between 2021 and 2023, with MASLD and at least one cardiometabolic risk factor, and with available baseline labs. Exclusions include MASLD absence, malignant liver disease, liver transplant history, alcohol use disorder, other chronic liver diseases, or conditions causing thrombocytopenia. The analysis will reflect routine clinical practice without a mandated intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novartis Investigative Site
  Badalona, Barcelona, Spain Recruiting
• Novartis Investigative Site
  San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain Recruiting
• Novartis Investigative Site
  Barcelona, Spain Recruiting
• Novartis Investigative Site
  Barcelona, Spain Recruiting
• Novartis Investigative Site
  Madrid, Spain Recruiting
• Novartis Investigative Site
  Madrid, Spain Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.