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

NCT07683065 | Recruiting

• 1 other identifier: CAIN457AES18
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Plaque Psoriasis; Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

Plaque psoriasis; MASLD Hepatic Biomarkers Trajectories

Outcome Measures

Primary Outcomes (1)

• Number of Definitive Discontinuation Events Per Patient-Year

  Definitive discontinuation is defined as the date of first documentation of secukinumab discontinuation or biologic switch, whichever is recorded first.

  Up to 5 years

Secondary Outcomes (12)

• Cumulative Incidence of Treatment Discontinuation Due to Lack of Response

  Up to 5 years

• Proportion of Patients who Achieve a Psoriasis Area and Severity Index (PASI) 100

  12 and 24 months

• Proportion of Patients who Achieve a PASI Score ≤ 3

  12 and 24 months

• Cumulative Incidence of a ≥20% Relative Increase in Fibrosis-4 Index (FIB-4) From Baseline

  Baseline up to 5 years

• Proportion of Patients With a Shift in Fibrosis Category

  Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months

Study Arms (1)

Secukinumab Cohort

Adult patients with plaque psoriasis (with or without PsA) and MASLD initiating secukinumab in routine clinical practice in Spain.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with plaque psoriasis (with or without PsA) and confirmed MASLD initiating secukinumab as first-, second-, or third-line biologic therapy during routine clinical practice in Spain.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

Novartis Investigative Site

Badalona, Barcelona, 08916, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28041, Spain

RECRUITING

Novartis Investigative Site

Málaga, 29010, Spain

RECRUITING

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: July 6, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)