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Plaque PsoriasisSEC-HOPENCT07683065

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

An observational study of Plaque Psoriasis and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Novartis Pharmaceuticals at 7 sites in Spain.

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Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
How many people
150 participants
Where
7 sitesSpain
Study dates
8 Jul 2026to 15 Jan 2027
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.
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  • Patients with at least one cardiometabolic risk factor.
  • Patients with a confirmed MASLD diagnosis.
  • Patients with baseline laboratory data available.

Who cannot join

  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

+41613241111

novartis.email@novartis.com

Novartis Pharmaceuticals contact

7 sites in 1 country

Spain7 sites, 7 recruiting
  • Novartis Investigative Site

    Badalona, Barcelona, 08916

    Recruiting
  • Novartis Investigative Site

    Barcelona, 08035

    Recruiting
  • Novartis Investigative Site

    Barcelona, 08036

    Recruiting
  • Novartis Investigative Site

    Madrid, 28041

    Recruiting
  • Novartis Investigative Site

    Málaga, 29010

    Recruiting
  • Novartis Investigative Site

    Valencia, 46026

    Recruiting
  • Novartis Investigative Site

    Zaragoza, 50009

    Recruiting

Other trials in Spain

About this study

Official title: SEC-HOPE: A Multicenter Retrospective Cohort Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD

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.

Keywords
Plaque psoriasis, MASLD Hepatic Biomarkers Trajectories

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07683065
Study groupRoleWhat they receive
Secukinumab CohortAdult patients with plaque psoriasis (with or without PsA) and MASLD initiating secukinumab in routine clinical practice in Spain.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 5 years

Secondary outcomes (12)
  1. Cumulative Incidence of Treatment Discontinuation Due to Lack of Response

    Discontinuation due to lack of response is defined as the first documentation of secukinumab discontinuation or biologic switch due to lack of response or similar assessment, whichever is recorded first

    Measured: Up to 5 years

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

    PASI is a combined assessment of lesion severity and affected area into a single score. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a maximum of 72.0. The body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area multiplied by the area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A PASI 100 response corresponds to complete clearing of psoriasis (PASI = 0).

    Measured: 12 and 24 months

  3. Proportion of Patients who Achieve a PASI Score ≤ 3

    PASI is a combined assessment of lesion severity and affected area into a single score. The body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area multiplied by the area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a maximum of 72.0.

    Measured: 12 and 24 months

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

    FIB-4 is a non-invasive tool used to assess liver fibrosis. The FIB-4 score is calculated using age, aspartate aminotransferase (AST) level, alanine aminotransferase (ALT) level, and platelet count.

    FIB-4 fibrosis risk categories:

    • Low risk: FIB-4 < 1.30
    • Intermediate risk: 1.30 ≤ FIB-4 ≤ 2.67
    • High risk: FIB-4 > 2.67

    Measured: Baseline up to 5 years

  5. Proportion of Patients With a Shift in Fibrosis Category

    FIB-4 and aspartate aminotransferase to platelet ratio index (APRI) are non-invasive tools used to assess liver fibrosis. The scores are calculated using age, AST level, ALT level, and platelet count

    FIB-4 fibrosis risk categories (patients aged ≥35 years):

    • Low risk: FIB-4 < 1.30
    • Intermediate risk: 1.30 ≤ FIB-4 ≤ 2.67
    • High risk: FIB-4 > 2.67

    APRI risk categories (patients aged <35 years):

    • Low risk: APRI < 0.50
    • Intermediate risk: 0.50 ≤ APRI ≤ 1.50
    • High risk: APRI > 1.50

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

  6. FIB-4 Score

    FIB-4 is a non-invasive tool used to assess liver fibrosis. The FIB-4 score is calculated using age, AST level, ALT level, and platelet count.

    FIB-4 fibrosis risk categories:

    • Low risk: FIB-4 < 1.30
    • Intermediate risk: 1.30 ≤ FIB-4 ≤ 2.67
    • High risk: FIB-4 > 2.67

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

  7. APRI Score

    APRI is a non-invasive tool used to assess liver fibrosis. The APRI score is calculated using AST level and platelet count

    APRI risk categories:

    • Low risk: APRI < 0.50
    • Intermediate risk: 0.50 ≤ APRI ≤ 1.50
    • High risk: APRI > 1.50

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

  8. AST Level

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

  9. ALT Level

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

  10. Platelet Count

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

  11. Correlation Between Changes in FIB-4 and Changes in PASI

    Associations between changes in the level of liver fibrosis (FIB-4) and changes in the severity of psoriasis (PASI) will be explored using Spearman correlations.

    Measured: Baseline to 12 and 24 months

  12. Correlation Between Changes in APRI and Changes in PASI

    Associations between changes in the level of liver fibrosis (APRI) and changes in the severity of psoriasis (PASI) will be explored using Spearman correlations.

    Measured: Baseline to 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2026
  2. Study start8 Jul 2026
  3. Primary completion15 Jan 2027 (estimated)
  4. Study completion15 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07683065
Sponsor's protocol ID
CAIN457AES18
Acronym
SEC-HOPE
Status last verified
Oct 2026
First submitted
12 Jun 2026
Last updated
16 Oct 2026
Results posted
No
Individual data sharing
No

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