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.
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
- Conditions the study is for
- Plaque Psoriasis, Metabolic Dysfunction-Associated Steatotic Liver Disease
- 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
7 sites in 1 country
Spain7 sites, 7 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Secukinumab Cohort | Adult 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.
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)
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
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
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
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
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
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
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
AST Level
Measured: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
ALT Level
Measured: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
Platelet Count
Measured: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
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
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.
- First posted6 Jul 2026
- Study start8 Jul 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
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