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
- Are there results?
- Not yet: the study is under way
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.
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEC-HOPE: A Multicenter Retrospective Cohort Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD
- ClinicalTrials.gov ID
- NCT07683065
- Acronym / sponsor ID
- SEC-HOPE / CAIN457AES18
- Keywords
- Plaque psoriasis, MASLD Hepatic Biomarkers Trajectories
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secukinumab Cohort | – | –Adult patients with plaque psoriasis (with or without PsA) and MASLD initiating secukinumab in routine clinical practice in Spain. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Definitive Discontinuation Events Per Patient-Year
Time frame: Up to 5 years
Definitive discontinuation is defined as the date of first documentation of secukinumab discontinuation or biologic switch, whichever is recorded first.
12 secondary outcomes
Cumulative Incidence of Treatment Discontinuation Due to Lack of Response
Time frame: Up to 5 years
Proportion of Patients who Achieve a Psoriasis Area and Severity Index (PASI) 100
Time frame: 12 and 24 months
Proportion of Patients who Achieve a PASI Score ≤ 3
Time frame: 12 and 24 months
Cumulative Incidence of a ≥20% Relative Increase in Fibrosis-4 Index (FIB-4) From Baseline
Time frame: Baseline up to 5 years
Proportion of Patients With a Shift in Fibrosis Category
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
FIB-4 Score
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
APRI Score
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
AST Level
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
ALT Level
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
Platelet Count
Time frame: Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months
Correlation Between Changes in FIB-4 and Changes in PASI
Time frame: Baseline to 12 and 24 months
Correlation Between Changes in APRI and Changes in PASI
Time frame: Baseline to 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Novartis Pharmaceuticals at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Definitive Discontinuation Events Per Patient-Year (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.