AzTrials
AzTrials

Plaque PsoriasisSTAY SEC PsONCT07881783

A Real-world Study of Treatment Retention and Adherence to Secukinumab in Patients With Plaque Psoriasis (PsO) With or Without Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) Co-therapy

An observational study of Plaque Psoriasis, run by Novartis Pharmaceuticals.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

Search all trials

Trial summary

The main aim of this study is to assess whether secukinumab treatment retention over 12 months in adult patients with moderate-to-severe plaque PsO receiving secukinumab in combination with a GLP-1 RA is non-inferior to that in patients receiving secukinumab monotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
How many people
3,718 participants
Where
No sites listed yet
Study dates
30 Oct 2026to 31 Mar 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with moderate-to-severe plaque PsO who newly initiate secukinumab, with or without GLP-1 RA co-therapy.

Who may be able to join

  • Age ≥18 years at index date.
  • At least one International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis code for plaque PsO (L40.0) in the 12 months prior to or on the index date; further specificity ensured by ≥2 diagnosis codes ≥30 days apart.
  • ≥12 months of continuous medical and pharmacy enrollment prior to the index date, with an allowable enrollment gap of up to 60 days.
  • A new user of secukinumab: no claim for secukinumab in the 12-month baseline period. Evidence of the prescription or administration of at least one dose of secukinumab (index date).
  • Concurrent-therapy cohort only: evidence of at least one prescription or administration claim for a GLP-1 RA (semaglutide, tirzepatide, lixisenatide, liraglutide, exenatide, or dulaglutide) within 28 days before or after the secukinumab index date. Evidence of gradual titration is permitted.
  • Monotherapy cohort only: no claim for any GLP-1 RA in the 12 months prior to and including the index date.
  • At least one medical or pharmacy claim after the index date.

Who cannot join

  • Missing or invalid patient identifier, year of birth, or sex in the data source.
  • Evidence of another biologic therapy approved for PsO with exposure overlapping the secukinumab index date. Patients switching from a prior biologic to secukinumab are allowed if the prior biologic was discontinued before the index date and there is no overlapping claim or administration on the index date.
  • At least one diagnosis code for type 1 diabetes mellitus (T1DM) during the 12-month baseline period or on the index date.

Trial locations and contacts

No sites are listed yet. 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

About this study

Official title: Treatment Retention and Adherence to Secukinumab in Patients With Moderate-to-Severe Plaque Psoriasis With or Without GLP-1 Receptor Agonist Co-therapy: A Real-world Data Analysis

The main aim of this study is to assess whether secukinumab treatment retention over 12 months in adult patients with moderate-to-severe plaque PsO receiving secukinumab in combination with a GLP-1 RA is non-inferior to that in patients receiving secukinumab monotherapy. The study will also evaluate adherence, long-term treatment retention, and healthcare resource utilization.

Read the detailed description

This is a retrospective, non-interventional cohort study based on the secondary use of de-identified administrative claims data. The study will be conducted using two independent United States (US) real-world data sources.

The overall study period will span 21 January 2014 to 30 April 2026, and the cohort identification period will span 21 January 2015 to 30 April 2025. Adult patients with moderate-to-severe plaque PsO initiating secukinumab will be assigned to either a concurrent-therapy cohort (secukinumab + GLP-1 RA) or a secukinumab monotherapy cohort based on GLP-1 RA exposure around the secukinumab index date. Patients will be followed from secukinumab initiation (index date) until secukinumab discontinuation, end of continuous enrollment, end of the study period, death or applicable cohort-specific censoring events.

Keywords
Plaque Psoriasis, Secukinumab, Real world evidence, GLP-1 receptor agonist, Treatment retention, Treatment persistence, Treatment adherence, Administrative claims
Medical subject headings
Treatment Adherence and Compliance

What participants receive

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

Study groups in NCT07881783
Study groupRoleWhat they receive
Concurrent-therapy CohortPatients initiating secukinumab with concurrent use of a GLP-1 RA (semaglutide, tirzepatide, lixisenatide, liraglutide, exenatide, and dulaglutide) within 28 days before or after the secukinumab index date.
Secukinumab Monotherapy CohortPatients initiating secukinumab without concurrent GLP-1 RA exposure during the baseline period or on the index date.

What is being measured

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

  1. Time to Secukinumab Treatment Discontinuation During the First 12 Months of Follow-up

    Measured: 12 months

Secondary outcomes (7)

  1. Number of Patients by Demographic and Clinical Characteristics

    Demographics and clinical characteristics include:

    • Age group
    • Sex
    • Race/ethnicity
    • Geographic region
    • Insurance type
    • Psoriatic arthritis diagnosis
    • Comorbidities
    • Prior treatments

    Measured: Baseline

  2. Duration of PsO Disease

    Measured: Baseline

  3. Number of Healthcare Visits

    Healthcare visits include hospitalizations, outpatient/physician visits, and emergency department visits.

    Measured: Baseline

  4. Proportion of Days Covered (PDC) for Secukinumab

    Adherence will be measured using PDC. PDC: the number of days with secukinumab available divided by the total number of days in the observation period. Adherence will be categorized as high (PDC ≥80%), medium (PDC 50-79%), or low (PDC <50%).

    Measured: 6, 12, and 24 months

  5. Percentage of Patients Remaining on Secukinumab Treatment at 6, 12, and 24 Months After Secukinumab Initiation

    Measured: 6, 12, and 24 months

  6. Time to Secukinumab Treatment Discontinuation

    Measured: Up to approximately 11 years

  7. Number of Healthcare Visits Per Patient-Year (PPY)

    Healthcare resource utilization will include all-cause and PsO-related hospitalizations, emergency department visits, and outpatient visits, where identifiable.

    Measured: Up to approximately 11 years

Timeline

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

  1. First posted19 Oct 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 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
3,718 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07881783
Sponsor's protocol ID
CAIN457A2029
Acronym
STAY SEC PsO
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
20 Oct 2026
Results posted
No
Individual data sharing
No

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in