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Not yet recruitingNCT07881783STAY SEC PsOUpdated Oct 20, 2026

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 in Plaque Psoriasis, sponsored by Novartis Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational

Updated Oct 20, 2026Start date movedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
3,718
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Plaque Psoriasis

Keywords

  • Plaque Psoriasis
  • Secukinumab
  • Real world evidence
  • GLP-1 receptor agonist
  • Treatment retention
  • Treatment persistence
  • Treatment adherence
  • Administrative claims
03

In context

Treatment Adherence and Compliance

128 studies on the registry are indexed under Treatment Adherence and Compliance; 64 are open to participants now.

This study's planned enrollment of 3,718 is above the median of 281 across 21 observational studies indexed under Treatment Adherence and Compliance.

Browse Treatment Adherence and Compliance studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,711 studies on the registry; 218 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 435 (75%) have results posted.

Browse Novartis Pharmaceuticals studies →All Novartis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18 years at index date.
  2. 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.
  3. ≥12 months of continuous medical and pharmacy enrollment prior to the index date, with an allowable enrollment gap of up to 60 days.
  4. 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).
  5. 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.
  6. Monotherapy cohort only: no claim for any GLP-1 RA in the 12 months prior to and including the index date.
  7. At least one medical or pharmacy claim after the index date.

Exclusion criteria

Exclusion criteria:

  1. Missing or invalid patient identifier, year of birth, or sex in the data source.
  2. 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.
  3. At least one diagnosis code for type 1 diabetes mellitus (T1DM) during the 12-month baseline period or on the index date.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
3,718 participants (estimated)
Patient registry
No

Groups and cohorts

  • Concurrent-therapy Cohort

    Patients 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 Cohort

    Patients initiating secukinumab without concurrent GLP-1 RA exposure during the baseline period or on the index date.

06

What researchers measure

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  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

    Time frame: Baseline

  2. Duration of PsO Disease

    Time frame: Baseline

  3. Number of Healthcare Visits

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

    Time frame: 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%).

    Time frame: 6, 12, and 24 months

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

    Time frame: 6, 12, and 24 months

  6. Time to Secukinumab Treatment Discontinuation

    Time frame: 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.

    Time frame: Up to approximately 11 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Oct 2026; primary completion for Mar 2027, 5 months later.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 20, 2026: primary completion Jan 2027 → Mar 2027 and completion Jan 2027 → Mar 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2026
First posted
Oct 19, 2026
StartEst.
Oct 30, 2026
Primary completionEst.
Mar 31, 2027was Jan 2027
CompletionEst.
Mar 31, 2027was Jan 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Oct 17, 2026→Oct 30, 2026
Oct 20, 2026
Primary completion
Jan 15, 2027→Mar 31, 2027
Oct 20, 2026
Study completion
Jan 15, 2027→Mar 31, 2027
Oct 20, 2026
Registered
First appeared on the registry
Oct 19, 2026
Show all 2 updates
  1. Oct 20, 2026
    Start date Oct 17, 2026→Oct 30, 2026
    Primary completion Jan 15, 2027→Mar 31, 2027
    Study completion Jan 15, 2027→Mar 31, 2027
  2. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07881783
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 19, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Oct 20, 2026

Study contacts

Novartis Pharmaceuticals
Contact
novartis.email@novartis.com
+41613241111
Novartis Pharmaceuticals
Contact
Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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