Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea. (ONSET)

February 19, 2026 updated by: Novartis Pharmaceuticals

Real-world Observational Study to Evaluate the Effectiveness of Secukinumab in Biologic-naive Ankylosing Spondylitis Patients in Korea

This is an observational study to evaluate the effectiveness and safety of secukinumab in participants with AS who have never used TNFi, JAKi, or IL-17i drugs before.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is an observational study to evaluate the effectiveness and safety of secukinumab in patients with ankylosing spondylitis who are naive to TNFi/JAKi/IL-17i in Korea. Subjects will be recruited from 10 institutions in Korea. The enrollment period is 8 months from the initiation at the first institution and the follow-up periods are 28 weeks(±4 weeks). Data will be gathered at initial visit, 16 weeks(±4 weeks), and 28 weeks(±4 weeks).

Secukinumab is prescribed within the scope of labeling approved in Korea.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
      • Busan, South Korea, 49201
        • Recruiting
        • Novartis Investigative Site
    • Gyeongsangnam-do
      • Jinju, Gyeongsangnam-do, South Korea, 52727
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The subjects are biologic-naive AS patients who are <40 years old and have a time of less than 5 years since AS diagnosis.

Description

Inclusion Criteria:

  1. Subjects diagnosed with ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria
  2. Subjects who have symptoms of active disease at screening and baseline, as evidenced by BASDAI score of ≥ 4
  3. Subjects who have never used TNFi, JAKi, or IL-17i drugs before
  4. Patients suitable for secukinumab treatment within the scope of labeling by the Ministry of Food and Drug Safety
  5. Subjects who have a time of less than 5 years since AS diagnosis
  6. Subjects who are above the age of 18 years and below 40years old
  7. Subjects who give informed consent form to participate in the study

Exclusion Criteria:

  1. Subjects who are in a medical or psychological condition which may prevent them from participating in the study for the study period(28±4 weeks)
  2. Subjects who have congenital/traumatic spinal deformities
  3. Subjects currently enrolled in other clinical studies
  4. Subjects who have any contraindications to secukinumab treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
The group will include subjects diagnosed with ankylosing spondylitis (AS) according to the modified 1984 New York criteria, who exhibit symptoms of active disease at both screening and baseline, as indicated by a BASDAI score of ≥ 4. Eligible participants must be biologic-naive, meaning they have no prior use of TNF inhibitors (TNFi), JAK inhibitors (JAKi), or IL-17 inhibitors (IL-17i). Additionally, patients must be deemed suitable for secukinumab treatment as per the labeling guidelines set by the Ministry of Food and Drug Safety. The study will focus on individuals with a time since AS diagnosis of less than 5 years, aged between 18 and 40 years.
Drug: Secukinumab
This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: Baseline and 28 weeks
The BASDAI consists of 6 questions to measure the participant's symptoms and disease activity, and each question is evaluated using a numeric rating scale from 0 to 10 or a 10 cm Visual Analog Scale (VAS) with 0 being no problem and 10 being the worst problem
Baseline and 28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in C-Reactive Protein (CRP)
Time Frame: Baseline, 16 and 28 weeks

CRP is a blood test that indicates levels of inflammation

  • CRP< 5mg/L: Normal
  • CRP>=5 mg/L: High
Baseline, 16 and 28 weeks
Change from baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP
Time Frame: Baseline, 16 and 28 week

ASDAS-CRP is the score for participant's evaluation of low back pain, peripheral pain/swelling, duration of morning stiffness, disease activity, and the disease activity score of ankylosing spondylitis calculated from CRP levels. Ranges for Disease activity status are defined as follows:

  • Disease activity status <1.3: Inactive disease
  • Disease activity status 1.3-2.1: Low disease activity
  • Disease activity status 2.1-3.5: High disease activity
  • Disease activity status >3.5 (No maximum limit): Very high disease activity
Baseline, 16 and 28 week
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) stratified by specific variables
Time Frame: Baseline, 16 and 28 weeks
The BASDAI consists of 6 questions to measure the participant's symptoms and disease activity, and each question is evaluated using a numeric rating scale from 0 to 10 or a 10 cm Visual Analog Scale (VAS) with 0 being no problem and 10 being the worst problem. Stratified by different baseline variables
Baseline, 16 and 28 weeks
Adverse events and Serious Adverse events
Time Frame: From baseline up to 28 weeks
Incidence of Adverse events and Serious Adverse events
From baseline up to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457HKR01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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