AzTrials
AzTrials

Ankylosing SpondylitisONSETNCT06905288

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

An observational study of Ankylosing Spondylitis, run by Novartis Pharmaceuticals at 3 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Secukinumab
How many people
70 participants
Where
3 sitesSouth Korea
Study dates
2 Apr 2025to 31 Dec 2026
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 40 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Who may be able to join

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

Who cannot join

  • 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)
  • Subjects who have congenital/traumatic spinal deformities
  • Subjects currently enrolled in other clinical studies
  • Subjects who have any contraindications to secukinumab treatment

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals, MD contact

+41613241111

thomas.paul@novartis.com

Novartis Pharmaceuticals contact

minsoo.jee@novartis.com

South Korea3 sites, 3 recruiting

  • Novartis Investigative Site

    Busan, 49201

    Recruiting

  • Novartis Investigative Site

    Gwangju, 61469

    Recruiting

  • Novartis Investigative Site

    Jinju, Gyeongsangnam-do, 52727

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
Secukinumab
Keywords
Secukinumab, Ankylosing Spondylitis, Biologic Naive, Real World Study, Korea, Rheumatology, AS Research, Rheumatic Disease, Biologics, Clinical Effectiveness
Medical subject headings
Spondylitis, Ankylosing, Rheumatic Diseases

What participants receive

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

  • SecukinumabDrug

    This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.

Study groups in NCT06905288
Study groupRoleWhat they receive
group 1The 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.
Receives: Drug: Secukinumab

What is being measured

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

  1. Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    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

    Measured: Baseline and 28 weeks

Secondary outcomes (4)

  1. Change from baseline in C-Reactive Protein (CRP)

    CRP is a blood test that indicates levels of inflammation

    • CRP< 5mg/L: Normal
    • CRP>=5 mg/L: High

    Measured: Baseline, 16 and 28 weeks

  2. Change from baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP

    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

    Measured: Baseline, 16 and 28 week

  3. Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) stratified by specific variables

    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

    Measured: Baseline, 16 and 28 weeks

  4. Adverse events and Serious Adverse events

    Incidence of Adverse events and Serious Adverse events

    Measured: From baseline up to 28 weeks

Timeline

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

  1. First posted1 Apr 2025
  2. Study start2 Apr 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (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
Case only
Time perspective
Prospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06905288
Sponsor's protocol ID
CAIN457HKR01
Acronym
ONSET
Status last verified
Aug 2026
First submitted
25 Mar 2025
Last updated
18 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chimenti MS, Fonti GL, Conigliaro P, Sunzini F, Scrivo R, Navarini L, Triggianese P, Peluso G, Scolieri P, Caccavale R, Picchianti Diamanti A, De Martino E, Salemi S, Birra D, Altobelli A, Paroli M, Bruzzese V, Lagana B, Gremese E, Conti F, Afeltra A, Perricone R. One-year effectiveness, retention rate, and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a real-life multicenter study. Expert Opin Biol Ther. 2020 Jul;20(7):813-821. doi: 10.1080/14712598.2020.1761957. Epub 2020 May 13.

    PubMed 32401062

  • Kiltz U, Sfikakis PP, Gaffney K, Sator PG, von Kiedrowski R, Bounas A, Gullick N, Conrad C, Rigopoulos D, Lespessailles E, Romanelli M, Ghislain PD, Brandt-Jurgens J, Rashkov R, Aassi M, Orsenigo R, Perella C, Pournara E, Gathmann S, Jagiello P, Veit J, Augustin M. Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study. Adv Ther. 2020 Jun;37(6):2865-2883. doi: 10.1007/s12325-020-01352-8. Epub 2020 May 6.

    PubMed 32378070

  • Dzubur E, Khalil C, Almario CV, Noah B, Minhas D, Ishimori M, Arnold C, Park Y, Kay J, Weisman MH, Spiegel BMR. Patient Concerns and Perceptions Regarding Biologic Therapies in Ankylosing Spondylitis: Insights From a Large-Scale Survey of Social Media Platforms. Arthritis Care Res (Hoboken). 2019 Feb;71(2):323-330. doi: 10.1002/acr.23600.

    PubMed 29781587

  • Micheroli R, Tellenbach C, Scherer A, Burki K, Niederman K, Nissen MJ, Zufferey P, Exer P, Moller B, Kyburz D, Ciurea A. Effectiveness of secukinumab versus an alternative TNF inhibitor in patients with axial spondyloarthritis previously exposed to TNF inhibitors in the Swiss Clinical Quality Management cohort. Ann Rheum Dis. 2020 Sep;79(9):1203-1209. doi: 10.1136/annrheumdis-2019-215934. Epub 2020 Jun 24.

    PubMed 32581090

  • Wang R, Ward MM. Epidemiology of axial spondyloarthritis: an update. Curr Opin Rheumatol. 2018 Mar;30(2):137-143. doi: 10.1097/BOR.0000000000000475.

    PubMed 29227352

  • Mauro D, Forte G, Poddubnyy D, Ciccia F. The Role of Early Treatment in the Management of Axial Spondyloarthritis: Challenges and Opportunities. Rheumatol Ther. 2024 Feb;11(1):19-34. doi: 10.1007/s40744-023-00627-0. Epub 2023 Dec 18.

    PubMed 38108992

Questions about this trial

What is this clinical trial studying?

An observational study of Ankylosing Spondylitis, run by Novartis Pharmaceuticals at 3 sites in South Korea.

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 7 inclusion and 4 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. 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, MD (+41613241111, thomas.paul@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (time frame: Baseline and 28 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06905288, which also lists 6 linked publications.

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 18 Aug 2026.

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

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in