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

Recruiting

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: Secukinumab

• Registration Number: NCT06905288
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

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 Timeline

• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Status Verified: 2025-04
• Study First Posted: 2025-04-01
• Study Start: 2025-04-02
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	Secukinumab	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in C-Reactive Protein (CRP)	Baseline, 16 and 28 weeks	CRP is a blood test that indicates levels of inflammation; * CRP\< 5mg/L: Normal; * CRP\>=5 mg/L: High
Change from baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP	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
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) stratified by specific variables	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
Adverse events and Serious Adverse events	From baseline up to 28 weeks	Incidence of Adverse events and Serious Adverse events

Trial Locations

Locations (1)

Novartis Investigative Site; 🇰🇷 Busan, Korea, Republic of