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Recruiting Observational

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

NCT06905288 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2025-04-02
Last updated
2026-08-18

Condition(s) studied

Ankylosing Spondylitis

Investigational drug(s) / intervention(s)

Secukinumab →

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (3)

FacilityCityRegionStatus
Novartis Investigative Site Jinju Gyeongsangnam-do Recruiting
Novartis Investigative Site Busan South Korea Recruiting
Novartis Investigative Site Gwangju South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06905288 on ClinicalTrials.gov ↗ ← All trials in South Korea