Evaluating secukinumab effectiveness in Korean patients with ankylosing spondylitis
Real-world Observational Study to Evaluate the Effectiveness of Secukinumab in Biologic-naive Ankylosing Spondylitis Patients in Korea
This study is testing how well secukinumab works for Korean patients with ankylosing spondylitis who haven't tried other treatments before.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | secukinumab |
| Locations | 2 sites (Jinju, Gyeongsangnam-do and 1 other locations) |
| Trial ID | NCT06905288 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness and safety of secukinumab in patients with ankylosing spondylitis (AS) who have never received treatment with TNF inhibitors, JAK inhibitors, or IL-17 inhibitors. Participants will be recruited from 10 institutions across Korea, with an enrollment period of 8 months and follow-up assessments at 16 and 28 weeks. The study will gather data on patient outcomes and treatment responses to secukinumab, which is approved for use in Korea.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 40 years diagnosed with ankylosing spondylitis who have not previously used TNFi, JAKi, or IL-17i treatments.
Not a fit: Patients with prior exposure to TNFi, JAKi, or IL-17i drugs, or those with specific medical conditions that prevent participation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of secukinumab for treating ankylosing spondylitis in biologic-naïve patients.
How similar studies have performed: While this study focuses on a specific population and treatment, similar studies evaluating secukinumab have shown promising results in other patient groups.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jinju, Gyeongsangnam-do and 1 other locations
- Novartis Investigative Site — Jinju, Gyeongsangnam-do, South Korea (Recruiting)
- Novartis Investigative Site — Busan, South Korea (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals, MD
- Email: thomas.paul@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.