Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea.
Launched by NOVARTIS PHARMACEUTICALS · Mar 25, 2025
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness and safety of a medication called secukinumab in people with ankylosing spondylitis (AS) who have never used certain types of medications before. The trial is specifically looking for participants between the ages of 18 and 40 who have been diagnosed with AS and are currently experiencing active symptoms. To qualify, participants must meet specific criteria, such as having a BASDAI score of 4 or higher, which indicates the level of their disease activity, and must not have used other treatments like TNFi, JAKi, or IL-17i drugs.
If you or someone you know is interested in participating, this study will last about 28 weeks and involves regular check-ins to monitor symptoms and treatment effects. The trial is not yet recruiting participants, but it aims to gather important information to help understand how well secukinumab works in this specific group of patients. It’s essential for potential participants to be in good health and not have any conditions that would prevent them from completing the study. This research could provide valuable insights for future treatments of ankylosing spondylitis.
Gender
ALL
Eligibility 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
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Busan, , Korea, Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported