RecruitingPhase 4NCT05303285

A Study Evaluating the Efficacy of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis

A Multicenter Study Evaluating the Efficacy and Safety of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis.


Sponsor

Tongji Hospital

Enrollment

100 participants

Start Date

Jun 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety and efficacy of secukinumab 300mg in Chinese adults participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether secukinumab (a biologic drug targeting the IL-17 pathway) at 300 mg effectively reduces symptoms in Chinese adults with active ankylosing spondylitis — an inflammatory disease that primarily affects the spine and causes chronic back pain and stiffness. You may be eligible if... - You are 18 to 80 years old - You have a confirmed diagnosis of ankylosing spondylitis (AS) meeting the modified New York criteria - Your disease is active: pain score and BASDAI score both at or above 4 out of 10 - At least two NSAIDs have not worked well enough for you over 4 or more weeks You may NOT be eligible if... - You have previously used any biologic therapy for spondyloarthritis - You have previously used a JAK inhibitor (like tofacitinib or baricitinib) - You use opioid pain medications (excluding acetaminophen/codeine combinations) - You have another type of inflammatory arthritis (e.g., rheumatoid arthritis, lupus) - Your blood counts or kidney/liver function values are outside acceptable ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSecukinumab 300mg s.c.

Induction: 5 x 150 mg secukinumab s.c. weekly. Maintenance: 300 mg secukinumab s.c. every 4 weeks

DRUGSecukinumab 150mg s.c.

Induction: 5 x 150 mg secukinumab s.c. weekly. Maintenance: 150 mg secukinumab s.c. every 4 weeks


Locations(3)

Department of RheumatologyTongji Hospital

Wuhan, Hubei, China

Tongji Hospital

Wuhan, Hubei, China

Tongji Hospital

Wuhan, Hubei, China

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NCT05303285


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