NCT05303285

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.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study includes two periods: a 16-week double-blind placebo-controlled period and a 52-week open-label long-term extension period. Eligible participants were randomly assigned in a 1:1 ratio to receive secukinumab 300 mg or placebo for 16 weeks in Period 1. Participants who completed Period 1 received secukinumab 300 mg for 36 weeks in the extension period.

Conditions

• Ankylosing Spondylitis (AS)

Interventions

Type	Name	Description
DRUG	Secukinumab 300mg s.c.	Induction: 5 x 150 mg secukinumab s.c. weekly. Maintenance: 300 mg secukinumab s.c. every 4 weeks
DRUG	Secukinumab 150mg s.c.	Induction: 5 x 150 mg secukinumab s.c. weekly. Maintenance: 150 mg secukinumab s.c. every 4 weeks

Timeline

• Start date: 2024-06-14
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2022-03-31
• Last updated: 2026-01-27

Locations

3 sites across 1 country: China