NCT02750592

Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis

An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections up to 52 weeks in Japanese patients with active AS despite current or previous non-steroidal anti-inflammatory drugs (NSAIDs) and/or anti-tumor necrosis factor (TNF) α therapy. Efficacy and safety data were used to support the registration of secukinumab in Japan for the treatment of active AS.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.	Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks.

Timeline

• Start date: 2016-03-22
• Primary completion: 2017-07-05
• Completion: 2018-05-16
• First posted: 2016-04-25
• Last updated: 2019-09-09
• Results posted: 2019-09-09

Locations

10 sites across 1 country: Japan