NCT01109940

Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis

An Open Label Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients With Moderate to Severe Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with moderate to severe ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of Intravenous infusion (IV) of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in ankylosing spondylitis a decision was taken to continue dosing for another 6 month period (Part 2).

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
BIOLOGICAL	AIN457A

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-04-23
• Last updated: 2021-06-24
• Results posted: 2021-06-24

Locations

15 sites across 4 countries: United States, Germany, Netherlands, United Kingdom