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

• Immunogenicity of AIN457 [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: Yes ]
• Total IL-17 concentration in blood at steady-state [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: No ]
• Pharmacokinetics of AIN457 at steady state [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: No ]

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 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).

Inclusion Criteria:

• A diagnosis of ankylosing spondylitis
• Patients who took part in the core CAIN457A2209 study

Exclusion Criteria:

• Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
• Patients who were non-compliant or who demonstrated a major protocol deviation in the core CAIN457A2209 study.
• Patients who discontinued from the core CAIN457A2209 study before Visit 14 (Week 16), and patients who completed the core study or discontinued the core study more than 2 weeks before the baseline visit.
• Pregnant or lactating women
• Presence of active infection
• Positive PPD or HIV test in patients where repeated testing was deemed appropriate due to their risk profile

Other protocol-defined inclusion/exclusion criteria may apply