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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Novartis Investigative Site
Paradise Valley, Arizona, United States
Novartis Investigative Site
Springfield, Illinois, United States
Novartis Investigative Site
Springfield, Illinois, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Duncansville, Pennsylvania, United States
Novartis Investigative Site
Jackson, Tennessee, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Novartis Investigative Site
Benbrook, Texas, United States
Novartis Investigative Site
Spokane, Washington, United States
Novartis Investigative Site
Berlin, Germany
...and 5 more locations
Number of Participants Reported Adverse Events (AE's)
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.
Time frame: From start of the study up to 64 weeks
Number of Participants Reported Positive Antibodies for Secukinumab
Immunogenicity (anti-drug antibodies) was assessed using an MSD bridging assay and a 3-tiered approach (screening, confirmation, titration).
Time frame: Pre-dose, Week 0, 8, 24, 40 and Week 64
Total Interleukin (IL)- 17A Concentration in Blood at Steady-State
Total serum IL17A was not measured due to assay limitations.
Time frame: Pre-dose and at the end of infusion (up to 64 weeks)
Maximum (Peak) Observed in Serum at Steady-State (Cmax,ss)
Concentration of Secukinumab at the end of infusion (Cmax,ss) was reported.
Time frame: At end of infusion (Week 64)
Minimum (Trough) Observed in Serum at Steady State (Cmin,ss)
The concentration of secukinumab at pre-dose (Cmin,ss) in serum was reported.
Time frame: Pre-dose (Week 0)
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