CAIN457A2209E1 Open Label Ankylosing Spondylitis
Research type
Research Study
Full title
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
IRAS ID
37749
Contact name
Paul Wordsworth
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2009-011591-30
ISRCTN Number
not available
Clinicaltrials.gov Identifier
Research 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, as well as additional PK data of AIN457. In order to allow all patients in the extension study to receive treatment with AIN457, an open label format was chosen. It will be assessed if 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) will be safe, and it will be explored if it is efficacious to control symptoms of psoriatic arthritis. Based on the safety and efficacy data obtained from the core Proof-of-Concept trial and justification for drug development in this indication, 3 mg/kg AIN457 may continue to be given every 4 weeks for a further 6 month period (Part 2). The information obtained from this study will be useful to optimize trial design in upcoming phase IIb/III trials. Based on analytical considerations, only one dose level will be administered to maximize the information obtained for this dose level (3 mg/kg every 4 weeks). This dose level has demonstrated efficacy in other indications including rheumatoid arthritis and chronic psoriasis.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
10/H0402/52
Date of REC Opinion
21 Sep 2010
REC opinion
Further Information Favourable Opinion