A Clinical Trial in subjects with active Ankylosing Spondylitis
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab in prefilled syringes, to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis
IRAS ID
203917
Contact name
Raj Sengupta
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-005021-39
Duration of Study in the UK
1 years, 10 months, 2 days
Research summary
Ankylosing spondylitis (AS) is a chronic inflammatory disease involving an overactive immune system. The disease typically causes painful inflammation in the bones and joints of the lower spine and pelvis, but sometimes also more
peripheral joints as well. It has a strong genetic link.Treatment of the disease aims to reduce pain and inflammation. Recently, biologic drugs have proven successful at treating AS. Biologics are protein based drugs which can target particular elements of the overactive immune system. The most commonly used biologic treatments for AS are drugs which block a particular chemical messenger called TNF alpha.
The purpose of this study is to provide up to 52 weeks of efficacy, safety and
tolerability data to support registration of secukinumab for subcutaneous self-administration in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNFα therapy. Efficacy and safety data may be used to support the registration of secukinumab in China and other countries with a significant population of Asian ethnicity, for the treatment of active Ankylosing Spondylitis.The study is looking to recruit approximately 324 patients worldwide into the study with 50 of these from 12 centres in the UK.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
16/SW/0202
Date of REC Opinion
2 Aug 2016
REC opinion
Favourable Opinion