Secukinumab in patients with active Ankylosing Spondylitis
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety and tolerability up to 2 years in patients with active ankylosing spondylitis.
IRAS ID
171072
Contact name
Gaelle Enderlin
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2013-005575-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 1 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 look at the safety and efficacy of secukinumab delivered by pre-filled syringe (PFS), with and without a loading regimen, in patients with active Ankylosing Spondylitis after 16 weeks of treatment. Patients who take part in the study will be randomly allocated to receive secukinumab or placebo for the first 16 weeks of the study. After 16 weeks, all patients will receive active treatment. Study participants will receive treatment for up to 2 years to assess the long-term efficacy, safety, and tolerability of the treatment. Patients with active AS will be treated despite current or previous NSAID, DMARD, and/or anti-TNF-alpha therapy.
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 Central - Hampshire A Research Ethics Committee
REC reference
15/SC/0146
Date of REC Opinion
26 Mar 2015
REC opinion
Further Information Favourable Opinion