Brodalumab Study in Patients with Axial Spondyloarthritis
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Axial Spondyloarthritis
IRAS ID
172170
Contact name
Stefan Siebert
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2014-003701-15
Duration of Study in the UK
6 years, 10 months, 4 days
Research summary
Axial spondyloarthritis is chronic inflammatory arthritis characterised by longstanding inflammatory back pain. In addition to involvement of the spine and neck, patients often also have involvement of other joints including hips, ribs and knees, as well as significant fatigue. Axial spondyloarthritis can be separated into two groups, based largely on x-ray features; i) ankylosing spondylitis, with confirmed x-ray changes and ii) non-radiographic axial spondyloarthritis. As more information is being found out about these conditions, new therapies are being developed for their treatment.
Brodalumab is a new unlicensed investigational product that has been developed by Amgen as a possible treatment for Axial Spondyloarthritis and other inflammatory conditions such as psoriasis.
The aim of the study is to test if Brodalumab is safe and effective as treatment for people with Axial Spondyloarthritis.Study participants with axial spondyloarthritis, who meet the eligibility criteria for the study, will be randomised to receive either Brodalumab or placebo (“dummy” inactive medicine) injections for 16 weeks. The main outcome of the study is to evaluate whether Brodalumab is effective for the treatment of axial spondyloarthritis by comparing the response to the Brodalumab to the placebo injections at 16 weeks.
After week 18 of the study, all participants will receive the active Brodalumab injections until the end of the study. During the study, participants will be regularly and carefully reviewed to assess the efficacy and safety of the medication. These assessments will include questionnaires, blood tests and procedures such as ECGs. Participants will remain on the study for approximately 6 years. In total 180 participants will be enrolled to the study at approximately 60 sites worldwide.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0246
Date of REC Opinion
21 Apr 2015
REC opinion
Further Information Favourable Opinion