CWoW - BE MOVING
Research type
Research Study
Full title
A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis
IRAS ID
1003028
Contact name
Karl Gaffney
Contact email
Sponsor organisation
UCB Biopharma SRL
Eudract number
2019-004163-47
Clinicaltrials.gov Identifier
Research summary
Axial spondyloarthritis (axSpA) is an umbrella term that includes both ankylosing
spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpA), which is
considered an earlier or milder form of AS. Active axSpA is a chronic form of arthritis
that typically originates in the sacroiliac joints (joints at the base of the backbone where
it connects with the hip bone), then progresses to the spine (backbone). In axSpA,
changes to the sacroiliac joints or the spine are visible on X-ray. This disease causes
inflammation of the joints and can lead to chronic pain and stiffness in the back and
possibly in other areas of the body.
The purpose of this study is to enhance our understanding on the long-term safety and
tolerability of Bimekizumab administered over a period up to 112 weeks, and to establish
if it is efficacious in the treatment of axSpA.
Bimekizumab is a new drug that may eventually be used in the treatment of axSpA. It is
investigational, meaning it is still being tested and has not yet been approved for
treatment by the health authorities. Bimekizumab is a monoclonal antibody which are
proteins that recognise and bind specifically to certain proteins in the body.
Bimekizumab belongs to a group of medicines called interleukin (IL) inhibitors.
Bimekizumab reduces the activity of 2 proteins called IL-17A and IL-17F which are
involved in axSpA and other inflammatory diseases. As of 23 Oct 2019, 2589 adults have
been given Bimekizumab in studies with healthy volunteers as well as participants with
psoriasis, psoriatic arthritis and AS. In these studies, Bimekizumab was generally well
tolerated by the people who received it.
This study will involve a total of about 485 participants across approximately 95 sites in
the US and countries in Asia and Europe.
This study is being sponsored by UCB Biopharma SRL.REC name
London - Westminster Research Ethics Committee
REC reference
20/LO/0964
Date of REC Opinion
8 Oct 2020
REC opinion
Further Information Favourable Opinion