BE MOBILE 2
Research type
Research Study
Full title
A phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitis
IRAS ID
259100
Contact name
Karl Gaffney
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2017-003065-95
Clinicaltrials.gov Identifier
128708, IND Number
Duration of Study in the UK
2 years, 3 months, 3 days
Research summary
Axial spondyloarthritis (axSpA) is an umbrella term that includes both ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpA). Active ankylosing spondylitis (AS) 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), with radiographic evidence of the disease in the sacroiliac joints. 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 establish if a new drug called bimekizumab is efficacious in the treatment of participants with AS and to enhance our understanding on the safety and tolerability of this drug.
Bimekizumab is a new drug that may eventually be used in the treatment of AS. It is investigational, which means that it is still being tested, and has not yet been approved for treatment by the health authorities. Bimekizumab is a monoclonal antibody, which is a class of proteins that 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 AS and other inflammatory diseases. To date, the bimekizumab program included patients with psoriasis, psoriatic arthritis and AS. In these studies, bimekizumab was generally well tolerated by the people who received it, with symptom improvement in patients with AS.
This study will involve a total of about 300 participants across approximately 95 sites in 14 countries including the United States, and countries in Eastern and Western Europe, and Asia.
This study is being sponsored by UCB Biopharma SPRL.Summary of study results:
https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.ucb.com%252Fsites%252Fdefault%252Ffiles%252F2023-12%252FAS0011_plain_language_summary_final.pdf%2FNBTI%2Filq5AQ%2FAQ%2Fac4dd5d1-82ce-424f-842d-a91094cfef02%2F2%2Fkc7wXvOiRf&data=05%7C02%7Cessex.rec%40hra.nhs.uk%7C021adcc03eda4a47f62408dd07bad34a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638675221187195816%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=cCplpsIImgPrDEJm933WbG7iFgbsjBUP4G23s0gifRg%3D&reserved=0
REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0165
Date of REC Opinion
1 Jul 2019
REC opinion
Further Information Favourable Opinion