BE COMPLETE
Research type
Research Study
Full title
A multicenter, phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of bimekizumab in the treatment of subjects with active psoriatic arthritis
IRAS ID
260308
Contact name
Sirjana Gurung
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2017-002804-29
Clinicaltrials.gov Identifier
128708, IND Number
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
Psoriasis is a long-term skin disease in which the skin cells grow abnormally causing a build-up of cells which appears as red, raised patches covered with silver-coloured scales on the surface of the skin. Psoriatic arthritis (arthritis refers to join pain) is usually a combination of skin and joint disease. Psoriatic arthritis is a long-term disorder causing swelling in multiple joints, which occurs in most of the people affected by psoriasis. Patients with psoriatic arthritis experience continuously increasing, severe pain in joints that is accompanied by tiredness and functional impairment.
The purpose of this study is to help us understand how safe and effective a new drug called bimekizumab is for a long-term use in treating psoriatic arthritis.
Bimekizumab is a new drug that may eventually be used in the treatment of psoriatic arthritis. It is investigational, which means that is it still being tested, and has not yet been approved for treatment by the health authorities. Bimekizumab is a monoclonal antibody. Monoclonal antibodies 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 1L-17F, which are involved in psoriatic arthritis and other inflammatory diseases. To date, the bimekizumab program included patients with psoriasis, ankylosing spondylitis and psoriatic arthritis. In these studies, bimekizumab was generally well tolerated by the people who received it.
This study will involve a total of about 390 participants across approximately 89 sites throughout North America, Europe, Asia, Australia and possibly other regions and countries.
This study is being sponsored by UCB Biopharma SPRL.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
19/EM/0141
Date of REC Opinion
31 Jul 2019
REC opinion
Further Information Favourable Opinion