BE VITAL
Research type
Research Study
Full title
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF BIMEKIZUMAB IN THE TREATMENT OF SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS.
IRAS ID
271764
Contact name
Ria Amiri
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2018-004725-86
Clinicaltrials.gov Identifier
128708, IND Number
Duration of Study in the UK
5 years, 2 months, 16 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 surface of the skin. 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 accompanied by tiredness and functional impairment.
The purpose of PA0012 is to understand how safe, effective and tolerable a new drug called bimekizumab is for a long-term use in treating psoriatic arthritis. It will also help us understand how bimekizumab acts in the body and how the body reacts to it. DV0004 substudy is being performed to assess the safe and effective use of two self-injecting devices with bimekizumab.
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.PA0012 will involve a total of about 1045 participants across approximately 162 sites throughout North America, Europe, Asia, and possibly other regions and countries. DV0004 is performed in about 200 study participants across approximately 115 hospitals/clinics only in North America and Europe. Each group of this substudy will consist of approximately 100 study participants each.
This study is being sponsored by UCB Biopharma SPRL.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
19/EM/0316
Date of REC Opinion
11 Dec 2019
REC opinion
Further Information Favourable Opinion