BE OPTIMAL
Research type
Research Study
Full title
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ACTIVE REFERENCE (ADALIMUMAB) STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN THE TREATMENT OF SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS
IRAS ID
260307
Contact name
Laura Coates
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2017-002322-20
Clinicaltrials.gov Identifier
128708, IND Number
Duration of Study in the UK
2 years, 9 months, 15 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 skin surface. Psoriatic arthritis (PsA) is usually a combination of skin and joint disease and is a long-term disorder causing swelling in multiple joints, which occurs in most of the people affected by psoriasis. PsA patients experience continuously increasing, severe pain in joints, with tiredness and functional impairment. Biologic disease modifying antirheumatic drugs are the drugs which slows down psoriasis and/or PsA progression.
The purpose of this study is to help us understand how safe and effective bimekizumab is in participants who have not received any biologic disease modifying antirheumatic drugs until the time of the start of this study.
Bimekizumab is a new investigational drug that may eventually be used in the treatment of PsA. 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 and reduces the activity of proteins called IL-17A and IL-17F which are involved in PsA 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 840 participants across approximately 150 sites throughout North America, Europe, Asia, Australia and possibly other regions/countries.
This study is sponsored by UCB Biopharma SPRL.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
19/EM/0142
Date of REC Opinion
1 Aug 2019
REC opinion
Further Information Favourable Opinion