Phase 2B Study of Bimekizumab in Active Ankylosing Spondylitis
Research type
Research Study
Full title
A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS
IRAS ID
220274
Contact name
Hasan Tahir
Contact email
Sponsor organisation
UCB Biosciences GmbH
Eudract number
2016-001102-42
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
128708, IND
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This is a randomised, double-blind, placebo controlled study investigating the treatment of Ankylosing Spondylitis (AS). AS is a form of arthritis that primarily affects the spine. It causes inflammation in the spinal joints and can lead to severe, chronic pain and discomfort. Recent data suggests that AS occurs in approximately 0.7 to 1.4% of the US population. Currently, there is no known cure for psoriatic arthritis, but there are treatments and medications available to reduce symptoms and manage pain.
The purpose of this study is to help the sponsor understand how safe and effective different doses of a new medication called bimekizumab is in treating AS.In this study, approximately 200 male and female adult participants will be enrolled to one of the following treatment groups:
Bimekizumab 16mg every 4 weeks
Bimekizumab 64mg every 4 weeks
Bimekizumab 160mg every 4 weeks
Bimekizumab 320mg every 4 weeks
Placebo every 4 weeks
After 12 weeks, depending on the treatment group assigned during part on (double-blind period), participants will then be assigned to another treatment group (dose-blind period) for 36 weeks.Eligible participants will visit the clinic at least 17 times over 68 weeks. They will undergo various study procedures to assess the safety and effectiveness of bimekizumab. Depending on their treatment response, there may be an option to enter an extension study at week 48.
REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/0593
Date of REC Opinion
24 May 2017
REC opinion
Further Information Favourable Opinion