Phase IIa study of Bimekizumab (UCB4940) in Ulcerative Colitis
Research type
Research Study
Full title
A Multicentre, Subject-Blind, Investigator-Blind, Randomised, Placebo-Controlled Study Evaluating The Efficacy, Safety, Tolerability, And Pharmacokinetics Of An IV Loading Dose Followed By SC Administration Of Bimekizumab (UCB4940) In Subjects With Moderate To Severe Active Ulcerative Colitis.
IRAS ID
207417
Contact name
Charlotte Pai
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2015-000420-26
Duration of Study in the UK
1 years, 0 months, 21 days
Research summary
Ulcerative colitis is a chronic condition where the colon and rectum become inflamed due to being targeted by the body’s own immune system (‘auto-immune’). Symptoms include bloody diarrhoea, abdominal cramps and weight loss. Current treatment options are limited in scope and efficacy, they aim to relieve symptoms during a flare-up and maintain the patient in remission. Drugs inhibiting anti-tumour necrosis factor (TNF) provided a major improvement in helping patients into remission, but some patients who don’t respond and whose disease may be so severe they require a colectomy (surgical removal of the affected bowel).
There is evidence to suggest that combined inhibition of two other pro-inflammatory targets (cytokines) called IL-17A and IL-17F may be an effective strategy for the treatment of ulcerative colitis.
Bimekizumab is an engineered antibody that inhibits IL-17A and IL-17F. As yet, no medicines are available which fully inhibit the activity of both of them. Bimekizumab is being tested in this study to see if it may be of benefit in ulcerative colitis.
UCB Biopharma SPRL is sponsoring the study to assess:
• Its safety, tolerability, effectiveness
• How long bimekizumab remains circulating in the blood stream
• The body’s responses to bimekizumab, including response of immune system and bowel
Participants will be randomly assigned to receive one infusion and two subsequent injections of either bimekizumab or placebo, spaced 3 weeks apart, and be followed up for 14 more weeks after the last injection.
This is a randomised, placebo-controlled, double-blind study meaning that neither the participant nor study doctor will know which medication is being given.
This is a multicentre study taking place across Europe and South Africa. It is anticipated that approximately 60 participants will be recruited worldwide, 20 of those in the UK.REC name
East Midlands - Derby Research Ethics Committee
REC reference
17/EM/0008
Date of REC Opinion
8 Mar 2017
REC opinion
Further Information Favourable Opinion