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Research type
Research Study
Full title
A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study with an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis
IRAS ID
243704
Contact name
Sirjana Gurung
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2016-003426-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 8 days
Research summary
Plaque Psoriasis is the most common form of Psoriasis, a long-term skin condition that appears as raised, red patches covered with a silvery white build-up of dead skin cells or scale. These patches or plaques most often appear on the scalp, knees, elbows and lower back. They are often itchy and painful, and they can crack and bleed.
The purpose of the study is to see if bimekizumab, the study drug is effective for treating patients with moderate to severe Plaque Psoriasis. It will also help to understand how bimekizumab acts in the body, and how the body reacts to bimekizumab.
In order to find out whether bimekizumab is effective or not it will be compared to treatment with placebo. The study medication will be randomly assigned; participants will receive either bimekizumab or placebo. This is a double-blinded study, meaning neither the participant nor the study doctor will know which medication (bimekizumab or placebo) is being given.UCB Biopharma SPRL is the sponsor of this study which will take place worldwide. It is anticipated that approximately 400 participants will be enrolled in the study. For each participant, the study will last a maximum of 76 weeks. Participants who meet the requirements will be invited to enter an open-label extension study.
REC name
East of England - Essex Research Ethics Committee
REC reference
18/EE/0136
Date of REC Opinion
12 Jul 2018
REC opinion
Further Information Favourable Opinion