Efficacy and Safety of Bimekizumab in Chronic Plaque Psoriasis

  • Research type

    Research Study

  • Full title

    A phase 3, multicentre, randomised, double-blind, placebo- and active comparator-controlled, parallel-group study to evaluate the efficacy and safety of Bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis.

  • IRAS ID

    235146

  • Contact name

    Sirjana Gurung

  • Contact email

    sirjana.gurung@parexel.com

  • Sponsor organisation

    UCB Biopharma SPRL

  • Eudract number

    2016-003425-42

  • Clinicaltrials.gov Identifier

    NCT03370133

  • Clinicaltrials.gov Identifier

    128707, IND Number

  • Duration of Study in the UK

    1 years, 9 months, 17 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 participants with moderate to severe plaque Psoriasis. The study is also done to see if Bimekizumab is safe and to monitor for side effects. An additional purpose is to understand participants' responses to Plaque Psoriasis treatments using an approved drug called Ustekinumab.

    This is a double-blinded study, meaning neither the participant nor the study doctor will know which medication is being given. The study medication will be randomly assigned; participants will receive either Bimekizumab, Ustekinumab or placebo. After Week 16, all participants will be treated with Bimekizumab or Ustekinumab.

    UCB Biopharma SPRL is the sponsor of this study which will take place worldwide. It is anticipated that approximately 560 participants will be enrolled in the study. For each participant, the study will last a maximum of 72 weeks.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    18/NW/0166

  • Date of REC Opinion

    20 Apr 2018

  • REC opinion

    Further Information Favourable Opinion