Compare Bimekizumab and Risankizumab in Psoriatic Arthritis Patients

  • Research type

    Research Study

  • Full title

    A Multicenter, Randomized, Double-Blind, Risankizumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants with Active Psoriatic Arthritis.

  • IRAS ID

    1010475

  • Contact name

    Bertram Knapp

  • Contact email

    bertram.knapp@ucb.com

  • Sponsor organisation

    UCB Biopharma SRL

  • Clinicaltrials.gov Identifier

    Not available yet

  • Research summary

    Psoriatic arthritis is a chronic inflammatory musculoskeletal disorder, which occurs in a substantial proportion of people also affected by psoriasis. Psoriatic arthritis can cause joint inflammation, leading to pain, stiffness, and swelling. It commonly affects joints such as the fingers, toes, wrists, knees, and spine.
    The purpose of this study is to evaluate the effectiveness and safety, of the study medication Bimekizumab in study participants with active psoriatic arthritis, in comparison to Risankizumab.
    Bimekizumab and the comparator medication, risankizumab are both monoclonal antibodies with demonstrated efficacy in psoriatic arthritis.
    Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body, in this case to reduce or prevent inflammation.
    Participants will have a 1 in 2 chance to receive bimekizumab or risankizumab. As the study is double-blind neither the participant, nor the study doctor will know which treatment is being received during the study.
    Bimekizumab:
    - Participants that have none or mild psoriasis, will receive bimekizumab dose 1
    - Participants that have moderate to severe psoriasis, will receive bimekizumab dose 2
    Risankizumab - Participants will receive risankizumab
    The study medication will be injected through a needle under the skin, also called a subcutaneous (SC) injection.
    This study will include a total of approximately 550 participants across several countries globally.
    Participants will be in this study for up to about 42 weeks.
    The Sponsor of the study is UCB Biopharma SRL.

  • REC name

    Wales REC 3

  • REC reference

    24/WA/0316

  • Date of REC Opinion

    26 Nov 2024

  • REC opinion

    Further Information Favourable Opinion