Mon-30-09-2024, 14:22 PM
UCB today announced the start of BE BOLD, a head-to-head Phase 3b study, comparing Bimzelx (bimekizumab), an IL-17A and IL-17F inhibitor, with Skyrizi (risankizumab), an IL-23 inhibitor, in the treatment of adults with active psoriatic arthritis (PsA). BE BOLD is the first head-to-head study in PsA evaluating the superiority of an IL-17A and IL-17F inhibitor to an IL-23 inhibitor.
Source: ucb.com
Biological Treatments For Psoriasis
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This is the first Phase 3b head-to-head study in psoriatic arthritis to utilize the primary endpoint of ACR50 at Week 16. This robust assessment is set to provide a meaningful comparison of bimekizumab vs. risankizumab on inflamed joints, one of the areas of most concern for many people living with psoriatic arthritis. We look forward to the results and the implications for future clinical practice.
In moderate to severe plaque psoriasis UCB has conducted three head-to-head Phase 3/3b studies with bimekizumab versus commonly used biologics, and results from these studies showed that bimekizumab was superior to secukinumab, ustekinumab and adalimumab,
BE BOLD represents the fourth head-to-head study in the bimekizumab clinical trial program, the first to be conducted in psoriatic arthritis, and the first versus an IL-23 inhibitor. This study underscores our confidence in the potential of bimekizumab for people living with psoriatic disease. We look forward to communicating the top-line results in 2026.
BE BOLD is a multicentre, randomized, double-blind, risankizumab controlled, parallel-group study designed to evaluate the efficacy and safety of bimekizumab in adult study participants (n=~550) with active psoriatic arthritis. The study population will include adults with active psoriatic arthritis who are biologic treatment naïve or who had previous exposure to one tumour necrosis factor-inhibitor (TNFi) with an inadequate or intolerant response. The primary endpoint will assess American College of Rheumatology 50 (ACR50, i.e., 50 percent or greater improvement in the signs and symptoms of psoriatic arthritis) at Week 16. Key ranked secondary endpoints include minimal disease activity at Week 16, and the composite endpoint, ACR50 and PASI100 (complete skin clearance) at Week 16.
Source: ucb.com
Biological Treatments For Psoriasis