UCB Announces Head-to-Head Trial Comparing Bimekizumab and Risankizumab

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UCB announced the commencement of the BE BOLD study, a pivotal phase 3b clinical trial aimed at comparing the efficacy of bimekizumab (Bimzelx; UCB) against risankizumab (Skyrizi; AbbVie) in treating adults with active psoriatic arthritis (PsA). The company stated in a news release that this trial marks a significant milestone as it is the first head-to-head study assessing the use of an IL-17A and IL-17F inhibitor, bimekizumab, over an IL-23 inhibitor, risankizumab, in this patient population.¹

"We’re excited to share the news of the BE BOLD study with the community across both dermatology and rheumatology, recognizing that the disease state of psoriatic arthritis is equally important to both therapeutic communities," said Jeff Stark, MD, vice president and head of immunology at UCB. "This will be the first study for the bimekizumab clinical program in the area of psoriatic arthritis that directly compares 2 active therapies in a head-to-head fashion powered for superiority."

Importance of Head-to-Head Studies

The need for rigorous clinical studies in PsA is underscored by Dr. Philip J. Mease, director of rheumatology research at the Providence Swedish Medical Center. “The conduct of head-to-head, evidence-based, clinical studies in psoriatic arthritis is important since they add to the existing scientific evidence available to healthcare professionals and patients and can help to make informed treatment decisions,” he said in the release. “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, 1 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 3 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,” Fiona du Monceau, executive vice president, head of patient evidence, UCB, said in the release. “BE BOLD represents the 4th 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.” 

Study Design and Objectives

The BE BOLD study is a multicenter, randomized, double-blind, controlled trial involving approximately 550 adult participants with PsA.The company said the participant pool will include individuals who are either biologic treatment-naïve or have had previous exposure to 1 tumor necrosis factor inhibitor (TNFi) but had an inadequate or intolerable response.

The primary endpoint of the study will be the assessment of the American College of Rheumatology 50 (ACR50) criteria at week 16, which measures a 50 percent or greater improvement in the signs and symptoms of PsA.The release stated that key secondary endpoints include evaluating minimal disease activity and the composite endpoint of ACR50 and PASI100 (complete skin clearance) at the same time point.

About Bimekizumab and Risankizumab

Bimekizumab is a humanized monoclonal IgG1 antibody designed to selectively inhibit IL-17A and IL-17F, 2 cytokines crucial in driving inflammatory processes in conditions like PsA. In the European Union, bimekizumab is indicated for several therapeutic uses, including the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa.

Risankizumab is an IL-23 inhibitor that selectively targets the p19 subunit of IL-23, a cytokine involved in various chronic immune-mediated diseases. Approved by the US FDA and the European Medicines Agency, it is indicated for several conditions, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Looking Ahead

According to UCB, the outcomes of this study are expected to be reported in 2026. The findings from BE BOLD could potentially reshape treatment strategies for PsA, providing new insights into effective management options for patients living with this challenging condition.

References

1. UCB announces a head-to-head study evaluating BIMZELX[®]▼(bimekizumab) versus SKYRIZI® (risankizumab) in active psoriatic arthritis. News Release. UCB. September 30, 2024. Accessed October 1, 2024. https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-a-head-to-head-study-evaluating-BIMZELXRVbimekizumab-versus-SKYRIZIR-risankizumab-in-active-psoriatic-arthritis