UCB Announces a Head-to-Head Study Evaluating BIMZELX® (bimekizumab) versus SKYRIZI® (risankizumab) in Active Psoriatic Arthritis
UCB has announced the initiation of BE BOLD, a Phase 3b head-to-head study comparing BIMZELX® (bimekizumab) and SKYRIZI® (risankizumab) in adults with active psoriatic arthritis (PsA). This study is the first to evaluate the superiority of an IL-17A and IL-17F inhibitor to an IL-23 inhibitor in PsA. BE BOLD will use the American College of Rheumatology 50 (ACR50) at Week 16 as its primary endpoint. The study will include around 550 adults with active PsA, who are either biologic treatment naïve or have had an inadequate response to one TNFi. Top-line results are expected in 2026.
UCB ha annunciato l'avvio di BE BOLD, uno studio di fase 3b in confronto diretto tra BIMZELX® (bimekizumab) e SKYRIZI® (risankizumab) in adulti con artrite psoriasica attiva (PsA). Questo studio è il primo a valutare la superiorità di un inibitore IL-17A e IL-17F rispetto a un inibitore IL-23 nella PsA. BE BOLD utilizzerà l'American College of Rheumatology 50 (ACR50) alla settimana 16 come suo obiettivo primario. Lo studio includerà circa 550 adulti con PsA attiva, che sono naïve al trattamento biologico o hanno avuto una risposta inadeguata a un TNFi. I risultati preliminari sono attesi nel 2026.
UCB ha anunciado el inicio de BE BOLD, un estudio de fase 3b comparativo entre BIMZELX® (bimekizumab) y SKYRIZI® (risankizumab) en adultos con artritis psoriásica activa (PsA). Este estudio es el primero en evaluar la superioridad de un inhibidor de IL-17A e IL-17F frente a un inhibidor de IL-23 en PsA. BE BOLD utilizará el American College of Rheumatology 50 (ACR50) a la semana 16 como su objetivo primario. El estudio incluirá alrededor de 550 adultos con PsA activa, que son naïve a tratamientos biológicos o que han tenido una respuesta inadecuada a un TNFi. Se esperan resultados preliminares en 2026.
UCB가 적극적인 건선 관절염(PsA) 성인의 BIMZELX®(bimekizumab)와 SKYRIZI®(risankizumab)를 비교하는 3b기 정면 연구 BE BOLD의 시작을 발표했습니다. 이 연구는 PsA에서 IL-17A 및 IL-17F 억제제가 IL-23 억제제보다 우수성을 평가하는 첫 번째 연구입니다. BE BOLD는 16주 차에 American College of Rheumatology 50(ACR50)를 주요 평가 지표로 사용할 것입니다. 이 연구에는 생물학적 치료를 받은 적이 없는 약 550명의 PsA 환자가 포함되며, TNFi에 대한 반응이 불충분한 경우도 포함됩니다. 주요 결과는 2026년에 발표될 예정입니다.
UCB a annoncé le lancement de BE BOLD, une étude de phase 3b comparant BIMZELX® (bimekizumab) et SKYRIZI® (risankizumab) chez des adultes souffrant d'arthrite psoriasique active (PsA). Cette étude est la première à évaluer la supériorité d'un inhibiteur d'IL-17A et d'IL-17F par rapport à un inhibiteur d'IL-23 dans la PsA. BE BOLD utilisera le American College of Rheumatology 50 (ACR50) à la semaine 16 comme critère principal. L'étude comprendra environ 550 adultes atteints de PsA active, qui sont soit naïfs de traitement biologique, soit ont eu une réponse insuffisante à un TNFi. Les résultats préliminaires sont attendus en 2026.
UCB hat den Beginn von BE BOLD angekündigt, einer Phase-3b-Studie, die BIMZELX® (bimekizumab) und SKYRIZI® (risankizumab) bei Erwachsenen mit aktiver Psoriasis-Arthritis (PsA) direkt vergleicht. Diese Studie ist die erste, die die Überlegenheit eines IL-17A- und IL-17F-Inhibitors gegenüber einem IL-23-Inhibitor bei PsA bewertet. BE BOLD wird den American College of Rheumatology 50 (ACR50) in Woche 16 als primären Endpunkt verwenden. Die Studie wird etwa 550 Erwachsene mit aktiver PsA einschließen, die entweder naive gegenüber biologischen Therapien sind oder auf ein TNFi unzureichend reagiert haben. Die ersten Ergebnisse werden für 2026 erwartet.
- Initiation of BE BOLD, a Phase 3b study comparing BIMZELX and SKYRIZI in PsA.
- First head-to-head study in PsA using ACR50 at Week 16 as a primary endpoint.
- Study includes around 550 adults with active PsA.
- Top-line results expected in 2026, indicating a long wait for potential impact.
- First Phase 3b study in psoriatic arthritis to evaluate the superiority of an IL-17A and IL-17F inhibitor to an IL-23 inhibitor
- This first head-to-head study in psoriatic arthritis to use ACR50 at Week 16 as a primary endpoint
- Study underscores UCB's belief in BIMZELX with top-line results expected in 2026
"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," said Philip J. Mease, MD, Director of Rheumatology Research at the Providence Swedish Medical Center and Clinical Professor at the University of Washington School of Medicine in
"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," said Fiona du Monceau, Executive Vice President, Head of Patient Evidence, UCB. "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 multicenter, randomized, double-blind, risankizumab-controlled, parallel-group study designed to evaluate the efficacy and safety of BIMZELX 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 tumor 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.
SKYRIZI® is a registered trademark of AbbVie Biotechnology Ltd.
Notes to editors:
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a serious, highly heterogeneous, chronic, systemic inflammatory condition affecting both the joints and skin, with a prevalence of 0.02 percent to 0.25 percent of the population and 6 percent to 41 percent of patients with psoriasis.1 Symptoms include joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis), inflammation of the sites where tendons or ligaments insert into the bone (enthesitis), and inflammatory axial involvement.2
About BIMZELX (bimekizumab-bkzx)
Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.3 Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.3
In the
Please see Important Safety Information below and full
BIMZELX
IMPORTANT SAFETY INFORMATION
Suicidal Ideation and Behavior
BIMZELX® (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, advise to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment.
Infections
BIMZELX may increase the risk of infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves.
Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment.
Liver Biochemical Abnormalities
Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis.
Inflammatory Bowel Disease
Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.
Immunizations
Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.
MOST COMMON ADVERSE REACTIONS
Most common (≥
Most common (≥
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For further information, contact UCB:
Investor Relations
Antje Witte
T +32.2.559.94.14
email antje.witte@ucb.com
Corporate Communications
Laurent Schots
T +32.2.559.92.64
email laurent.schots@ucb.com
Brand Communications
Nicole Herga
T +1.773.960.5349
email nicole.herga@ucb.com
About UCB
UCB,
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References
- Ogdie A, Weiss P. The epidemiology of psoriatic arthritis. Rheum Dis Clin North Am. 2015;41:545-68.
- Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014;74:423–41.
- BIMZELX® (bimekizumab-bkzx)
U.S. Prescribing Information. https://www.ucb-usa.com/Innovation/Products/BIMZELX. Accessed September 2024.
US-BK-2401152
Date of preparation: September 2024
BIMZELX® is a registered trademark of the UCB Group of Companies.
SKYRIZI® is a registered trademark of AbbVie Biotechnology Ltd.
All other trademarks are the property of their respective holders.
©2024 UCB, Inc.,
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