Bimekizumab for Psoriatic Arthritis

(BE VITAL Trial)

Not currently recruiting at 212 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

Disqualifiers: Pregnancy, Serious infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 140 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of bimekizumab for individuals with psoriatic arthritis, a condition causing joint pain and skin issues. Participants will receive bimekizumab injections to assess its long-term benefits and any side effects. This study is ideal for those who have completed previous related studies without major issues and are likely to benefit from further treatment. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that bimekizumab is likely to be safe for humans?

Research has shown that bimekizumab is generally well-tolerated by people with psoriatic arthritis. Studies have found that common side effects include colds, mouth infections (oral thrush), headaches, diarrhea, and bladder infections, occurring in at least 2% of patients. Importantly, the treatment has been studied for up to three years and continues to effectively control inflammation. While some risks of side effects exist, the overall safety profile remains positive. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriatic arthritis?

Researchers are excited about bimekizumab for psoriatic arthritis because it offers a unique approach compared to current treatments like TNF inhibitors and IL-17 inhibitors. Bimekizumab works by targeting both IL-17A and IL-17F, two key proteins involved in inflammatory processes, which might enhance its effectiveness in reducing symptoms. This dual-action mechanism could potentially offer better control of inflammation and joint damage, making it a promising option for those who might not respond well to existing therapies.

What evidence suggests that bimekizumab might be an effective treatment for psoriatic arthritis?

Research has shown that bimekizumab effectively treats psoriatic arthritis. Studies have found that it controls inflammation and improves symptoms for up to three years. Many patients experienced a significant reduction in symptoms, with some improving by 50% or more. This improvement occurred quickly and persisted over time. In this trial, participants will receive an assigned bimekizumab dosage regimen to evaluate its effectiveness in managing the inflammation and symptoms of psoriatic arthritis. ^{1 2 3 6 7}

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 2273

Are You a Good Fit for This Trial?

This trial is for adults with active Psoriatic Arthritis who previously completed certain studies (PA0010 or PA0011) without withdrawal. Women must be postmenopausal, sterilized, or use effective contraception and not plan pregnancy during the study or within 20 weeks after the last dose.

Inclusion Criteria

I am postmenopausal, permanently sterilized, or I use effective birth control.

In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study

You have participated in a previous study (PA0010 or PA0011) and did not meet the withdrawal criteria.

Exclusion Criteria

Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator

I do not plan to become pregnant during the study or within 5 months after the last dose.

I have had positive or unclear TB tests but have been checked or treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bimekizumab subcutaneously for the treatment of psoriatic arthritis

140 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

72 weeks

Open-label extension

Participants may continue to receive bimekizumab to assess long-term safety and efficacy

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Bimekizumab

Trial Overview The trial tests Bimekizumab's long-term safety and effectiveness when given as a subcutaneous injection to treat Psoriatic Arthritis. It aims to understand how well patients tolerate this medication over an extended period.

How Is the Trial Designed?

Group I: Bimekzumab dosage regimen Experimental Treatment 1 Intervention

Subjects participating in the study will receive assigned bimekizumab dosage regimen during the Treatment Period.

Bimekizumab is already approved in European Union, United States for the following indications:

Approved in European Union as Bimzelx for:

• Moderate to severe plaque psoriasis
• Active psoriatic arthritis
• Non-radiographic axial spondyloarthritis
• Active ankylosing spondylitis

Approved in United States as Bimzelx for:

• Moderate-to-severe plaque psoriasis
• Active psoriatic arthritis
• Non-radiographic axial spondyloarthritis
• Active ankylosing spondylitis
• Hidradenitis suppurativa

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven

Citations

1. ucb.com ucb.com/newsroom/press-releases/article/bimzelxr-bimekizumab-bkzx-three-year-rheumatology-data-at-acr-2025-demonstrated-sustained-inflammation-control-in-psoriatic-arthritis-and-axial-spondyloarthritis

BIMZELX[®] (bimekizumab-bkzx) three year rheumatology ... “These compelling data show sustained improvements over three years across key PsA disease domains. This demonstrates that bimekizumab-bkzx has ...

2. ucb-usa.com ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelxr-bimekizumab-bkzx-three-year-data-at-eular-2025-showed-lasting-efficacy-and-control-of-inflammation-in-psoriatic-arthritis-and-axial-spondyloarthritis

BIMZELX® (bimekizumab-bkzx) Three-Year Data at ... BIMZELX (bimekizumab-bkzx) three-year data at EULAR 2025 showed lasting efficacy and control of inflammation in psoriatic arthritis and axial spondyloarthritis.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39215949/

Safety and Efficacy of Bimekizumab in Patients with ... The proportion of patients achieving efficacy outcomes (≥ 50% improvement from baseline in American College of Rheumatology [ACR] response ...

4. prnewswire.com prnewswire.com/news-releases/bimzelx-bimekizumab-bkzx-three-year-rheumatology-data-at-acr-2025-demonstrated-sustained-inflammation-control-in-psoriatic-arthritis-and-axial-spondyloarthritis-302594241.html

BIMZELX® (bimekizumab-bkzx) Three-Year Rheumatology ... Sustained improvements across stringent measures of disease in patients with psoriatic arthritis (PsA): One-year improvements were sustained ...

5. bimzelxhcp.com bimzelxhcp.com/rheumatology/Psoriatic-Arthritis/ACR50

ACR50: Proven Efficacy in a Bold Endpoint BIMZELX delivered rapid and sustained ACR50 response · Improvements were sustained through 2 years · ACR20/50/70: sustained efficacy ...

6. bimzelxhcp.com bimzelxhcp.com/rheumatology/Safety

Safety Profile|BIMZELX® (bimekizumab-bkzx) Most common (≥2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract ...

7. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/full/10.1002/acr2.11727

Efficacy and Safety of Bimekizumab in Patients With Psoriatic ... Safety outcomes, reported to Week 52, include treatment-emergent adverse events (TEAEs), serious TEAEs, and study discontinuations due to TEAEs.