Bimekizumab for Ankylosing Spondylitis

(BE MOVING Trial)

Recruiting at 96 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: 112 weeks

508 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called bimekizumab to see if it is safe and effective for people with a type of chronic back and joint inflammation called axial spondyloarthritis, which includes ankylosing spondylitis. The medication works by blocking proteins that cause inflammation, helping to reduce pain and swelling. Bimekizumab has shown promising results in previous studies for conditions like psoriatic arthritis and ankylosing spondylitis.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug Bimekizumab for treating ankylosing spondylitis?

Research shows that Bimekizumab, which blocks certain proteins (IL-17A and IL-17F) involved in inflammation, is effective in reducing symptoms of ankylosing spondylitis over 48 weeks and has shown superior results compared to a placebo in related conditions. ^{1 2 3 4 5}

Is Bimekizumab safe for humans?

Bimekizumab has been studied for safety in people with ankylosing spondylitis, showing it is generally safe over periods of up to three years, though like any medication, it may have side effects. ^{1 2 3 4 6}

How is the drug Bimekizumab unique for treating ankylosing spondylitis?

Bimekizumab is unique because it targets and neutralizes both interleukin-17A and interleukin-17F, whereas other treatments like ixekizumab only target interleukin-17A. This dual action may offer enhanced efficacy for patients with ankylosing spondylitis. ^{1 2 4 7 8}

Research Team

UCB Cares

Principal Investigator

001 844 599 2273 (UCB)

Eligibility Criteria

This trial is for people with active axial spondyloarthritis, including ankylosing spondylitis and nonradiographic forms. Participants must have completed previous related studies (AS0010 or AS0011), be reliable in following the study protocol, and are expected to benefit from it. Those with ongoing serious adverse events, serious infections history, or positive IGRA tests need medical consultation before joining.

Inclusion Criteria

Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator In the opinion of the Investigator, the study participant is expected to benefit from participation in this extension study

I can follow the study's schedule and take medications as directed.

Study participant completed AS0010 (NCT03928704) or AS0011 (NCT03928743)

Exclusion Criteria

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

I have a positive or unclear TB test result but have been checked or treated.

I am a male and may plan to father a child during the study or within 5 months after it ends.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bimekizumab to assess long-term safety, tolerability, and efficacy

112 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 68 weeks

Open-label extension

Participants may continue receiving bimekizumab to further assess long-term outcomes

Long-term

Treatment Details

Interventions

• Bimekizumab

Trial Overview The trial is testing Bimekizumab's long-term safety, tolerability, and effectiveness in treating axial spondyloarthritis conditions like ankylosing spondylitis. It aims to show how well patients do over a longer period while taking this medication.

Participant Groups

Group I: Bimekizumab Experimental Treatment 1 Intervention

Subjects will receive bimekizumab throughout 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

Findings from Research

Bimekizumab (BKZ) showed sustained efficacy in treating both non-radiographic and radiographic axial spondyloarthritis over 52 weeks, maintaining improvements in key measures like disease activity and inflammation levels.

The safety profile of BKZ remained consistent, with 75% of patients experiencing treatment-emergent adverse events, but serious events were relatively low, indicating it is a safe option for long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies. Baraliakos, X., Deodhar, A., van der Heijde, D., et al.[2023]

In the BUILDER-1 trial, tocilizumab (TCZ) did not show significant efficacy in improving symptoms of ankylosing spondylitis (AS) in patients who had not previously received anti-TNF treatment, with ASAS20 response rates of 37.3% for TCZ compared to 27.5% for placebo.

Safety results for TCZ were generally consistent with previous studies in rheumatoid arthritis, but there was a concerning cluster of anaphylactic and hypersensitivity reactions at specific study sites in Bulgaria, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials. Sieper, J., Porter-Brown, B., Thompson, L., et al.[2023]

Bimekizumab (BKZ) demonstrated sustained efficacy in treating active psoriatic arthritis (PsA) from Week 16 to Week 52, maintaining significant improvements in ACR response criteria and psoriasis severity measures.

The treatment was well tolerated, with a similar rate of treatment-emergent adverse events (TEAEs) compared to adalimumab, and no new safety concerns were identified, although localized Candida infections were noted in a small percentage of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ritchlin, CT., Coates, LC., McInnes, IB., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of bimekizumab in axial spondyloarthritis: a systematic literature review and network meta-analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Bimekizumab in Patients With Active Ankylosing Spondylitis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axial spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial. [2020]