What side effects are associated with this type of intervention?

Common treatments for Ankylosing Spondylitis that target Interleukin-17A, such as Secukinumab and Ixekizumab, have several known side effects. These include an increased risk of infections, particularly upper respiratory tract infections, and nasopharyngitis. Other potential side effects are headache, injection site reactions, and gastrointestinal issues. There is also a noted risk of exacerbating inflammatory bowel disease in some patients. It is important for patients to discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of Ankylosing Spondylitis (AS) that target Interleukin-17A, similar to Bimekizumab. Secukinumab (Cosentyx) and Ixekizumab (Taltz) are both monoclonal antibodies that inhibit Interleukin-17A and have been approved for AS. These drugs have shown efficacy in reducing symptoms and slowing disease progression in AS patients. Other biologic agents, such as TNF inhibitors (e.g., Infliximab, Adalimumab), are also commonly used in the treatment of AS and have been approved by the FDA for this indication.

What other types of research exist?

Promising alternatives to Bimekizumab for Ankylosing Spondylitis patients include Secukinumab and Ixekizumab, both of which are IL-17 inhibitors. Additionally, JAK inhibitors such as Tofacitinib and Upadacitinib offer novel mechanisms of action and have shown efficacy in AS treatment.

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Monoclonal Antibodies

Bimekizumab for Ankylosing Spondylitis (BE MOVING Trial)

Phase 3

Waitlist Available

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Female study participants who plan to become pregnant during the study or within 20 weeks following final dose of Investigational Medicinal Product (IMP)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline of as0010 (nct03928704) or as0011 (nct03928743) to week 112

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, Bimekizumab may cause side effects such as injection site reactions, infections due to immune system suppression, allergic reactions, gastrointestinal issues among others based on its mechanism of action.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline of as0010 (nct03928704) or as0011 (nct03928743) to week 112

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline of as0010 (nct03928704) or as0011 (nct03928743) to week 112

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline of as0010 (nct03928704) or as0011 (nct03928743) to week 112 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants with serious adverse events (SAEs) during the study

Percentage of participants with treatment-emergent adverse events (TEAEs) during the study

Percentage of participants with with treatment-emergent adverse Events (TEAEs) leading to withdrawal from the study

Secondary study objectives

Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 112

Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 28

Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 52

+33 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BimekizumabExperimental Treatment1 Intervention

Subjects will receive bimekizumab throughout the Treatment Period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bimekizumab

2018

Completed Phase 3

~6510

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ankylosing Spondylitis (AS) target specific cytokines involved in the inflammatory process. Bimekizumab, for example, inhibits both Interleukin-17A (IL-17A) and Interleukin-17F (IL-17F), which are key drivers of inflammation and new bone formation in AS. By blocking these cytokines, Bimekizumab can reduce inflammation and prevent structural damage to the spine and sacroiliac joints. Similarly, TNF inhibitors, another common treatment, block Tumor Necrosis Factor-alpha (TNF-alpha), a cytokine that promotes inflammation and joint damage. These treatments are crucial for AS patients as they help manage symptoms, maintain function, and prevent long-term complications.

Targeting the Interleukin-23/Interleukin-17 Inflammatory Pathway: Successes and Failures in the Treatment of Axial Spondyloarthritis.Treating to target in axial spondyloarthritis: defining the target and the arrow.