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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
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 moreAwards & 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
~6500
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.
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.
Find a Location
Who is running the clinical trial?
UCB Biopharma SRLLead Sponsor
115 Previous Clinical Trials
22,398 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273 (UCB)
219 Previous Clinical Trials
45,772 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can follow the study's schedule and take medications as directed.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.
Research Study Groups:
This trial has the following groups:- Group 1: Bimekizumab
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Ankylosing Spondylitis Patient Testimony for trial: Trial Name: NCT04436640 — Phase 3