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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

BE MOVING Trial Summary

This trial is testing a medication for long-term safety in patients with active axial spondyloarthritis, including ankylosing spondylitis and nonradiographic axial spondyloarthritis.

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.Check my eligibility

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.See study design

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.

BE MOVING Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

BE MOVING 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor

101 Previous Clinical Trials

20,928 Total Patients Enrolled

UCB CaresStudy Director001 844 599 2273 (UCB)

205 Previous Clinical Trials

44,455 Total Patients Enrolled

Media Library

Bimekizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04436640 — Phase 3

Ankylosing Spondylitis Research Study Groups: Bimekizumab

Ankylosing Spondylitis Clinical Trial 2023: Bimekizumab Highlights & Side Effects. Trial Name: NCT04436640 — Phase 3

Bimekizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04436640 — Phase 3

Ankylosing Spondylitis Patient Testimony for trial: Trial Name: NCT04436640 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Bimekizumab a safe medication for human use?

"There is some data to support efficacy and safety for Bimekizumab, thus it received a 3."

Answered by AI

What is the precedent for Bimekizumab's use in medical research?

"The clinical efficacy of bimekizumab was first observed in Ps0015 372 in 2018. As of now, there have been a total of 25 completed clinical trials and 8 live trials studying this medication. Most of the ongoing research is based in Sarasota, Florida."

Answered by AI

To the best of your knowledge, does this type of experiment have any precedent?

"There are 8 ongoing clinical trials for Bimekizumab in 26 countries and 120 cities. The first study was sponsored by UCB Biopharma SRL in 2018. That initial trial had 743 participants and completed Phase 3 in 2018. In total, 25 trials have been completed."

Answered by AI

What are the essential goals of this research?

"According to the sponsoring pharmaceutical company, UCB Biopharma SRL, the primary outcome metric for this study will be the percentage of participants who experience serious adverse events (SAEs) during the study period. This study will also measure secondary outcomes including change from baseline in Bath Ankylosing spondylitis Functional Index (BASFI) at Week 112, Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28, and Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week"

Answered by AI

How many facilities does this research project span?

"Enrollment for this trial is currently happening at 11 different locations, which can be found in Sarasota, Portland, Glendale, and 11 other cities. If you are interested in enrolling, try to select a location near you to cut down on travel time."

Answered by AI

Who else is applying?

What state do they live in?

New Jersey

Oregon

Texas

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

What site did they apply to?

As0014 50057

Why did patients apply to this trial?

looking for additional resources to address chronic pain. I had restless leg syndrome since I was 18 I have taken Requip I have taken meloxicam I have taken opiates I have taken benzodiazepines nothing helps. I am currently on carbidopa levodopa, which is for Parkinson like symptoms. It helps most of the night sometimes it doesn’t I would like to try something that is specifically made to help the symptoms of restless leg syndrome because it is absolutely horrendous sometimes.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis

2020. "A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04436640.

All > Axial Spondyloarthritis > Ankylosing Spondylitis