Bimekizumab for Ankylosing Spondylitis
(BE MOVING Trial)

Recruiting in Palo Alto (17 mi)

+96 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: UCB Biopharma SRL

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

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.

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)

+1 more

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.

+2 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: BimekizumabExperimental Treatment1 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: