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Monoclonal Antibodies

Bimekizumab for Ankylosing Spondylitis (BE AGILE 2 Trial)

Phase 2
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 entry visit (visit 1) until last visit (up to week 208)
Awards & highlights

BE AGILE 2 Trial Summary

This trial will help researchers understand if the drug bimekizumab is safe and effective for people with ankylosing spondylitis.

Eligible Conditions
  • Ankylosing Spondylitis

BE AGILE 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from entry visit (visit 1) until last visit (up to week 208)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from entry visit (visit 1) until last visit (up to week 208) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of serious adverse event (SAE) during the study
Incidence of treatment-emergent adverse events (TEAEs) during the study
Secondary outcome measures
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 48
Subjects who withdrew due to an treatment-emergent adverse event (TEAE) during the study
Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 48 calculated relative to Baseline of AS0008
+1 more

BE AGILE 2 Trial Design

1Treatment groups
Experimental Treatment
Group I: BimekizumabExperimental Treatment1 Intervention
Subjects will receive bimekizumab up to 4 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bimekizumab
2018
Completed Phase 3
~6510

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
102 Previous Clinical Trials
21,348 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
205 Previous Clinical Trials
44,708 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
California
Maryland
Minnesota
How old are they?
18 - 65
What site did they apply to?
As0009 001
AS0009 1
As0009 466
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
ACR Open RheumatologyJournal
Minimal Impact of the <scp>covid</scp> ‐19 Pandemic on Disease Activity and <scp>health‐related</scp> Quality of Life in Patients with Ankylosing Spondylitis Receiving Bimekizumab: Exploratory Analyses from a Phase 2b <scp>open‐label</scp> Extension Study
Robinson, Philip C., Pedro M. Machado, Nigil Haroon, Lianne S. Gensler, John D. Reveille, Vanessa Taieb, Thomas Vaux, et al.. 2022. “Minimal Impact of the covid ‐19 Pandemic on Disease Activity and health‐related Quality of Life in Patients with Ankylosing Spondylitis Receiving Bimekizumab: Exploratory Analyses from a Phase 2b open‐label Extension Study”. ACR Open Rheumatology. Wiley. doi:10.1002/acr2.11486.
clinicaltrials.govStudy
A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
2017. "A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03355573.
~35 spots leftby Apr 2025
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