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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
No Placebo-Only Group
Summary
This trial is studying the safety and tolerability of bimekizumab in people with ankylosing spondylitis. Bimekizumab helps reduce inflammation and pain by blocking proteins that cause these symptoms. It has shown promise in early studies for treating psoriatic disease and ankylosing spondylitis.
Eligible Conditions
- Ankylosing Spondylitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from entry visit (visit 1) until last visit (up to week 208)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from entry visit (visit 1) until last visit (up to week 208)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of serious adverse event (SAE) during the study
Incidence of treatment-emergent adverse events (TEAEs) during the study
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
UCB Biopharma SRLLead Sponsor
113 Previous Clinical Trials
22,894 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
216 Previous Clinical Trials
46,236 Total Patients Enrolled
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