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Monoclonal Antibodies
Bimekizumab for Psoriatic Arthritis (BE OPTIMAL 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 until safety follow-up (up to week 72)
Awards & highlights
BE OPTIMAL Trial Summary
This study is evaluating whether a drug called bimekizumab can help treat psoriatic arthritis.
Eligible Conditions
- Psoriatic Arthritis
BE OPTIMAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline until safety follow-up (up to week 72)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until safety follow-up (up to week 72)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
American College of Rheumatology (ACR) 50 response at Week 16
Secondary outcome measures
American College of Rheumatology (ACR) 20 response at Week 16
American College of Rheumatology (ACR) 70 response at Week 16
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
+16 moreBE OPTIMAL Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Bimekzumab dosage regimenExperimental Treatment2 Interventions
Subjects randomized to this arm will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
Group II: Adalimumab dosage regimenActive Control1 Intervention
Subjects randomized to this arm will receive the assigned adalimumab dosage regimen during the Treatment Period.
Group III: PlaceboPlacebo Group2 Interventions
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be reallocated to receive bimekizumab dosage regimen during the Maintenance Period.
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
101 Previous Clinical Trials
20,571 Total Patients Enrolled
7 Trials studying Psoriatic Arthritis
2,953 Patients Enrolled for Psoriatic Arthritis
UCB CaresStudy Director001 844 599 2273
205 Previous Clinical Trials
44,098 Total Patients Enrolled
11 Trials studying Psoriatic Arthritis
3,214 Patients Enrolled for Psoriatic Arthritis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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