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Monoclonal Antibodies

Bimekizumab Arm 1 for Plaque Psoriasis (BE SURE Trial)

Phase 3
Waitlist Available
Research Sponsored by UCB Biopharma S.P.R.L.
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 to safety follow-up visit (up to week 72)
Awards & highlights
Pivotal Trial

Summary

This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).

Eligible Conditions
  • Plaque Psoriasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to safety follow-up visit (up to week 72)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to safety follow-up visit (up to week 72) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16
Secondary study objectives
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72)
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72)
+10 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Bimekizumab Arm 2Experimental Treatment2 Interventions
Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Group II: Bimekizumab Arm 1Experimental Treatment2 Interventions
Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Group III: Adalimumab ArmActive Control3 Interventions
Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
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 S.P.R.L.Lead Sponsor
71 Previous Clinical Trials
11,326 Total Patients Enrolled
UCB Biopharma SRLLead Sponsor
112 Previous Clinical Trials
22,631 Total Patients Enrolled
UCB CaresStudy Director+1 844 599 2273 (UCB)
215 Previous Clinical Trials
45,973 Total Patients Enrolled
~62 spots leftby Oct 2025
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