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Monoclonal Antibodies

A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (BE COMPLETE 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 37 weeks)
Awards & highlights
Pivotal Trial

Summary

This trial tests an injectable medication called bimekizumab for people with Psoriatic Arthritis who didn't get better with usual treatments. It works by reducing swelling and pain by blocking certain harmful proteins. Bimekizumab shows promise in treating psoriasis and psoriatic arthritis.

Eligible Conditions
  • Psoriatic Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until safety follow-up (up to 37 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until safety follow-up (up to 37 weeks) 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 American College of Rheumatology 50 (ACR50) Response
Secondary study objectives
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score at Week 16
Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Total Score at Week 16
Change From Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16
+11 more

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bimekizumab dosage regimenExperimental Treatment1 Intervention
Subjects randomized to this arm will receive assigned bimekizumab dosage regimen.
Group II: PlaceboPlacebo Group1 Intervention
Subjects randomized to this arm will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bimekizumab
2018
Completed Phase 3
~6500

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
115 Previous Clinical Trials
22,506 Total Patients Enrolled
9 Trials studying Psoriatic Arthritis
4,045 Patients Enrolled for Psoriatic Arthritis
UCB CaresStudy Director001 844 599 2273 (UCB)
219 Previous Clinical Trials
45,880 Total Patients Enrolled
13 Trials studying Psoriatic Arthritis
4,306 Patients Enrolled for Psoriatic Arthritis
~60 spots leftby Dec 2025
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