← Back to Search

Monoclonal Antibodies

Bimekizumab for Psoriatic Arthritis (BE VITAL 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

Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline of pa0010 or pa0011, week 140 in pa0012

Awards & highlights

BE VITAL Trial Summary

This trial will test the safety and effectiveness of a new drug for psoriatic arthritis.

Who is the study for?

This trial is for adults with active Psoriatic Arthritis who previously completed certain studies (PA0010 or PA0011) without withdrawal. Women must be postmenopausal, sterilized, or use effective contraception and not plan pregnancy during the study or within 20 weeks after the last dose.Check my eligibility

What is being tested?

The trial tests Bimekizumab's long-term safety and effectiveness when given as a subcutaneous injection to treat Psoriatic Arthritis. It aims to understand how well patients tolerate this medication over an extended period.See study design

What are the potential side effects?

While specific side effects are not listed here, Bimekizumab may cause reactions at the injection site, increase infection risk, and potentially lead to other immune-related conditions due to its action on the immune system.

BE VITAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am postmenopausal, permanently sterilized, or I use effective birth control.

BE VITAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline of pa0010 or pa0011, week 140 in pa0012

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline of pa0010 or pa0011, week 140 in pa0012

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline of pa0010 or pa0011, week 140 in pa0012 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 treatment-emergent adverse events (TEAEs) during the study

Incidence of treatment-emergent serious adverse events (SAEs) during the study

Secondary outcome measures

American College of Rheumatology 20% improvement (ACR20) response at Week 140 in PA0012 using the Baseline of PA0010 or PA0011

American College of Rheumatology 20% improvement (ACR20) response at Week 24 in PA0012 using the Baseline of PA0010 or PA0011

American College of Rheumatology 20% improvement (ACR20) response at Week 52 in PA0012 using the Baseline of PA0010 or PA0011

+25 more

BE VITAL Trial Design

1Treatment groups

Experimental Treatment

Group I: Bimekzumab dosage regimenExperimental Treatment1 Intervention

Subjects participating in the study will receive assigned bimekizumab dosage regimen during the Treatment Period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bimekizumab

2018

Completed Phase 3

~6510

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor

101 Previous Clinical Trials

20,305 Total Patients Enrolled

7 Trials studying Psoriatic Arthritis

2,674 Patients Enrolled for Psoriatic Arthritis

UCB CaresStudy Director001 844 599 2273

205 Previous Clinical Trials

43,832 Total Patients Enrolled

11 Trials studying Psoriatic Arthritis

2,935 Patients Enrolled for Psoriatic Arthritis

Media Library

Bimekizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04009499 — Phase 3

Psoriatic Arthritis Research Study Groups: Bimekzumab dosage regimen

Psoriatic Arthritis Clinical Trial 2023: Bimekizumab Highlights & Side Effects. Trial Name: NCT04009499 — Phase 3

Bimekizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04009499 — Phase 3

Frequently Asked Questions

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

How many locations are conducting this trial?

"From Quebec City to Trois-rivieres to Sydney, this trial has 38 different locations where patients can receive care."

Answered by AI

Have other patients undergone this treatment before?

"Bimekizumab has been the focus of medical research since 2018. The first study, sponsored by UCB Biopharma SRL was completed that same year and involved 743 patients. Bimekizumab received Phase 3 approval after this initial trial in 2018. Currently, there are 8 active trials involving this drug taking place across 26 countries and 120 cities."

Answered by AI

What are the short and long-term risks of Bimekizumab?

"There is some data to support efficacy and multiple rounds of safety data, so Bimekizumab received a score of 3 for safety."

Answered by AI

Does this research follow-up on any previous Bimekizumab projects?

"First investigated in 2018 at Ps0015 372, bimekizumab has had 25 completed clinical trials as of now. There are 8 active studies being conducted presently, many of which are based out of Quebec City and Maryland."

Answered by AI

How many people are qualified to participate in this clinical trial?

"Presently, this trial is not recruiting patients. The study was first advertised on August 13th, 2019 and has since been edited November 10th, 2022. There are 387 other trials that might be of interest to you if you have psoriatic arthritis and 8 studies involving Bimekizumab are actively looking for participants."

Answered by AI

What are the parameters of this research?

"The primary objective of this study, which will be conducted over the course of approximately 24 weeks, is to observe and document the incidence of treatment-emergent adverse events. Secondary objectives include measuring the rate of improvement in arthritis symptoms among patients using the ACR70, ACR20, and ACR50 response criteria at Weeks 24 and 52 respectively."

Answered by AI

Are we still enrolling patients for this experiment?

"The clinicaltrial.gov website indicates that this study is not looking for new patients at the moment. This trial was made public on August 13th, 2019 and has not been updated since November 10th, 2020. There are 395 other trials that are currently recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

2019. "A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04009499.

All > Arthritis > Psoriatic Arthritis