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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 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Psoriatic Arthritis (PsA) often target specific interleukins involved in the inflammatory process. Bimekizumab, for example, inhibits both IL-17A and IL-17F, which are cytokines that play a crucial role in the pathogenesis of PsA by promoting inflammation and joint damage. Other treatments, such as Ustekinumab, target IL-12 and IL-23, which are also involved in the inflammatory cascade. TNF inhibitors like Adalimumab block tumor necrosis factor-alpha (TNF-α), another key cytokine in PsA. These targeted therapies are important for PsA patients as they help reduce inflammation, alleviate symptoms, and prevent joint damage, thereby improving quality of life.

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
103 Previous Clinical Trials
20,675 Total Patients Enrolled
7 Trials studying Psoriatic Arthritis
2,674 Patients Enrolled for Psoriatic Arthritis
UCB CaresStudy Director001 844 599 2273
206 Previous Clinical Trials
44,035 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
~321 spots leftby May 2026
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