What side effects are associated with this type of intervention?

Common treatments for Psoriatic Arthritis, particularly biologics like Bimekizumab, secukinumab, ixekizumab, and ustekinumab, often have side effects such as nasopharyngitis, headache, and injection site reactions. TNF inhibitors like adalimumab and infliximab can cause gastrointestinal distress, hepatotoxicity, hematologic toxicity, and increased risk of infections. Monitoring for serious infections and liver abnormalities is necessary during treatment. These treatments are generally well-tolerated but require careful management of potential adverse effects.

What prior FDA approvals exist?

Several biologic agents have been approved by the FDA for the treatment of Psoriatic Arthritis, particularly those targeting the IL-17 pathway. Secukinumab (Cosentyx) and Ixekizumab (Taltz) are IL-17A inhibitors that have shown efficacy in treating Psoriatic Arthritis. Additionally, Ustekinumab (Stelara), which targets IL-12 and IL-23, and Guselkumab (Tremfya), an IL-23 inhibitor, have also been approved for this condition. These treatments are similar to Bimekizumab, which inhibits both IL-17A and IL-17F, and are part of the broader category of biologics used to manage Psoriatic Arthritis.

What other types of research exist?

Promising novel alternatives to Bimekizumab for Psoriatic Arthritis patients include: <ol> <li>Guselkumab: An anti-IL-23 monoclonal antibody that has shown efficacy in PsA.</li> <li></li> </ol> Risankizumab: Another anti-IL-23 monoclonal antibody with positive results in clinical trials for PsA. 3. Tildrakizumab: An IL-23 inhibitor that has demonstrated clinical improvement in PsA. 4. Secukinumab: An IL-17A inhibitor with long-term safety and efficacy data in PsA. 5. Ixekizumab: An IL-17A inhibitor with proven efficacy in PsA. 6. Upadacitinib: A Janus kinase (JAK) inhibitor that has shown promise in PsA treatment.

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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

Must not have

Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of bimekizumab, a medication given as an injection under the skin. It is aimed at adults who have psoriatic arthritis, a condition that causes joint pain and swelling. Bimekizumab works by blocking proteins that cause inflammation, helping to reduce pain and swelling.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not plan to become pregnant during the study or within 5 months after the last dose.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6500

0 / 2Eligibility criteria met

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.