Bimekizumab for Psoriatic Arthritis

(BE VITAL Trial)

Recruiting at 178 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB Biopharma SRL

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 140 weeks

1131 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

UCB Cares

Principal Investigator

001 844 599 2273

Eligibility Criteria

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.

Inclusion Criteria

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

In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study

You have participated in a previous study (PA0010 or PA0011) and did not meet the withdrawal criteria.

Exclusion Criteria

Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator

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

I have had positive or unclear TB tests but have been checked or treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bimekizumab subcutaneously for the treatment of psoriatic arthritis

140 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

72 weeks

Open-label extension

Participants may continue to receive bimekizumab to assess long-term safety and efficacy

Long-term

Treatment Details

Interventions

• Bimekizumab

Trial Overview 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.

Participant Groups

Group I: Bimekzumab dosage regimen Experimental Treatment 1 Intervention

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

Bimekizumab is already approved in European Union, United States for the following indications:

Approved in European Union as Bimzelx for:

• Moderate to severe plaque psoriasis
• Active psoriatic arthritis
• Non-radiographic axial spondyloarthritis
• Active ankylosing spondylitis

Approved in United States as Bimzelx for:

• Moderate-to-severe plaque psoriasis
• Active psoriatic arthritis
• Non-radiographic axial spondyloarthritis
• Active ankylosing spondylitis
• Hidradenitis suppurativa

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven