Bimekizumab for Psoriatic Arthritis
(BE VITAL Trial)

Recruiting in Palo Alto (17 mi)

+177 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: UCB Biopharma SRL

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

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.

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.

Participant Groups

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.

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.

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

🇪🇺 Approved in European Union as Bimzelx for: