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

UCB

Status and phase

Active, not recruiting

Phase 3

Conditions

Psoriatic Arthritis

Treatments

Drug: Bimekizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04009499

2023-506528-95 (Registry Identifier)

PA0012

2018-004725-86 (EudraCT Number)

U1111-1304-6874 (Other Identifier)

Details and patient eligibility

About

This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).

Enrollment

1,131 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study
Subject completed PA0010 [NCT03895203] or PA0011 [NCT03896581] without meeting any withdrawal criteria
Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception

Exclusion criteria

Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)
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
Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated