A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis (BE AGILE 2)

UCB

Status and phase

Completed

Phase 2

Conditions

Ankylosing Spondylitis

Treatments

Drug: Bimekizumab

Study type

Interventional

Funder types

Industry

Identifiers

2017-001002-15 (EudraCT Number)

AS0009

Details and patient eligibility

About

This is a study to assess the long term safety and tolerability of bimekizumab in subjects with ankylosing spondylitis

Enrollment

255 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 an Open Label Extension (OLE) study
Subject completed AS0008 without meeting any withdrawal criteria
Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception
Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active

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). Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
Subjects who meet any withdrawal criteria in AS0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject's entry into AS0009