A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis

• Register: ClinicalTrials.gov
• Last refreshed on: 30 October 2023
• Main ID: NCT03355573
• Date of registration: 22/11/2017
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SRL
• Public title: A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis BE AGILE 2
• Scientific title: A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
• Date of first enrolment: November 28, 2017
• Target sample size: 255
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03355573
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Canada, Czechia, Germany, Hungary, Poland, Russian Federation, Spain, Ukraine, United States

Contacts

• Name: UCB Cares
• Affiliation: 001 844 599 2273

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Bimekizumab

Primary Outcome(s)

Incidence of serious adverse event (SAE) during the study [Time Frame: From Entry Visit (Visit 1) until Last Visit (up to Week 208)]

Incidence of treatment-emergent adverse events (TEAEs) during the study [Time Frame: From Entry Visit (Visit 1) until Last Visit (up to Week 208)]

Secondary Outcome(s)

Subjects who withdrew due to an treatment-emergent adverse event (TEAE) during the study [Time Frame: From Entry Visit (Visit 1) until Last Visit (up to Week 208)]

Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 48 calculated relative to Baseline of AS0008 [Time Frame: Baseline of AS0008, Week 48]

Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 48 [Time Frame: Baseline of AS0008, Week 48]

Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 calculated relative to Baseline of AS0008 [Time Frame: Baseline of AS0008, Week 48]

Secondary ID(s)

2017-001002-15

AS0009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors