A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- UCB Biopharma SRL
- Enrollment
- 255
- Locations
- 50
- Primary Endpoint
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
Study Overview
Brief Summary
This is a study to assess the long term safety and tolerability of bimekizumab in subjects with ankylosing spondylitis
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 AS
- •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
Arms & Interventions
Bimekizumab
Subjects will receive bimekizumab up to 4 years.
Intervention: Bimekizumab (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
Time Frame: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment emergent adverse events were defined as those events with onset date on or after the first administration of study medication in AS0009 and on or before 140 days after the final study medication administration.
Percentage of Participants With Serious Adverse Event (SAE) During the Study
Time Frame: From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 1) Results in death 2) Is life-threatening 3) Requires in participant hospitalisation or prolongation of existing hospitalisation 4) Is a congenital anomaly or birth defect 5) Is an infection that requires treatment with parenteral antibiotics 6) Other important medical events which based on medical or scientific judgement may jeopardise the participants, or may require medical or surgical intervention to prevent any of the above.
Secondary Outcomes
- Percentage of Participants Who Withdrew Due to an Treatment-emergent Adverse Event (TEAE) During the Study(From Entry Visit (Visit 1) until Safety Follow Up (up to Week 224))
- Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 48 Calculated Relative to Baseline of AS0008(Baseline of AS0008, Week 48 (AS0009))
- Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 48 Calculated Relative to Baseline of AS0008(Baseline of AS0008, Week 48 (AS0009))
- Change From Baseline of AS0008 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score to Week 48(Baseline of AS0008, Week 48 (AS0009))