Axial Spondyloarthritis MedDRA version: 21.1 Level: PT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator - In the opinion of the Investigator, the study participant is expected to benefit from participation in this extension study - Study participant completed AS0010 (NCT03928704) or AS0011 (NCT03928743) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: - Female study participants who plan to become pregnant during the study or within 20 weeks following final dose of Investigational Medicinal Product (IMP). Male study participants who are planning a partner pregnancy during the study or within 20 weeks following the final dose - Study participants who meet any withdrawal criteria in AS0010 or AS0011. For any study participant with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder study, the Medical Monitor must be consulted prior to the study participant’s entry into AS0014 - Study participant has a positive or indeterminate interferon gamma release assay (IGRA) in AS0010 or AS0011, unless appropriately evaluated and treated
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28 2. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52 3. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112 4. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28 5. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52 6. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112 7. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 28 8. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52 9. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 112 10. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 28 11. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 52 12. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 112 13. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 28 14. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 52 15. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 112 16. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 28 17. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 52 18. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 112 19. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 28 20. Change from Baseline in Bath Ankylo | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the long-term safety and tolerability of bimekizumab in patients with active axial spondyloarthritis ;Secondary Objective: Assess the impact of bimekizumab on: - Long-term efficacy - Patient-reported outcomes including health-related quality of life - Spinal mobility - Enthesitis and peripheral arthritis ;Primary end point(s): 1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of serious adverse events (SAEs) during the study 3. Treatment-emergent adverse events (TEAEs) leading to withdrawal from the study ;Timepoint(s) of evaluation of this end point: From Baseline (Day 1) until Safety Follow-Up (up to Week 128) | — |
Countries
Belgium, Bulgaria, China, Czech Republic, France, Germany, Hungary, Japan, Netherlands, Poland, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactDDGS
UCB Biosciences GmbH
Outcome results
None listed