Back to resultsA Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis (BE MOVING)
Primary Purpose
Axial Spondyloarthritis, Ankylosing Spondylitis, r-axSpa
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Sponsored by
About this trial
This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring AxSpa, Radiographic, Non-radiographic, AS, Bimekizumab, Axial spondyloarthritis, Ankylosing spondylitis
Eligibility 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)
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
Sites / Locations
- As0014 50062
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bimekizumab
Arm Description
Subjects will receive bimekizumab throughout the Treatment Period.
Outcomes
Primary Outcome Measures
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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.
Percentage of participants with serious adverse events (SAEs) during the study
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalisation or prolongation of existing hospitalisation
Is a congenital anomaly or birth defect
Is an infection that requires treatment with parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
Percentage of participants with with treatment-emergent adverse Events (TEAEs) leading to withdrawal from the study
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Secondary Outcome Measures
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28
ASAS40 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are defined as relative improvements of at least 40%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains and no worsening at all in the remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))-
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 concerning morning stiffness intensity and duration)
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52
ASAS40 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are defined as relative improvements of at least 40%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains and no worsening at all in the remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112
ASAS40 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are defined as relative improvements of at least 40%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains and no worsening at all in the remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28
ASAS20 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 20% improvement are defined as relative improvements of at least 20%, and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52
ASAS20 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 20% improvement are defined as relative improvements of at least 20%, and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112
ASAS20 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 20% improvement are defined as relative improvements of at least 20%, and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 28
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity.
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity.
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 112
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity.
Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 28
The Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) is defined as a score of <=2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS40 domains.
Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 52
The Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) is defined as a score of <=2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS domains.
Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 112
The Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) is defined as a score of <=2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS domains.
Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 28
The ASDAS-C-Reactive Protein (ASDAS-CRP) consists of a number of assessments which are scored by the study participant and physician and multiplied by a proven formula as shown below:
0.121 x Total back pain (represented by the BASDAI Question 2 result) 0.058 x Duration of morning stiffness (represented by the BASDAI Question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (represented by the BASDAI Question 3 result) 0.579 x (natural logarithm of the hs-CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The sum of these weighted components gives the ASDAS-CRP.
Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 52
The ASDAS-C-Reactive Protein (ASDAS-CRP) consists of a number of assessments which are scored by the study participant and physician and multiplied by a proven formula as shown below:
0.121 x Total back pain (represented by the BASDAI Question 2 result) 0.058 x Duration of morning stiffness (represented by the BASDAI Question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (represented by the BASDAI Question 3 result) 0.579 x (natural logarithm of the hs-CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The sum of these weighted components gives the ASDAS-CRP.
Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 112
The ASDAS-C-Reactive Protein (ASDAS-CRP) consists of a number of assessments which are scored by the study participant and physician and multiplied by a proven formula as shown below:
0.121 x Total back pain (represented by the BASDAI Question 2 result) 0.058 x Duration of morning stiffness (represented by the BASDAI Question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (represented by the BASDAI Question 3 result) 0.579 x (natural logarithm of the hs-CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The sum of these weighted components gives the ASDAS-CRP.+ 1)
Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 28
The Assessment of SpondyloArthritis International Society (ASAS) 5/6 response is defined as achieving at least 20% improvement in 5 of 6 domains, including the 4 domains defined for ASAS40 domains as well as spinal mobility (lateral spinal flexion) and high sensitivity C-reactive Protein (hs-CRP).
Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 52
The Assessment of SpondyloArthritis International Society (ASAS) 5/6 response is defined as achieving at least 20% improvement in 5 of 6 domains, including the 4 domains defined for ASAS domains as well as spinal mobility (lateral spinal flexion) and high sensitivity C-reactive Protein (hs-CRP).
Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 112
The Assessment of SpondyloArthritis International Society (ASAS) 5/6 response is defined as achieving at least 20% improvement in 5 of 6 domains, including the 4 domains defined for ASAS domains as well as spinal mobility (lateral spinal flexion) and high sensitivity C-reactive Protein (hs-CRP).
Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 28
The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ('Easy') to 10 ('Impossible'). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52
The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ('Easy') to 10 ('Impossible'). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 112
The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ('Easy') to 10 ('Impossible'). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 28
Nocturnal spinal pain experienced by ankylosing spondylitis (AS) subjects is measured by one question: pain in the spine at night due to AS?. When responding, the subject is to consider the average amount of pain in the preceding week. It is assessed on a numerical scale (0 to 10 units). A lower score indicates less pain and an improvement of the outcome.
Change from Baseline in nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 52
Nocturnal spinal pain experienced by ankylosing spondylitis (AS) subjects is measured by one question: pain in the spine at night due to AS?. When responding, the subject is to consider the average amount of pain in the preceding week. It is assessed on a numerical scale (0 to 10 units). A lower score indicates less pain and an improvement of the outcome.
Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 112
Nocturnal spinal pain experienced by ankylosing spondylitis (AS) subjects is measured by one question: pain in the spine at night due to AS?. When responding, the subject is to consider the average amount of pain in the preceding week. It is assessed on a numerical scale (0 to 10 units). A lower score indicates less pain and an improvement of the outcome.
Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 28
The Ankylosing Spondylitis Quality of Life (ASQoL), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in subjects with ankylosing spondylitis (AS) and has shown to be responsive in axial spondyloarthritis (axSpA). The ASQoL score ranges from 0 to 18 with a higher score indicating worse HRQoL.
Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52
The Ankylosing Spondylitis Quality of Life (ASQoL), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in subjects with ankylosing spondylitis (AS) and has shown to be responsive in axial spondyloarthritis (axSpA). The ASQoL score ranges from 0 to 18 with a higher score indicating worse HRQoL.
Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 112
The Ankylosing Spondylitis Quality of Life (ASQoL), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in subjects with ankylosing spondylitis (AS) and has shown to be responsive in axial spondyloarthritis (axSpA). The ASQoL score ranges from 0 to 18 with a higher score indicating worse HRQoL.
Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 28
There are 8 Short-Form 36-item Health Survey (SF-36) domain scores. In addition to domain scores, the Physical Component Summary (PCS) scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 52
There are 8 Short-Form 36-item Health Survey (SF-36) domain scores. In addition to domain scores, the Physical Component Summary (PCS) scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 28
The Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 52
The Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 112
The Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 28
The Maastricht Ankylosing Spondylitis Enthesitis (MASES) is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score indicates worsening.
Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 52
The Maastricht Ankylosing Spondylitis Enthesitis (MASES) is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score indicates worsening.
Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 112
The Maastricht Ankylosing Spondylitis Enthesitis (MASES) is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score indicates worsening.
Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 112
There are 8 Short-Form 36-item Health Survey (SF-36) domain scores. In addition to domain scores, the Physical Component Summary (PCS) scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04436640
Brief Title
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis
Acronym
BE MOVING
Official Title
A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
August 7, 2026 (Anticipated)
Study Completion Date
August 7, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis, Ankylosing Spondylitis, r-axSpa, Nr-axSpa
Keywords
AxSpa, Radiographic, Non-radiographic, AS, Bimekizumab, Axial spondyloarthritis, Ankylosing spondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
508 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimekizumab
Arm Type
Experimental
Arm Description
Subjects will receive bimekizumab throughout the Treatment Period.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
BKZ, UCB4940
Intervention Description
Subjects will receive bimekizumab at prespecified time-points.
Primary Outcome Measure Information:
Title
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject 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.
Time Frame
From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
Title
Percentage of participants with serious adverse events (SAEs) during the study
Description
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalisation or prolongation of existing hospitalisation
Is a congenital anomaly or birth defect
Is an infection that requires treatment with parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
Time Frame
From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
Title
Percentage of participants with with treatment-emergent adverse Events (TEAEs) leading to withdrawal from the study
Description
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Time Frame
From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
Secondary Outcome Measure Information:
Title
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28
Description
ASAS40 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are defined as relative improvements of at least 40%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains and no worsening at all in the remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))-
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 concerning morning stiffness intensity and duration)
Time Frame
Week 28
Title
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52
Description
ASAS40 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are defined as relative improvements of at least 40%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains and no worsening at all in the remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Time Frame
Week 52
Title
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112
Description
ASAS40 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are defined as relative improvements of at least 40%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains and no worsening at all in the remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Time Frame
Week 112
Title
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28
Description
ASAS20 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 20% improvement are defined as relative improvements of at least 20%, and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Time Frame
Week 28
Title
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52
Description
ASAS20 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 20% improvement are defined as relative improvements of at least 20%, and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Time Frame
Week 52
Title
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112
Description
ASAS20 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 20% improvement are defined as relative improvements of at least 20%, and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Time Frame
Week 112
Title
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 28
Description
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Title
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52
Description
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Title
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 112
Description
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Title
Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 28
Description
The Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) is defined as a score of <=2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS40 domains.
Time Frame
Week 28
Title
Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 52
Description
The Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) is defined as a score of <=2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS domains.
Time Frame
Week 52
Title
Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 112
Description
The Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) is defined as a score of <=2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS domains.
Time Frame
Week 112
Title
Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 28
Description
The ASDAS-C-Reactive Protein (ASDAS-CRP) consists of a number of assessments which are scored by the study participant and physician and multiplied by a proven formula as shown below:
0.121 x Total back pain (represented by the BASDAI Question 2 result) 0.058 x Duration of morning stiffness (represented by the BASDAI Question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (represented by the BASDAI Question 3 result) 0.579 x (natural logarithm of the hs-CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The sum of these weighted components gives the ASDAS-CRP.
Time Frame
Week 28
Title
Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 52
Description
The ASDAS-C-Reactive Protein (ASDAS-CRP) consists of a number of assessments which are scored by the study participant and physician and multiplied by a proven formula as shown below:
0.121 x Total back pain (represented by the BASDAI Question 2 result) 0.058 x Duration of morning stiffness (represented by the BASDAI Question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (represented by the BASDAI Question 3 result) 0.579 x (natural logarithm of the hs-CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The sum of these weighted components gives the ASDAS-CRP.
Time Frame
Week 52
Title
Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 112
Description
The ASDAS-C-Reactive Protein (ASDAS-CRP) consists of a number of assessments which are scored by the study participant and physician and multiplied by a proven formula as shown below:
0.121 x Total back pain (represented by the BASDAI Question 2 result) 0.058 x Duration of morning stiffness (represented by the BASDAI Question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (represented by the BASDAI Question 3 result) 0.579 x (natural logarithm of the hs-CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The sum of these weighted components gives the ASDAS-CRP.+ 1)
Time Frame
Week 112
Title
Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 28
Description
The Assessment of SpondyloArthritis International Society (ASAS) 5/6 response is defined as achieving at least 20% improvement in 5 of 6 domains, including the 4 domains defined for ASAS40 domains as well as spinal mobility (lateral spinal flexion) and high sensitivity C-reactive Protein (hs-CRP).
Time Frame
Week 28
Title
Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 52
Description
The Assessment of SpondyloArthritis International Society (ASAS) 5/6 response is defined as achieving at least 20% improvement in 5 of 6 domains, including the 4 domains defined for ASAS domains as well as spinal mobility (lateral spinal flexion) and high sensitivity C-reactive Protein (hs-CRP).
Time Frame
Week 52
Title
Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 112
Description
The Assessment of SpondyloArthritis International Society (ASAS) 5/6 response is defined as achieving at least 20% improvement in 5 of 6 domains, including the 4 domains defined for ASAS domains as well as spinal mobility (lateral spinal flexion) and high sensitivity C-reactive Protein (hs-CRP).
Time Frame
Week 112
Title
Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 28
Description
The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ('Easy') to 10 ('Impossible'). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Title
Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52
Description
The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ('Easy') to 10 ('Impossible'). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Title
Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 112
Description
The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ('Easy') to 10 ('Impossible'). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Title
Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 28
Description
Nocturnal spinal pain experienced by ankylosing spondylitis (AS) subjects is measured by one question: pain in the spine at night due to AS?. When responding, the subject is to consider the average amount of pain in the preceding week. It is assessed on a numerical scale (0 to 10 units). A lower score indicates less pain and an improvement of the outcome.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Title
Change from Baseline in nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 52
Description
Nocturnal spinal pain experienced by ankylosing spondylitis (AS) subjects is measured by one question: pain in the spine at night due to AS?. When responding, the subject is to consider the average amount of pain in the preceding week. It is assessed on a numerical scale (0 to 10 units). A lower score indicates less pain and an improvement of the outcome.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Title
Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 112
Description
Nocturnal spinal pain experienced by ankylosing spondylitis (AS) subjects is measured by one question: pain in the spine at night due to AS?. When responding, the subject is to consider the average amount of pain in the preceding week. It is assessed on a numerical scale (0 to 10 units). A lower score indicates less pain and an improvement of the outcome.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Title
Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 28
Description
The Ankylosing Spondylitis Quality of Life (ASQoL), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in subjects with ankylosing spondylitis (AS) and has shown to be responsive in axial spondyloarthritis (axSpA). The ASQoL score ranges from 0 to 18 with a higher score indicating worse HRQoL.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Title
Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52
Description
The Ankylosing Spondylitis Quality of Life (ASQoL), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in subjects with ankylosing spondylitis (AS) and has shown to be responsive in axial spondyloarthritis (axSpA). The ASQoL score ranges from 0 to 18 with a higher score indicating worse HRQoL.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Title
Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 112
Description
The Ankylosing Spondylitis Quality of Life (ASQoL), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in subjects with ankylosing spondylitis (AS) and has shown to be responsive in axial spondyloarthritis (axSpA). The ASQoL score ranges from 0 to 18 with a higher score indicating worse HRQoL.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Title
Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 28
Description
There are 8 Short-Form 36-item Health Survey (SF-36) domain scores. In addition to domain scores, the Physical Component Summary (PCS) scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Title
Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 52
Description
There are 8 Short-Form 36-item Health Survey (SF-36) domain scores. In addition to domain scores, the Physical Component Summary (PCS) scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Title
Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 28
Description
The Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Title
Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 52
Description
The Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Title
Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 112
Description
The Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Title
Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 28
Description
The Maastricht Ankylosing Spondylitis Enthesitis (MASES) is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score indicates worsening.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Title
Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 52
Description
The Maastricht Ankylosing Spondylitis Enthesitis (MASES) is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score indicates worsening.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Title
Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 112
Description
The Maastricht Ankylosing Spondylitis Enthesitis (MASES) is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score indicates worsening.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Title
Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 112
Description
There are 8 Short-Form 36-item Health Survey (SF-36) domain scores. In addition to domain scores, the Physical Component Summary (PCS) scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
Time Frame
From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
As0014 50062
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
As0014 50052
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
As0014 50060
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
As0014 50059
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
As0014 50056
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
As0014 50015
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
As0014 50016
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
As0014 50055
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
As0014 50020
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
As0014 50057
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
As0014 40004
City
Bruxelles
Country
Belgium
Facility Name
As0014 40003
City
Genk
Country
Belgium
Facility Name
As0014 40001
City
Gent
Country
Belgium
Facility Name
As0014 40006
City
Plovdiv
Country
Bulgaria
Facility Name
As0014 40007
City
Plovdiv
Country
Bulgaria
Facility Name
As0014 40005
City
Sofia
Country
Bulgaria
Facility Name
As0014 40008
City
Sofia
Country
Bulgaria
Facility Name
As0014 20040
City
Beijing
Country
China
Facility Name
As0014 20021
City
Chengdu
Country
China
Facility Name
As0014 20019
City
Guangzhou
Country
China
Facility Name
As0014 20034
City
Hefei
Country
China
Facility Name
As0014 20024
City
Nanjing
Country
China
Facility Name
As0014 20018
City
Shanghai
Country
China
Facility Name
As0014 20020
City
Shanghai
Country
China
Facility Name
As0014 20026
City
Shanghai
Country
China
Facility Name
As0014 20025
City
Wenzhou
Country
China
Facility Name
As0014 40011
City
Brno
Country
Czechia
Facility Name
As0014 40009
City
Pardubice
Country
Czechia
Facility Name
As0014 40013
City
Praha 11
Country
Czechia
Facility Name
As0014 40016
City
Praha 2
Country
Czechia
Facility Name
As0014 40015
City
Praha 3
Country
Czechia
Facility Name
As0014 40014
City
Praha 4
Country
Czechia
Facility Name
As0014 40010
City
Uherske Hradiste
Country
Czechia
Facility Name
As0014 40012
City
Zlin
Country
Czechia
Facility Name
As0014 40018
City
Boulogne Billancourt
Country
France
Facility Name
As0014 40022
City
Limoges
Country
France
Facility Name
As0014 40025
City
Berlin
Country
Germany
Facility Name
As0014 40029
City
Hamburg
Country
Germany
Facility Name
As0014 40024
City
Hanover
Country
Germany
Facility Name
As0014 40027
City
Herne
Country
Germany
Facility Name
As0014 40078
City
Leipzig
Country
Germany
Facility Name
As0014 40026
City
Ratingen
Country
Germany
Facility Name
As0014 40032
City
Debrecen
Country
Hungary
Facility Name
As0014 40031
City
Szeged
Country
Hungary
Facility Name
As0014 40033
City
Székesfehérvár
Country
Hungary
Facility Name
As0014 20035
City
Bunkyo-ku
Country
Japan
Facility Name
As0014 20030
City
Chuo-ku
Country
Japan
Facility Name
As0014 20039
City
Iruma-gun
Country
Japan
Facility Name
As0014 20036
City
Kawachinagano
Country
Japan
Facility Name
As0014 20045
City
Kita-gun
Country
Japan
Facility Name
As0014 20065
City
Kitakyushu
Country
Japan
Facility Name
As0014 20037
City
Osaka
Country
Japan
Facility Name
As0014 20084
City
Saga
Country
Japan
Facility Name
As0014 20048
City
Saitama
Country
Japan
Facility Name
As0014 20031
City
Sapporo
Country
Japan
Facility Name
As0014 20032
City
Suita
Country
Japan
Facility Name
As0014 40034
City
Amsterdam
Country
Netherlands
Facility Name
As0014 40038
City
Elblag
Country
Poland
Facility Name
As0014 40042
City
Krakow
Country
Poland
Facility Name
As0014 40037
City
Lublin
Country
Poland
Facility Name
As0014 40044
City
Poznan
Country
Poland
Facility Name
As0014 40040
City
Torun
Country
Poland
Facility Name
As0014 40041
City
Warszawa
Country
Poland
Facility Name
As0014 40039
City
Wroclaw
Country
Poland
Facility Name
As0014 40043
City
Wroclaw
Country
Poland
Facility Name
As0014 40045
City
A Coruna
Country
Spain
Facility Name
As0014 40046
City
Cordoba
Country
Spain
Facility Name
As0014 40048
City
Santiago de Compostela
Country
Spain
Facility Name
As0014 40049
City
Sevilla
Country
Spain
Facility Name
As0014 40052
City
Ankara
Country
Turkey
Facility Name
As0014 40053
City
Ankara
Country
Turkey
Facility Name
As0014 40050
City
Istanbul
Country
Turkey
Facility Name
As0014 40057
City
Edinburgh
Country
United Kingdom
Facility Name
As0014 40056
City
Leeds
Country
United Kingdom
Facility Name
As0014 40055
City
Norwich
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD Sharing Time Frame
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD Sharing URL
https://www.Vivli.org
Learn more about this trial
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis
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