Back to resultsA Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis (BE MOBILE 1)
Primary Purpose
Nonradiographic Axial Spondyloarthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nonradiographic Axial Spondyloarthritis focused on measuring Nonradiographic axial spondyloarthritis, Axial spondyloarthritis, Nr-axSpA, Bimekizumab
Eligibility Criteria
Inclusion Criteria:
- Male or female patients at least 18 years of age
Patient has nonradiographic axial spondyloarthritis (nr-axSpA) with all of the following criteria:
- Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) classification criteria
- Inflammatory back pain for at least 3 months
- Age at symptom onset of less than 45 years
- NO sacroiliitis (in Anterior-Posterior pelvis or sacroiliac x-ray)
- Active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 AND spinal pain >=4 on a 0 to 10 Numeric Rating Scale
- Objective inflammation defined by sacroiliitis on magnetic resonance imaging and/or elevated C-reactive protein
- Subjects had to have either failed to respond to 2 different nonsteroidal anti-inflammatory drugs (NSAIDs) given at the maximum tolerated dose for a total of 4 weeks or have a history of intolerance to or a contraindication to NSAID therapy
- Patients who have taken a tumor necrosis factor alpha (TNFα) inhibitor must have experienced an inadequate response or intolerance to treatment given at an approved dose for at least 12 weeks
- Patients currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics, corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
Exclusion Criteria:
- Treatment with more than 1 TNFα inhibitor and/or more than 2 additional non-TNFα biological response modifiers, or any interleukin (IL)-17 biological response modifier
- Active infection or history of recent serious infections
- Viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- Any live (includes attenuated) vaccination within the 8 weeks prior to entering the study or TB (Bacillus Calmette-Guerin) vaccination within 1 year prior entering the study
- Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection
- Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma or in situ cervical cancer
- Diagnosis of inflammatory conditions other than axial spondyloarthritis (axSpA), including but not limited to psoriatic arthritis, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, and reactive arthritis. Patients with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease when entering the study
- Presence of active suicidal ideation, or moderately severe major depression or severe major depression
- Female patients who are breastfeeding, pregnant, or planning to become pregnant during the study
- Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
Sites / Locations
- As0010 50131
- As0010 50052
- As0010 50062
- As0010 50060
- As0010 50059
- As0010 50056
- As0010 50015
- As0010 50016
- As0010 50055
- As0010 50020
- As0010 50012
- As0010 50057
- As0010 50036
- As0010 50061
- As0010 40004
- As0010 40003
- As0010 40001
- As0010 40002
- As0010 40006
- As0010 40007
- As0010 40005
- As0010 40008
- As0010 20040
- As0010 20021
- As0010 20019
- As0010 20034
- As0010 20024
- As0010 20018
- As0010 20020
- As0010 20026
- As0010 20025
- As0010 40011
- As0010 40009
- As0010 40013
- As0010 40016
- As0010 40014
- As0010 40015
- As0010 40010
- As0010 40012
- As0010 40018
- As0010 40022
- As0010 40025
- As0010 40029
- As0010 40024
- As0010 40027
- As0010 40078
- As0010 40026
- As0010 40032
- As0010 40031
- As0010 40080
- As0010 40033
- As0010 20030
- As0010 20039
- As0010 20036
- As0010 20045
- As0010 20065
- As0010 20038
- As0010 20037
- As0010 20084
- As0010 20048
- As0010 20031
- As0010 20035
- As0010 40038
- As0010 40042
- As0010 40037
- As0010 40044
- As0010 40040
- As0010 40041
- As0010 40039
- As0010 40043
- As0010 40045
- As0010 40046
- As0010 40047
- As0010 40048
- As0010 40049
- As0010 40052
- As0010 40053
- As0010 40050
- As0010 40051
- As0010 40057
- As0010 40056
- As0010 40054
- As0010 40055
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bimekizumab
Placebo
Arm Description
Subjects randomized to this arm will receive bimekizumab during the Double-Blind Treatment Period and the Maintenance Period.
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and receive bimekizumab during the Maintenance Period.
Outcomes
Primary Outcome Measures
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 16
ASAS40 will be calculated relative to Baseline. 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))
Secondary Outcome Measures
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response in TNFα inhibitor-naïve subjects at Week 16
ASAS40 will be calculated relative to Baseline. 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))
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) total score at Week 16
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 scores ranges from 0 to 10, with lower scores indicating lower disease activity.
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 16
ASAS20 will be calculated relative to Baseline. 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 (ASAS) partial remission (PR) at Week 16
The Assessment of SpondyloArthritis International Society (ASAS) partial remission (PR) is defined as a score of <=2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.
Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) at Week 16
Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) is achieved when there is a reduction (improvement) >= 2.0 in the Ankylosing Spondylitis Disease Activity Score (ASDAS) relative to Baseline.
ASDAS is calculated as the sum of the following components:
0.121 × Total back pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q2 result)
0.058 × Duration of morning stiffness (BASDAI Q6 result)
0.110 × Patient's Global Assessment of Disease Activity (PGADA)
0.073 × Peripheral pain/swelling (BASDAI Q3 result)
0.579 × (natural logarithm of the C-reactive protein (CRP) [mg/L] + 1) Total back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units).
High ASDAS scores mean worse disease. If a subjects achieves the ASDAS-MI it indicates a major improvement of their disease.
Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 16
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 ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).
Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16
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 score Numeric Rating Scale (NRS) at Week 16
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) total score at Week 16
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) score at Week 16
There are 8 SF-36 domain scores. In addition to domain scores, the 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 16
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 in the subgroup of subjects with enthesitis at Baseline at Week 16
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.
Enthesitis-free state based on the Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) Index in the subgroup of subjects with enthesitis at Baseline at Week 16
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.
Incidence of 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.
Incidence of treatment-emergent 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
Treatment-emergent adverse events (AEs) leading to withdrawal from investigational medicinal product (IMP) 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03928704
Brief Title
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis
Acronym
BE MOBILE 1
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
June 29, 2022 (Actual)
Study Completion Date
April 17, 2023 (Actual)
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 efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active nonradiographic axial spondyloarthritis (nr-axSpA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonradiographic Axial Spondyloarthritis
Keywords
Nonradiographic axial spondyloarthritis, Axial spondyloarthritis, Nr-axSpA, Bimekizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimekizumab
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive bimekizumab during the Double-Blind Treatment Period and the Maintenance Period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and receive bimekizumab during the Maintenance Period.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
BKZ, UCB4940
Intervention Description
Subjects will receive bimekizumab at pre-specified time-points.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Subjects will receive placebo at pre-specified time-points during the Double-Blind Treatment Period.
Primary Outcome Measure Information:
Title
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 16
Description
ASAS40 will be calculated relative to Baseline. 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 16
Secondary Outcome Measure Information:
Title
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response in TNFα inhibitor-naïve subjects at Week 16
Description
ASAS40 will be calculated relative to Baseline. 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 16
Title
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) total score at Week 16
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 scores ranges from 0 to 10, with lower scores indicating lower disease activity.
Time Frame
Baseline, Week 16
Title
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 16
Description
ASAS20 will be calculated relative to Baseline. 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 16
Title
Assessment of SpondyloArthritis International Society (ASAS) partial remission (PR) at Week 16
Description
The Assessment of SpondyloArthritis International Society (ASAS) partial remission (PR) is defined as a score of <=2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.
Time Frame
Week 16
Title
Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) at Week 16
Description
Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) is achieved when there is a reduction (improvement) >= 2.0 in the Ankylosing Spondylitis Disease Activity Score (ASDAS) relative to Baseline.
ASDAS is calculated as the sum of the following components:
0.121 × Total back pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q2 result)
0.058 × Duration of morning stiffness (BASDAI Q6 result)
0.110 × Patient's Global Assessment of Disease Activity (PGADA)
0.073 × Peripheral pain/swelling (BASDAI Q3 result)
0.579 × (natural logarithm of the C-reactive protein (CRP) [mg/L] + 1) Total back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units).
High ASDAS scores mean worse disease. If a subjects achieves the ASDAS-MI it indicates a major improvement of their disease.
Time Frame
Week 16
Title
Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 16
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 ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).
Time Frame
Week 16
Title
Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16
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
Baseline, Week 16
Title
Change from Baseline in nocturnal spinal pain score Numeric Rating Scale (NRS) at Week 16
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
Baseline, Week 16
Title
Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) total score at Week 16
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
Baseline, Week 16
Title
Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) score at Week 16
Description
There are 8 SF-36 domain scores. In addition to domain scores, the 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
Baseline, Week 16
Title
Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 16
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
Baseline, Week 16
Title
Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index in the subgroup of subjects with enthesitis at Baseline at Week 16
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
Baseline, Week 16
Title
Enthesitis-free state based on the Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) Index in the subgroup of subjects with enthesitis at Baseline at Week 16
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
Baseline, Week 16
Title
Incidence of 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 72)
Title
Incidence of treatment-emergent 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 72)
Title
Treatment-emergent adverse events (AEs) leading to withdrawal from investigational medicinal product (IMP) 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 72)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients at least 18 years of age
Patient has nonradiographic axial spondyloarthritis (nr-axSpA) with all of the following criteria:
Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) classification criteria
Inflammatory back pain for at least 3 months
Age at symptom onset of less than 45 years
NO sacroiliitis (in Anterior-Posterior pelvis or sacroiliac x-ray)
Active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 AND spinal pain >=4 on a 0 to 10 Numeric Rating Scale
Objective inflammation defined by sacroiliitis on magnetic resonance imaging and/or elevated C-reactive protein
Subjects had to have either failed to respond to 2 different nonsteroidal anti-inflammatory drugs (NSAIDs) given at the maximum tolerated dose for a total of 4 weeks or have a history of intolerance to or a contraindication to NSAID therapy
Patients who have taken a tumor necrosis factor alpha (TNFα) inhibitor must have experienced an inadequate response or intolerance to treatment given at an approved dose for at least 12 weeks
Patients currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics, corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
Exclusion Criteria:
Treatment with more than 1 TNFα inhibitor and/or more than 2 additional non-TNFα biological response modifiers, or any interleukin (IL)-17 biological response modifier
Active infection or history of recent serious infections
Viral hepatitis B or C or human immunodeficiency virus (HIV) infection
Any live (includes attenuated) vaccination within the 8 weeks prior to entering the study or TB (Bacillus Calmette-Guerin) vaccination within 1 year prior entering the study
Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection
Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma or in situ cervical cancer
Diagnosis of inflammatory conditions other than axial spondyloarthritis (axSpA), including but not limited to psoriatic arthritis, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, and reactive arthritis. Patients with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease when entering the study
Presence of active suicidal ideation, or moderately severe major depression or severe major depression
Female patients who are breastfeeding, pregnant, or planning to become pregnant during the study
Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273
Official's Role
Study Director
Facility Information:
Facility Name
As0010 50131
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
As0010 50052
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
As0010 50062
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
As0010 50060
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
As0010 50059
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
As0010 50056
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
As0010 50015
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
As0010 50016
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
As0010 50055
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3011
Country
United States
Facility Name
As0010 50020
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
As0010 50012
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119-5214
Country
United States
Facility Name
As0010 50057
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
As0010 50036
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
As0010 50061
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
As0010 40004
City
Bruxelles
Country
Belgium
Facility Name
As0010 40003
City
Genk
Country
Belgium
Facility Name
As0010 40001
City
Gent
Country
Belgium
Facility Name
As0010 40002
City
Merksem
Country
Belgium
Facility Name
As0010 40006
City
Plovdiv
Country
Bulgaria
Facility Name
As0010 40007
City
Plovdiv
Country
Bulgaria
Facility Name
As0010 40005
City
Sofia
Country
Bulgaria
Facility Name
As0010 40008
City
Sofia
Country
Bulgaria
Facility Name
As0010 20040
City
Beijing
Country
China
Facility Name
As0010 20021
City
Chengdu
Country
China
Facility Name
As0010 20019
City
Guangzhou
Country
China
Facility Name
As0010 20034
City
Hefei
Country
China
Facility Name
As0010 20024
City
Nanjing
Country
China
Facility Name
As0010 20018
City
Shanghai
Country
China
Facility Name
As0010 20020
City
Shanghai
Country
China
Facility Name
As0010 20026
City
Shanghai
Country
China
Facility Name
As0010 20025
City
Wenzhou
Country
China
Facility Name
As0010 40011
City
Brno
Country
Czechia
Facility Name
As0010 40009
City
Pardubice
Country
Czechia
Facility Name
As0010 40013
City
Praha 11
Country
Czechia
Facility Name
As0010 40016
City
Praha 2
Country
Czechia
Facility Name
As0010 40014
City
Praha 4
Country
Czechia
Facility Name
As0010 40015
City
Praha
Country
Czechia
Facility Name
As0010 40010
City
Uherske Hradiste
Country
Czechia
Facility Name
As0010 40012
City
Zlin
Country
Czechia
Facility Name
As0010 40018
City
Boulogne Billancourt
Country
France
Facility Name
As0010 40022
City
Limoges
Country
France
Facility Name
As0010 40025
City
Berlin
Country
Germany
Facility Name
As0010 40029
City
Hamburg
Country
Germany
Facility Name
As0010 40024
City
Hanover
Country
Germany
Facility Name
As0010 40027
City
Herne
Country
Germany
Facility Name
As0010 40078
City
Leipzig
Country
Germany
Facility Name
As0010 40026
City
Ratingen
Country
Germany
Facility Name
As0010 40032
City
Debrecen
Country
Hungary
Facility Name
As0010 40031
City
Szeged
Country
Hungary
Facility Name
As0010 40080
City
Szombathely
Country
Hungary
Facility Name
As0010 40033
City
Székesfehérvár
Country
Hungary
Facility Name
As0010 20030
City
Chuo-ku
Country
Japan
Facility Name
As0010 20039
City
Iruma-gun
Country
Japan
Facility Name
As0010 20036
City
Kawachinagano
Country
Japan
Facility Name
As0010 20045
City
Kita-gun
Country
Japan
Facility Name
As0010 20065
City
Kitakyushu
Country
Japan
Facility Name
As0010 20038
City
Nankoku-shi
Country
Japan
Facility Name
As0010 20037
City
Osaka
Country
Japan
Facility Name
As0010 20084
City
Saga
Country
Japan
Facility Name
As0010 20048
City
Saitama
Country
Japan
Facility Name
As0010 20031
City
Sapporo
Country
Japan
Facility Name
As0010 20035
City
Tokyo
Country
Japan
Facility Name
As0010 40038
City
Elblag
Country
Poland
Facility Name
As0010 40042
City
Krakow
Country
Poland
Facility Name
As0010 40037
City
Lublin
Country
Poland
Facility Name
As0010 40044
City
Poznan
Country
Poland
Facility Name
As0010 40040
City
Torun
Country
Poland
Facility Name
As0010 40041
City
Warszawa
Country
Poland
Facility Name
As0010 40039
City
Wroclaw
Country
Poland
Facility Name
As0010 40043
City
Wroclaw
Country
Poland
Facility Name
As0010 40045
City
A Coruna
Country
Spain
Facility Name
As0010 40046
City
Cordoba
Country
Spain
Facility Name
As0010 40047
City
Madrid
Country
Spain
Facility Name
As0010 40048
City
Santiago de Compostela
Country
Spain
Facility Name
As0010 40049
City
Sevilla
Country
Spain
Facility Name
As0010 40052
City
Ankara
Country
Turkey
Facility Name
As0010 40053
City
Ankara
Country
Turkey
Facility Name
As0010 40050
City
Istanbul
Country
Turkey
Facility Name
As0010 40051
City
Izmir
Country
Turkey
Facility Name
As0010 40057
City
Edinburgh
Country
United Kingdom
Facility Name
As0010 40056
City
Leeds
Country
United Kingdom
Facility Name
As0010 40054
City
London
Country
United Kingdom
Facility Name
As0010 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
http://www.Vivli.org
Citations:
PubMed Identifier
36649967
Citation
van der Heijde D, Deodhar A, Baraliakos X, Brown MA, Dobashi H, Dougados M, Elewaut D, Ellis AM, Fleurinck C, Gaffney K, Gensler LS, Haroon N, Magrey M, Maksymowych WP, Marten A, Massow U, Oortgiesen M, Poddubnyy D, Rudwaleit M, Shepherd-Smith J, Tomita T, Van den Bosch F, Vaux T, Xu H. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials. Ann Rheum Dis. 2023 Apr;82(4):515-526. doi: 10.1136/ard-2022-223595. Epub 2023 Jan 17. Erratum In: Ann Rheum Dis. 2023 Sep;82(9):e213.
Results Reference
result
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis
We'll reach out to this number within 24 hrs