BE MOVING: 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
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bimekizumab Subjects will receive bimekizumab throughout the Treatment Period. |
Drug: Bimekizumab
Subjects will receive bimekizumab at prespecified time-points.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with treatment-emergent adverse events (TEAEs) during the study [From Baseline (Day 1) until Safety Follow-Up (up to Week 128)]
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 [From Baseline (Day 1) until Safety Follow-Up (up to Week 128)]
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 [From Baseline (Day 1) until Safety Follow-Up (up to Week 128)]
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 [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))
- Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52 [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 [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 [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 [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 [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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [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 ASAS domains.
- Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 52 [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 [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 [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 [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 [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 [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 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 52 [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 [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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28]
Change from baseline in the nocturnal spinal pain 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 nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 52 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52]
Change from baseline in the nocturnal spinal pain 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 Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 112 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112]
Change from baseline in the nocturnal spinal pain 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) at Week 28 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 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 52 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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 [From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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In the opinion of the Investigator, the study participant is expected to benefit from participation in this extension study
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Study participant completed AS0010 (NCT03928704) or AS0011 (NCT03928743)
Exclusion Criteria:
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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
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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
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Study participant has a positive or indeterminate interferon gamma release assay (IGRA) in AS0010 or AS0011, unless appropriately evaluated and treated
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | As0014 50062 | Glendale | Arizona | United States | 85306 |
| 2 | As0014 50052 | Phoenix | Arizona | United States | 85032 |
| 3 | As0014 50060 | Upland | California | United States | 91786 |
| 4 | As0014 50059 | Ormond Beach | Florida | United States | 32174 |
| 5 | As0014 50056 | Sarasota | Florida | United States | 34239 |
| 6 | As0014 50015 | Hagerstown | Maryland | United States | 21740 |
| 7 | As0014 50016 | Saint Louis | Missouri | United States | 63141 |
| 8 | As0014 50055 | Portland | Oregon | United States | 97239 |
| 9 | As0014 50020 | Duncansville | Pennsylvania | United States | 16635 |
| 10 | As0014 50057 | Dallas | Texas | United States | 75231 |
| 11 | As0014 50061 | Spokane | Washington | United States | 99204 |
| 12 | As0014 40004 | Brussels | Belgium | ||
| 13 | As0014 40003 | Genk | Belgium | ||
| 14 | As0014 40001 | Gent | Belgium | ||
| 15 | As0014 40006 | Plovdiv | Bulgaria | ||
| 16 | As0014 40007 | Plovdiv | Bulgaria | ||
| 17 | As0014 40005 | Sofia | Bulgaria | ||
| 18 | As0014 40008 | Sofia | Bulgaria | ||
| 19 | As0014 20040 | Beijing | China | ||
| 20 | As0014 20021 | Chengdu | China | ||
| 21 | As0014 20019 | Guangzhou | China | ||
| 22 | As0014 20024 | Nanjing | China | ||
| 23 | As0014 20020 | Shanghai | China | ||
| 24 | As0014 20026 | Shanghai | China | ||
| 25 | As0014 20025 | Wenzhou | China | ||
| 26 | As0014 40011 | Brno | Czechia | ||
| 27 | As0014 40009 | Pardubice | Czechia | ||
| 28 | As0014 40013 | Praha 11 | Czechia | ||
| 29 | As0014 40016 | Praha 2 | Czechia | ||
| 30 | As0014 40014 | Praha 4 | Czechia | ||
| 31 | As0014 40015 | Praha | Czechia | ||
| 32 | As0014 40010 | Uherské Hradiště | Czechia | ||
| 33 | As0014 40012 | Zlín | Czechia | ||
| 34 | As0014 40018 | Boulogne-Billancourt | France | ||
| 35 | As0014 40022 | Limoges | France | ||
| 36 | As0014 40025 | Berlin | Germany | ||
| 37 | As0014 40029 | Hamburg | Germany | ||
| 38 | As0014 40024 | Hannover | Germany | ||
| 39 | As0014 40027 | Herne | Germany | ||
| 40 | As0014 40078 | Leipzig | Germany | ||
| 41 | As0014 40026 | Ratingen | Germany | ||
| 42 | As0014 40032 | Debrecen | Hungary | ||
| 43 | As0014 40031 | Szeged | Hungary | ||
| 44 | As0014 40033 | Székesfehérvár | Hungary | ||
| 45 | As0014 20035 | Bunkyō-Ku | Japan | ||
| 46 | As0014 20030 | Chuo Ku | Japan | ||
| 47 | As0014 20039 | Iruma-Gun | Japan | ||
| 48 | As0014 20036 | Kawachi-Nagano | Japan | ||
| 49 | As0014 20045 | Kita-Gun | Japan | ||
| 50 | As0014 20065 | Kitakyushu | Japan | ||
| 51 | As0014 20037 | Osaka | Japan | ||
| 52 | As0014 20084 | Saga | Japan | ||
| 53 | As0014 20048 | Saitama | Japan | ||
| 54 | As0014 20031 | Sapporo | Japan | ||
| 55 | As0014 20032 | Suita | Japan | ||
| 56 | As0014 40034 | Amsterdam | Netherlands | ||
| 57 | As0014 40038 | Elbląg | Poland | ||
| 58 | As0014 40042 | Kraków | Poland | ||
| 59 | As0014 40037 | Lublin | Poland | ||
| 60 | As0014 40044 | Poznań | Poland | ||
| 61 | As0014 40040 | Toruń | Poland | ||
| 62 | As0014 40041 | Warsaw | Poland | ||
| 63 | As0014 40043 | Wroclaw | Poland | ||
| 64 | As0014 40039 | Wrocław | Poland | ||
| 65 | S0014 40045 | Coruña | Spain | ||
| 66 | As0014 40046 | Córdoba | Spain | ||
| 67 | As0014 40048 | Santiago De Compostela | Spain | ||
| 68 | As0014 40049 | Sevilla | Spain | ||
| 69 | As0014 40052 | Ankara | Turkey | ||
| 70 | As0014 40053 | Ankara | Turkey | ||
| 71 | As0014 40050 | Istanbul | Turkey | ||
| 72 | As0014 40057 | Edinburgh | United Kingdom | ||
| 73 | As0014 40056 | Leeds | United Kingdom | ||
| 74 | As0014 40055 | Norwich | United Kingdom |
Sponsors and Collaborators
- UCB Biopharma SRL
Investigators
- Study Director: UCB Cares, 001 844 599 2273 (UCB)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AS0014
- 2019-004163-47