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Trial record 1 of 1 for:    NCT04436640
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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 (BE MOVING)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04436640
Recruitment Status : Enrolling by invitation
First Posted : June 18, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

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
Axial Spondyloarthritis Ankylosing Spondylitis r-axSpa Drug: Bimekizumab Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 485 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 16, 2020
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


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:
  • BKZ
  • UCB4940




Primary Outcome Measures :
  1. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study [ Time Frame: 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.

  2. Percentage of participants with serious adverse events (SAEs) during the study [ Time Frame: 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

  3. Percentage of participants with with treatment-emergent adverse Events (TEAEs) leading to withdrawal from the study [ Time Frame: 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 :
  1. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28 [ Time Frame: 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))

  2. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52 [ Time Frame: 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))

  3. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112 [ Time Frame: 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))

  4. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28 [ Time Frame: 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))

  5. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52 [ Time Frame: 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))

  6. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112 [ Time Frame: 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))

  7. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 28 [ Time Frame: 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.

  8. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52 [ Time Frame: 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.

  9. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 112 [ Time Frame: 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.

  10. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 28 [ Time Frame: 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.

  11. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 52 [ Time Frame: 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.

  12. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 112 [ Time Frame: 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.

  13. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 28 [ Time Frame: 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.


  14. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 52 [ Time Frame: 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.


  15. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 112 [ Time Frame: 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)


  16. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 28 [ Time Frame: 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).

  17. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 52 [ Time Frame: 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).

  18. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 112 [ Time Frame: 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).

  19. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 28 [ Time Frame: 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.

  20. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52 [ Time Frame: 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.

  21. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 112 [ Time Frame: 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.

  22. Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 28 [ Time Frame: 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.

  23. Change from Baseline in nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 52 [ Time Frame: 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.

  24. Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 112 [ Time Frame: 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.

  25. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 28 [ Time Frame: 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.

  26. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52 [ Time Frame: 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.

  27. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 112 [ Time Frame: 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.

  28. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 28 [ Time Frame: 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.

  29. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 52 [ Time Frame: 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.

  30. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 28 [ Time Frame: 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.

  31. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 52 [ Time Frame: 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.

  32. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 112 [ Time Frame: 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.

  33. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 28 [ Time Frame: 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.

  34. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 52 [ Time Frame: 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.

  35. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 112 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436640


Locations
Show Show 36 study locations
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
Layout table for investigator information
Study Director: UCB Cares 001 844 599 2273 (UCB)
Layout table for additonal information
Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04436640    
Other Study ID Numbers: AS0014
2019-004163-47 ( EudraCT Number )
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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.
URL: https://www.Vivli.org

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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
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
AxSpa
Radiographic
Non-radiographic
AS
Bimekizumab
Axial spondyloarthritis
Ankylosing spondylitis
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis