Axial SpondyloarthritisPhase 3BE MOVINGNCT04436640
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
A Phase 3 study testing Bimekizumab in people with Axial Spondyloarthritis and Ankylosing Spondylitis, run by UCB Biopharma SRL at 75 sites in 14 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis, Ankylosing Spondylitis, r-axSpa
- What is being tested?
- Bimekizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 75 sitesin 14 countries
- Study dates
- 16 Jun 2020to 9 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
75 sites in 14 countries.
75 sites in 14 countries
Japan11 sites
As0014 20035
Bunkyō City
As0014 20030
Chūōku
As0014 20039
Iruma-gun
As0014 20036
Kawachi-Nagano
As0014 20045
Kita-gun
As0014 20065
Kitakyushu
As0014 20037
Osaka
As0014 20084
Saga
As0014 20048
Saitama
As0014 20031
Sapporo
As0014 20032
Suita
United States10 sites
As0014 50057
Dallas, Texas, 75231
As0014 50020
Duncansville, Pennsylvania, 16635
As0014 50062
Glendale, Arizona, 85306
As0014 50015
Hagerstown, Maryland, 21740
As0014 50059
Ormond Beach, Florida, 32174
As0014 50052
Phoenix, Arizona, 85032
As0014 50055
Portland, Oregon, 97239
As0014 50056
Sarasota, Florida, 34239
As0014 50016
St Louis, Missouri, 63141
As0014 50060
Upland, California, 91786
China9 sites
As0014 20040
Beijing
As0014 20021
Chengdu
As0014 20019
Guangzhou
As0014 20034
Hefei
As0014 20024
Nanjing
As0014 20018
Shanghai
As0014 20020
Shanghai
As0014 20026
Shanghai
As0014 20025
Wenzhou
Czechia8 sites
As0014 40011
Brno
As0014 40009
Pardubice
As0014 40013
Prague
As0014 40014
Prague
As0014 40015
Prague
As0014 40016
Prague
As0014 40010
Uherské Hradiště
As0014 40012
Zlín
Poland8 sites
As0014 40038
Elblag
As0014 40042
Krakow
As0014 40037
Lublin
As0014 40044
Poznan
As0014 40040
Torun
As0014 40041
Warsaw
As0014 40039
Wroclaw
As0014 40043
Wroclaw
Germany6 sites
As0014 40025
Berlin
As0014 40029
Hamburg
As0014 40024
Hanover
As0014 40027
Herne
As0014 40078
Leipzig
As0014 40026
Ratingen
Bulgaria4 sites
As0014 40006
Plovdiv
As0014 40007
Plovdiv
As0014 40005
Sofia
As0014 40008
Sofia
Spain4 sites
As0014 40045
A Coruña
As0014 40046
Córdoba
As0014 40048
Santiago de Compostela
As0014 40049
Seville
Hungary3 sites
As0014 40032
Debrecen
As0014 40031
Szeged
As0014 40033
Székesfehérvár
Turkey (Türkiye)3 sites
As0014 40052
Ankara
As0014 40053
Ankara
As0014 40050
Istanbul
United Kingdom3 sites
As0014 40057
Edinburgh
As0014 40056
Leeds
As0014 40055
Norwich
About this study
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
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).
- Conditions
- Axial Spondyloarthritis, Ankylosing Spondylitis, r-axSpa, Nr-axSpa
- Being tested
- Bimekizumab
- Keywords
- AxSpa, Radiographic, Non-radiographic, AS, Bimekizumab, Axial spondyloarthritis, Ankylosing spondylitis
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing, Non-Radiographic Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimekizumabDrug
Also called BKZ, UCB4940
Subjects will receive bimekizumab at prespecified time-points.
| Study group | Role | What they receive |
|---|---|---|
| Bimekizumab | Experimental | Subjects will receive bimekizumab throughout the Treatment Period. Receives: Drug: Bimekizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
Percentage of participants with serious adverse events (SAEs) during the study
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
- Results in death
- Is life-threatening
- Requires in patient hospitalisation or prolongation of existing hospitalisation
- Is a congenital anomaly or birth defect
- Is an infection that requires treatment with parenteral antibiotics
- Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
Measured: From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
Percentage of participants with with treatment-emergent adverse Events (TEAEs) leading to withdrawal from the study
Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Measured: From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
Secondary outcomes (36)
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28
ASAS40 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are defined as relative improvements of at least 40%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains and no worsening at all in the remaining domain.
The domains are:
- Patient's Global Assessment of Disease Activity (PGADA)
- Pain assessment (the total spinal pain, NRS score)
- Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))-
- Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 concerning morning stiffness intensity and duration)
Measured: Week 28
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52
ASAS40 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are defined as relative improvements of at least 40%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains and no worsening at all in the remaining domain.
The domains are:
- Patient's Global Assessment of Disease Activity (PGADA)
- Pain assessment (the total spinal pain, NRS score)
- Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
- Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Measured: Week 52
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112
ASAS40 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are defined as relative improvements of at least 40%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains and no worsening at all in the remaining domain.
The domains are:
- Patient's Global Assessment of Disease Activity (PGADA)
- Pain assessment (the total spinal pain, NRS score)
- Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
- Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Measured: Week 112
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28
ASAS20 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 20% improvement are defined as relative improvements of at least 20%, and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain.
The domains are:
- Patient's Global Assessment of Disease Activity (PGADA)
- Pain assessment (the total spinal pain, NRS score)
- Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
- Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Measured: Week 28
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52
ASAS20 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 20% improvement are defined as relative improvements of at least 20%, and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain.
The domains are:
- Patient's Global Assessment of Disease Activity (PGADA)
- Pain assessment (the total spinal pain, NRS score)
- Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
- Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Measured: Week 52
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112
ASAS20 will be calculated relative to Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743). The Assessment of SpondyloArthritis International Society (ASAS) criteria for 20% improvement are defined as relative improvements of at least 20%, and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain.
The domains are:
- Patient's Global Assessment of Disease Activity (PGADA)
- Pain assessment (the total spinal pain, NRS score)
- Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
- Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Measured: Week 112
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 28
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 112
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated self-reported instrument, which consists of six 10-unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 28
The Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) is defined as a score of <=2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS40 domains.
Measured: Week 28
Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 52
The Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) is defined as a score of <=2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS domains.
Measured: Week 52
Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 112
The Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) is defined as a score of <=2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS domains.
Measured: Week 112
Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 28
The ASDAS-C-Reactive Protein (ASDAS-CRP) consists of a number of assessments which are scored by the study participant and physician and multiplied by a proven formula as shown below:
0.121 x Total back pain (represented by the BASDAI Question 2 result) 0.058 x Duration of morning stiffness (represented by the BASDAI Question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (represented by the BASDAI Question 3 result) 0.579 x (natural logarithm of the hs-CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The sum of these weighted components gives the ASDAS-CRP.
Measured: Week 28
Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 52
The ASDAS-C-Reactive Protein (ASDAS-CRP) consists of a number of assessments which are scored by the study participant and physician and multiplied by a proven formula as shown below:
0.121 x Total back pain (represented by the BASDAI Question 2 result) 0.058 x Duration of morning stiffness (represented by the BASDAI Question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (represented by the BASDAI Question 3 result) 0.579 x (natural logarithm of the hs-CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The sum of these weighted components gives the ASDAS-CRP.
Measured: Week 52
Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 112
The ASDAS-C-Reactive Protein (ASDAS-CRP) consists of a number of assessments which are scored by the study participant and physician and multiplied by a proven formula as shown below:
0.121 x Total back pain (represented by the BASDAI Question 2 result) 0.058 x Duration of morning stiffness (represented by the BASDAI Question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (represented by the BASDAI Question 3 result) 0.579 x (natural logarithm of the hs-CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The sum of these weighted components gives the ASDAS-CRP.+ 1)
Measured: Week 112
Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 28
The Assessment of SpondyloArthritis International Society (ASAS) 5/6 response is defined as achieving at least 20% improvement in 5 of 6 domains, including the 4 domains defined for ASAS40 domains as well as spinal mobility (lateral spinal flexion) and high sensitivity C-reactive Protein (hs-CRP).
Measured: Week 28
Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 52
The Assessment of SpondyloArthritis International Society (ASAS) 5/6 response is defined as achieving at least 20% improvement in 5 of 6 domains, including the 4 domains defined for ASAS domains as well as spinal mobility (lateral spinal flexion) and high sensitivity C-reactive Protein (hs-CRP).
Measured: Week 52
Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 112
The Assessment of SpondyloArthritis International Society (ASAS) 5/6 response is defined as achieving at least 20% improvement in 5 of 6 domains, including the 4 domains defined for ASAS domains as well as spinal mobility (lateral spinal flexion) and high sensitivity C-reactive Protein (hs-CRP).
Measured: Week 112
Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 28
The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ('Easy') to 10 ('Impossible'). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52
The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ('Easy') to 10 ('Impossible'). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 112
The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ('Easy') to 10 ('Impossible'). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 28
Nocturnal spinal pain experienced by ankylosing spondylitis (AS) subjects is measured by one question: pain in the spine at night due to AS?. When responding, the subject is to consider the average amount of pain in the preceding week. It is assessed on a numerical scale (0 to 10 units). A lower score indicates less pain and an improvement of the outcome.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Change from Baseline in nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 52
Nocturnal spinal pain experienced by ankylosing spondylitis (AS) subjects is measured by one question: pain in the spine at night due to AS?. When responding, the subject is to consider the average amount of pain in the preceding week. It is assessed on a numerical scale (0 to 10 units). A lower score indicates less pain and an improvement of the outcome.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 112
Nocturnal spinal pain experienced by ankylosing spondylitis (AS) subjects is measured by one question: pain in the spine at night due to AS?. When responding, the subject is to consider the average amount of pain in the preceding week. It is assessed on a numerical scale (0 to 10 units). A lower score indicates less pain and an improvement of the outcome.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 28
The Ankylosing Spondylitis Quality of Life (ASQoL), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in subjects with ankylosing spondylitis (AS) and has shown to be responsive in axial spondyloarthritis (axSpA). The ASQoL score ranges from 0 to 18 with a higher score indicating worse HRQoL.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52
The Ankylosing Spondylitis Quality of Life (ASQoL), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in subjects with ankylosing spondylitis (AS) and has shown to be responsive in axial spondyloarthritis (axSpA). The ASQoL score ranges from 0 to 18 with a higher score indicating worse HRQoL.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 112
The Ankylosing Spondylitis Quality of Life (ASQoL), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in subjects with ankylosing spondylitis (AS) and has shown to be responsive in axial spondyloarthritis (axSpA). The ASQoL score ranges from 0 to 18 with a higher score indicating worse HRQoL.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 28
There are 8 Short-Form 36-item Health Survey (SF-36) domain scores. In addition to domain scores, the Physical Component Summary (PCS) scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 52
There are 8 Short-Form 36-item Health Survey (SF-36) domain scores. In addition to domain scores, the Physical Component Summary (PCS) scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 28
The Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 52
The Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 112
The Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 28
The Maastricht Ankylosing Spondylitis Enthesitis (MASES) is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score indicates worsening.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 52
The Maastricht Ankylosing Spondylitis Enthesitis (MASES) is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score indicates worsening.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 112
The Maastricht Ankylosing Spondylitis Enthesitis (MASES) is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score indicates worsening.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 112
There are 8 Short-Form 36-item Health Survey (SF-36) domain scores. In addition to domain scores, the Physical Component Summary (PCS) scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
Measured: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start16 Jun 2020
- Primary completion9 Aug 2026
- Study completion9 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436640
- Sponsor's protocol ID
- AS0014
- Other IDs
- 2019-004163-47, 2023-506527-28, U1111-1304-6865, 2023, 2019
- Acronym
- BE MOVING
- Status last verified
- Sep 2026
- First submitted
- 15 Jun 2020
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Brown MA, Rudwaleit M, van Gaalen FA, Haroon N, Gensler LS, Fleurinck C, Marten A, Massow U, de Peyrecave N, Vaux T, White K, Deodhar A, van der Horst-Bruinsma I. Low uveitis rates in patients with axial spondyloarthritis treated with bimekizumab: pooled results from phase 2b/3 trials. Ann Rheum Dis. 2024 Nov 14;83(12):1722-1730. doi: 10.1136/ard-2024-225933.
PubMed 38977276Ramiro S, Poddubnyy D, Mease PJ, Lopez-Medina C, Kim M, Massow U, Taieb V, Kragstrup TW, McGonagle D. Sustained resolution of enthesitis and peripheral arthritis over 104 weeks with bimekizumab in axial spondyloarthritis. RMD Open. 2025 Oct 22;11(4):e005969. doi: 10.1136/rmdopen-2025-005969.
PubMed 41125403Nikiphorou E, Tillett W, Deodhar A, Dubreuil M, Gossec L, Hwang M, Lubrano E, Machado PM, Rudwaleit M, de Wit M, Kavanagh S, de la Loge C, Ink B, Lambert J, Morup M, Boonen A, Walsh J. Effect of Bimekizumab Treatment on Health Status, Work Productivity, and Productivity Costs Through 3 Years in Axial Spondyloarthritis and Psoriatic Arthritis. J Rheumatol. 2026 Aug 1:jrheum.2026-0104. doi: 10.3899/jrheum.2026-0104. Online ahead of print.
PubMed 42386286Baraliakos X, Deodhar A, van der Heijde D, Van den Bosch F, Magrey M, Maksymowych WP, Tomita T, Xu H, Coarse J, Prajapati C, Manente M, Marten A, Gensler LS. Bimekizumab Long-Term Safety and Efficacy Across the Spectrum of Axial Spondyloarthritis Over 3 Years: Results From 2 Phase III Studies. J Rheumatol. 2026 Aug 1:jrheum.2026-0113. doi: 10.3899/jrheum.2026-0113. Online ahead of print.
PubMed 42297437Navarro-Compan V, Kiltz U, Mease PJ, Dubreuil M, Gaffney K, Deodhar A, de la Loge C, Prajapati C, Kavanagh S, Marzo-Ortega H. Bimekizumab treatment for sustained improvements in patient symptoms and health-related quality of life to 3 years in axial spondyloarthritis: results from the BE MOBILE studies and their open-label extension. RMD Open. 2026 May 13;12(2):e006670. doi: 10.1136/rmdopen-2025-006670.
PubMed 42128532Mease PJ, Merola JF, Magrey M, Nash P, Poddubnyy D, Lebwohl M, Bajracharya R, Ink B, Marten A, Manente M, Peterson L, White K, Gensler LS. Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. 2026 Mar 10;12(1):e006174. doi: 10.1136/rmdopen-2025-006174.
PubMed 41807031Ramiro S, Proft F, Sengupta R, van Tubergen A, Molto A, Gensler LS, Kishimoto M, Taieb V, Kavanagh S, Evans S, Navarro-Compan V. Impact of symptom duration on the short- and long-term efficacy of bimekizumab in axial spondyloarthritis: results up to 2 years. Arthritis Res Ther. 2026 Jan 19;28(1):40. doi: 10.1186/s13075-026-03729-6.
PubMed 41555451Marzo-Ortega H, Navarro-Compan V, Dubreuil M, Mease PJ, Magrey M, Rudwaleit M, D'Agostino MA, Gaffney K, Kay J, de la Loge C, Massow U, Taieb V, Vaux T, Deodhar A. Sustained improvements in spinal pain, morning stiffness, fatigue, sleep, physical function and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: 2-year results from two phase 3 studies. RMD Open. 2025 Nov 28;11(4):e006013. doi: 10.1136/rmdopen-2025-006013.
PubMed 41314667Mease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.
PubMed 40194794
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04436640
- Acronym / sponsor ID
- BE MOVING / AS0014
- Conditions
- Axial Spondyloarthritis, Ankylosing Spondylitis, r-axSpa, Nr-axSpa
- Keywords
- AxSpa, Radiographic, Non-radiographic, AS, Bimekizumab, Axial spondyloarthritis, Ankylosing spondylitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 9 Aug 2026 (actual)
- Study completion
- 9 Aug 2026 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bimekizumab | Experimental | Drug: BimekizumabSubjects will receive bimekizumab throughout the Treatment Period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BimekizumabAlso: BKZ, UCB4940Subjects will receive bimekizumab at prespecified time-points. | Drug | Bimekizumab |
Primary outcome
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 180)
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
Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
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
Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
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.
36 secondary outcomes
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28
Time frame: Week 28
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52
Time frame: Week 52
Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112
Time frame: Week 112
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28
Time frame: Week 28
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52
Time frame: Week 52
Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112
Time frame: Week 112
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
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
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
Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 28
Time frame: Week 28
Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 52
Time frame: Week 52
Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 112
Time frame: Week 112
Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 28
Time frame: Week 28
Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 52
Time frame: Week 52
Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 112
Time frame: Week 112
Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 28
Time frame: Week 28
Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 52
Time frame: Week 52
Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 112
Time frame: Week 112
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
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
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
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 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 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 Ankylosing Spondylitis Quality of Life (ASQoL) at Week 28
Time frame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
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
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
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
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
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
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
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
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
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
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
Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 112
Time frame: From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Results publication: PubMed 38977276Brown MA, Rudwaleit M, van Gaalen FA, Haroon N, Gensler LS, Fleurinck C, Marten A, Massow U, de Peyrecave N, Vaux T, White K, Deodhar A, van der Horst-Bruinsma I. Low uveitis rates in patients with axial spondyloarthritis treated with bimekizumab: pooled results from phase 2b/3 trials. Ann Rheum Dis. 2024 Nov 14;83(12):1722-1730. doi: 10.1136/ard-2024-225933.
- Results publication: PubMed 41125403Ramiro S, Poddubnyy D, Mease PJ, Lopez-Medina C, Kim M, Massow U, Taieb V, Kragstrup TW, McGonagle D. Sustained resolution of enthesitis and peripheral arthritis over 104 weeks with bimekizumab in axial spondyloarthritis. RMD Open. 2025 Oct 22;11(4):e005969. doi: 10.1136/rmdopen-2025-005969.
- Results publication: PubMed 42386286Nikiphorou E, Tillett W, Deodhar A, Dubreuil M, Gossec L, Hwang M, Lubrano E, Machado PM, Rudwaleit M, de Wit M, Kavanagh S, de la Loge C, Ink B, Lambert J, Morup M, Boonen A, Walsh J. Effect of Bimekizumab Treatment on Health Status, Work Productivity, and Productivity Costs Through 3 Years in Axial Spondyloarthritis and Psoriatic Arthritis. J Rheumatol. 2026 Aug 1:jrheum.2026-0104. doi: 10.3899/jrheum.2026-0104. Online ahead of print.
- Results publication: PubMed 42297437Baraliakos X, Deodhar A, van der Heijde D, Van den Bosch F, Magrey M, Maksymowych WP, Tomita T, Xu H, Coarse J, Prajapati C, Manente M, Marten A, Gensler LS. Bimekizumab Long-Term Safety and Efficacy Across the Spectrum of Axial Spondyloarthritis Over 3 Years: Results From 2 Phase III Studies. J Rheumatol. 2026 Aug 1:jrheum.2026-0113. doi: 10.3899/jrheum.2026-0113. Online ahead of print.
- Derived from this study: PubMed 42128532Navarro-Compan V, Kiltz U, Mease PJ, Dubreuil M, Gaffney K, Deodhar A, de la Loge C, Prajapati C, Kavanagh S, Marzo-Ortega H. Bimekizumab treatment for sustained improvements in patient symptoms and health-related quality of life to 3 years in axial spondyloarthritis: results from the BE MOBILE studies and their open-label extension. RMD Open. 2026 May 13;12(2):e006670. doi: 10.1136/rmdopen-2025-006670.
- Derived from this study: PubMed 41807031Mease PJ, Merola JF, Magrey M, Nash P, Poddubnyy D, Lebwohl M, Bajracharya R, Ink B, Marten A, Manente M, Peterson L, White K, Gensler LS. Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. 2026 Mar 10;12(1):e006174. doi: 10.1136/rmdopen-2025-006174.
- Derived from this study: PubMed 41555451Ramiro S, Proft F, Sengupta R, van Tubergen A, Molto A, Gensler LS, Kishimoto M, Taieb V, Kavanagh S, Evans S, Navarro-Compan V. Impact of symptom duration on the short- and long-term efficacy of bimekizumab in axial spondyloarthritis: results up to 2 years. Arthritis Res Ther. 2026 Jan 19;28(1):40. doi: 10.1186/s13075-026-03729-6.
- Derived from this study: PubMed 41314667Marzo-Ortega H, Navarro-Compan V, Dubreuil M, Mease PJ, Magrey M, Rudwaleit M, D'Agostino MA, Gaffney K, Kay J, de la Loge C, Massow U, Taieb V, Vaux T, Deodhar A. Sustained improvements in spinal pain, morning stiffness, fatigue, sleep, physical function and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: 2-year results from two phase 3 studies. RMD Open. 2025 Nov 28;11(4):e006013. doi: 10.1136/rmdopen-2025-006013.
- Derived from this study: PubMed 40194794Mease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
75 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bimekizumab in people with Axial Spondyloarthritis and Ankylosing Spondylitis, run by UCB Biopharma SRL at 75 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in Japan, United States, China, Czechia, Poland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 180)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04436640, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.