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

Ankylosing Spondylitis Clinical Trial

— BE MOVING  

Official title:

A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04436640
• Other study ID #: AS0014
• Secondary ID: 2019-004163-47
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 16, 2020
• Est. completion date: August 7, 2026

Study information

• Verified date: June 2024
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 508
• Est. completion date: August 7, 2026
• Est. primary completion date: August 7, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Axial Spondyloarthritis
• Non-Radiographic Axial Spondyloarthritis
• Nr-axSpa
• r-axSpa
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Bimekizumab
Subjects will receive bimekizumab at prespecified time-points.

Locations

Country	Name	City	State
Belgium	As0014 40004	Bruxelles
Belgium	As0014 40003	Genk
Belgium	As0014 40001	Gent
Bulgaria	As0014 40006	Plovdiv
Bulgaria	As0014 40007	Plovdiv
Bulgaria	As0014 40005	Sofia
Bulgaria	As0014 40008	Sofia
China	As0014 20040	Beijing
China	As0014 20021	Chengdu
China	As0014 20019	Guangzhou
China	As0014 20034	Hefei
China	As0014 20024	Nanjing
China	As0014 20018	Shanghai
China	As0014 20020	Shanghai
China	As0014 20026	Shanghai
China	As0014 20025	Wenzhou
Czechia	As0014 40011	Brno
Czechia	As0014 40009	Pardubice
Czechia	As0014 40013	Praha 11
Czechia	As0014 40016	Praha 2
Czechia	As0014 40015	Praha 3
Czechia	As0014 40014	Praha 4
Czechia	As0014 40010	Uherske Hradiste
Czechia	As0014 40012	Zlin
France	As0014 40018	Boulogne Billancourt
France	As0014 40022	Limoges
Germany	As0014 40025	Berlin
Germany	As0014 40029	Hamburg
Germany	As0014 40024	Hanover
Germany	As0014 40027	Herne
Germany	As0014 40078	Leipzig
Germany	As0014 40026	Ratingen
Hungary	As0014 40032	Debrecen
Hungary	As0014 40031	Szeged
Hungary	As0014 40033	Székesfehérvár
Japan	As0014 20035	Bunkyo-ku
Japan	As0014 20030	Chuo-ku
Japan	As0014 20039	Iruma-gun
Japan	As0014 20036	Kawachinagano
Japan	As0014 20045	Kita-gun
Japan	As0014 20065	Kitakyushu
Japan	As0014 20037	Osaka
Japan	As0014 20084	Saga
Japan	As0014 20048	Saitama
Japan	As0014 20031	Sapporo
Japan	As0014 20032	Suita
Netherlands	As0014 40034	Amsterdam
Poland	As0014 40038	Elblag
Poland	As0014 40042	Krakow
Poland	As0014 40037	Lublin
Poland	As0014 40044	Poznan
Poland	As0014 40040	Torun
Poland	As0014 40041	Warszawa
Poland	As0014 40039	Wroclaw
Poland	As0014 40043	Wroclaw
Spain	As0014 40045	A Coruna
Spain	As0014 40046	Cordoba
Spain	As0014 40048	Santiago de Compostela
Spain	As0014 40049	Sevilla
Turkey	As0014 40052	Ankara
Turkey	As0014 40053	Ankara
Turkey	As0014 40050	Istanbul
United Kingdom	As0014 40057	Edinburgh
United Kingdom	As0014 40056	Leeds
United Kingdom	As0014 40055	Norwich
United States	As0014 50057	Dallas	Texas
United States	As0014 50020	Duncansville	Pennsylvania
United States	As0014 50062	Glendale	Arizona
United States	As0014 50015	Hagerstown	Maryland
United States	As0014 50059	Ormond Beach	Florida
United States	As0014 50052	Phoenix	Arizona
United States	As0014 50055	Portland	Oregon
United States	As0014 50016	Saint Louis	Missouri
United States	As0014 50056	Sarasota	Florida
United States	As0014 50060	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  China,  Czechia,  France,  Germany,  Hungary,  Japan,  Netherlands,  Poland,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
Primary	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	From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
Primary	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.	From Baseline (Day 1) until Safety Follow-Up (up to Week 180)
Secondary	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)	Week 28
Secondary	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))	Week 52
Secondary	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))	Week 112
Secondary	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))	Week 28
Secondary	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))	Week 52
Secondary	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))	Week 112
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Secondary	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.	Week 28
Secondary	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.	Week 52
Secondary	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.	Week 112
Secondary	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.	Week 28
Secondary	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.	Week 52
Secondary	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)	Week 112
Secondary	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).	Week 28
Secondary	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).	Week 52
Secondary	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).	Week 112
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112
Secondary	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.	From Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112