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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03928743
Other study ID # AS0011
Secondary ID 2017-003065-95
Status Completed
Phase Phase 3
First received
Last updated
Start date April 25, 2019
Est. completion date August 8, 2022

Study information

Verified date April 2024
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).


Recruitment information / eligibility

Status Completed
Enrollment 332
Est. completion date August 8, 2022
Est. primary completion date September 3, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female patients at least 18 years of age - Subject has ankylosing spondylitis (AS) as per the Modified New York (mNY) criteria with documented radiologic evidence, and at least 3 months of symptoms with age at symptom onset less than 45 years - Subjects has moderate-to-severe active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 AND spinal pain >=4 on a 0 to 10 Numeric Rating Scale - Subjects had to have either failed to respond to 2 different nonsteroidal anti-inflammatory drugs (NSAIDs) given at the maximum tolerated dose for a total of 4 weeks or have a history of intolerance to or a contraindication to NSAID therapy - Patients who have taken a tumor necrosis factor alpha (TNFa) inhibitor must have experienced an inadequate response or intolerance to treatment given at an approved dose for at least 12 weeks - Patients currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics, corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry Exclusion Criteria: - Total ankylosis of the spine - Treatment with more than 1 TNFa inhibitor and/or more than 2 additional non-TNFa biological response modifiers, or any interleukin (IL)-17 biological response modifier at any time are excluded - Active infection or history of recent serious infections - Viral hepatitis B or C or human immunodeficiency virus (HIV) infection - Any live (includes attenuated) vaccination within the 8 weeks prior to entering the study or TB (Bacillus Calmette-Guerin) vaccination within 1 year prior entering the study - Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection - Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma or in situ cervical cancer - Diagnosis of inflammatory conditions other than AxSpA, eg, rheumatoid arthritis. Patients with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease when entering the study. - Presence of active suicidal ideation, or moderately severe major depression or severe major depression - Female patients who are breastfeeding, pregnant, or planning to become pregnant during the study - Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

Study Design


Intervention

Drug:
Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other:
Placebo
Subjects will receive placebo at pre-specified time-points during the Double-Blind Treatment Period.

Locations

Country Name City State
Belgium As0011 40004 Bruxelles
Belgium As0011 40003 Genk
Belgium As0011 40001 Gent
Bulgaria As0011 40006 Plovdiv
Bulgaria As0011 40007 Plovdiv
Bulgaria As0011 40005 Sofia
Bulgaria As0011 40008 Sofia
China As0011 20040 Beijing
China As0011 20021 Chengdu
China As0011 20019 Guangzhou SHI
China As0011 20034 Hefei
China As0011 20024 Nanjing
China As0011 20018 Shanghai
China As0011 20020 Shanghai
China As0011 20026 Shanghai
China As0011 20025 Wenzhou
Czechia As0011 40011 Brno
Czechia As0011 40009 Pardubice
Czechia As0011 40015 Praha
Czechia As0011 40013 Praha 11
Czechia As0011 40016 Praha 2
Czechia As0011 40014 Praha 4
Czechia As0011 40010 Uherske Hradiste
Czechia As0011 40012 Zlin
France As0011 40018 Boulogne Billancourt
France As0011 40022 Limoges
Germany As0011 40025 Berlin
Germany As0011 40028 Berlin
Germany As0011 40029 Hamburg
Germany As0011 40024 Hanover
Germany As0011 40027 Herne
Germany As0011 40078 Leipzig
Germany As0011 40026 Ratingen
Hungary As0011 40032 Debrecen
Hungary As0011 40031 Szeged
Hungary As0011 40033 Székesfehérvár
Hungary As0011 40080 Szombathely
Japan As0011 20030 Chuo-ku
Japan As0011 20047 Himeji-shi
Japan As0011 20045 Kita-gun
Japan As0011 20065 Kitakyushu
Japan As0011 20037 Osaka
Japan As0011 20084 Saga
Japan As0011 20048 Saitama
Japan As0011 20031 Sapporo
Japan As0011 20042 Sasebo
Japan As0011 20032 Suita
Japan As0011 20035 Tokyo
Netherlands As0011 40034 Amsterdam
Poland As0011 40038 Elblag
Poland As0011 40042 Krakow
Poland As0011 40037 Lublin
Poland As0011 40044 Poznan
Poland As0011 40040 Torun
Poland As0011 40041 Warszawa
Poland As0011 40039 Wroclaw
Poland As0011 40043 Wroclaw
Spain As0011 40045 A Coruna
Spain As0011 40046 Cordoba
Spain As0011 40047 Madrid
Spain As0011 40048 Santiago de Compostela
Spain As0011 40049 Sevilla
Turkey As0011 40052 Ankara
Turkey As0011 40053 Ankara
Turkey As0011 40050 Istanbul
United Kingdom As0011 40057 Edinburgh
United Kingdom As0011 40056 Leeds
United Kingdom As0011 40054 London
United Kingdom As0011 40055 Norwich
United States As0011 50057 Dallas Texas
United States As0011 50020 Duncansville Pennsylvania
United States As0011 50015 Hagerstown Maryland
United States As0011 50001 Jackson Tennessee
United States As0011 50012 Memphis Tennessee
United States As0011 50131 Mesa Arizona
United States As0011 50036 Mesquite Texas
United States As0011 50054 Oklahoma City Oklahoma
United States As0011 50052 Phoenix Arizona
United States As0011 50058 Phoenix Arizona
United States As0011 50016 Saint Louis Missouri
United States As0011 50056 Sarasota Florida
United States As0011 50062 Sun City Arizona
United States As0011 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, 

References & Publications (2)

Navarro-Compan V, Ramiro S, Deodhar A, Mease PJ, Rudwaleit M, de la Loge C, Fleurinck C, Taieb V, Morup MF, Massow U, Kay J, Magrey M. Association of clinical response criteria and disease activity levels with axial spondyloarthritis core domains: results — View Citation

van der Heijde D, Deodhar A, Baraliakos X, Brown MA, Dobashi H, Dougados M, Elewaut D, Ellis AM, Fleurinck C, Gaffney K, Gensler LS, Haroon N, Magrey M, Maksymowych WP, Marten A, Massow U, Oortgiesen M, Poddubnyy D, Rudwaleit M, Shepherd-Smith J, Tomita T — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 16 ASAS40 will be calculated relative to Baseline. The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are defined as relative improvements of at least 40%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains and no worsening at all in the remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Week 16
Secondary Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response in TNFa inhibitor-naïve subjects at Week 16 ASAS40 will be calculated relative to Baseline. The Assessment of SpondyloArthritis International Society (ASAS) criteria for 40% improvement are defined as relative improvements of at least 40%, and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains and no worsening at all in the remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Week 16
Secondary Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 16 ASAS20 will be calculated relative to Baseline. The Assessment of SpondyloArthritis International Society (ASAS) criteria for 20% improvement are defined as relative improvements of at least 20%, and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains and absence of deterioration in the potential remaining domain.
The domains are:
Patient's Global Assessment of Disease Activity (PGADA)
Pain assessment (the total spinal pain, NRS score)
Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))
Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI))
Week 16
Secondary Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) total score at Week 16 The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity. Baseline, Week 16
Secondary Assessment of SpondyloArthritis International Society (ASAS) partial remission (PR) at Week 16 The Assessment of SpondyloArthritis International Society (ASAS) partial remission (PR) is defined as a score of <=2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20. Week 16
Secondary Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) at Week 16 Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) is achieved when there is a reduction (improvement) >= 2.0 in the Ankylosing Spondylitis Disease Activity Score (ASDAS) relative to Baseline.
ASDAS is calculated as the sum of the following components:
0.121 × Total back pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q2 result)
0.058 × Duration of morning stiffness (BASDAI Q6 result)
0.110 × Patient's Global Assessment of Disease Activity (PGADA)
0.073 × Peripheral pain/swelling (BASDAI Q3 result)
0.579 × (natural logarithm of the C-reactive protein (CRP) [mg/L] + 1)
Total back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units).
High ASDAS scores mean worse disease. If a subjects achieves the ASDAS-MI it indicates a major improvement of their disease.
Week 16
Secondary Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 16 The Assessment of SpondyloArthritis International Society (ASAS) 5/6 response is defined as achieving at least 20% improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP). Week 16
Secondary Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16 The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ('Easy') to 10 ('Impossible'). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. Baseline, Week 16
Secondary Change from Baseline in nocturnal spinal pain score Numeric Rating Scale (NRS) at Week 16 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. Baseline, Week 16
Secondary Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) total score at Week 16 The Ankylosing Spondylitis Quality of Life (ASQoL), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in subjects with ankylosing spondylitis (AS) and has shown to be responsive in axial spondyloarthritis (axSpA). The ASQoL score ranges from 0 to 18 with a higher score indicating worse HRQoL. Baseline, Week 16
Secondary Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) score at Week 16 There are 8 SF-36 domain scores. In addition to domain scores, the PCS scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement. Baseline, Week 16
Secondary Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 16 The Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. Baseline, Week 16
Secondary Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index in the subgroup of subjects with enthesitis at Baseline at Week 16 The Maastricht Ankylosing Spondylitis Enthesitis (MASES) is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score indicates worsening. Baseline, Week 16
Secondary Enthesitis-free state based on the Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) Index in the subgroup of subjects with enthesitis at Baseline at Week 16 The Maastricht Ankylosing Spondylitis Enthesitis (MASES) is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses (bilateral costochondral 1, costochondral 7, anterior superior iliac spine, posterior iliac spine, iliac crest and proximal insertion of the Achilles tendon sites, and the fifth lumbar vertebral body spinous process) each scored as 0 or 1 and then summed for a possible score of 0 to 13. A higher score indicates worsening. Baseline, Week 16
Secondary Incidence of treatment-emergent adverse events (TEAEs) during the study An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. From Baseline (Day 1) until Safety-Follow-Up (up to Week 72)
Secondary Incidence of treatment-emergent serious adverse events (SAEs) during the study A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalisation or prolongation of existing hospitalisation
Is a congenital anomaly or birth defect
Is an infection that requires treatment with parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
From Baseline (Day 1) until Safety-Follow-Up (up to Week 72)
Secondary Treatment-emergent adverse events (AEs) leading to withdrawal from investigational medicinal product (IMP) during the study An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. From Baseline (Day 1) until Safety-Follow-Up (up to Week 72)
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