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A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis (BE MOBILE 1)

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ClinicalTrials.gov Identifier: NCT03928704
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief 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 nonradiographic axial spondyloarthritis (nr-axSpA).

Condition or disease Intervention/treatment Phase
Nonradiographic Axial Spondyloarthritis Drug: Bimekizumab Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: Bimekizumab
Subjects randomized to this arm will receive bimekizumab during the Double-Blind Treatment Period and the Maintenance Period.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Names:
  • BKZ
  • UCB4940

Placebo Comparator: Placebo
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and receive bimekizumab during the Maintenance Period.
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Names:
  • BKZ
  • UCB4940

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




Primary Outcome Measures :
  1. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 16 [ Time Frame: 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))


Secondary Outcome Measures :
  1. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response in TNFα inhibitor-naïve subjects at Week 16 [ Time Frame: 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))

  2. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16 [ Time Frame: Baseline, 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.

  3. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 16 [ Time Frame: 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))

  4. Assessment of SpondyloArthritis International Society (ASAS) partial remission (PR) at Week 16 [ Time Frame: 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.

  5. Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) at Week 16 [ Time Frame: 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.


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

  7. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16 [ Time Frame: Baseline, 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.

  8. Change from Baseline in nocturnal spinal pain Numeric Rating Scale (NRS) at Week 16 [ Time Frame: Baseline, 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.

  9. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16 [ Time Frame: Baseline, 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.

  10. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 16 [ Time Frame: Baseline, 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.

  11. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 16 [ Time Frame: Baseline, 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.

  12. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index in the subgroup of subjects with enthesitis at Baseline at Week 16 [ Time Frame: Baseline, 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.

  13. 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 [ Time Frame: Baseline, 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.

  14. Incidence of treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From Baseline (Day 1) until Safety-Follow-Up (up to Week 72) ]
    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.

  15. Incidence of serious adverse events (SAEs) during the study [ Time Frame: From Baseline (Day 1) until Safety-Follow-Up (up to Week 72) ]

    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

  16. Adverse events (AEs) leading to withdrawal from investigational medicinal product (IMP) during the study [ Time Frame: From Baseline (Day 1) until Safety-Follow-Up (up to Week 72) ]
    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.



Information from the National Library of Medicine

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


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

Inclusion Criteria:

  • Male or female patients at least 18 years of age
  • Patient has nonradiographic axial spondyloarthritis with all of the following criteria:

    1. Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) criteria
    2. Inflammatory back pain for at least 3 months
    3. Age at symptom onset of less than 45 years.
    4. NO sacroiliitis (in Anterior-Posterior pelvis or sacroiliac x-ray)
  • Active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 AND spinal pain >=4 on a 0 to 10 Numeric Rating Scale
  • Objective inflammation defined by sacroiliitis on magnetic resonance imaging and/or elevated C-reactive protein.
  • Patients must have inadequate response to NSAIDs, intolerance to administration of at least 1 NSAID, or contraindication(s) to NSAID therapy
  • Patients who have taken a tumor necrosis factor alpha (TNFα) 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:

  • Treatment with more than 1 TNFα inhibitor and/or more than 2 additional non-TNFα biological response modifiers, or any interleukin (IL)-17 biological response modifier
  • 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

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928704


Contacts
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Contact: UCB Cares +1844599 ext 2273 UCBCares@ucb.com

Locations
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United States, California
As0010 50060 Recruiting
Upland, California, United States, 91786
United States, Maryland
As0010 50015 Recruiting
Hagerstown, Maryland, United States, 21742
United States, Missouri
As0010 50016 Recruiting
Saint Louis, Missouri, United States, 63141
United States, Oklahoma
As0010 50054 Recruiting
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
As0010 50020 Recruiting
Duncansville, Pennsylvania, United States, 16635
United States, Tennessee
As0010 50001 Recruiting
Jackson, Tennessee, United States, 38305
As0010 50012 Recruiting
Memphis, Tennessee, United States, 38119
United States, Washington
As0010 50061 Recruiting
Spokane, Washington, United States, 99204
Belgium
As0010 40003 Recruiting
Genk, Belgium
As0010 40001 Recruiting
Gent, Belgium
Bulgaria
As0010 40006 Recruiting
Plovdiv, Bulgaria
As0010 40007 Recruiting
Plovdiv, Bulgaria
As0010 40008 Recruiting
Sofia, Bulgaria
Czechia
As0010 40011 Recruiting
Brno, Czechia
As0010 40012 Recruiting
Ziln, Czechia
Hungary
As0010 40032 Recruiting
Debrecen, Hungary
As0010 40031 Recruiting
Szeged, Hungary
Poland
As0010 40038 Recruiting
Elbląg, Poland
As0010 40042 Recruiting
Kraków, Poland
As0010 40037 Recruiting
Lublin, Poland
As0010 40044 Recruiting
Poznań, Poland
As0010 40040 Recruiting
Toruń, Poland
As0010 40041 Recruiting
Warsaw, Poland
As0010 40043 Recruiting
Wrocław, Poland
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)

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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03928704     History of Changes
Other Study ID Numbers: AS0010
2017-003064-13 ( EudraCT Number )
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from this study 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 IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Nonradiographic axial spondyloarthritis
Axial spondyloarthritis
Nr-axSpA
Bimekizumab

Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases