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    Summary
    EudraCT Number:2019-004163-47
    Sponsor's Protocol Code Number:AS0014
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2019-004163-47
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.4.1Sponsor's protocol code numberAS0014
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUCB Biopharma SRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB Biosciences GmbH
    B.5.2Functional name of contact pointDDGS
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBimekizumab
    D.3.2Product code UCB4940
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIMEKIZUMAB
    D.3.9.1CAS number 1418205-77-2
    D.3.9.2Current sponsor codeUCB4940
    D.3.9.4EV Substance CodeSUB182636
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Axial Spondyloarthritis
    E.1.1.1Medical condition in easily understood language
    Axial spondyloarthritis (axSpA), is a form of arthritis that primarily affects the spine and sacroiliac joints, although other joints can become involved. It may cause pain, stiffness, and fatigue.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10071400
    E.1.2Term Axial spondyloarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the long-term safety and tolerability of bimekizumab in patients with active axial spondyloarthritis
    E.2.2Secondary objectives of the trial
    Assess the impact of bimekizumab on:
    - Long-term efficacy
    - Patient-reported outcomes including health-related quality of life
    - Spinal mobility
    - Enthesitis and peripheral arthritis
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sacroiliac joint and spine MRI assessments will be performed at Week 52 of the feeder studies (AS0010 or AS0011), and will be performed in AS0014 at Week 52 and Week 112 within a window of ±5 days for study participants consenting to continue in the MRI substudy.
    E.3Principal 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)
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of treatment-emergent adverse events (TEAEs) during the study
    2. Incidence of serious adverse events (SAEs) during the study
    3. Treatment-emergent adverse events (TEAEs) leading to withdrawal from the study
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline (Day 1) until Safety Follow-Up (up to Week 128)
    E.5.2Secondary end point(s)
    1. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28
    2. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52
    3. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112
    4. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28
    5. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52
    6. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112
    7. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 28
    8. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52
    9. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 112
    10. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 28
    11. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 52
    12. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 112
    13. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 28
    14. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP)
    at Week 52
    15. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP)
    at Week 112
    16. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 28
    17. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 52
    18. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 112
    19. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 28
    20. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52
    21. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 112
    22. Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 28
    23. Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 52
    24. Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 112
    25. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 28
    26. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52
    27. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 112
    28. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 28
    29. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 52
    30. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 112
    31. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 28
    32. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 52
    33. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 112
    34. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 28
    35. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 52
    36. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 112







    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 4, 10, 13, 16: Week 28
    2, 5, 11, 14, 17: Week 52
    3, 6, 12, 15, 18: Week 112
    7, 19, 22, 25, 28, 31, 34: Change from Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
    8, 20, 23, 26, 29, 32, 35: Change from Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
    9, 21, 24, 27, 30, 33, 36: Change from Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Bulgaria
    China
    Czech Republic
    France
    Germany
    Hungary
    Japan
    Netherlands
    Poland
    Spain
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 365
    F.4.2.2In the whole clinical trial 485
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
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