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    Summary
    EudraCT Number:2017-003065-95
    Sponsor's Protocol Code Number:AS0011
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2019-05-21
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-003065-95
    A.3Full title of the trial
    A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE
    EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS
    ESTUDIO DE FASE 3, MULTICÉNTRICO, ALEATORIZADO, EN DOBLE CIEGO Y CONTROLADO CON PLACEBO, PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE BIMEKIZUMAB EN SUJETOS CON ESPONDILITIS ANQUILOSANTE ACTIVA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitis
    Estudio para evaluar la eficacia y seguridad de bimekizumab en sujetos con espondilitis anquilosante activa
    A.4.1Sponsor's protocol code numberAS0011
    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 SPRL
    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 SPRL
    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 pointClin Trial Reg & Results Disclosure
    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 CodeSUB130157
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ankylosing spondylitis
    Espondilitis anquilosante
    E.1.1.1Medical condition in easily understood language
    Ankylosing spondylitis or AS, is a form of arthritis that primarily affects the spine and sacroiliac joints, although other joints can become involved.
    La espondilitis anquilosante or EA, es un tipo de artritis que afecta principalmente a la columna vertebral y a las articulaciones sacroiliacas, aunque otras articulaciones pueden estar involucradas.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    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
    Demonstrate the efficacy of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS)
    Demostrar la eficacia de bimekizumab administrado por vía subcutánea (sc), en comparación con placebo, en el tratamiento de sujetos con espondilitis anquilosante (AS) activa.
    E.2.2Secondary objectives of the trial
    - Assess the efficacy of bimekizumab compared to placebo
    - Assess the safety and tolerability of bimekizumab
    - Assess the impact of bimekizumab on patient-reported quality of life
    - Assess the impact of bimekizumab on spinal mobility
    - Assess the impact of bimekizumab on enthesitis and on peripheral arthritis
    - Evaluar la eficacia de bimekizumab comparado con placebo
    - Evaluar la seguridad y la tolerabilidad de bimekizumab
    - Evaluar el efecto de bimekizumab sobre la calidad de vida comunicada por el paciente
    - Evaluar el efecto de bimekizumab sobre la movilidad de la columna vertebral
    - Evaluar el efecto de bimekizumab sobre la entesitis y sobre la artritis periférica
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There will be two optional substudies: a pharmacogenomic substudy and a magnetic resonance imaging (MRI) substudy. For subjects consenting to the genomics, genetics, and proteomics substudy, blood samples and stool samples will be drawn for exploratory genetic/epigenetic, genomic, proteomic, and metabolomics analysis and for candidate exploratory biomarker analyses. For subjects participating in the MRI substudy further sacroiliac joint and spine MRIs will be performed.
    Habrá dos subestudios opcionales: un subestudio farmacogenómico y un subestudio de resonancia magnética (MRI). Para los sujetos que consientan el subestudio de genómica, genética y proteómica, se extraerán muestras de sangre y de heces para análisis genéticos / epigenéticos, genómicos, proteómicos y metabólicos exploratorios y para análisis de biomarcadores exploratorios. Para los sujetos que participan en el subestudio de RM, se realizarán más resonancias magnéticas de la articulación sacroilíaca y la columna vertebral
    E.3Principal inclusion criteria
    -Male or female patients at least 18 years of age
    -Subject has ankylosing spondylitis 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
    -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
    -El sujeto es varón o mujer de al menos 18 años.
    -El sujeto padece espondilitis anquilosante según los criterios de Nueva York modificados (mNY), con evidencia radiológica documentada y con al menos 3 meses de síntomas y edad al comienzo de estos <45 años
    -Sujeto con enfermedad activa de grado moderado o severo definido por el Índice de actividad de la espondilitis anquilosante de Bath (BASDAI) >=4 Y raquialgia >= en una escala de valoración numérica de 0 a 10.
    -Pacientes con respuesta inadecuada al tratamiento con antiinflamatorios no esteroideos, intolerancia a la administración de al menos un antiinflamatorio no esteroideo, o contraindicación al tratamiento con antiinflamatorios no esteroideos
    -Los sujetos que hayan recibido un inhibidor del TNFα deberán haber presentado una respuesta insuficiente al tratamiento previo, administrado a la dosis aprobada durante por lo menos 12 semanas, o intolerancia al tratamiento.
    -Los sujetos que tomen habitualmente antiinflamatorios no esteroideos/inhibidores de la ciclooxigenasa 2 (COX-2), analgésicos corticoesteroides, metotrexano (MTX), leflunomida (LEF), sulfasalazina (SSZ), hidroxicloroquina (HCQ) y/o apremilast serán permitidos siempre que cumplan los requerimientos específicos antes de entrar en el estudio
    E.4Principal exclusion criteria
    -Total ankylosis of the spine
    -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 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
    -Sujetos con anquilosis vertebral total.
    -Sujetos que hayan recibido en cualquier momento más de un inhibidor del TNFα y/o más de 2 modificadores de la respuesta biológica adicionales distintos de los inhibidores del TNFα o cualquier modificador de la respuesta biológica de tipo IL-17.
    -Sujeto con infección activa o antecedentes infecciosos
    -Sujeto con infección por los virus de las hepatitis B o C o de la inmunodeficiencia humana (HIV).
    -Sujeto que ha recibido una vacuna de gérmenes vivos (incluso atenuados) en el plazo de las 8 semanas previas a la Visita Basal o una vacuna antituberculosa (bacilo de Calmette y Guérin, BCG) en el plazo del año previo a la Visita Basal.
    -Sujeto con tuberculosis (TB), con elevado riesgo de contraer esta infección o con infección actual o pasada por una micobacteria no tuberculosa.
    -Sujeto con neoplasia maligna activa o antecedentes de neoplasia en el plazo de los 5 años previos a la Visita de Selección, EXCEPTO el carcinoma cutáneo espinocelular o basocelular o el carcinoma in situ de cuello uterino que se consideren curados.
    -Sujeto con diagnóstico de trastornos inflamatorios distintos de la axSpA, como, entre otros, artritis reumatoide. Se permite participar a los sujetos con diagnóstico de enfermedad de Crohn, colitis ulcerosa u otra enfermedad inflamatoria intestinal, siempre que no presenten enfermedad sintomática activa en la Selección o en el momento Basal.
    -Presencia de ideación suicida activa o con depresión mayor moderadamente severa o severa
    -Mujer en periodo de lactancia, embarazada o que tenga previsto quedarse embarazada durante el estudio
    -Sujeto con antecedentes de abuso crónico de alcohol o drogas en el plazo de los 6 meses previos a la Selección
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 16
    Respuesta del 40% según la Sociedad Internacional de Espondiloartritis (Spondylo Arthritis International Society 40%, ASAS40) en la semana 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 16
    Basal, semana 16
    E.5.2Secondary end point(s)
    1. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response in TNFα inhibitor-naïve subjects at Week 16
    2. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 16
    3. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16
    4. Assessment of SpondyloArthritis International Society (ASAS) partial remission (PR) at Week 16
    5. Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) at Week 16
    6. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 16
    7. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16
    8. Change from Baseline in nocturnal spinal pain Numeric Rating Scale (NRS) at Week 16
    9. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16
    10. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 16
    11. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 16
    12. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index in the subgroup of subjects with enthesitis at Baseline at Week 16
    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
    14. Incidence of treatment-emergent adverse events (TEAEs) during the study
    15. Incidence of serious adverse events (SAEs) during the study
    16. Adverse events (AEs) leading to withdrawal from investigational medicinal product (IMP) during the study
    1. Respuesta ASAS40 en la Semana 16 en sujetos no tratados nunca con inhibidores del TNFα
    2. Respuesta ASAS20 en la Semana 16
    3. Variación respecto al valor Basal del BASDAI en la Semana 16
    4. Remisión parcial según ASAS (ASAS-PR) en la Semana 16
    5. Mejoría importante de la puntuación de la actividad de la espondilitis anquilosante (ASDAS-MI) en la Semana 16
    6. Respuesta ASAS5/6 en la Semana 16
    7. Variación respecto al valor Basal del índice funcional de espondilitis anquilosante de Bath (BASFI) en la Semana 16
    8. Variación respecto al valor Basal de la raquialgia nocturna (NRS) en la Semana 16
    9. Variación respecto al valor Basal del instrumento de la calidad de vida con espondilitis anquilosante (ASQoL) en la Semana 16
    10. Variación respecto al valor Basal del resumen del componente físico (PCS) de la encuesta de salud abreviada de 36 ítems (SF-36) en la Semana 16
    11. Variación respecto al valor Basal del índice metrológico de espondilitis anquilosante de Bath (BASMI) en la Semana 16
    12. Variación respecto al valor Basal del índice de entesitis en la espondilitis anquilosante de Maastricht (MASES) en el subgrupo de sujetos con entesitis en el momento Basal, en la Semana 16
    13. Ausencia de entesitis según el índice MASES en el subgrupo de sujetos con entesitis el momento Basal, en la Semana 16
    14. Incidencia de acontecimientos adversos surgidos en el tratamiento (TEAE) durante el estudio
    15. Incidencia de acontecimientos adversos graves (SAEs) durante el estudio
    16. Acontecimientos adversos (AE) que lleven a la retirada del medicamento en investigación
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.-13. Baseline, Week 16
    14.-16. From Baseline (Day 1) until Safety Follow-Up (up to Week 72)
    1. -13. Basal, semana 16
    14.-16. Desde el valor basal (día 1) hasta el seguimiento de seguridad (hasta la semana 72)
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Tolerability
    Inmunogenia, Tolerabilidad
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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
    Ultima Visita del Ultimo Sujeto (LVLP)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days26
    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: 288
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 217
    F.4.2.2In the whole clinical trial 300
    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)
    Eligible subjects will be allowed to enroll in an extension study.
    Los pacientes elegibles podrán ser incluidos en un estudio de extensión
    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 Decision2019-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-11
    P. End of Trial
    P.End of Trial StatusRestarted
    The status of studies in GB is no longer updated from 1.1.2021
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