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    Summary
    EudraCT Number:2017-002322-20
    Sponsor's Protocol Code Number:PA0010
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-12
    Trial results View 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 number2017-002322-20
    A.3Full title of the trial
    A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ACTIVE REFERENCE (ADALIMUMAB) STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN THE TREATMENT OF SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS
    ESTUDIO DE FASE 3, MULTICÉNTRICO, ALEATORIZADO, EN DOBLE CIEGO, CONTROLADO CON PLACEBO Y CON FÁRMACO ACTIVO DE REFERENCIA (ADALIMUMAB), PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE BIMEKIZUMAB EN EL TRATAMIENTO DE SUJETOS CON ARTRITIS PSORIÁSICA ACTIVA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the efficacy and safety of bimekizumab in the treatment of subjects with active psoriatic arthritis
    Un estudio para evaluar la eficacia y la seguridad de bimekizumab en el tratamiento de sujetos con artritis psoriásica activa.
    A.3.2Name or abbreviated title of the trial where available
    BE OPTIMAL
    A.4.1Sponsor's protocol code numberPA0010
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Humira®
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAdalimumab
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboSolution 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
    Psoriatic Arthritis
    Artritis psoriásica
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis is a type of inflammatory arthritis that can cause swelling, stiffness and pain in the joints.
    La artritis psoriásica es un tipo de artritis inflamatoria que puede causar hinchazón, rigidez y dolor en las articulaciones
    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 LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    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 clinical efficacy of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA), as assessed by the American College of Rheumatology 50% Improvement (ACR50) response
    demostrar la eficacia clínica de bimekizumab, administrado por vía subcutánea (s.c.) con placebo, en el tratamiento de sujetos con artritis psoriásica (PsA), en su determinación por la respuesta de mejora del 50% del American College of Rheumatology (ACR50).
    E.2.2Secondary objectives of the trial
    -Assess the efficacy of bimekizumab compared with 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 skin psoriasis (PSO) in the
    subgroup of affected subjects at Baseline
    -Assess the impact of bimekizumab on functional improvement
    -Assess the impact of bimekizumab on radiographic changes in the
    hands and feet
    -Assess the impact of bimekizumab on extra-articular disease
    manifestations (dactylitis, enthesitis)
    - Evaluar la eficacia del bimekizumab en comparación con placebo
    - Evaluar la seguridad y la tolerabilidad del bimekizumab
    - Evaluar el impacto del bimekizumab sobre la calidad de vida comunicada por el paciente
    - Evaluar el impacto del bimekizumab sobre la psoriasis (PSO) cutánea en el subgrupo de sujetos afectados en la evaluación basal
    - Evaluar el impacto del bimekizumab sobre la mejoría funcional
    - Evaluar el impacto del bimekizumab sobre los cambios radiográficos en las manos y los pies
    - Determinar el impacto del bimekizumab sobre las manifestaciones extraarticulares de la enfermedad (dactilitis, entesitis)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    For individuals consenting to the genomics, genetics, and proteomics substudy, blood samples will be drawn for exploratory genetic/epigenetic, genomic, proteomic, and metabolomics analysis and for candidate exploratory biomarker analyses.
    Para los individuos que consienten en el subestudio de genómica, genética y proteómica, se extraerán muestras de sangre para análisis genéticos / epigenéticos, genómicos, proteómicos y metabólicos exploratorios y para candidatos análisis de biomarcadores exploratorios
    E.3Principal inclusion criteria
    - Subject is male or female at least 18 years of age
    - Female subject must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
    - Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
    - Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
    - Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
    - Subject must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator
    - Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), 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 hombre o mujer y tiene al menos 18 años.
    - Las mujeres deben ser posmenopáusicas, haber sido esterilizadas de forma definitiva o, estar dispuestas a utilizar un método anticonceptivo.
    - El sujeto tiene un diagnóstico documentado de artritis psoriásica de comienzo en la edad adulta clasificada que cumple los Criterios CASPAR para la clasificación de la artritis psoriásica desde al menos 6 meses antes de la Selección, con artritis psoriásica activa, y debe tener un número de articulaciones dolorosas (tender joint count, TJC) basal de >/=3 de 68 y un número de articulaciones inflamadas (swollen joint count, SJC) de >/=3 de 66
    - El sujeto debe dar negativo en el análisis de factor reumatoide y de anticuerpos anti péptido cíclico citrulinado (anti-cyclic citrullinated peptide, anti-CCP)
    - El sujeto debe tener al menos 1 lesión psoriásica activa y/o historia documentada de psoriasis.
    - El sujeto debe ser considerado, en opinión del investigador, candidato adecuado al tratamiento con adalimumab según la ficha técnica regional y no tener ninguna contraindicación para recibir adalimumab según la ficha técnica local.
    - Los sujetos que estén tomando de forma regular antiinflamatorios no esteroideos (AINE), inhibidores de la ciclooxigenasa (COX) 2, analgésicos (entre ellos los opioides débiles), corticoesteroides, metotrexato (MTX), leflunomida (LEF), sulfasalazina (SSZ), hidroxicloroquina (HCQ) Y/O apremilast puden ser incluidos si cumplen con los requisitos específicos antes de la entrada al estudio.
    E.4Principal exclusion criteria
    - Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
    - Subjects with current or prior exposure to any biologics for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (PSO)
    - Subject has an active infection or a history of recent serious infections
    - Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
    - Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects 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 at Screening or Baseline
    - Subject had acute anterior uveitis within 6 weeks of Baseline
    - 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
    - Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
    - Presence of active suicidal ideation, or moderately severe major depression or severe major depression
    - Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
    - Mujeres que estén amamantando, embarazadas o quieran quedarse embarazadas durante el estudio
    - Sujeto con exposición actual o anterior a cualquier tratamiento biológico para la artritis psoriásica o la psoriasis
    - El sujeto tiene una infección activa o antecedentes de reciente infección grave.
    - El sujeto tiene una infección tuberculosa (TB), tiene un riesgo elevado de contraer una infección TB, o tiene actualmente o ha tenido en pasado una infección no tuberculosa por micobacterias (NTMB).
    - El sujeto tiene diagnóstico de enfermedades inflamatorias aparte de la psoriasis o la artritis psoriásica, Se permite la inclusión de sujetos con diagnóstico de enfermedad de Crohn, colitis ulcerosa u otra enfermedad inflamatoria intestinal, siempre que no presenten enfermedad activa sintomática en la Selección o en la evaluación basal.
    - Sujetos que hayan tenido uveítis anterior en las 6 semanas previas a la evaluación basal
    - El sujeto tiene una neoplasia maligna activa o antecedentes de neoplasia maligna en los 5 años anteriores a la visita de Selección, EXCEPTO carcinoma cutáneo espinocelular o basocelular o cáncer cervical in situ tratados y que se consideren curados
    - El sujeto tiene una forma de psoriasis que no sea del tipo crónico en placas (p. ej., psoriasis pustulosa, eritrodémica y guttata, o psoriasis inducida por fármacos).
    - Presencia de ideación suicida activa, o depresión mayor moderadamente severa o severa.
    - Sujeto con antecedentes de abuso de alcohol o drogas continuado en los 6 meses anteriores a la Selección.
    E.5 End points
    E.5.1Primary end point(s)
    American College of Rheumatology 50% improvement (ACR50) response at Week 16
    Respuesta de mejora del 50% (ACR50) determinda por el índice del American College of Rheumatology 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. Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
    2. Psoriasis Area Severity Index 90 (PASI90) response at Week 16 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
    3. Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
    4. Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16
    5. Minimal Disease Activity (MDA) at Week 16
    6. Change from Baseline in Van der Heijde modified Total Sharp Score (vdHmTSS) at Week 16
    7. Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 16 in the subgroup of subjects with dactylitis at Baseline
    8. Enthesitis-free state based on the Leeds Enthesitis Index (LEI) at Week 16 in the subgroup of subjects with enthesitis at Baseline
    9. American College of Rheumatology 20% improvement (ACR20) response at Week 16
    10. American College of Rheumatology 70% improvement (ACR70) response at Week 16
    11. Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 4 in the subset of subjects with psoriatic skin lesions at Baseline
    12. Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 16 in the subset of subjects with psoriatic skin lesions at Baseline
    13. Change from Baseline in the Patient’s Assessment of Arthritis Pain (PtAAP) at Week 16
    14. Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 16 in the subgroup of subjects with enthesitis at Baseline
    15. Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) at Week 16
    16. Incidence of treatment-emergent adverse events (TEAEs) during the study
    17. Incidence of serious adverse events (SAEs) during the study
    18. Adverse events (AEs) leading to withdrawal from investigational medicinal product (IMP) during the study
    1. Respuesta PASI 90 (Psoriasis Area and Severity Index) en la semana 4 en el subgrupo de sujetos con psoriasis presente en al menos al 3% de la superficie corporal (body surface area, BSA) en la evaluación basal.
    2. Respuesta PASI 90 (Psoriasis Area and Severity Index) en la semana 16 en el subgrupo de sujetos con psoriasis presente en al menos al 3% de la superficie corporal (body surface area, BSA) en la evaluación basal.
    3. Variación del HAQ-DI (Health Assessment Questionnaire—Disability Index) en la semana 16 con respecto al basal.
    4. Variación del resumen del componente físico (Physical Component Summary, PCS) del formulario de Salud de 36 elementos (Short Form 36-item Health Survey, SF-36) en la semana 16 con respecto al basal.
    5. Mínima actividad de la enfermedad (Minimal Disease Activity, MDA) en la semana 16.
    6. Variación del Índice total de Sharp modificado por Van der Heijde (Van der Heijde modified Total Sharp Score, vdHmTSS) en la semana 16 con respecto al basal.
    7. Estado sin dactilitis según el Índice de dactilitis de Leeds (Leeds Dactylitis Index, LDI) en la semana 16 en el subgrupo de sujetos con dactilitis en la evaluación basal.
    8. Estado sin entesitis según el Índice de entesitis de Leeds (Leeds Enthesitis Index, LEI) en la semana 16 en el subgrupo de sujetos con entesitis en la evaluación basal.
    9. Respuesta de mejora del 20% del American College of Rheumatology (ACR20) en la semana 16.
    10. Respuesta de mejora del 70% del American College of Rheumatology (ACR70) en la semana 16.
    11. Porcentaje de sujetos con una puntuación en la evaluación global del investigador (Investigator Global Assessment, IGA) de 0 (ausente) o 1 (casi ausente) Y al menos una reducción de 2 grados en la semana 4 con respecto a la evaluación basal en el subgrupo de sujetos con lesiones psoriásicas cutáneas en la evaluación basal.
    12. Porcentaje de sujetos con una puntuación en la evaluación global del investigador (Investigator Global Assessment, IGA) de 0 (ausente) o 1 (casi ausente) Y al menos una reducción de 2 grados en la semana 16 con respecto a la evaluación basal en el subgrupo de sujetos con lesiones psoriásicas cutáneas en la evaluación basal.
    13. Variación de la evaluación del dolor de la artritis por parte del paciente (Patient’s Assessment of Arthritis Pain, PtAAP) en la semana 16 con respecto al basal.
    14. Estado sin entesitis según el índice del Consorcio para la investigación de la espondiloartritis de Canadá (Spondyloarthritis Research Consortium of Canada, SPARCC) en la semana 16 en el subgrupo de sujetos con entesitis en la evaluación basal.
    15. Variación del Psoriatic Arthritis Impact of Disease-12 (PsAID-12) en la semana 16 con respecto a la evaluación basal.
    16. Incidencia de acontecimientos adversos surgidos durante el tratamiento (treatment-emergent adverse events, TEAEs).
    17. Incidencia de acontecimientos adversos graves (serious adverse events, SAE).
    18. Acontecimientos adversos (adverse events, AEs) que conducen a la retirada del IMP .
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.; 11. Baseline, Week 4
    5. Week 16
    2.-4.; 6.-10.; 12.-15. Baseline, Week 16
    16.-18. From Baseline until Safety Follow-Up
    (up to Week 72)
    1.; 11. Basal, Semana 4
    5. Semana 16
    2.-4.; 6.-10.; 12.-15. Basal, Semana 16
    16.-18. Desde Basal hasta Seguimiento de la 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Australia
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Japan
    Poland
    Russian Federation
    Spain
    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
    Last subject last visit (LSLV)
    Última visita último paciente (LPLV)
    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 months11
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days13
    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: 754
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 86
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 445
    F.4.2.2In the whole clinical trial 840
    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.
    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 Decision2019-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
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