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    Summary
    EudraCT Number:2018-001808-11
    Sponsor's Protocol Code Number:ID-064A202
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-11-16
    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 number2018-001808-11
    A.3Full title of the trial
    A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE)
    Estudio en fase IIb, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia, seguridad y tolerabilidad de cenerimod en pacientes con lupus eritematoso sistémico (LES) de moderado a grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease
    Un estudio de investigación para evaluar los efectos de una medicación oral nueva llamada cenerimod en adultos con lupus eritematoso sistémico.
    A.4.1Sponsor's protocol code numberID-064A202
    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 SponsorIdorsia Pharmaceuticals Ltd
    B.1.3.4CountrySwitzerland
    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 supportIdorsia Pharmaceuticals Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIdorsia Pharmaceuticals Ltd
    B.5.2Functional name of contact pointClinical Trial Disclosure Desk
    B.5.3 Address:
    B.5.3.1Street AddressHegenheimermattweg 91
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 58 844 0000
    B.5.6E-mailclinical-trials-disclosure@idorsia.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 nameCenerimod
    D.3.2Product code ACT-334441
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCenerimod
    D.3.9.2Current sponsor codeACT-334441
    D.3.9.4EV Substance CodeSUB193350
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 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 nameCenerimod
    D.3.2Product code ACT-334441
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCenerimod
    D.3.9.2Current sponsor codeACT-334441
    D.3.9.4EV Substance CodeSUB193350
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 3
    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 nameCenerimod
    D.3.2Product code ACT-334441
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCenerimod
    D.3.9.2Current sponsor codeACT-334441
    D.3.9.4EV Substance CodeSUB193350
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 4
    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 nameCenerimod
    D.3.2Product code ACT-334441
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCenerimod
    D.3.9.2Current sponsor codeACT-334441
    D.3.9.4EV Substance CodeSUB193350
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe systemic lupus erythematosus
    Lupus eritematoso sistémico de moderado a grave.
    E.1.1.1Medical condition in easily understood language
    Lupus
    Lupus
    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 10042945
    E.1.2Term Systemic lupus erythematosus
    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
    To assess the efficacy of 6 months cenerimod treatment given at 4 different dose levels (0.5, 1, 2, and 4 mg once daily) on disease activity in adult subjects with moderate to severe SLE concurrently receiving background therapy
    Evaluar la eficacia de un tratamiento con cenerimod durante 6 meses administrado en 4 niveles de dosis diferentes (0,5, 1, 2 y 4 mg una vez al día) sobre la actividad de la enfermedad en pacientes adultos con LES de moderado a grave que reciben simultáneamente tratamiento
    de base.
    E.2.2Secondary objectives of the trial
    To evaluate over 6 months in adult subjects with moderate to severe SLE concurrently receiving background therapy:
    • the safety and tolerability of cenerimod treatment
    • the effect of cenerimod treatment on quality of life and fatigue using relevant patient reported outcome (PRO) instruments
    • the effect of cenerimod treatment on SLE biomarkers
    Evaluar los siguientes aspectos durante un periodo de 6 meses en
    pacientes adultos con LES de moderado a grave que reciben
    simultáneamente tratamiento de base:
    • La seguridad y tolerabilidad del tratamiento con cenerimod.
    • El efecto del tratamiento con cenerimod en la calidad de vida y en la fatiga usando los instrumentos de resultados percibidos por el paciente (RPP) pertinentes.
    • El efecto del tratamiento con cenerimod en biomarcadores de LES.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    At randomization, approximately 125 subjects will be assigned to the echocardiography ancillary study through the IRT system. The echocardiography ancillary study will run concurrently with the main study. Subjects assigned into the echocardiography ancillary study will undergo an echocardiography assessment at Month 6, in addition to echocardiography assessments that will be performed for all subjects during the screening period.
    Aproximadamente 125 sujetos serán asignados al estudio de ecocardiograma mediante el sistéma IRT durante la aleatorización. El estudio de ecocardiograma se llevará a cabo a la vez que el estudio principal. Se realizará un ecocardiograma adicional a los sujetos asignadoas en el mes 6, además de los demás ecocardiogramas que se realizarán a todos los sujetos durante el periodo de screening.
    E.3Principal inclusion criteria
    - Signed ICF prior to any study-mandated procedure
    - Diagnosis of SLE made at least 6 months prior to Screening, by fulfilling at least 4 of the 11 criteria for SLE as defined by the American College of Rheumatology (ACR) criteria
    - A mSLEDAI-2K score ≥ 6 of at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers). The mSLEDAI-2K score does not take into account “leukopenia”
    - Currently treated with stable doses of one or more of the following background medications:
    • NSAIDs
    • Anti-malarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine)
    • Mycophenolate mofetil (≤ 2 g/day)
    • Azathioprine (≤ 2 mg/kg/day)
    • Methotrexate (≤ 20 mg/week)
    • Corticosteroids (≤ 40 mg/day prednisone or equivalent)
    • Belimumab (≤10 mg/kg every 4 weeks)
    - History or presence of positive autoantibodies measured by central laboratory defined as follows: (a) Positive antinuclear antibody (ANA) test measured by immunofluorescence assay (IFA) with titre ≥1:80; AND/OR (b) positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies with titre ≥30 IU/mL
    - Women of childbearing potential (WOCBP):
    • Must have a negative serum pregnancy test at Screening
    • Must agree to undertake monthly urine pregnancy tests during the study
    • Must use highly effective methods of contraception from the screening visit until 4 months after taking the last dose of study treatment
    -FCI firmado previo a cualquier procedimiento que se incluya en el estudio
    -diagnóstico de LES realizado con una antelación de al menos 6 meses antes de la selección y que cumpla al menos cuatro de los 11 criterios del LES, según el American College of Rheumatology (ACR, Colegio Estadounidense de Reumatología).
    -Una puntuación del SLEDAI-2K modificado ≥ 6 de al menos 2 puntos en cuanto a manifestaciones musculoesqueléticas o mucocutáneas (es decir, miositis, artritis, erupción cutánea, alopecia, úlceras en las mucosas).
    La puntuación del SLEDAI-2K modificado no tiene en cuenta "leucopenia".
    -Actualmente en tratamiento con dosis estables de una o más de las siguientes medicaciones de base:
    • Antiinflamatorios no esteroideos (AINE),
    • Antipalúdicos (≤ 400 mg/día de hidroxicloroquina, ≤ 500 mg/día de cloroquina, ≤ 100 mg/día de quinacrina)
    • Micofenolato de mofetilo (≤ 2 g/día),
    • Azatioprina (≤ 2 mg/kg/día),
    • Metotrexato (≤ 20 mg/semana),
    • Corticoesteroides (≤ 40 mg/día de prednisona o equivalente),
    • Belimumab (≤ 10 mg/kg cada 4 semanas)
    -Historia o presencia de anticuerpos positivos medidos por un laboratorio central definida del siguiente modo (en base a la muestra de selección): (a) análisis AAN positivo medido por ensayo por inmunofluorescencia con valor ≥ 1:80; Y/O (b) anticuerpos anti-ADNbc positivos con valor ≥ 30 UI/ml.
    -Mujeres en edad fértil (MEEF):
    • Deben haberse realizado una prueba de embarazo con resultado negativo durante la selección.
    • Se comprometerán a someterse a pruebas de embarazo en orina mensuales durante el estudio.
    • Deberán utilizar métodos anticonceptivos eficaces desde la visita de selección hasta transcurridos 4 meses tras la última dosis del tratamiento del estudio.
    E.4Principal exclusion criteria
    - Active lupus nephritis or a renal biopsy demonstrating immune complex mediated glomerulonephritis compatible with lupus nephritis.
    - CNS lupus and severe forms of vasculitis requiring systemic immunosuppressive treatment.
    - A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with rheumatoid arthritis, erosive arthritis, scleroderma or autoimmune hepatitis.
    - History or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia or syncope associated with cardiac disorders.
    - Subjects who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure defined by the New York Heart Association Class III/IV within six months prior to Screening.
    - An elevated QT corrected for HR on the basis of Fridericia’s formula interval of > 470 ms (females) / > 450 ms (males).
    - History or presence of severe respiratory disease or pulmonary fibrosis.
    - Active or latent tuberculosis .
    - Ongoing bacterial, viral or fungal infection that is of clinical concern in the judgment of the investigator or history of any serious infection.
    - Subjects who have congenital or acquired severe immunodeficiency or known HIV infection or positive HIV testing.
    - Presence of macular edema or active uveitis.
    - Type 1 or 2 diabetes that is poorly controlled according to investigator judgment, or diabetes complicated with organ involvement such as diabetic nephropathy or retinopathy.
    - Significant hematology abnormality: Lymphocyte count < 800 /μL (0.8 × 10e9/L); hemoglobin < 9 g/dL; WBC count < 2500/μL (2.5 × 10e9/L) or platelets < 75000/μL (75 × 10e9/L).
    - Estimated glomerular filtration rate < 60 mL/min/1.73 m2.
    - Known allergy to S1P receptor modulators or any of the cenerimod formulation excipients
    -Nefritis en el lupus activa o una biopsia renal que demuestre una glomerulonefritis mediada por inmunocomplejos compatible con nefritis en el lupus.
    -Lupus en el sistema nervioso central (SNC) y formas graves de vasculitis que requieren tratamiento sistémico inmunosupresor.
    -Diagnóstico de enfermedad mixta del tejido conjuntivo o antecedentes de síndrome de superposición de LES con artritis reumatoide, artritis erosiva, esclerodermia o hepatitis autoinmunitaria.
    -Antecedentes o presencia de Mobitz de tipo II o bloqueo auriculoventricular de tercer grado, síndrome del nodo sinusal enfermo, bradicardia sintomática o síncope asociados con enfermedades cardíacas.
    -Pacientes que hayan sufrido infarto de miocardio, angina de pecho inestable, derrame cerebral, ataque isquémico transitorio, trombosis vascular, insuficiencia cardíaca descompensada que requiere hospitalización o insuficiencia cardíaca de las clases III-IV de la New York Heart Association durante los seis meses anteriores a la selección.
    -Un QT corregido para frecuencia cardíaca (FC) elevado según el intervalo de la fórmula de Fridericia (QTcF) de > 470 ms (mujeres) / > 450 ms (hombres).
    -Antecedentes o presencia de enfermedad respiratoria grave o fibrosis pulmonar.
    -Tuberculosis activa o latente.
    -Infección bacteriana, vírica o fúngica en curso de interés clínico a juicio del investigador o antecedentes de infecciones graves.
    -Pacientes con inmunodeficiencia grave congénita o adquirida o infección por VIH conocida o pruebas del VIH positivas.
    -Presencia de edema macular o de uveitis activa.
    -Diabetes de tipo 1 o 2 mal controlada a juicio del investigador o diabetes complicada con implicación de órganos, tal como nefropatía o retinopatía diabética.
    -Anormalidad hematológica significativa: Recuento de linfocitos < 800 /μL (0,8 × 109/l); hemoglobina < 9 g/dl; recuento de leucocitos < 2500/μL (2,5 × 109/l) o plaquetas < 75 000/μL (75 × 109/l).
    -Tasa de filtración glomerular estimada < 60 ml/min/1,73 m2.
    -Alergia conocida a los moduladores del receptor esfingosina-1-fosfato (S1P) o a cualquiera de los excipientes de la fórmula de cenerimod.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Month 6 in the mSLEDAI-2K score
    Cambio desde visita basal a mes 6 en la puntuación SLEDAI-2K modificado.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Month 6
    Desde visita basal a mes 6.
    E.5.2Secondary end point(s)
    Response on SRI4 at Month 6 as compared to baseline
    Percent of subjects with no new organ system affected as defined by one or more BILAG A or 2 or more BILAG B items as compared with baseline at Month 6
    Respuesta del Índice de respuesta del LES (SRI) 4 en el mes 6 en comparación con los valores iniciales
    Porcentaje de pacientes sin afectación de nuevos órganos, definida por uno o más elementos del BILAG A o bien 2 o más elementos del BILAG B, en comparación con los valores iniciales del mes 6.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At month 6 after study treatment initiation
    Mes 6 tras el inicio del tratamiento con la medicación en estudio.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    Biomarkers, tolerability, patient reported outcomes
    Biomarcadores, tolerabilidad y resultados reportados por el paciente.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial5
    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 EEA73
    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
    Bulgaria
    China
    Czech Republic
    France
    Georgia
    Germany
    Hong Kong
    Hungary
    Israel
    Italy
    Lithuania
    Mexico
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    Thailand
    Turkey
    Ukraine
    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
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months32
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months32
    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: 50
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 201
    F.4.2.2In the whole clinical trial 500
    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)
    After the subject’s study completion from the study the investigator will explain to subjects what treatment(s) / medical care is necessary and available according to local practice
    Una vez los sujetos completen el estudio el investigador les explicará que tratamientos/cuidados médicos son necesario y se encuentran disponibles conforme a la práctical local.
    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 Decision2019-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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