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    Summary
    EudraCT Number:2019-000906-31
    Sponsor's Protocol Code Number:IgPro10_2001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-12-20
    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 number2019-000906-31
    A.3Full title of the trial
    A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis
    Estudio de fase II multicéntrico, aleatorizado, con doble enmascaramiento y controlado con placebo para evaluar la eficacia y seguridad de IgPro10 (inmunoglobulina intravenosa, Privigen®) en el tratamiento de adultos con esclerosis sistémica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)
    Evaluar la eficacia y seguridad de IgPro10 en el tratamiento de adultos con esclerosis sistémica
    A.4.1Sponsor's protocol code numberIgPro10_2001
    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 SponsorCSL Behring GmbH
    B.1.3.4CountryGermany
    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 supportCSL Behring GmbH (CSLB)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCSLB
    B.5.2Functional name of contact pointTrial Registration Coordinator
    B.5.3 Address:
    B.5.3.1Street Address1020 First Ave
    B.5.3.2Town/ cityKing of Prussia,PA
    B.5.3.3Post code19406
    B.5.3.4CountryUnited States
    B.5.4Telephone number001610 8784000
    B.5.6E-mailclinicaltrials@cslbehring.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 Yes
    D.2.1.1.1Trade name Privigen
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring GmbH
    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 nameHuman normal immunoglobulin for intravenous (IV) administration
    D.3.2Product code IgPro10
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman normal immunoglobulin
    D.3.9.2Current sponsor codeIgPro10
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN
    D.3.9.4EV Substance CodeSUB14196MIG
    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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
    eficacia y seguridad en sujetos con esclerosis sistémica cutánea difusa
    E.1.1.1Medical condition in easily understood language
    scleroderma
    scleroderma
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10012977
    E.1.2Term Diffuse systemic sclerosis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10010331
    E.1.2Term Congenital, familial and genetic disorders
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy of IgPro10 in comparison to placebo in adults with Diffuse systemic sclerosis (dcSSc) assessed by improvement as measured by American College of Rheumatology Combined Response Index in Diffuse Systemic Sclerosis (ACR CRISS) score.
    El objetivo principal es evaluar la eficacia de IgPro10 en comparación con un placebo en adultos con esclerosis sistémica cutánea difusa (EScd); esta se valorará mediante la mejoría de la puntuación del índice de respuesta combinada de la esclerosis sistémica difusa del Colegio Americano de Reumatología ( ACR CRISS).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate:
    1. To further assess the efficacy of IgPro10 as compared to placebo
    2. To assess safety of IgPro10 as compared to placebo
    3. To assess the IgPro10 concentrations at steady state
    4. To assess longer term efficacy and safety of IgPro10 at the end of an OL Treatment Period at Week 72.
    Los objetivos secundarios del estudio son:
    1 Evaluar la eficacia de IgPro10 en comparación con placebo
    2 Evaluar la seguridad de IgPro10 en comparación con placebo
    3 Evaluar las concentraciones de IgPro10 en estado estacionario
    4 Evaluar la eficacia y la seguridad de IgPro10 a largo plazo al final del período de tratamiento A, en la semana 72.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years (male or female) at time of providing written informed consent
    2. Documented diagnosis of dcSSc according to ACR / EULAR criteria 2013
    3. mRSS ≥ 15 and ≤ 45
    4. Disease duration ≤ 5 years defined as the time from the first non-Raynaud’s phenomenon manifestation
    5. Subjects within first 18 months of disease duration from first non-Raynaud’s phenomenon manifestation. For those >18 to ≤ 60 months, subjects with worsening of sclerodermatous skin involvement in one or more body areas (including any new areas of involvement) within 6 months prior to Screening and/or the presence of a tendon friction rub within 3 months prior to Screening as documented and determined by the investigator
    based on medical history and medical records
    1. Edad ≥18 años (ambos sexos) en el momento de la firma del consentimiento informado
    2. Diagnóstico documentado de EScd según el ACR/los criterios de la Liga europea contra las enfermedades reumáticas de 2013
    3. mRSS ≥15 y ≤45
    4. Duración de la enfermedad ≤5 años, definida como el tiempo transcurrido desde la primera manifestación que no sea el fenómeno de Raynaud
    5. Sujetos cuya duración de la enfermedad esté dentro de los primeros 18 meses, desde la primera manifestación que no sea el fenómeno de Raynaud. Los sujetos cuya duración de la enfermedad se sitúe entre >18 y ≤60 meses deberán presentar empeoramiento de la afectación esclerodérmica cutánea en una o más áreas corporales (lo que incluye cualquier nueva área de afectación) dentro de los 6 meses previos a la selección y/o presencia de fricción tendinosa de un tendón dentro de los 3 meses anteriores a la selección, documentados y determinados por el investigador basándose en los antecedentes patológicos y la historia clínica.
    E.4Principal exclusion criteria
    1. Primary rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, and dermatomyositis, as determined by the investigator
    Note: Subjects with fibromyalgia, secondary Sjogren’s syndrome, and scleroderma-associated myopathy or myositis at Screening are not excluded
    2. Positive anti-centromere autoantibodies at Screening
    3. Evidence of severe chronic kidney disease with estimated glomerular filtration rate < 30 mL/min/1.73m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation) or receiving dialysis
    4. History of documented thrombotic episode eg, PE, DVT, myocardial infarction, thromboembolic stroke at any time
    Note: past superficial thrombophlebitis more than two years from Screening is not exclusionary
    5. Documented thrombophilic abnormalities including blood hyperviscosity, protein S or protein C deficiency, anti-thrombin-3 deficiency, plasminogen deficiency, antiphospholipid syndrome, Factor V Leiden mutation, dysfibrinogenemia, or prothrombin G20210A mutation
    6. Greater than 3 specified current risk factors for TEEs (documented and currents conditions): atrial fibrillation, coronary disease, diabetes mellitus, dyslipidemia, hypertension, obesity (Body Mass Index ≥ 30 kg/m2), recent significant trauma, and immobility (wheelchair-bound or bedridden)
    7. Ongoing active serious infection at Screening (including, but not limited to, pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess)
    8. Malignancy in the past 2 years, except for non-melanoma skin cancer, cervical carcinoma in situ, or other in situ cancer if it has been excised and treated within in the past year
    9. Known hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L)
    10. Known IgA deficiency or serum IgA level < 5% lower limit of normal
    11. Known or suspected antibodies to the IP, or to excipients of the IP.
    1. Enfermedad autoinmunitaria reumática primaria que no sea la EScd, lo que incluye, entre otras, la artritis reumatoide, el lupus eritematoso sistémico, los trastornos mixtos del tejido conjuntivo, la polimiositis y la dermatomiositis, según la determinación del investigador
    Nota: No se excluirá a los sujetos con fibromialgia, síndrome de Sjögren secundario, miopatía asociada a la esclerodermia o miositis en el momento de realizar la selección
    2. Anticuerpos anti-centrómero positivos en la selección
    3. Nefropatía crónica grave, evidenciada por una tasa de filtración glomerular estimada <30 ml/min/1,73 m2 (calculada con la ecuación de la Chronic Kidney Disease Epidemiology Collaboration) o por hallarse en diálisis
    4. Antecedentes de algún episodio trombótico documentado, como embolia pulmonar, trombosis venosa profunda, infarto de miocardio o accidente cerebrovascular troboembólico en cualquier momento
    Nota: los antecedentes de tromboflebitis superficial de una anterioridad superior a 2 años respecto a la selección no serán motivo de exclusión
    5. Anormalidades trombofílicas documentadas, que incluyen: hiperviscosidad sanguínea, deficiencia de proteínas S o C, deficiencia de antitrombina-3, deficiencia de plasminógeno, síndrome antifosfolípidos, mutación del Factor V de Leiden, disfibrinogenemia o mutación G20210A de la protrombina
    6. Más de tres factores de riesgo especificados para los eventos tromboembólicos (ETE) (previos o actuales): fibrilación auricular, cardiopatía coronaria, diabetes mellitus, dislipemia, hipertensión arterial, obesidad (índice de masa corporal ≥30 kg/m2), traumatismo reciente importante o inmovilidad (en silla de ruedas o en cama)
    7. Infección grave activa presente en la selección (entre otras: neumonía, bacteriemia/septicemia, osteomielitis/artritis séptica, meningitis bacteriana o absceso visceral)
    8. Neoplasia maligna dentro de los 2 años previos, a excepción del cáncer de piel no melanoma, el carcinoma localizado de cuello del útero u otras neoplasias malignas localizadas que se hayan extirpado y tratado durante el año anterior
    9. Hipoalbuminemia, enteropatías con pérdida de proteínas o cualquier tipo de proteinuria (definida como una concentración total de proteínas en orina >0,2 g/l) conocidas
    10. Deficiencia de IgA conocida o nivel sérico de IgA <5 % con respecto al límite inferior de la normalidad
    11. Presencia conocida o sospechada de anticuerpos frente al producto en investigación (PEI) o a sus excipientes
    E.5 End points
    E.5.1Primary end point(s)
    Response on American College of Rheumatology Combined Response Index in Diffuse Systemic Sclerosis (ACR CRISS) score in IgPro10 vs Placebo
    Respuesta sobre el índice de respuesta combinada del Colegio Americano de Reumatologia en la puntuación de la esclerosis sistémica difusa (ACR CRISS) en IgPro10 vs Placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    over 48 weeks
    Sobre 48 semanas
    E.5.2Secondary end point(s)
    1. Proportion of subjects meeting cardiopulmonary or renal failure criteria in ACR CRISS Step 1 events
    2. Proportion of responders (ACR CRISS > 0.6)
    3. Mean change from Baseline in Modified Rodnan Skin Score (mRSS)
    4. Mean change from Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI)
    5. Mean change from Baseline in Forced Vital Capacity (FVC)% predicted
    6. Mean change from Baseline in Physician Global Assessment (MDGA)
    7. Mean change from Baseline in Patient Global Assessment (PGA)
    8. Mean change from Baseline in UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0 (UCLA SCTC GIT 2.0) total score and subscale
    9. Mean change from Baseline in Scleroderma Skin Patient Reported Outcome (SSPRO) score in IgPro10 vs Placebo
    10. Proportion of responders in mRSS
    11. Time to treatment failure(time from first infusion to time of first event) in IgPro10 vs Placebo
    12. Proportion of subjects with events at Week 48 in IgPro10 vs Placebo
    13. Mean change from Baseline in Cochin Hand Function Scale in IgPro10 vs Placebo
    14. Mean change from Baseline in Scleroderma Health Assessment Questionnaire (SHAQ) score in IgPro10 vs Placebo
    15. Mean change from baseline in muscle strength as measured by Manual Muscle Testing 8 (MMT) in IgPro10 vs Placebo
    16. Number of subjects with adverse events (AEs) including any AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
    17. Percentage of subjects with AEs, TEAEs, SAEs, AESIs
    18. Change in Vital signs
    19. Change in body weight
    20. Change in Electrocardiogram (ECG)
    21. Change in pulmonary function tests ( PFTs)
    22. Serum trough IgG levels at Baseline and prior to first infusion
    23. Proportion of responders (ACR CRISS > 0.6)
    24. Mean change from Baseline in mRSS
    25. Mean change from Baseline in HAQ-DI
    26. Mean change from Baseline in Forced Vital Capacity (FVC)% predicted
    27. Mean change from Baseline in MDGA
    28. Mean change from Baseline in PGA
    29. Number of subjects with adverse events (AEs) including any AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
    30. Percentage of subjects with AEs, TEAEs, SAEs, AESIs
    31. Change in Vital signs
    32. Change in Electrocardiogram (ECG)
    33. Change in FVC and DLCO
    1. Proporción de sujetos que cumplen los criterios de insuficiencia cardiopulmonar o renal en los acontecimientos del paso 1 del CRISS del ACR
    2. Proporción de sujetos que responden al tratamiento (CRISS del ACR >0,6)
    3. Cambio promedio con respecto al inicio en la puntuación cutánea de la escala de Rodnan modificada (mRSS)
    4. Cambio promedio con respecto al inicio en el índice de discapacidad del cuestionario de evaluación de la salud (HAQ-DI)
    5. Cambio promedio con respecto al inicio en el porcentaje de la capacidad vital forzada (CVF) prevista
    6. Cambio promedio con respecto al inicio en la evaluación global del médico (EGM)
    7. Cambio promedio con respecto al inicio en la evaluación global del paciente (EGP)
    8. Cambio promedio con respecto al inicio en la puntuación total y la subescala del cuestionario relativo al tubo gastrointestinal del consorcio de ensayos clínicos sobre esclerodermia de la Universidad de California en Los Ángeles 2.0 (UCLA SCTC GIT 2.0)
    9. Cambio promedio con respecto al inicio en la puntuación de los resultados comunicados por los pacientes con esclerodermia en relación con la piel (SSPRO) obtenido con IgPro10 frente al obtenido con el placebo
    10. Proporción de sujetos que responden al tratamiento determinada mediante la mRSS
    11. Tiempo hasta el fracaso del tratamiento (tiempo transcurrido desde la primera infusión hasta el momento del primer acontecimiento) obtenido con IgPro10 frente al obtenido con el placebo
    12. Proporción de sujetos con acontecimientos en la semana 48 obtenida con IgPro10 frente a la obtenida con el placebo
    13. Cambio promedio con respecto al inicio en la escala de Cochin de funcionalidad de las manos obtenido con IgPro10 frente al obtenido con el placebo
    14. Cambio promedio con respecto al inicio en la puntuación del cuestionario de evaluación de la salud en la esclerodermia (SHAQ) obtenido con IgPro10 frente al obtenido con el placebo
    15. Cambio promedio con respecto al inicio en la fuerza muscular determinada mediante la prueba de musculatura manual 8 obtenido con IgPro10 frente al obtenido con el placebo
    16. Número de sujetos con acontecimientos adversos (AA), incluidos los AA, AA surgidos durante el tratamiento (AAST), AA graves (AAG) y AA de interés especial (AAIE)
    17. Porcentaje de sujetos con AA, AAST, AAG y AAIE
    18. Cambio en las constantes vitales
    19. Cambio en el peso corporal
    20. Cambio en el electrocardiograma (ECG)
    21. Cambio en las pruebas de funcionamiento pulmonar (PFP)
    22. Concentraciones séricas mínimas de IgG en el inicio y antes de la primera infusión
    23. Proporción de sujetos que responden al tratamiento (CRISS del ACR >0,6)
    24. Cambio promedio con respecto al inicio en la mRSS
    25. Cambio promedio con respecto al inicio en el HAQ-DI
    26. Cambio promedio con respecto al inicio en el porcentaje de la capacidad vital forzada (CVF) prevista
    27. Cambio promedio con respecto al inicio en la EGM
    28. Cambio promedio con respecto al inicio en la EGP
    29. Número de sujetos con acontecimientos adversos (AA), incluidos los AA, AA surgidos durante el tratamiento (AAST), AA graves (AAG) y AA de interés especial (AAIE)
    30. Porcentaje de sujetos con AA, AAST, AAG y AAIE
    31. Cambio en las constantes vitales
    32. Cambio en el electrocardiograma (ECG)
    33. Cambio en la CVF y la difusión pulmonar para el monóxido de carbono (DPCO)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. over 48 weeks
    2. over 48 weeks
    3. over 48 weeks
    4. over 48 weeks
    5. over 48 weeks
    6. over 48 weeks
    7. over 48 weeks
    8. over 48 weeks
    9. up to 48 weeks
    10. up to 48 weeks
    11. over 48 weeks
    12. over 48 weeks
    13. over 48 weeks
    14. over 48 weeks
    15. over 48 weeks
    16. over 48 weeks
    17. over 48 weeks
    18. over 48 weeks
    19. over 48 weeks
    20. over 48 weeks
    21. over 48 weeks
    22. At baseline and up to Weeks 24, 48, 60 and 72.
    23. over 72 weeks
    24. over 72 weeks
    25. over 72 weeks
    26. over 72 weeks
    27. over 72 weeks
    28. over 72 weeks
    29. over 72 weeks
    30. over 72 weeks
    31. over 72 weeks
    32. over 72 weeks
    33. over 72 weeks
    1. más de 48 semanas
    2. más de 48 semanas
    3. más de 48 semanas
    4. más de 48 semanas
    5. más de 48 semanas
    6. más de 48 semanas
    7. más de 48 semanas
    8. más de 48 semanas
    9. hasta 48 semanas
    10. hasta 48 semanas
    11. más de 48 semanas
    12. más de 48 semanas
    13. más de 48 semanas
    14. más de 48 semanas
    15. más de 48 semanas
    16. más de 48 semanas
    17. más de 48 semanas
    18. más de 48 semanas
    19. más de 48 semanas
    20. más de 48 semanas
    21. más de 48 semanas
    22. En el inicio y hasta las semanas 24, 48, 60 y 72.
    23. más de 72 semanas
    24. más de 72 semanas
    25. más de 72 semanas
    26. más de 72 semanas
    27. más de 72 semanas
    28. más de 72 semanas
    29. más de 72 semanas
    30. más de 72 semanas
    31. más de 72 semanas
    32. más de 72 semanas
    33. más de 72 semanas
    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 No
    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 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 concerned7
    E.8.5The trial involves multiple Member States No
    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
    Argentina
    Australia
    Belgium
    Canada
    France
    Germany
    Italy
    Mexico
    Poland
    Spain
    Switzerland
    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
    The end of the clinical study for DB and OL treatment periods (ie, completion of the study at all participating study sites) is defined as the date of the final completing follow-up phone call (Follow-up Period).
    El final del estudio clínico para los períodos de tratamiento de DB y OL (es decir, la finalización del estudio en todos los centros de estudio participantes) se define como la fecha de la última llamada telefónica de seguimiento completa (Período de seguimiento).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 188
    F.1.3Elderly (>=65 years) No
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 144
    F.4.2.2In the whole clinical trial 188
    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
    Ninguno
    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 Decision2019-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-09-15
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