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    Summary
    EudraCT Number:2016-003190-17
    Sponsor's Protocol Code Number:M15-991
    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:2017-10-20
    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 number2016-003190-17
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
    Estudio de inducción multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de risankizumab en sujetos con enfermedad de Crohn activa moderada o grave sin respuesta al tratamiento biológico previo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease.
    Estudio de eficacia y seguridad de risankizumab en sujetos con enfermedad de Crohn activa moderada o grave
    A.4.1Sponsor's protocol code numberM15-991
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03104413
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    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 supportAbbVie.Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34901200103
    B.5.6E-mailabbvie_reec@abbvie.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 nameRisankizumab
    D.3.2Product code ABBV-066
    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 INNRISANKIZUMAB
    D.3.9.1CAS number ABBV-066
    D.3.9.4EV Substance CodeSUB182635
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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 Yes
    D.3.11.13.1Other medicinal product typeHumanized IgG monoclonal antibody
    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 nameRisankizumab
    D.3.2Product code ABBV-066
    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 INNRISANKIZUMAB
    D.3.9.1CAS number ABBV-066
    D.3.9.4EV Substance CodeSUB182635
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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 Yes
    D.3.11.13.1Other medicinal product typeHumanized IgG monoclonal antibody
    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 nameRisankizumab
    D.3.2Product code ABBV-066
    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 INNRISANKIZUMAB
    D.3.9.1CAS number ABBV-066
    D.3.9.4EV Substance CodeSUB182635
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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 Yes
    D.3.11.13.1Other medicinal product typeHumanized IgG monoclonal antibody
    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 nameRisankizumab
    D.3.2Product code ABBV-066
    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 INNRISANKIZUMAB
    D.3.9.1CAS number ABBV-066
    D.3.9.4EV Substance CodeSUB182635
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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 Yes
    D.3.11.13.1Other medicinal product typeHumanized IgG monoclonal antibody
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion 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
    Crohn's disease
    Enfermedad de Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's disease
    Enfermedad de Crohn
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10013099
    E.1.2Term Disease Crohns
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.
    El objetivo del estudio M15-991 es evaluar la eficacia y seguridad de Risankizumab versus placebo durante la terapia de inducción en sujetos con enfermedad de Crohn activa moderada o grave
    E.2.2Secondary objectives of the trial
    Not applicable.
    no aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit
    - Diagnosis of CD for at least 3 months prior to Baseline
    - Crohn's disease activity index (CDAI) score 220-450 during the screening period
    - Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
    - Demonstrated intolerance or inadequate response to biologic therapy for CD
    - If female, subject must meet the contraception recommendations
    - Varón o mujer >= 18 años <= 80 años en el momento de la visita basal. Donde sea localmente permitido, sujetos de 16 a <18 años de edad que cumplan con el estadío 5 de desarrollo según la definición de Tanner en la visita basal
    - Diagnóstico de Enfermedad de Crohn al menos 3 meses antes de la visita basal
    -Puntuación 220-450 en Índice de actividad de la enfermedad de Crohn (CDAI) durante el período de screening
    - Diagnóstico confirmado de enfermedad de Crohn de moderada a grave según la frecuencia de heces (SF), el puntaje de dolor abdominal (AP) y la puntuación endoscópica simple para la enfermedad de Crohn (SES-CD)
    - Intolerancia demostrada o respuesta inadecuada a terapia convencional o biológica para enfermedad de Crohn
    - Si es mujer, debe cumplir con las recomendaciones de anticoncepción
    E.4Principal exclusion criteria
    - Subject with a current diagnosis of ulcerative colitis or indeterminate colitis
    - Subjects with unstable doses of concomitant Crohn’s disease therapy
    - Receipt of Crohn’s disease approved biologic agents (within 8 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days prior to the Baseline
    - Prior exposure to p40 inhibitors (e.g., ustekinumab [Stelara]) or p19 inhibitors (e.g., risankizumab)
    - Complications of Crohn’s disease (strictures, stenosis, short bowel, etc)
    - Having an ostomy or ileoanal pouch
    -Sujeto con un diagnóstico actual de colitis ulcerosa o colitis indeterminada
    -Sujetos con dosis inestables de terapia concomitante para la enfermedad de Crohn
    - Haber recibido agentes biológicos aprobados para la enfermedad de Crohn (dentro de las 8 semanas anteriores a la visita basal), o cualquier agente biológico u otro agente de investigación en un mínimo de 35 días antes de la visita basal
    - Exposición previa a inhibidores p40 (por ejemplo, ustekinumab [Stelara]) o inhibidores p19 (por ejemplo, risankizumab)
    - Complicaciones de la enfermedad de Crohn (estenosis, intestino corto, etc.)
    - Tener bolsa de ostomía o ileoanal
    E.5 End points
    E.5.1Primary end point(s)
    Co-Primary Endpoints:
    Proportion of participants with clinical remission (per daily stool frequency [SF] and average daily abdominal pain [AP] score) at Week 12 and percentage of participants with endoscopic response at Week 12
    Criterios de valoración co-primarios:

    -Proporción de participantes con remisión clínica (por frecuencia diaria de heces [SF] y puntuación promedio de dolor abdominal diario [AP]) en la semana 12 y porcentaje de participantes con respuesta endoscópica en la semana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    1. Proportion of participants with enhanced clinical response at Week 4, defined as decrease in average daily SF and/or decrease in average daily AP score and/or clinical remission per average daily SF and average daily AP score
    2. Proportion of participants with clinical remission per Crohn's disease activity index (CDAI) at Week 12
    3. Proportion of participants with enhanced clinical response at Week 12, defined as defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score
    4. Proportion of participants with clinical remission per average daily SF and average daily AP score at Week 4
    5. Proportion of participants with enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score and endoscopic response defined as decrease from Baseline in SES-CD at Week 12
    6. Proportion of participants with endoscopic healing, assessed using SES-CD, at Week 12
    7. Crohn's Symptom Severity (CSS): Change from Baseline to Week 12
    8. Proportion of participants with resolution of extra-intestinal manifestations (EIMs) at Week 12, in subjects with EIMs at Baseline
    9. Proportion of participants with hospitalization through Week 12
    10. Proportion of participants with draining fistulas at Week 12 in participants with draining fistulas at Baseline
    11. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12
    12. 36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12
    13. Proportion of participants with Crohn's disease (CD)-related surgeries through Week 12
    1. Proporción de participantes con respuesta clínica mejorada en la semana 4, definida como disminución en la frecuencia de heces media diaria y / o disminución en la puntuación media AP y / o remisión clínica medida por promedio diario de frecuencia de heces y la puntuación media de AP
    2. Proporción de participantes con remisión clínica por índice de actividad de la enfermedad de Crohn (CDAI) en la semana 12
    3. Proporción de participantes con respuesta clínica mejorada en la semana 12, definida como disminución en la frecuencia de heces diaria promedio y / o disminución en la puntuación media AP y / o remisión clínica por frecuencia de heces promedia diaria y puntuación AP media diaria
    4. Proporción de participantes con remisión clínica por frecuencia de heces promedio diaria y puntuación promedio AP en la semana 4
    5. Proporción de participantes con respuesta clínica mejorada definida como disminución en la frecuencia de heces promedia diaria y / o disminución en la puntuación media AP y respuesta endoscópica definida como disminución en SES-CD en la semana 12 comparada con la visita basal
    6. Proporción de participantes con curación endoscópica, evaluada mediante SES-CD, en la semana 12
    7. Gravedad de los síntomas de Crohn (CSS): Cambios desde la visita basal en la semana 12
    8. Proporción de participantes con resolución de manifestaciones extraintestinales (EIM) en la semana 12, en sujetos con EIMs en la visita basal
    9. Proporción de participantes que han sido hospitalizados hasta la semana 12
    10. Proporción de participantes con fístulas de drenaje en la Semana 12 comparada con los participantes con fístulas de drenaje en la visita basal
    11. Evaluación Funcional para el Tratamiento de Enfermedades Crónicas - Fatiga (FACIT-Fatiga): Cambios entre la visita basal y la Semana 12
    12. Encuesta sobre el estado de salud de 36 elementos (SF-36): Cambios entre la visita basal y la Semana 12
    13. Porcentaje de participantes con cirugías relacionadas con la enfermedad de Crohn (CD) hasta la semana 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 4
    2. Week 12
    3. Week 12
    4. Week 4
    5. Week 12
    6. Week 12
    7. Week 12
    8. Week 12
    9. 12 weeks
    10. Week 12
    11. Baseline, Week 12
    12. Baseline, Week 12
    13. 12 weeks
    1. Semana 4
    2. Semana 12
    3. Semana 12
    4. Semana 4
    5. Semana 12
    6. Semana 12
    7. Semana 12
    8. Semana 12
    9. 12 Semanas
    10. Semana 12
    11. Baseline, Semana 12
    12. Baseline, Semana 12
    13. 12 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 EEA162
    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
    Austria
    Belarus
    Belgium
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czech Republic
    Denmark
    Egypt
    Estonia
    Finland
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Ireland
    Israel
    Italy
    Korea, Republic of
    Latvia
    Lithuania
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Norway
    Poland
    Portugal
    Puerto Rico
    Romania
    Russian Federation
    Serbia
    Singapore
    Slovakia
    Slovenia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    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
    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 months6
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 18
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 18
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 543
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 223
    F.4.2.2In the whole clinical trial 579
    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)
    An ongoing maintenance study will be available for subjects who respond in this study and continue to fulfill inclusion/exclusion criteria.
    Un estudio de mantenimiento continuo estará disponible para los sujetos que respondan en este estudio y continúen cumpliendo con los criterios de inclusión / exclusión.
    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 Decision2017-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-19
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