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    Summary
    EudraCT Number:2016-003190-17
    Sponsor's Protocol Code Number:M15-991
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-10-01
    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 ConcernedItaly - Italian Medicines Agency
    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
    Sperimentazione Multicentrica, Randomizzata, in Doppio Cieco, Controllata verso Placebo e di Induzione per Valutare l¿Efficacia e la Sicurezza di Risankizumab in Soggetti con Malattia di Crohn in Fase Attiva e di Grado da Moderato a Grave per cui ¿ Fallita una Pregressa Terapia con Biologici
    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.
    Sperimentazione di Efficacia e Sicurezza di Risankizumab in Soggetti con Malattia di Crohn in Fase Attiva e di Grado da Moderato.
    A.3.2Name or abbreviated title of the trial where available
    not applicable
    not applicable
    A.4.1Sponsor's protocol code numberM15-991
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03104413
    A.5.4Other Identifiers
    Name:not applicableNumber:not applicable
    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 number0441628561090
    B.5.5Fax number0441628461153
    B.5.6E-maileu-clinical-trials@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 1612838-76-2
    D.3.9.2Current sponsor codeNot applicable
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 1612838-76-2
    D.3.9.2Current sponsor codenot applicable
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    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 1612838-76-2
    D.3.9.2Current sponsor codenot applicable
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    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 1612838-76-2
    D.3.9.2Current sponsor codenot applicable
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    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
    Malattia di Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's disease
    Malattia di 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.
    L¿obiettivo della Sperimentazione M15-991 ¿ quello di valutare l¿efficacia e la sicurezza di risankizumab rispetto a placebo durante la terapia di induzione in soggetti affetti da malattia di Crohn in fase attiva di grado da moderato a grave.
    E.2.2Secondary objectives of the trial
    Not applicable
    Not applicable
    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.
    - Soggetti di ambo i sessi di età compresa fra = 18 e = 80 anni alla visita di Baseline. Ove localmente permesso , soggetti di età = 16 e < 18 anni il cui sviluppo è classificato come stadio 5 secondo Tanner alla visita di Baseline.
    - Diagnosi confermata di malattia di Crohn da almeno 3 mesi prima del Baseline.
    - Indice di attività della malattia di Crohn (CDAI) di 220 – 450 durante il periodo di screening
    - Diagnosi confermata di malattia di Crohn in stadio da moderato a severo, valutata attraverso la frequenza di evacuazione (SF), scala relativa al dolore addominale ed Simple Endoscopic Score per la malattia di Crohn (SES-CD).
    - Dimostrata intolleranza o risposta inadeguata a teriapia biologica per la malattia di Crohn.
    - I soggetti di sesso femminile devono soddisfare le raccomnadazioni relative alle misure contraccettive.
    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
    -Soggetto con diagnosi attuale di colite ulcerosa oppure colite di natura indeterminata.
    - Soggetto in trattamento con terapie concomitanti della Malattia di Crohn la cui dose non è rimasta stabile.
    - Soggetto che ha ricevuto qualsiasi agente biologico approvato (entro le 8 settimane precedenti la visita di Baseline), o qualsiasi agente biologico sperimentale o altro agente o procedura entro minimo 35 giorni prima della visita di Baseline
    - Soggetto con pregressa esposizione a inibitori del p40 (ad esempio, ustekinumab [Stelara] o
    inibitori del p19 [ad esempio, risankizumab].
    - Soggetto con presenza nota di complicanze associate alla malattia di Crohn (ascesso, stenosi, restringimenti intestinali sintomatici etc)
    - Soggetto con stomia o sacchetto ileoanale.
    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
    Co-Primary endpoints:
    Percentuale di soggetti con remissione clinica (per frequenza giornaliera di evaquazione [SF] e media giornaliera del punteggio relativo al dolore addominale [AP]) alla Settimana 12 e percentuale di soggetto con risposta endoscopica alla settimana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Settimana 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 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 subjects with endoscopic remission at Week 12
    9. Proportion of participants with resolution of extra-intestinal manifestations (EIMs) at Week 12, in subjects with EIMs at Baseline
    10. Proportion of participants with hospitalization through Week 12
    11. Proportion of participants with draining fistulas at Week 12 in participants with draining fistulas at Baseline
    12. Functional Assessment of Chronic Illness Therapy-Fatigue (FACITFatigue): Change from Baseline to Week 12
    13. 36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12
    14. Proportion of participants with Crohn's disease (CD)-related surgeries through Week 12
    ; 1.Percentuale di soggetti con risposta clinica incrementata alla Settimana 4, definita come riduzione della media giornaliera di evaquazione (SF) e/o riduzione della media giornaliara del punteggio relativo al dolore addominale (AP) e/o remissione clinica della media giornaliera di SFe media giornaliera del punteggio AP.
    2. Percentuale di soggetti con Crohn¿s Disease Activity Index (CDAI) alla Settimana 12
    3.Percentuale di soggetti con risposta clinica incrementata alla Settimana 12, definita come riduzione della media giornaliera di
    evaquazione (SF) e/o riduzione della media giornaliara del punteggio relativo al dolore addominale (AP) e/o remissione clinica della media giornaliera di SFe media giornaliera del punteggio AP.
    4. Percentuale di soggetti con remissione clinica, per media giornaliera di SF e media giornaliera del punteggio AP alla Settimana 4
    5.Percentuale di soggetti con risposta clinica incrementata, definita come riduzione della media giornaliera di evaquazione (SF) e/o
    riduzione della media giornaliara del punteggio relativo al dolore addominale (AP) e risposta endoscopica definita come
    regressione dalla Baseline alla Settimana 12 in termini di SES-CD.
    6.Percentuale di soggetti con guarigione endoscopica accertata mediante l'utilizzo di SES-CD alla Settimana 12
    7. Variazione rispetto al Baseline del Crohn¿s Symptom Severity (CSS) alla Settimana 12
    8. Percentuale di soggetti con remissione endoscopica alla Settimana 12.
    9. Percentuale di soggetti con risoluzione delle manifestazioni extra-intestinali (extra-intestinal manifestations, EIM) alla Settimana 12, nei soggetti che presentavano EIM al Baseline
    10. Percentuale di soggetti con ricovero ospedaliero fino alla Settimana 12 compresa
    11. Percentuale di soggetti con fistole secernenti alla Settimana 12 nei soggetti che presentavano fistole secernenti al Baseline.
    12. Variazione rispetto al Baseline del Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) alla Settimana 12
    13. Variazione rispetto al Baseline nello SF-36 alla Settimana 12.
    14. Percentuale di soggetti sottoposti a interventi chirurgici associati alla malattia di Crohn fino alla Settimana 12 compresa
    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. Week 12
    10. Week 12
    11. Week 12
    12. Week 12
    13. Week 12
    14. Week 12
    1. Settimana 4
    2. Settimana 12
    3. Settimana 12
    4. Settimana 4
    5. Settimana 12
    6. Settimana 12
    7. Settimana 12
    8. Settimana12
    9. Settimana 12
    10. Settimana 12
    11. Settimana 12
    12. Settimana 12
    13. Settimana 12
    14. Settimana 12
    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 concerned12
    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 Information not present in EudraCT
    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
    Belarus
    Bosnia and Herzegovina
    Brazil
    Canada
    Chile
    Colombia
    Egypt
    Hong Kong
    Israel
    Korea, Democratic People's Republic of
    Malaysia
    Mexico
    New Zealand
    Puerto Rico
    Russian Federation
    Serbia
    Singapore
    South Africa
    Taiwan
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Croatia
    Denmark
    Estonia
    Finland
    France
    Germany
    Hungary
    Ireland
    Italy
    Latvia
    Lithuania
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    Slovakia
    Slovenia
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    Greece
    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
    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.1.1.1In 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 state52
    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
    Sar¿ disponibile uno studio di mantenimento per soggetti che rispondono in questo studio e continuano a soddisfare i criteri di inclusione / esclusione
    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 Decision2017-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-19
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