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    Summary
    EudraCT Number:2019-000176-41
    Sponsor's Protocol Code Number:341-201-00004
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-05
    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 number2019-000176-41
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment
    Studio proof-of-concept di fase 2, multicentrico, randomizzato, in doppio cieco, controllato con placebo volto a valutare l’efficacia e la sicurezza di OPS-2071 somministrato per via orale per 12 settimane a soggetti con malattia di Crohn che mostrano sintomi di infiammazione attiva nonostante il trattamento in corso
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment
    Studio proof-of-concept di fase 2, multicentrico, randomizzato, in doppio cieco, controllato con placebo volto a valutare l’efficacia e la sicurezza di OPS-2071 somministrato per via orale per 12 settimane a soggetti con malattia di Crohn che mostrano sintomi di infiammazione attiva nonostante il trattamento in corso
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code number341-201-00004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03850509
    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 SponsorOtsuka Pharmaceutical Development and Commercialization, Inc
    B.1.3.4CountryUnited States
    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 supportOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation Otsuka Pharmaceutical Development & Commercialization, Inc.
    B.5.2Functional name of contact pointKimberly Sikes
    B.5.3 Address:
    B.5.3.1Street Address2440 Research Boulevard
    B.5.3.2Town/ cityRockville
    B.5.3.3Post codeMaryland 20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number12407804266
    B.5.5Fax number13017218592
    B.5.6E-mailkimberly.sikes@otsuka-us.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 nameOPS-2071
    D.3.2Product code [OPS-2071]
    D.3.4Pharmaceutical form 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 INNOPS-2071
    D.3.9.1CAS number 1426216-93-4
    D.3.9.2Current sponsor codeOPS-2071
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 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 nameOPS-2071
    D.3.2Product code [OPS-2071]
    D.3.4Pharmaceutical form 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 INNOPS-2071
    D.3.9.1CAS number 1426216-93-4
    D.3.9.2Current sponsor codeOPS-2071
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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 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 nameOPS-2071
    D.3.2Product code [OPS-2071]
    D.3.4Pharmaceutical form 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 INNOPS-2071
    D.3.9.1CAS number 1426216-93-4
    D.3.9.2Current sponsor codeOPS-2071
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    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
    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 PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 investigate the therapeutic effect of OPS-2071 (150, 300, or 600 mg twice a day [BID]) add-on therapy administered orally for 12 weeks in subjects with Crohn’s disease showing symptoms of active inflammation despite ongoing treatment.
    Esaminare l’efficacia terapeutica della terapia aggiuntiva con OPS-2071 (150, 300 o 600 mg due volte al giorno [BID]) somministrato per via orale per 12 settimane in soggetti affetti da malattia di Crohn che mostrano sintomi di infiammazione attiva nonostante il trattamento in corso.
    E.2.2Secondary objectives of the trial
    To determine the safety and tolerability of OPS-2071 (150, 300, or 600 mg BID) add-on therapy administered orally for 12 weeks in subjects with Crohn’s disease showing symptoms of active inflammation despite ongoing treatment.
    Stabilire la sicurezza e la tollerabilità della terapia aggiuntiva con OPS-2071 (150, 300 o 600 mg BID) somministrato per via orale per 12 settimane in soggetti affetti da malattia di Crohn che mostrano sintomi di infiammazione attiva nonostante il trattamento in corso.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Diagnosis of Crohn's disease localized in the ileum and/or colon, with active mucosal inflammation and visible
    lesion(s), documented by centrally read ileocolonoscopy and a Simple Endoscopic Score for Crohn’s Disease
    (SES-CD) = 6 (= 4 for isolated ileal disease).
    2) Subjects who do not have an optimal response (daily stool frequency > 3 and pain score > 1) to their current ongoing
    treatment of biologics (eg, first anti-tumor necrosis factor-alpha [TNF-a] monoclonal antibody), immunosuppressants, low-dose steroids, or 5-aminosalicylic acid (5-ASA) formulations.
    3) Subjects who are on stable Crohn’s disease medications for at least 4 weeks.
    4) Subjects with a CDAI score between 180 and 450 points, inclusive.
    1) Diagnosi di malattia di Crohn localizzata nell’ileo e/o colon, con infiammazione attiva delle mucose e lesione/i visibile/i, documentate mediante ileocolonscopia letta a livello centrale e un punteggio endoscopico semplificato per la malattia di Crohn (SES-CD) = 6 (= 4 per malattia ileale isolata).
    2) Soggetti che non presentano una risposta ottimale (frequenza di evacuazione giornaliera > 3 e punteggio del dolore > 1) al trattamento in corso con farmaci biologici (ad es. anticorpi monoclonali contro il fattore di necrosi tumorale [TNF-a]), immunosoppressori, steroidi a basso dosaggio o preparati a base di acido 5 aminosalicilico (5-ASA).
    Nota: La durata minima del trattamento precedente, richiesta affinché un soggetto possa essere considerato come avente una risposta non ottimale, comprende l’aver completato almeno il regime di induzione raccomandato per i farmaci biologici approvati e/o il trattamento a una dose terapeutica per una durata stabile e con il quale sarebbe prevedibile un miglioramento (ovvero 12 settimane di azatioprina, 4 settimane di metotrexato).
    3) Soggetti che assumono farmaci per la cura della malattia di Crohn su base stabile da almeno 4 settimane.
    4) Soggetti con un punteggio CDAI compreso tra 180 e 450 punti, inclusi.
    E.4Principal exclusion criteria
    1) Low-dose steroids may be tapered down during the trial, based on inflammatory biomarkers and the investigator’s judgment.
    2) Use of prednisone or prednisolone > 30 mg/day or budesonide > 9 mg/day within 4 weeks prior to screening; or intravenous steroids within 4 weeks prior to screening.
    3) Subjects with known or suspected (family history, unexplained syncope) long QT syndrome or QT interval corrected for heart rate by the Fridericia formula (QTcF) > 470 msec for females or > 450 msec for males at baseline.
    4) Subjects with known existing aortic aneurysm, or who are at risk for an aortic aneurysm, such as subjects with
    peripheral atherosclerotic vascular diseases, uncontrolled hypertension, certain genetic conditions such as Marfan
    syndrome and Ehlers-Danlos syndrome, and elderly subjects (over the age of 70).
    5) Subjects with inadequate organ function, as follows: Serum creatinine > 1.5 x the upper limit of normal (ULN); Aspartate aminotransferase or alanine aminotransferase levels > 1.5 x ULN; Total bilirubin > 1.5 x ULN. Elevated unconjugated bilirubin related to Gilbert's syndrome is allowed.
    6) Known hypersensitivity to quinolones.
    7) Subjects with a history of treatment failure with 2 or more biologics.
    8) Subjects with risk factors for tendon rupture (ie, psoriasis, ankylosing spondylitis, competitive athletes, renal failure,
    diabetes mellitus) or who have a history of tendon rupture and/or ongoing tendinopathy.
    9) Subjects with systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg.
    10) Subjects taking quinidine, procainamide, disopyramide, encainide, flecainide, sotalol, amiodarone, ibutilide, dronedarone, or propafenone.
    1) Gli steroidi a basso dosaggio possono essere ridotti durante lo studio, sulla base dei biomarcatori infiammatori e del giudizio dello sperimentatore.
    2) Uso di prednisone o prednisolone > 30 mg/giorno o budesonide > 9 mg/giorno nelle 4 settimane precedenti lo screening; oppure steroidi somministrati per via endovenosa nelle 4 settimane precedenti lo screening.
    3) Soggetti con nota o sospetta (anamnesi familiare, sincope inspiegata) sindrome del QT lungo o intervallo QT corretto per la frequenza cardiaca mediante la formula di Fridericia (QTcF) > 470 msec per i soggetti di sesso femminile o > 450 msec per gli uomini al basale.
    4) Soggetti con noto aneurisma aortico preesistente o che sono a rischio di aneurisma aortico, come i soggetti con malattie vascolari periferiche aterosclerotiche, ipertensione non controllata, determinate condizioni genetiche quali la sindrome di Marfan e la sindrome di Ehlers-Danlos, nonché i soggetti anziani (di età superiore ai 70 anni).
    5) Soggetti con inadeguata funzionalità d’organo, così come segue:
    • Creatinina sierica > 1,5 ¿¿il limite superiore della norma (ULN)
    • Livelli di aspartato aminotransferasi o di alanina aminotransferasi > 1,5 ¿¿ULN.
    • Bilirubina totale > 1,5 ¿¿ULN. Sono consentiti livelli elevati di bilirubina non coniugata correlati alla sindrome di Gilbert.
    6) Ipersensibilità nota ai chinoloni o altra reazione avversa significativa ai chinoloni.
    7) Soggetti con anamnesi di fallimento al trattamento con 2 o più farmaci biologici.
    8) Soggetti con fattori di rischio per la rottura dei tendini (vale a dire, psoriasi, spondilite anchilosante, atleti agonisti, insufficienza renale, diabete mellito), o che presentano un’anamnesi di rottura dei tendini e/o tendinopatia in corso.
    9) Soggetti con pressione arteriosa sistolica > 150 mmHg o pressione arteriosa diastolica > 90 mmHg.
    10) Soggetti che assumono chinidina, procainamide, disopiramide, encainide, flecainide, sotalolo, amiodarone, ibutilide, dronedarone o propafenone.
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of subjects who, at Week 12, achieve clinical remission (defined as a CDAI score < 150).
    Percentuale di soggetti che, alla Settimana 12, raggiungono la remissione clinica (definita come un punteggio CDAI < 150).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Settimana 12
    E.5.2Secondary end point(s)
    Efficacy endpoints:
    1) The percentage of subjects with endoscopic response, defined as a reduction of the SES-CD by at least 50%, at Week 12.
    2) Change from baseline in the SES-CD score.
    3) The percentage of subjects with PRO-2 remission (defined as stool frequency = 3 times per day and abdominal pain = 1) at Week 12.
    4) The percentage of subjects with clinical response, defined as at least a 25% decrease in the CDAI score, at Week 12.
    5) The percentage of subjects who, at Week 12, achieve endoscopic remission (defined as a SES-CD score of 0 to 2; or a score of 0 to 4, with no individual subscore greater than 1).
    6) The percentage of subjects with a decrease from baseline of = 100 points in the CDAI score.

    Safety endpoints:
    The percentage of subjects by specific AEs, which will be recorded with the onset date, resolution or stabilization date, severity grade, and relatedness to IMP.
    1) Percentuale di soggetti con risposta endoscopica, definita come una riduzione del SES-CD di almeno il 50%, alla Settimana 12.
    2) Variazione rispetto al basale nel punteggio SES-CD.
    3) Percentuale di soggetti con remissione PRO-2 (definita come frequenza delle feci = 3 volte al giorno e dolore addominale = 1), alla Settimana 12.
    4) Percentuale di soggetti con risposta clinica, definita come una diminuzione di almeno il 25% nel punteggio CDAI, alla Settimana 12.
    5) Percentuale di soggetti che, alla Settimana 12, raggiungono la remissione endoscopica (definita come punteggio SES-CD da 0 a 2; oppure punteggio da 0 a 4, senza sottopunteggio individuale superiore a 1).
    6) Percentuale di soggetti con una riduzione rispetto al basale = 100 punti nel punteggio CDAI.

    Endpoint secondari di sicurezza: percentuale di soggetti sulla base di EA specifici che saranno registrati secondo la data di insorgenza, la data di risoluzione o stabilizzazione, il grado di gravità e la relazione con l’IMP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    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 Yes
    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 Yes
    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 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 trial4
    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 EEA45
    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
    Belgium
    Canada
    Germany
    Italy
    Poland
    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 trial date is defined as the last date of contact from the 30-day post-treatment follow-up visit screen in eSource for the last subject completing or withdrawing from the trial.
    La data di fine della sperimentazione è definita come l'ultima data di contatto dal 30 giorno visita di follow-up post-trattamento in eSource per l'ultimo soggetto che completa o si ritira dal processo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 117
    F.4.2.2In the whole clinical trial 240
    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)
    Standard of care
    Terapia standard
    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 Decision2020-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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