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    Summary
    EudraCT Number:2014-002556-77
    Sponsor's Protocol Code Number:MT-1303-E13
    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:2014-11-11
    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 number2014-002556-77
    A.3Full title of the trial
    A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease
    Studio di fase II, multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo per valutare la sicurezza, la tollerabilità e l’efficacia clinica di MT-1303 in soggetti affetti da malattia di Crohn attiva da moderata a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s Disease
    Uno studio clinico per valutare la sicurezza, la tollerabilità e gli effetti clinici di MT-1303 in soggetti con malattia di Chron attiva da moderata a grave
    A.4.1Sponsor's protocol code numberMT-1303-E13
    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 SponsorMitsubishi Tanabe Pharma Corporation (MTPC)
    B.1.3.4CountryJapan
    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 supportMitsubishi Tanabe Pharma Corporation (MTPC)
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMitsubishi Tanabe Pharma Europe Ltd (MTPE)
    B.5.2Functional name of contact pointGeneral Information
    B.5.3 Address:
    B.5.3.1Street AddressDashwood House, 69 Old Broad Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC2M 1QS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044(0)2070655000
    B.5.5Fax number0044(0)2070655050
    B.5.6E-mailregulatory@mt-pharma-eu.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 nameMT-1303
    D.3.2Product code MT-1303
    D.3.4Pharmaceutical form Capsule, hard
    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 INNMT-1303
    D.3.9.2Current sponsor codeMT-1303
    D.3.9.4EV Substance CodeSUB118859
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Subjects with moderate to severe crohn's disease
    Soggetti con malattia di Chron attiva da moderata a grave
    E.1.1.1Medical condition in easily understood language
    Subjects with moderate to severe crohn's disease
    Soggetti con malattia di Chron attiva da moderata a grave
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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
    • To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active CD
    • To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.
    • Valutare la sicurezza e la tollerabilità di MT-1303 in soggetti con MC attiva da moderata a grave
    • Valutare l’efficacia clinica di MT-1303 in soggetti con MC attiva da moderata a grave.
    E.2.2Secondary objectives of the trial
    • To explore the pharmacokinetics (PK) of MT-1303 in subjects with moderate to severe active CD
    • To explore the pharmacodynamic (PD) effect of MT 1303 in subjects with moderate to severe active CD.
    • Esplorare la farmacocinetica (pharmacokinetics, PK) di MT-1303 in soggetti con MC attiva da moderata a grave
    • Esplorare l’effetto farmacodinamico (pharmacodynamic, PD) di MT-1303 in soggetti con MC attiva da moderata a grave.
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    pharmacogenomic
    farmacogenomica
    E.3Principal inclusion criteria
    1. Able to provide written informed consent and to comply with the requirements of the Protocol
    2. Male or female subjects aged between 18 and 65 years (inclusive). For subjects of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.
    3. Diagnosis of CD (involving small intestine and/or colon), confirmed at the time by endoscopy and histology at least 3 months prior to Visit 1 (Screening)
    4. Previous use of corticosteroids or immunosuppressants (such as azathioprine [AZA]/ 6-mercaptopurine [6-MP] or methotrexate [MTX]) or anti-TNF-alpha agents (such as infliximab, adalimumab or certolizumab pegol) for the treatment of CD
    5. Moderate to severe active CD defined by a CDAI score of ≥220 to ≤450 points at Visit 1
    6. C-reactive protein (CRP) ≥5 mg per litre (/L) and/or faecal calprotectin ≥250 µg/g
    7. A negative stool test result for Clostridium difficile (C. difficile) toxin at Visit 1
    8. Negative results for both QuantiFERON-TB Gold (or T-SPOT) test and chest x-ray (i.e., no evidence of tuberculosis [TB]) at Visit 1

    For detailed information, please refer to the Protocol.
    1. Capacità di fornire il consenso informato scritto e di attenersi ai requisiti previsti dal protocollo;
    2. Soggetti di sesso maschile o femminile di età compresa tra 18 e 65 anni (compresi). Per i soggetti in grado di procreare, devono essere adottati due metodi contraccettivi per l’intera durata dello studio e per le 12 settimane successive alla cessazione del farmaco dello studio. Almeno uno dei metodi contraccettivi deve essere un metodo barriera;
    3. Diagnosi di MC (che interessi l’intestino tenue e/o il colon), confermata al momento dell’esame endoscopico e istologico almeno 3 mesi prima della Visita 1 (Screening);
    4. Precedente uso di corticosteroidi o immunosoppressivi (come azatioprina [AZA]/ 6-mercaptopurina [6-MP] o metotrexato [MTX]) o agenti anti-TNF- (come infliximab, adalimumab o certolizumab pegol) per il trattamento della MC
    5. MC attiva da moderata a grave definita da un punteggio CDAI da ≥220 a ≤450 punti alla Visita 1;
    6. Proteina C-reattiva (C-reactive protein, CRP) ≥5 mg per litro (/L) e/o calprotectina fecale ≥250 μg/g;
    7. Un risultato del test sulle feci negativo per la tossina Clostridium difficile (C. difficile) alla Visita 1;
    8. Risultati negativi sia per il test QuantiFERON-TB Gold (o T-SPOT) che per la radiografia del torace (ovvero, nessuna evidenza di tubercolosi [TB]) alla Visita 1
    E.4Principal exclusion criteria
    1. Diagnosis of ulcerative colitis, indeterminate colitis, pseudomembranous colitis or coeliac disease
    2. Enterocutaneous, abdominal or pelvic active fistulae, abscesses or fistulae likely to require surgery during the study
    3. Gastrointestinal (GI) surgery (including appendectomy) within 12 weeks prior to Visit 2 (Baseline) or has surgery planned or deemed likely to require surgery for CD during the study
    4. History or evidence of ileostomy, colostomy, rectal pouch, significant stenosis or extensive resection in GI tract that could impair the drug absorption or interfere with the objectives of the study, as judged by the Investigator
    5. History or evidence of unresected adenomatous colonic polyps or colonic mucosal dysplasia
    6. Chronic use of opioid for chronic pain which, in the opinion of the Investigator, would influence the subject reported CDAI parameters.
    7. Use of concomitant medications as described in the protocol.
    8. Presence or history of clinically significant disease (except CD) that could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator
    9. Body weight ≤35 kg at Visit 1
    10. Presence or history of any of cardiovascular diseases as decsribed in the protocol.
    11. Need for, or likely need for treatment with Class I or Class III anti-arrhythmic drugs, or with beta-blockers or heart-rate-lowering calcium-channel blockers, or with any other drugs which can reduce the heart rate
    12. Known high risk for QT/QTc prolongation such as a family history of long QT syndrome or sudden death
    13. History or known presence of cerebrovascular diseases
    14. Presence or history (within 5 years prior to initial screening) of malignancy, except for successfully treated basal cell and in situ squamous cell carcinomas of the skin
    15. Known history of recurrent or chronic infection such as TB, hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
    16. Receipt of live vaccine within 4 weeks prior to Visit 2
    17. Diagnosis of diabetes mellitus (Type I or II)
    18. Presence or prior history of macular oedema, uveitis or evolutive retinopathy, or any other condition that could increase the risk of macular oedema in the opinion of the Investigator
    19. History of substance abuse (drug or alcohol) or any other factor that limits the subject’s ability to cooperate with the study procedures.
    20. Known history of allergy, hypersensitivity or any serious reaction to any component of the study medication
    21. Previous treatment with any investigational agent within 12 weeks prior to Visit 1 OR five half-lives of the investigational product, whichever is the longer.
    22. WBC count <3,500/µL at Visit 1
    23. Lymphocyte count <800/µL at Visit 1
    24. LFT (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) ≥2 x ULN at Visit 1
    25. HbA1c >6.5% at Visit 1
    26. Negative or indeterminate results for antibodies (IgG) to Varicella Zoster virus (VZV) at Visit 1
    27. [For female subjects only] A positive pregnancy test at Visit 1 (serum beta-human chorionic gonadotropin [hCG] level or urine dipstick) or Visit 2 (urine dipstick)
    28. Low heart rate (<50 beats per minute [bpm]) in 12-lead ECG at Visit 1 or Visit 2 (pre-dose)
    29. QTcF interval ≥450 milliseconds (msec) in 12-lead ECG at Visit 1 or Visit 2 (pre-dose)
    30. Clinically significant abnormal findings in 12-lead ECG (at Visit 1 or Visit 2 [pre-dose]) and/or in Holter ECG (at Visit 1) that the Investigator considers may jeopardise the subject's health

    For detailed information, please refer to the Protocol.
    1. colite ulcerosa, indeterminata, pseudomembranosa o malattia celiaca;2. Fistole enterocutanee, addominali o pelviche attive, ascessi o fistole che potrebbero necessitare un intervento chirurgico durante lo studio; 3.Chirurgia GI nelle 12 settimane precedenti la Visita 2 o intervento chirurgico pianificato per la MC durante lo studio; 4. Anamnesi di ileostomia, colostomia, sacca rettale, stenosi significativa o resezione estesa nel tratto GI che potrebbe compromettere l’assorbimento del farmaco o interferire con gli obiettivi dello studio; 5. Anamnesidi polipi del colon adenomatosi non resecati o di displasia della mucosa del colon; 6. Uso cronico di oppioidi per il dolore cronico che influirebbe sui parametri del CDAI riportati dal soggetto;
    7. uso di farmaci concomitanti descritti sopra. a. Uso di agenti anti-TNF- nelle 8 settimane precedenti la Visita 1 e durante lo studio b. natalizumab, vedolizumab, efalizumab, rituximab o altro biofarmaco in qualunque momento prima della Visita 1 e durante lo studio
    c. ciclosporina, tacrolimus, micofenolato mofetile, tofacitinib o talidomide nelle 8 settimane precedenti la Visita 1 e durante lo studio d. corticosteroidi o 5-ASA non orali nelle 2 settimane precedenti la Visita 1 e durante lo studio e. corticosteroidi orali che sia stato iniziato nelle 4 settimane precedenti la Visita 1, o una dose elevata ( >20 mg/giorno di prednisolone [o equivalente] o budesonide >9 mg/giorno) alla Visita 1, o qualsiasi dose che non sia stabile da almeno 2 settimane prima della Visita 2 f. Uso di 5-ASA orale che sia stato iniziato nelle 2 settimane precedenti la Visita 1 o che non segua una dose stabile da almeno 2 settimane prima della Visita 2 g. AZA, 6-MP o MTX nelle 2 settimane precedenti la Visita 2 e durante lo studio.
    h. antibiotici per il trattamento della MC che sia stato iniziato nelle 2 settimane precedenti la Visita 1 o che non segua una dose stabile da almeno 2 settimane prima della Visita 2 i. Uso di terapia nutrizionale non parenterale che sia stato iniziato nelle 2 settimane precedenti la Visita 1 o che non segua una dose stabile da almeno 2 settimane prima della Visita 2 j. Uso della terapia citaferesi nelle 4 settimane precedenti la Visita 1 e durante lo studio 8. Presenza o anamnesi di malattia clinicamente significativa (eccetto MC) che possa interferire con gli obiettivi dello studio o la sicurezza del soggetto 9. Peso ≤35 kg alla Visita 1
    10. anamnesi di: sindrome del nodo del seno, b. sincope ricorrente, c. bradicardia sintomatica, d. blocco seno-atriale, e. blocco atrioventricolare (AV) di tipo Mobitz II di secondo grado o di grado elevato f. cardiopatia ischemica (inclusa angina pectoris), g. infarto del miocardio, h. insufficienza cardiaca congestizia, i. arresto cardiaco, j. grave apnea del sonno,
    k. ipertensione non controllata. 11. Necessità di trattamento con farmaci antiaritmici di Classe I o III o con betabloccanti o bloccanti dei canali del calcio che abbassano la frequenza del battito cardiaco, o altro farmaco che possa ridurre il battito cardiaco; 12. Rischio elevato noto di prolungamento dell’intervallo di QT/QTc,; 13. Anamnesi o presenza nota di malattie cerebrovascolari; 14. Presenza o anamnesi (nei 5 anni precedenti lo screening iniziale) di neoplasia, eccetto i carcinomi della pelle a cellule basali o squamose in situ trattati con successo;15. Anamnesi nota di infezione ricorrente o cronica come TB, epatite B, epatite C o virus HIV; 16. Vaccinazione con vaccino vivo nelle 4 settimane precedenti la Visita 2; 17. diabete mellito (di tipo I o II);
    18. anamnesi di edema maculare, uveite o retinopatia evolutiva o qualsiasi altra condizione che possa aumentare il rischio di edema maculare; 19. Anamnesi di abuso di sostanze stupefacenti o di qualsiasi altro fattoreche limiti la capacità del soggetto di cooperare con le procedure dello studio. 20. allergia, ipersensibilità o qualsiasi reazione grave a qualsiasi componente del farmaco dello studio;
    21. Precedente trattamento con agente sperimentale nelle 12 settimane precedenti la Visita 1 o cinque emivite del prodotto sperimentale, a seconda di quale sia il periodo più lungo; 22. Conta dei globuli bianchi <3.500/μL alla Visita 1; 23. Conta linfocitaria <800/μL alla Visita 1; 24. [AST] o [ALT] ≥2 x il limite superiore di normalità (ULN) alla Visita 1; 25. HbA1c >6,5% alla Visita 1;
    26. Risultati negativi o indeterminati per gli anticorpi (IgG) a Varicella Zoster virus, VZV alla Visita 1; 27. test di gravidanza positivo alla Visita 1 (livello di β-hCG o striscia reattiva delle urine o Visita 2 (striscia reattiva delle urine);
    28. <50 battiti al minuto bpm] alla Visita 1 o Visita 2 (pre-dose); 29. Intervallo QTcF ≥450 msec alla Visita 1 o Visita 2 (pre-dose); 30. Risultati anomali clinicamente significativi nell’ECG a 12 derivazioni (alla Visita 1 o Visita 2 [pre-dose] e/o nell’ECG Holter (alla Visita 1) che potrebbero compromettere la salute del soggetto.



    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects who achieve a 100-point decrease from Baseline in CDAI score (i.e., CDAI 100) at Visit 6 (Week 12)
    Percentuale di soggetti che ottengono una diminuzione di 100 punti secondo l’indice CDAI (ovvero, CDAI 100) rispetto al basale alla Visita 6 (Settimana 12)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various time points throughout the study - please refer to the detailed ‘Time and Events Schedule’ table in the protocol for full details.
    Diversi punti temporali durante lo studio. Per maggiori informazioni consultare il calendario del tempo e degli eventi nel protocollo.
    E.5.2Secondary end point(s)
    Efficacy
    • Proportion of subjects who achieve a 70-point decrease from Baseline in CDAI score (i.e., CDAI 70) at Protocol-scheduled visits.
    • Proportion of subjects who achieve a 100-point decrease from Baseline in CDAI score (i.e., CDAI 100) at other Protocol-scheduled visits.
    • Proportion of subjects who achieve clinical remission (i.e., CDAI score of <150) at Protocol-scheduled visits.
    • CDAI score and change from Baseline in CDAI score at Protocol-scheduled visits.

    Pharmacodynamics
    • Lymphocyte count and lymphocyte subsets, their change from Baseline, and percentage of Baseline at Protocol-scheduled visits.

    Pharmacokinetics
    • PK concentration of MT-1303 and its active metabolite MT-1303-P at Protocol-scheduled visits.

    Exploratory Endpoints:
    • Time to the first clinical remission during the study
    • Time to the first clinical response of CDAI 100 during the study
    • Time to the first clinical response of CDAI 70 during the study
    • Change from Baseline in CDAI sub-scores
    • CRP and faecal calprotectin value and their change from Baseline at Protocol-scheduled visits.

    Safety
    • Incidence and severity of adverse events (AEs)
    • Physical examination
    • 12-lead ECG parameters
    • 24-h/48-h Holter ECG parameters
    • Vital signs (pulse rate, systolic and diastolic blood pressure [BP], and body temperature)
    • Safety laboratory parameters
    • Optical coherence tomography (OCT).
    Efficacia
    • Percentuale di soggetti che ottengono una diminuzione di 70 punti secondo l’indice CDAI (ovvero, CDAI 70) rispetto al basale alle visite programmate secondo il protocollo;
    • Percentuale di soggetti che ottengono una diminuzione di 100 punti secondo l’indice CDAI (ovvero, CDAI 100) rispetto al basale ad altre visite programmate secondo il protocollo;
    • La percentuale di soggetti che ottengono una remissione clinica (ovvero, punteggio CDAI di <150) alle visite programmate del protocollo;
    • Punteggio CDAI e variazione del punteggio CDAI rispetto al basale alle visite programmate secondo il protocollo.
    Farmacodinamica
    • Conta linfocitaria e sottopopolazioni linfocitarie, loro variazione rispetto al basale e percentuale del basale alle visite programmate secondo il protocollo.
    Farmacocinetica
    • Concentrazione PK di MT-1303 e del suo metabolita attivo MT-1303-P alle visite programmate secondo il protocollo.

    Endpoint esplorativi:
    • Tempo alla prima remissione clinica durante lo studio
    • Tempo alla prima risposta clinica di CDAI 100 durante lo studio
    • Tempo alla prima risposta clinica di CDAI 70 durante lo studio
    • Variazione rispetto al basale dei sottopunteggi CDAI
    • Valore della CRP e della calprotectina fecale e loro variazione rispetto al basale alle visite programmate secondo il protocollo.
    Sicurezza:
    Valutazioni di sicurezza per:
    • Incidenza e gravità degli eventi avversi (EA)
    • Esame obiettivo
    • Parametri di ECG a 12 derivazioni
    • Parametri di ECG Holter nelle 24/48 ore
    • Segni vitali (battito cardiaco, pressione sanguigna sistolica e diastolica [blood pressure, BP] e temperatura corporea)
    • Parametri di laboratorio di sicurezza
    • Tomografia a coerenza ottica (optical coherence tomography, OCT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various time points throughout the study - please refer to the detailed ‘Time and Events Schedule’ table in the protocol for full details.
    Diversi punti temporali durante lo studio. Per maggiori informazioni consultare il calendario del tempo e degli eventi nel protocollo.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA87
    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
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Netherlands
    Poland
    Slovakia
    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
    Ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 79
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 80
    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
    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 Decision2015-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-10
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