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    Summary
    EudraCT Number:2018-002932-26
    Sponsor's Protocol Code Number:D9108C00002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-04
    Trial 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 number2018-002932-26
    A.3Full title of the trial
    A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Neoadjuvant Durvalumab Alone or in Combination with Novel Agents in Subjects with Resectable, Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer (NeoCOAST)
    Studio di fase 2 in aperto, multicentrico, randomizzato, con piattaforma multifarmaco su durvalumab neoadiuvante in monoterapia o in combinazione con nuovi agenti in soggetti con carcinoma polmonare non a piccole cellule resecabile allo stadio iniziale (da I [> 2 cm] a IIIA) (NeoCOAST)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Durvalumab neoadiuvante da solo o in combinazione con nuovi agenti nel carcinoma polmonare non a piccole cellule resecabile
    Neoadjuvant Durvalumab Alone or in Combination with Novel Agents in Resectable Non-Small Cell Lung Cancer
    A.3.2Name or abbreviated title of the trial where available
    NeoCOAST
    NeoCOAST
    A.4.1Sponsor's protocol code numberD9108C00002
    A.5.4Other Identifiers
    Name:IND numberNumber:140575
    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 SponsorMEDIMMUNE, LLC
    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 supportMedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
    B.5.2Functional name of contact pointClinical Trial Enquiries
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way 0
    B.5.3.2Town/ cityGaithersburg, Maryland
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number0013013980000
    B.5.5Fax number00000000000000000
    B.5.6E-mailclinicaltrialenquiries@medimmune.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 namedurvalumab
    D.3.2Product code [MEDI4736]
    D.3.4Pharmaceutical form Concentrate for 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 INNDurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.3Other descriptive nameImmunoglobulin G1, anti-human CD antigen
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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 nameoleclumab
    D.3.2Product code [MEDI9447]
    D.3.4Pharmaceutical form Concentrate for 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 INNOleclumab
    D.3.9.2Current sponsor codeMEDI9447
    D.3.9.3Other descriptive namehuman IgG1¿ monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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 namemonalizumab
    D.3.2Product code [IPH2201]
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    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 INNmonalizumab
    D.3.9.2Current sponsor codeIPH2201
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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 Yes
    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: 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 namedanvatirsen
    D.3.2Product code [AZD9150]
    D.3.4Pharmaceutical form Concentrate for 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 INNDanvatirsen
    D.3.9.1CAS number 1402100-56-4
    D.3.9.2Current sponsor codeAZD9150
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer
    Carcinoma polmonare non a piccole cellule allo stadio iniziale (da I [> 2 cm] a IIIA)
    E.1.1.1Medical condition in easily understood language
    Carcinoma polmonare non a piccole cellule allo stadio iniziale
    Early-stage Non-small Cell Lung Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029517
    E.1.2Term Non-small cell lung cancer stage I
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029518
    E.1.2Term Non-small cell lung cancer stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029520
    E.1.2Term Non-small cell lung cancer stage IIIA
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy
    - Assess the antitumor activity of durvalumab alone and/or in combination with novel agents
    Efficacia
    - Valutare l’attività antitumorale di durvalumab in monoterapia e/o in combinazione con nuovi agenti
    E.2.2Secondary objectives of the trial
    Safety
    - Assess the feasibility of receiving the planned surgical resection
    - Assess the safety and tolerability of durvalumab alone and/or in combination with novel agents
    Efficacy
    - Assess the antitumor activity of durvalumab alone and/or in combination with novel agents
    Pharmacokinetics
    - To describe the PK of durvalumab alone and/or in combination with novel agents
    Immunogenicity
    (a) To assess the immunogenicity of durvalumab alone or in combination with novel agents
    (b) To assess the immunogenicity of novel biologic agents in combination with durvalumab
    Sicurezza
    - Valutare la fattibilità di eseguire la resezione chirurgica programmata
    - Valutare la sicurezza e la tollerabilità di durvalumab in monoterapia e/o in combinazione con nuovi agenti
    Efficacia
    - Valutare l’attività antitumorale di durvalumab in monoterapia e/o in combinazione con nuovi agenti
    Farmacocinetica
    -Descrivere la PK di durvalumab in monoterapia e/o in combinazione con nuovi agenti
    Immunogenicità
    - (a) Valutare l’immunogenicità di durvalumab in monoterapia o in combinazione con nuovi agenti
    - (b) Valutare l’immunogenicità di nuovi agenti biologici in combinazione con durvalumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Cytologically and/or histologically-documented NSCLC
    (a) Stage I (> 2 cm) to IIIA (For subjects with N2 disease, only those
    with 1 single nodal station = 3 cm are eligible) NSCLC
    (b) Amenable to complete surgical resection
    (c) Have not received any other therapy for this condition
    2. Age =18 years old
    3. Predicted FEV1 = 50%
    4. Predicted DLCO = 50%
    5. ECOG 0 or 1
    6. Adequate organ function
    1. NSCLC documentato con esame citologico e/o istologico
    (a) NSCLC di Stadio da I (> 2 cm) a IIIA (nei casi di malattia N2, sono idonei solo i soggetti con 1 singola stazione nodale = 3 cm)
    (b) Suscettibile di resezione chirurgica completa
    (c) Nessuna terapia pregressa per il trattamento di questa condizione
    2. Età =18 anni
    3. FEV1 = 50% del valore predetto
    4. DLCO = 50% del valore predetto
    5. ECOG 0 o 1
    6. Funzionalità organica adeguata
    E.4Principal exclusion criteria
    1. Subjects with small-cell lung cancer or mixed small-cell lung cancer
    2. Subjects who require or may require pneumonectomy
    3. Prior treatment with PD-L1, PD-L1, or CTLA-4 inhibitors
    4. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
    5. Active or prior documented autoimmune or inflammatory disorders.
    The following are exceptions to this criterion:
    a. Subjects with vitiligo or alopecia
    b. Subjects with hypothyroidism on hormone replacement
    c. Any chronic skin condition that does not require systemic therapy
    d. Subjects without active disease in the last 5 years may be included
    but only after consultation with the study physician
    e. Subjects with celiac disease controlled by diet alone
    6. Pregnant or breast-feeding female
    7. Major surgical procedure within prior 30 days
    8. History of active primary immunodeficiency
    9. Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV
    10. QTc interval (QTc) = 470 ms
    11. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent
    12. Receipt of live attenuated vaccination within 30 days prior to study entry
    13. History of another primary malignancy except for:
    a. Curative-treated malignancy with no known active disease > 2 years before enrollment on the study
    b. Curative-treated non-melanoma skin cancer and/or carcinoma in-situ
    1. Soggetti con carcinoma polmonare a piccole cellule o carcinoma polmonare misto a piccole cellule
    2. Soggetti (potenzialmente) necessitanti di pneumonectomia
    3. Pregresso trattamento con inibitori di PD-L1, PD-L1 o CTLA-4
    4. Impiego attuale o pregresso di farmaci immunosoppressori nei 14 giorni precedenti alla somministrazione della prima dose del farmaco in studio
    5. Patologie autoimmuni o infiammatorie attive o pregresse.
    Fanno eccezione a questo criterio:
    a. Soggetti con vitiligine o alopecia
    b. Soggetti con ipotiroidismo in terapia ormonale sostitutiva
    c. Qualsiasi patologia cutanea cronica non necessitante di terapia sistemica
    d. I soggetti senza malattia attiva negli ultimi 5 anni possono essere inclusi, ma solo dopo consultazione con il medico dello studio
    e. Soggetti con malattia celiaca controllati con sola dieta
    6. Donne in gravidanza o allattamento
    7. Intervento di chirurgia maggiore nei 30 giorni precedenti
    8. Anamnesi di immunodeficienza primaria attiva
    9. Infezione attiva, tra cui tubercolosi, epatite B, epatite C o HIV
    10. Intervallo QTc (QTc) = 470 ms
    11. Malattia intercorrente non controllata, che limiterebbe la conformità ai requisiti dello studio, determinerebbe un sostanziale aumento del rischio di EA o comprometterebbe la capacità del soggetto di fornire il consenso informato scritto
    12. Trattamento con vaccino vivo attenuato nei 30 giorni precedenti all’ingresso in studio
    13. Anamnesi di altra malignità primaria, ad eccezione di:
    a. Neoplasia maligna sottoposta a trattamento curativo senza malattia attiva nota > 2 anni prima dell’arruolamento nello studio
    b. Carcinoma cutaneo non melanoma e/o carcinoma in situ sottoposto a trattamento curativo
    E.5 End points
    E.5.1Primary end point(s)
    Clinical activity
    - Major Pathological Response (MPR) rate
    Attività clinica
    - Tasso di MPR
    E.5.1.1Timepoint(s) of evaluation of this end point
    MPR will be done in the resected specimen. Surgery is planned to take place within 14 days after the 4 weeks treatment period
    L’analisi della MPR sarà eseguita sul campione resecato. L’intervento chirurgico è programmato per svolgersi entro 14 giorni dal termine del periodo di 4 settimane di trattamento.
    E.5.2Secondary end point(s)
    Safety
    - Feasibility, defined as having the planned surgical resection within Day 29 to Day 42 after Week 1, Day 1
    - Presence of AEs, SAEs, laboratory abnormalities, and vital signs
    Efficacy
    - Pathological Complete Response (pCR) rate
    Pharmacokinetics
    - Concentration of durvalumab or novel agents in plasma or serum
    Immunogenicity
    - ADA incidence of durvalumab or novel biologic agents
    Sicurezza
    - Fattibilità definita come programmazione della resezione chirurgica dal Giorno 29 al Giorno 42 dopo il Giorno 1 della Settimana 1
    - Presenza di eventi avversi (EA), eventi avversi gravi (EAG), anomalie nei valori di laboratorio e segni vitali
    Efficacia
    - Tasso pCR
    Farmacocinetica
    - Concentrazione di durvalumab o dei nuovi agenti nel plasma o nel siero
    Immunogeniticità
    - Incidenza di ADA di durvalumab o nuovi agenti biologici
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety
    - Feasibility - Surgery is planned to take place within 14 days after the 4 weeks treatment period.
    - AEs, SAEs, laboratory abnormalities, and vital signs - Up to 126 days after C1D1
    Efficacy
    - pCR will be done in the resected specimen. Surgery is planned to take place within 14 days after the 4 weeks treatment period.
    Pharmacokinetics and Immunogenicity
    - Up to 126 days after C1D1
    Sicurezza
    - Fattibilità - L’intervento chirurgico è programmato per svolgersi entro 14 giorni a partire dal termine delle 4 settimane del periodo di trattamento.
    - EA, SAE, anomalie di laboratorio e segni vitali - Fino a 126 giorni dopo C1D1
    Efficacia
    - L’analisi della pCR sarà eseguita sul campione resecato. L’intervento chirurgico è programmato per svolgersi entro 14 giorni dal termine del periodo di 4 settimane di trattamento.
    Farmacocinetica e immunogenicità
    - Fino a 126 giorni dopo C1D1
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Immunogenicità
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Studio piattaforma
    Platform study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Canada
    France
    Italy
    Portugal
    Spain
    Switzerland
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study ("study completion") is defined as the date of the last protocol-specified visit/assessment for the last subject in the study. This date will be 1 year after the final subject is entered into the study or when the sponsor stops the study, whichever occurs first.
    Con fine dello studio (“completamento dello studio”) si denota la data dell’ultima valutazione/visita specificata nel protocollo per l’ultimo soggetto partecipante allo studio. Tale data sarà 1 anno dopo l’ingresso dell’ultimo soggetto o quando lo sponsor interrompe lo studio, in base all’evento che si verifica prima.
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 96
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 160
    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
    Nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-15
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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