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    Summary
    EudraCT Number:2020-000442-34
    Sponsor's Protocol Code Number:NN1436-4477
    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:2021-06-15
    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 number2020-000442-34
    A.3Full title of the trial
    A 78-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin glargine 100 units/mL, both in combination with non-insulin anti-diabetic treatment, in insulin naïve subjects with type 2 diabetes.
    Studio clinico di 78 settimane per confrontare gli effetti e la sicurezza dell’insulina settimanale icodec e dell’insulina giornaliera glargine 100 unità/mL, entrambe in combinazione con un trattamento antidiabetico non insulinico, in soggetti con diabete di tipo 2 che non hanno mai assunto insulina prima
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to compare two types of insulin, a new insulin, insulin icodec and an available insulin, insulin glargine, in people with type 2 diabetes who have not used insulin before
    Studio clinico di confronto tra due tipi di insuline, una nuova (insulina icodec) ed una già conosciuta (insulina glargine), in persone con diabete di tipo 2 che non hanno mai assunto insulina prima
    A.3.2Name or abbreviated title of the trial where available
    ONWARDS 1
    ONWARDS 1
    A.4.1Sponsor's protocol code numberNN1436-4477
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1247-3878
    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 SponsorNOVO NORDISK. S.P.A.
    B.1.3.4CountryItaly
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointClinical Disclosure (1452)
    B.5.3 Address:
    B.5.3.1Street AddressNovo Allé
    B.5.3.2Town/ cityBagsværd
    B.5.3.3Post code2880
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.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 nameinsulin icodec 700 U/mL PDS290
    D.3.2Product code [.]
    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.3.9.2Current sponsor codeInsulina 287
    D.3.9.3Other descriptive nameINSULIN 287
    D.3.9.4EV Substance CodeSUB50453
    D.3.10 Strength
    D.3.10.1Concentration unit nmol/ml nanomole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4200
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Lantus 100 units/mL
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLantus
    D.3.2Product code [N/A]
    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 INNInsulina glargine
    D.3.9.1CAS number 160337-95-1
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameInsulin glargine
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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
    Diabetes Mellitus, Type 2
    Diabete mellito di tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    Diabete di tipo 2
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the effect on glycaemic control of once weekly insulin icodec, in combination with non-insulin anti-diabetic drugs, in insulin naïve subjects with type 2 diabetes (T2D). This includes comparing the difference in change from baseline in glycosylated haemoglobin (HbA1c) between insulin icodec and insulin glargine after 52 weeks of treatment to a non-inferiority limit of 0.3%.
    Dimostrare l'effetto sul controllo glicemico dell'insulina icodec assunta una volta alla settimana, in combinazione con farmaci antidiabetici non insulinici, in soggetti con diabete di tipo 2 che non hanno mai assunto insulina prima. A tal fine si valuta la differenza nella variazione rispetto al basale dell'emoglobina glicosilata (HbA1c) tra insulina icodec e insulina glargine dopo 52 settimane di trattamento ad un limite di non inferiorità dello 0,3%.
    E.2.2Secondary objectives of the trial
    To compare parameters of glycaemic control and safety of once weekly insulin icodec with once daily insulin glargine, both in combination with non-insulin anti-diabetic drugs, in insulin naïve subjects with T2D.
    Confrontare dei parametri di controllo glicemico e sicurezza dell'insulina icodec assunta una volta alla settimana rispetto all'insulina glargine assunta una volta al giorno, entrambe in combinazione con farmaci antidiabetici non insulinici, in soggetti con diabete di tipo 2 che non hanno mai assunto insulina prima.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female aged above or equal to 18 years at the time of signing informed consent.
    - Diagnosed with T2D 180 days or more prior to the day of screening.
    - HbA1c from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
    - Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
    - Stable daily dose(s) 90 days or more prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s):
    a. Any metformin formulations equal to or above 1500 mg or maximum tolerated or effective dose.
    b. Any metformin combination formulations equal to or above 1500 mg or maximum tolerated or effective dose.
    c. Any of the following oral anti-diabetic drug classes including combinations (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).
    - Sulfonylureas
    - Meglitinides (glinides)
    - Dipeptidyl peptidase 4 (DPP-4) inhibitors
    - Sodium-glucose Cotransporter-2 (SGLT2) inhibitors
    - Thiazolidinedione
    - Alpha-glucosidase inhibitor
    - Oral combination products (for the allowed individual Oral Anti-diabetic Drugs (OADs))
    - Oral or injectable glucagon-like peptide 1 (GLP-1)-receptor agonists
    - Body mass index (BMI) equal to or below 40.0 kg/m^2
    - Soggetti di sesso maschile o femminile, con età pari o superiore a 18 anni al momento della firma del consenso informato
    - Diagnosi di diabete mellito di tipo 2 da almeno 180 giorni alla data della visita di screening
    - HbA1c (emoglobina glicata) nell'intervallo 7,0-11,0% (53,0-96,7 mmol / mol), estremi compresi, alla visita di screening confermato da analisi presso il laboratorio centrale
    - non avere mai assunto insulina prima. Tuttavia, un breve trattamento con insulina per un massimo di 14 giorni prima del giorno dello screening, così come precedenti trattamenti insulinici per il diabete gestazionale
    - Dose giornaliera stabile da almeno 90 giorni prima della visita di screening di uno qualsiasi dei seguenti farmaci antidiabetici o regime di associazione:
    a. Qualsiasi formulazione di metformina uguale o superiore a 1500 mg o alla dose massima tollerata o efficace
    b. Qualsiasi formulazione di combinazione di metformina uguale o superiore a 1500 mg o alla dose massima tollerata o efficace
    c. Una delle seguenti classi di farmaci antidiabetici orali, incluso combinazioni (uguali o superiori alla metà della dose massima approvata secondo l'etichetta locale o alla dose massima tollerata o efficace):
    - Solfaniluree
    - Meglitinidi (glinidi)
    - Inibitori della dipeptidil peptidasi 4 (DPP-4)
    - Inibitori del sodio-glucosio Cotransporter-2 (SGLT2)
    - Tiazolidinedione
    - Inibitore dell'alfa-glucosidasi
    - Prodotti di combinazione orale (per i singoli farmaci antidiabetici orali consentiti (OAD))
    - Agonisti dei recettori del peptide glucagon-like 1 (GLP-1) orali o iniettabili
    - Indice di massa corporea (BMI) uguale o inferiore a 40,0 kg/m^2
    E.4Principal exclusion criteria
    - Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening.
    - Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
    - Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.
    - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
    - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
    - Eventuali episodi (dichiarati dal soggetto o nelle cartelle cliniche) di chetoacidosi diabetica entro 90 giorni prima del giorno di screening.
    - Infarto del miocardo, ictus, ospedalizzazione per angina pectoris instabile o attacco ischemico transitorio nei 180 giorni precedenti il giorno dello screening.
    - Insufficienza cardiaca cronica classificata come appartenente alla Classe IV della New York Heart Association (NYHA) allo screening.
    - Inizio o modifica anticipata di farmaci concomitanti (per più di 14 giorni consecutivi) noti per influenzare il peso o il metabolismo del glucosio (ad es. trattamento con orlistat, ormoni tiroidei o corticosteroidi).
    - Retinopatia o maculopatia diabetica incontrollata e potenzialmente instabile. Verificato da un esame del fondo eseguito negli ultimi 90 giorni prima dello screening o nel periodo tra lo screening e la randomizzazione. E' richiesta la dilatazione farmacologica della pupilla a meno che non si utilizzi una fotocamera digitale per la fotografia del fondo oculare specificata per l'esame senza dilatazione.
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c
    Variazione nella HbA1c (emoglobina glicata)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline week 0 (V2) to week 52 (V46)
    Dal valore basale (settimana 0, V2) alla settimana 52 (V46)
    E.5.2Secondary end point(s)
    1. Time in target range 3.9-10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
    2. Change in fasting plasma glucose (FPG)
    3. Number of severe hypoglycaemic episodes (level 3)
    4. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL) confirmed by BG meter)
    5. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
    6. Number of severe hypoglycaemic episodes (level 3)
    7. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL) confirmed by BG meter)
    8. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
    9. Mean weekly insulin dose
    10. Change in body weight
    11. Time spent below 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
    12. Time spent below 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
    1. Tempo nell'intervallo target 3,9-10,0 mmol / L (70-180 mg/dL) misurato utilizzando il sistema di monitoraggio continuo del glucosio (CGM), Dexcom G6
    2. Variazione della glicemia a digiuno (FPG)
    3. Numero di episodi ipoglicemici gravi (livello 3)
    4. Numero di episodi ipoglicemici clinicamente significativi (livello 2) (inferiore a 3,0 mmol/L (54 mg/dL) confermato dal glucometro)
    5. Numero di episodi ipoglicemici clinicamente significativi (livello 2) (inferiore a 3,0 mmol/L (54 mg/dL), confermato dal glucometro) o episodi ipoglicemici gravi (livello 3)
    6. Numero di episodi ipoglicemici gravi (livello 3)
    7. Numero di episodi ipoglicemici clinicamente significativi (livello 2) (inferiore a 3,0 mmol/L (54 mg/dL) confermati dal misuratore BG)
    8. Numero di episodi ipoglicemici clinicamente significativi (livello 2) (inferiore a 3,0 mmol/L (54 mg/dL), confermati dal misuratore BG) o episodi ipoglicemici gravi (livello 3)
    9. Dose settimanale media di insulina
    10. Variazione del peso corporeo
    11. Tempo trascorso al di sotto di 3,0 mmol/L (54 mg/dL) utilizzando il sistema di monitoraggio continuo del glucosio (CGM), Dexcom G6
    12. Tempo trascorso al di sotto di 10 mmol/L (180 mg/dL) utilizzando il sistema di monitoraggio continuo del glucosio (CGM), Dexcom G6
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From week 48 (V42) to week 52 (V46)
    2.-5. From baseline week 0 (V2) to week 52 (V46)
    6.-8. From baseline week 0 (V2) to week 83 (V63)
    9. From week 50 (V44) to week 52 (V46)
    10. From baseline week 0 (V2) to week 52 (V46)
    11.-12. From week 48 (V42) to week 52 (V46)
    1. Dalla settimana 48 (V42) alla settimana 52 (V46)
    2.-5. Dalla settimana 0 (V2) (valore basale) alla settimana 52 (V46)
    6.-8. Dalla settimana 0 (V2) (valore basale) alla settimana 83 (V63)
    9. Dalla settimana 50 (V44) alla settimana 52 (V46)
    10. Dalla settimana 0 (V2) (valore basale) alla settimana 52 (V46)
    11.-12. Dalla settimana 48 (V42) alla settimana 52 (V46)
    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 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
    Trattamento adattato per raggiungere il target
    Treat-to-target design
    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 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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    India
    Israel
    Japan
    Mexico
    Russian Federation
    United States
    European Union
    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
    LVLS
    LVLS, Last Visit Last Subject, ultima visita dell'ultimo paziente
    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 months0
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days5
    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: 960
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 325
    F.4.2.2In the whole clinical trial 970
    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 Decision2020-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-17
    P. End of Trial
    P.End of Trial StatusOngoing
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