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    Summary
    EudraCT Number:2020-005281-34
    Sponsor's Protocol Code Number:NN1535-4591
    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:2022-09-13
    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 number2020-005281-34
    A.3Full title of the trial
    A 52 week study comparing the efficacy and safety of once weekly IcoSema and once weekly insulin icodec, both treatment arms with or without oral anti diabetic drugs, in participants with type 2 diabetes inadequately controlled with daily basal insulin. (COMBINE 1)
    Studio clinico di 52 settimane che confronta l’efficacia e la sicurezza dei prodotti sperimentali a somministrazione settimanale IcoSema e insulina icodec, con o senza trattamento antidiabetico orale, in persone con diabete di tipo 2 non adeguatamente controllato e in trattamento giornaliero con insulina basale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to see how well the new weekly medicine IcoSema, which is a combination of insulin icodec and semaglutide, controls blood sugar level in people with type 2 diabetes compared to weekly insulin icodec (COMBINE 1)
    Studio clinico volto a valutare l’efficacia del prodotto sperimentale a somministrazione settimanale IcoSema, una combinazione di insulina icodec e semaglutide, nel controllare i livelli di zucchero nel sangue nelle persone con diabete di tipo 2 rispetto all’insulina icodec a somministrazione settimanale (COMBINE 1)
    A.3.2Name or abbreviated title of the trial where available
    COMBINE 1
    COMBINE 1
    A.4.1Sponsor's protocol code numberNN1535-4591
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1260-8259
    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 Transparency (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.5.4Telephone number004544448888
    B.5.5Fax number004544490555
    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 nameIcoSema 700 U/ml + 2 mg/mL PDS290
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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
    D.3.9.1CAS number 1188379-43-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameInsulin icodec
    D.3.9.4EV Substance CodeSUB50453
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULINA
    D.3.9.1CAS number 910463-68-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameSemaglutide
    D.3.9.4EV Substance CodeSUB32188
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    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 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 [NA]
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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
    D.3.9.1CAS number 1188379-43-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameinsulin icodec
    D.3.9.4EV Substance CodeSUB50453
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    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 Yes
    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
    Diabetes Mellitus, Type 2
    Diabete Mellito, 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 confirm superiority of once weekly IcoSema compared with once weekly insulin icodec, both treatment arms with or without OADs, in terms of glycaemic control measured by change in HbA1c from baseline after 52 weeks in participants with T2D inadequately controlled with daily basal insulin.
    Confermare la superiorità del trattamento con Icosema ad assunzione settimanale rispetto ad insulina icodec assunta settimanalmente, in assenza o presenza di senza terapia antidiabetica orale, in termini di controllo glicemico misurato in base alla variazione del valore diHbA1c rispetto al basale dopo 52 settimane in soggetti con diabete di tipo due non adeguatamente controllato con insulina basale giornaliera.
    E.2.2Secondary objectives of the trial
    To confirm superiority of once weekly IcoSema compared to once weekly insulin icodec, both treatment arms with or without OADs, in participants with T2D inadequately controlled with daily basal insulin in terms of:
    • Change in body weight from baseline after 52 weeks
    • Number of clinically significant hypoglycaemic (level 2) or severe hypoglycaemic (level 3) episodes during 52 weeks and the 5 week follow-up period
    To compare parameters of glycaemic control and safety of once weekly IcoSema with once weekly insulin icodec, both treatment arms with or without OADs, in participants with T2D inadequately controlled with daily basal insulin.
    Confermare la superiorità di Icosema assunto settimanalmente rispetto ad insulina icodec assunta settimanalmente, in assenza o in presenza di terapia antidiabetica orale, in termini di:
    • Variazione del peso corporeo (%) dal basale fino a dopo 52 settimane di trattamento
    • Numero di episodi ipoglicemici clinicamente significativi (livello 2) o di episodi ipoglicemici gravi (livello 3) nel corso delle 52 settimane di trattamento e durante il periodo di follow-up di 5 settimane
    Confrontare i parametri del controllo glicemico e la sicurezza di IcoSema assunto una volta alla settimana rispetto a quelli di insulina icodec assunta una volta alla settimana, con o senza terapia antidiabetica orale, in soggetti con diabete di tipo 2 non adeguatamente controllato con insulina basale giornaliera.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female and age above or equal to 18 years at the time of signing informed consent.
    2. Diagnosed with type 2 diabetes mellitus = 180 days before screening.
    3. HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory on
    the day of screening.
    4. Treated with once daily or twice-daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20-80 units/day = 90 days before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti-diabetic drugs with stable doses = 90 days before screening:
    • Metformin
    • Sulfonylureasa
    • Meglitinides (glinides)a
    • DPP-4 inhibitorsa
    • Sodium-glucose co-transporter 2 inhibitors
    • Alpha-glucosidase-inhibitors
    • Thiazolidinediones
    • Marketed oral combination products only including the products listed above.
    5. Body mass index (BMI) = 40.0 kg/m2.
    a Sulfonylureas, meglitinides (glinides) and DPP-4 inhibitors must be discontinued at randomisation.
    1. Soggetti di sesso maschile e femminile di età pari o superiore ai 18 anni al momento della firma del modulo di consenso informato.
    2. Diagnosi di diabete mellito di tipo 2 =180 giorni prima dello screening
    3. HbA1c compresa tra 7,0-10,0% (53.0-85.8 mmol/mol) (estremi compresi) secondo la valutazione del laboratorio centrale il giorno dello screening
    4. Trattamento con insulina basale una volta al giorno o due volte al giorno (Insulina NPH (Neutral Protamine Hagedorn insulin), insulina degludec, insulina detemir, insulina glargine 100 unità/ml o insulina glargine 300 unità/ml) con 20-80 unità/giorno =90 giorni prima dello screening. È consentito il trattamento con insulina in bolo a breve termine per un massimo di 14 giorni prima dello screening, così come un precedente trattamento con insulina per il diabete gestazionale.
    Il trattamento può avvenire con o senza uno dei seguenti farmaci antidiabetici mantenuto con dosi stabili =90 giorni prima dello screening:
    • Metformina
    • Sulfaniluree*
    • Meglitinidi(glinidi)*
    • Inibitori della DPP-4*
    • Inibitori del co-trasportatore sodio-glucosio 2
    • Inibitori dell’alfa-glucosidasi
    • Tiazolidinedioni
    • Prodotti di combinazione orale commercializzati che includono solo i prodotti elencati sopra.
    5. Indice di massa corporea (IMC) =40,0 kg/m^2 il giorno dello screening.
    * Sulfoniluree, meglitinidi (glinidi) e inibitori della DPP-4 devono essere interrotti alla randomizzazione.
    E.4Principal exclusion criteria
    1. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
    2. Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).
    3. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
    4. Any episodes (as declared by the participant or in the medical records) of diabetic ketoacidosis within 90 days before screening.
    5. Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
    6. Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
    7. Chronic heart failure classified as being in New York Heart Association Class IV at screening.
    8. Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
    9. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before 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.
    1. Soggetto di sesso femminile che sia in gravidanza, in allattamento o intenda iniziare una gravidanza, oppure in età fertile e che non utilizzi metodi contraccettivi altamente efficaci
    2. Inizio o variazione pianificata (per oltre 14 giorni consecutivi) nell’assunzione di farmaci concomitanti dei quali è nota l’influenza sul peso o sul metabolismo glicemico (ad es., trattamento con orlistat, ormoni tiroidei, corticosteroidi sistemici)
    3. Trattamento con qualsiasi farmaco indicato per il diabete o l’obesità, diverso da quelli stabiliti nei criteri di inclusione, nei 90 giorni precedenti lo screening
    4. Qualsiasi episodio (come dichiarato dal partecipante o nella cartella clinica) di chetoacidosi diabetica nei 90 giorni precedenti lo screening
    5. Presenza o storia medica di pancreatite (acuta o cronica) nei 180 giorni precedenti lo screening
    6. Uno dei seguenti eventi: infarto del miocardio, ictus, ricovero per angina pectoris instabile o attacco ischemico transitorio nei 180 giorni precedenti lo screening
    7. Insufficienza cardiaca cronica classificata di Classe IV secondo la New York Heart Association allo screening
    8. Episodi ipoglicemici severi ricorrenti nell’ultimo anno (12 mesi) secondo il giudizio dello Sperimentatore
    9. Retinopatia o maculopatia diabetica non controllata o potenzialmente instabile, verificata mediante esame del fondo oculare eseguito negli ultimi 90 giorni precedenti lo screening o nell’intervallo di tempo compreso tra lo screening e la randomizzazione. La dilatazione farmacologica della pupilla è un requisito a meno che non venga usata una fotocamera digitale specifica per un esame del fondo oculare senza dilatazione della pupilla.
    (a) come dichiarato dal partecipante o nella cartella clinica.
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c
    Variazione nei livelli di HbA1c
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline week 0 (V2) to week 52 (V54)
    Dalla settimana basale 0 (V2) alla settimana 52 (V54)
    E.5.2Secondary end point(s)
    1. Change in body weight
    2. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
    3. Time in range 70-180 mg/dL, using continuous glucose monitoring (CGM) system, Dexcom G6
    4. Time spent less than 54 mg/dL, using continuous glucose monitoring (CGM) system, Dexcom G6
    5. Time spent more than 180 mg/dL, using continuous glucose monitoring (CGM) system, Dexcom G6
    6. Change in fasting plasma glucose (FPG)
    7. Weekly basal insulin dose
    8. Number of clinically significant hypoglycaemic episodes (level 2)
    (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)
    9. Number of severe hypoglycaemic episodes (level 3)
    1. Variazione nel peso corporeo
    2. Numero di episodi ipoglicemici clinicamente significativi (livello 2) (<54 mg/dL, confermato mediante glucometro) o episodi ipoglicemici gravi (livello 3)
    3. Tempo trascorso nell’intervallo 70-180 mg/dL, misurato mediante dispositivo di monitoraggio in continuo della glicemia (Continuous Glucose Monitoring, CGM), Dexcom G6
    4. Tempo trascorso con valori <54 mg/dL, misurato mediante dispositivo di monitoraggio in continuo della glicemia (Continuous Glucose Monitoring, CGM), Dexcom G6
    5. Tempo trascorso > 180¿mg/dL, misurato mediante dispositivo di monitoraggio in continuo della glicemia (Continuous Glucose Monitoring, CGM), Dexcom G6
    6. Variazione della glicemia plasmatica a digiuno (FPG)
    7. Dose di insulina basale settimanale
    8. Numero di episodi ipoglicemici clinicamente significativi (livello 2) <54 mg/dL, confermato mediante glucometro
    9. Numero di eventi ipoglicemici seri (livello 3)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From baseline week 0 (V2) to week 52 (V54)
    2. From baseline week 0 (V2) to week 57 (V56)
    3-5. From week 48 (V50) to week 52 (V54)
    6. From baseline week 0 (V2) to week 52 (V54)
    7. From week 50 (V52) to week 52 (V54)
    8-9. From baseline week 0 (V2) to week 57 (V56)
    1. Dalla settimana basale 0 (V2) alla settimana 52 (V54)
    2. Dalla settimana basale 0 (V2) alla settimana 57 (V56)
    3-5. Dalla settimana 48 (V50) alla settimana 52 (V54)
    6. Dalla settimana basale 0 (V2) alla settimana 52 (V54)
    7. Dalla settimana 50 (V52) alla settimana 52 (V54)
    8-9. Dalla settimana basale 0 (V2) alla settimana 57 (V56)
    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 No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    China
    India
    Japan
    Korea, Democratic People's Republic of
    Korea, Republic of
    Mexico
    South Africa
    Taiwan
    United States
    Austria
    Cyprus
    Estonia
    Finland
    France
    Latvia
    Lithuania
    Luxembourg
    Malta
    Poland
    Sweden
    Bulgaria
    Netherlands
    Romania
    Spain
    Czechia
    Germany
    Greece
    Italy
    Belgium
    Croatia
    Denmark
    Hungary
    Ireland
    Norway
    Portugal
    Russian Federation
    Slovakia
    Slovenia
    Turkey
    Serbia
    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
    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 months8
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days22
    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: 1160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 1290
    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)
    NA
    NA
    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 Decision2022-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-10
    P. End of Trial
    P.End of Trial StatusOngoing
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