Clinical Trials Register

Summary
EudraCT Number:	2021-003037-11
Sponsor's Protocol Code Number:	21839
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:	2022-03-15
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2021-003037-11

A.3

Full title of the trial

A parallel-group treatment, Phase 2, double-blind, three-arm study to assess efficacy and safety of finerenone plus empagliflozin compared with either finerenone or empagliflozin in participants with chronic kidney disease and type 2 diabetes.

Studio di fase 2, in doppio cieco, a gruppi paralleli a tre bracci di trattamento, per valutare l’efficacia e la sicurezza di finerenone più empagliflozin rispetto a finerenone o empagliflozin in partecipanti con malattia renale cronica e diabete di tipo 2.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to learn how well the treatment combination of finerenone and empagliflozin works and how safe it is compared to each treatment alone in adult participants with long-term kidney disease (chronic kidney disease) and type 2 diabetes.

Uno studio volto a capire quanto il trattamento combinato di finerenone ed empagliflozin funzioni e quanto sicuro sia comparato a ciascun trattamento in monoterapia nei partecipanti adulti con malattia renale a lungo termine (malattia renale cronica) e diabete tipo 2.

A.3.2

Name or abbreviated title of the trial where available

CONFIDENCE

A.4.1

Sponsor's protocol code number

21839

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	BAYER AG
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bayer AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bayer AG
B.5.2	Functional name of contact point	Bayer Clinical Trials Contact
B.5.3	Address:
B.5.3.1	Street Address	Müllerstraße 178
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13353
B.5.3.4	Country	Germany
B.5.4	Telephone number	004930300139005
B.5.6	E-mail	clinical-trials-contact@bayer.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Finerenone
D.3.2	Product code	[BAY 94-8862 IR tablet 10 mg]
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Finerenone
D.3.9.1	CAS number	1050477-31-0
D.3.9.2	Current sponsor code	BAY 94-8862
D.3.9.4	EV Substance Code	SUB183743
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Empagliflozin coated tablet 10 mg (Jardiance)
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH - EU/1/14/930
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Empagliflozin
D.3.2	Product code	[BI 10773]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Empagliflozin
D.3.9.1	CAS number	864070-44-0
D.3.9.2	Current sponsor code	BI 10773
D.3.9.4	EV Substance Code	SUB35915
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Finerenone
D.3.2	Product code	[BAY 94-8862 IR tablet 20 mg]
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Finerenone
D.3.9.1	CAS number	1050477-31-0
D.3.9.2	Current sponsor code	BAY 94-8862
D.3.9.4	EV Substance Code	SUB183743
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic kidney disease in type 2 diabetes mellitus

Malattia renale cronica nel diabete mellito tipo 2

E.1.1.1

Medical condition in easily understood language

Chronic kidney disease, a long-term progressive decrease in the kidneys' ability to work properly, and type 2 diabetes, a condition characterized by high blood sugar levels.

Malattia renale cronica,una riduzione progressiva a lungo termine della capacità renale di funzionare correttamente,e diabete tipo 2,condizione caratterizzata da alti livelli di zucchero nel sangue.

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10045250
E.1.2	Term	Type II diabetes mellitus with renal manifestations
E.1.2	System Organ Class	100000004857

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to demonstrate that combination therapy using finerenone and empagliflozin is superior in reducing UACR that either empagliflozin or finerenone alone.

L'obiettivo primario è dimostrare che la terapia combinata di finerenone ed empagliflozin è superiore nel ridurre l' UACR rispetto a empagliflozin o finerenone in monoterapia.

E.2.2

Secondary objectives of the trial

The secondary outcomes are:
- to further investigate the efficacy of combination therapy using finerenone and empagliflozin versus either finerenone or empagliflozin alone
- to evaluate the safety of combination therapy using finerenone and empagliflozin versus either finerenone or empagliflozin alone

Gli obiettivi secondari sono:
- studiare ulterioremente l'efficacia della terapia combinata con finerenone ed empagliflozin rispetto a finerenone o empagliflozin in monoterapia
- valutare la sicurezza della terapia combinata con finerenone ed empagliflozin rispetto a finerenone o empagliflozin in monoterapia

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Participant with a clinical diagnosis of chronic kidney disease (CKD) and the following:
a. In Part A: eGFR 40-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using Chronic Kidney Disease
Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnosis of CKD.
b. In Part B: eGFR 30-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnostic of CKD.
- 300 <=UACR <5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant's medical records at least 3 months prior to screening
2. Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening <11%.
3. Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor
(ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit.

1. Partecipante con diagnosi clinica di malattia renale cronica (MRC) e i seguenti:
a. Nella Parte A: tasso di filtrazione glomerulare stimato (eGFR) 40-90 ml/min/1,73 m2 (con non più del 20% con eGFR > 75 ml/min/1,73 m2) utilizzando la formula Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) alla visita di screening e almeno un valore storico di eGFR < 60 ml/min/1,73 m2 entro 3 mesi o diagnosi registrata di MRC.
b. Nella Parte B: eGFR 30-90 ml/min/1,73 m2 (con non più del 20% con eGFR > 75 ml/min/1,73 m2) utilizzando la formula CKD-EPI alla visita di screening e almeno un valore storico di eGFR < 60 ml/min/1,73 m2 entro 3 mesi o diagnosi registrata di MRC.
- 300 <= rapporto albumina/creatinina nelle urine (UACR) < 5000 mg/g alla visita di screening (valore medio da 3 campioni di urine del mattino) e documentazione di albuminuria/proteinuria (misurazione quantitativa o semi-quantitativa) presente nelle cartelle cliniche del partecipante almeno 3 mesi prima dello screening
2. Partecipante con diabete di tipo 2 (DT2) come definito American Diabetes Association (ADA 2021), con emoglobina glicata (HbA1c) allo screening < 11%.
3. Il partecipante è stato trattato con la dose massima clinicamente tollerata, a giudizio dello sperimentatore, dell’inibitore dell’enzima di conversione dell’angiotensina (ACEi) o del bloccante del recettore dell’angiotensina (ARB), ma non con entrambi, per più di 1 mese alla visita di screening

E.4

Principal exclusion criteria

1. Participants with type 1 diabetes (T1D).
2. Participant with hepatic insufficiency classified as Child-Pugh C.
3. Participant with blood pressure at Day 1 visit higher than 160/100 or systolic blood pressure lower than 90 mmHg.
4. Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
5. Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
6. Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit.
7. Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening.

1. Partecipanti con diabete di tipo 1 (DT1).
2. Partecipante con insufficienza epatica classificata come Child-Pugh C.
3. Partecipante con pressione sanguigna superiore a 160/100 o pressione arteriosa sistolica inferiore a 90 mmHg alla visita del Giorno 1.
4. Partecipante attualmente trattato con un SGLT2i o un inibitore combinato di SGLT-1 e 2 (SGLT-1/2i) o che ha ricevuto un SGLT2i o SGLT-1/2i che non può essere interrotto almeno 8 settimane prima della visita di screening e durante il trattamento dello studio.
5. Partecipante trattato con un altro MRA (ad es., eplerenone, esaxerenone, spironolattone, canrenone), un inibitore della renina, integratori K+, un diuretico risparmiatore di K+ (ad es., amiloride, triamterene), un agente legante di K+ o un inibitore del recettore dell’angiotensina-neprilisina (ARNI) che non possono essere discontinuati almeno nelle 8 settimane precedenti la visita di screening e durante il trattamento dello studio.
6. Partecipanti attualmente trattati o che sono stati trattati con finerenone (Kerendia©) nelle 8 settimane precedenti la visita di screening.
7. Partecipante con K+ siero/plasma superiore a 4,8 mmol/L alla visita di screening

E.5 End points

E.5.1

Primary end point(s)

1. Mean ratio of change from baseline to Day 180 in Urinary albumin to creatinine ratio (UACR) for the combination therapy group, to empagliflozin alone
2. Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone.

- rapporto medio della variazione dal basale al giorno 180 nell' UACR per il gruppo della terapia di combinazione, rispetto a empagliflozin in monoterapia
-rapporto medio della variazione dal basale al giorno 180 nell' UACR per il gruppo della terapia di combinazione, rispetto a finerenone in monoterapia

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 180 days

Fino a 180 giorni

E.5.2

Secondary end point(s)

1. Relative change in UACR between end of treatment visit and 30 days after end of treatment visit
2. Relative change in UACR between 30 days after end of treatment visit and baseline
3. Relative change in UACR category (>30%, >40%, >50% at 180 days) in each group
4. Ratio of change from baseline in eGFR at 30 days
5. eGFR decline greater than 30% at 30 days from baseline
6. Ratio of change in eGFR at 180 days and 210 days from day 30
7. Number of participants with of AKI events
8. Total number of AKI events
9. Number of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ =6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])
10. Total number of hyperkalemia events (moderate hyperkalemia [5.5 <K+ <=6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])
11. Change from baseline in K+
12. Number of participants with severe hypoglycemia events
13. Total number of events of severe hypoglycemia events
14. Number of participants with symptomatic hypotension events
15. Total number of symptomatic hypotension events
16. Number of participants with genital mycotic events
17. Total number of genital mycotic events
18. Number of participants with ketoacidosis events
19. Total number of ketoacidosis events
20. Number of participants with necrotizing fasciitis of the perineum events
21. Total number of necrotizing fasciitis of the perineum events
22. Number of participants with urosepsis and pyelonephritis events
23. Total number of urosepsis and pyelonephritis events

1. Variazione relativa nell’UACR tra la visita di fine trattamento e 30 giorni dopo la visita di fine trattamento
2. Variazione relativa nell’UACR tra 30 giorni dopo la visita di fine trattamento e il basale
3. Variazione relativa nella categoria UACR (>30%, >40%, >50% a 180 giorni) in ogni gruppo
4. Rapporto di variazione rispetto al basale nell' eGFR a 30 giorni
5. Riduzione dell’eGFR superiore al 30% a 30 giorni dal basale
6. Rapporto di variazione nell’eGFR a 180 giorni e a 210 giorni dal Giorno 30
7. Numero di partecipanti con eventi AKI
8. Numero totale di eventi AKI
9. Numero di partecipanti con eventi di iperkaliemia (iperkaliemia moderata [5,5 <K+ =6,0 mmol/l], iperkaliemia grave [K+ >6,0 mmol/l])
10. Numero totale di eventi di iperkaliemia (iperkaliemia moderata [5,5 <K+ =6,0 mmol/l], iperkaliemia grave [K+ >6,0 mmol/l])
11. Variazione rispetto al basale nei livelli di K+
12. Numero di partecipanti con eventi ipoglicemici gravi
13. Numero totale di eventi ipoglicemici gravi
14. Numero di partecipanti con eventi ipotensivi sintomatici
15. Numero totale di eventi ipotensivi sintomatici
16. Numero di partecipanti con eventi micotici genitali
17. Numero totale di eventi micotici genitali
18. Numero di partecipanti con eventi di chetoacidosi
19. Numero totale di eventi di chetoacidosi
20. Numero di partecipanti con eventi di fascite necrotizzante del perineo
21. Numero totale con eventi di fascite necrotizzante del perineo
22. Numero di partecipanti con eventi di urosepsi e pielonefrite
23. Numero totale di eventi di urosepsi e pielonefrite

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Up to 210 days
2. Up to 210 days
3. Up to 180 days
4. Up t0 30 days
5. Up to 30 days
6. Up to 210 days
7. to 23. Up to 180 days

1. Fino a 210 giorni
2. Fino a 210 giorni
3. Fino a 180 giorni
4. Fino a 30 giorni
5. Fino a 30 giorni
6. Fino a 210 giorni
7. to 23. Fino a 180 giorni

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

Israel

Japan

Korea, Republic of

Taiwan

United States

Belgium

Denmark

France

Germany

Italy

Netherlands

Spain

E.8.7

Trial 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

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

600

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

207

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Subjects who can not consent themselves, but with a legal guardian

Soggetti che non sono in grado di fornire il proprio consenso, ma con un tutore legale

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

400

F.4.2.2

In the whole clinical trial

807

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-04-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-03-09

P. End of Trial
P.	End of Trial Status	Ongoing

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