Clinical Trials Register

Summary
EudraCT Number:	2021-004392-13
Sponsor's Protocol Code Number:	NN9535-4801
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:	2022-01-05
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

2021-004392-13

A.3

Full title of the trial

Sustain Optimize: Efficacy and safety of once-weekly semaglutide s.c. 2.0 mg as add-on to dose reduced insulin glargine vs titrated insulin glargine in participants with type 2 diabetes and overweight

Sustain Optimize: Efficacia e sicurezza di semaglutide sottocutanea 2.0 mg assunta una volta alla settimana in aggiunta all’insulina glargine a dose ridotta vs insulina glargine titolata in partecipanti con diabete di tipo 2 e in sovrappeso.

A.3.1

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

A research study to look into how well semaglutide, together with insulin glargine, compares to a higher dose of insulin glargine alone in people with type 2 diabetes

Uno studio di ricerca per esaminare come semaglutide, insieme a insulina glargine, si confronta con una dose più elevata di insulina glargine da sola nelle persone con diabete di tipo 2

A.3.2

Name or abbreviated title of the trial where available

Sustain Optimize

A.4.1

Sponsor's protocol code number

NN9535-4801

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1267-0312

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	NOVO NORDISK. S.P.A.
B.1.3.4	Country	Italy
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	Novo Nordisk A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novo Nordisk A/S
B.5.2	Functional name of contact point	Clinical Transparency (1452)
B.5.3	Address:
B.5.3.1	Street Address	Novo Allé
B.5.3.2	Town/ city	Bagsværd
B.5.3.3	Post code	2880
B.5.3.4	Country	Denmark
B.5.4	Telephone number	004544448888
B.5.5	Fax number	004544490555
B.5.6	E-mail	clinicaltrials@novonordisk.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	Semaglutide B 2.68 mg/ml PDS290
D.3.2	Product code	[Semaglutide]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	semaglutide
D.3.9.1	CAS number	910463-68-2
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Semaglutide
D.3.9.4	EV Substance Code	SUB32188
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
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	Lantus SoloStar
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis
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	Lantus
D.3.2	Product code	[N/A]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Insulin glargine
D.3.9.1	CAS number	160337-95-1
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	INSULIN GLARGINE
D.3.9.4	EV Substance Code	SUB08196MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
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	Yes
D.2.1.1.1	Trade name	Ozempic
D.2.1.1.2	Name of the Marketing Authorisation holder	Novo Nordisk A/S
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	Ozempic
D.3.2	Product code	[Semaglutide]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SEMAGLUTIDE
D.3.9.1	CAS number	910463-68-2
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Semaglutide
D.3.9.4	EV Substance Code	SUB32188
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	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Diabetes Mellitus, type 2

Diabete Mellito di tipo 2

E.1.1.1

Medical condition in easily understood language

Type 2 diabetes

Diabete di tipo 2

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

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	10045242
E.1.2	Term	Type II diabetes mellitus
E.1.2	System Organ Class	100000004861

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To confirm that efficacy as measured by change from baseline to week 40 in HbA1c (% point) of OW (once weekly) semaglutide s.c. 2.0 mg as add-on to dose-reduced insulin glargine is not unacceptably worse (i.e., non-inferior) to that of titrated insulin glargine on change from baseline to week 40 in HbA1c (%-point) in participants with T2D and overweight treated with 40 units or less of insulin glargine per day. Non-inferiority is assessed based on the clinically acceptable margin of 0.3%-point for the mean treatment difference in HbA1c.

Confermare che l’efficacia, misurata in base alla variazione dal basale alla Settimana 40 della HbA1c (in punti %), di semaglutide 2,0 mg s.c. OW come terapia aggiuntiva all’insulina glargine a dose ridotta non è inaccettabilmente peggiore (ovvero, non inferiore) a quella dell’insulina glargine titolata in termini di variazione dal basale alla Settimana 40 della HbA1c (in punti %) nei partecipanti con T2D e in sovrappeso trattati con 40 unità o meno di insulina glargine al giorno. La non inferiorità viene valutata in base al margine clinicamente accettabile di 0,3 punti percentuali per la differenza media dei trattamenti in termini di HbA1c.

E.2.2

Secondary objectives of the trial

1. To confirm superiority of OW semaglutide s.c. 2.0 mg as add-on to dose-reduced insulin glargine versus titrated insulin glargine on:
a. change from baseline to week 40 in body weight (kg) and HbA1c (%) and in DTSQc score in participants with T2D and overweight treated with 40 units or less of insulin glargine per day.
b. relative change from baseline to week 40 in daily insulin dose (%) in participants with T2D and overweight treated with 40 units or less of insulin glargine per day.
2. To compare the effect of OW semaglutide s.c. 2.0 mg as add-on to dose-reduced insulin glargine versus titrated insulin glargine on insulin requirements, glycaemic control, hypoglycaemia, and patient reported outcome in participants with T2D and overweight treated with 40 units or less of insulin glargine per day.

1. Confermare la superiorità di semaglutide 2,0 mg s.c. OW come terapia aggiuntiva all’insulina glargine a dose ridotta rispetto all’insulina glargine titolata in termini di:
a. variazione dal basale alla Settimana 40 del peso corporeo (kg) e dei livelli di HbA1c (punti percentuali) e del del punteggio DTSQc nei partecipanti con T2D e in sovrappeso trattati con 40 unità o meno di insulina glargine al giorno.
b. variazione relativa dal basale alla Settimana 40 della dose giornaliera di insulina (%) nei partecipanti con T2D e in sovrappeso trattati con 40 unità o meno di insulina glargine al giorno.
2. Confrontare effetto di semaglutide 2,0 mg s.c. OW come terapia aggiuntiva a glargine a dose ridotta vs glargine titolata sul fabbisogno insulinico, controllo glicemico, ipoglicemia e gli gli esiti riferiti dal paziente nei partecipanti con T2D e in sovrappeso trattati con 40U o meno di insulina glargine al giorno.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Diagnosed with T2D mellitus greater than or equal to 180 days before screening.
- HbA1c of 7-9% (53-75 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
- Body mass index (BMI) greater than or equal to 25 kg/m^2 on the day of screening.
- Stable daily dose(s) greater than or equal to 90 days before screening of any of the following anti-diabetic drugs or combination regimens:
- Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose.
- Any metformin combination formulation greater than or equal to 1500 mg or maximum tolerated or effective dose.
The treatment can be with or without SGLT-2 inhibitors.
- Treated with once daily insulin glargine U100 injections less than or equal to 40 units/day greater than or equal to 90 days before screening.
Short term bolus insulin treatment for a maximum of 14 days before screening is allowed.

- Soggetti che hanno ricevuto una diagnosi di T2D mellito =180 giorni prima dello screening
- HbA1c pari a 7-9% (53-75 mmol/mol) (estremi compresi) secondo la valutazione del laboratorio centrale il giorno dello screening.
- IMC (indice di massa corporea) =25 kg/m2 il giorno dello screening.
- Dose/i giornaliera/e stabile/i di uno qualsiasi dei seguenti farmaci antidiabetici o regimi combinati =90 giorni prima dello screening:
• Qualsiasi formulazione di metformina =1500 mg o dose massima tollerata o efficace.
• Qualsiasi formulazione di metformina in combinazione =1500 mg o dose massima tollerata o efficace.
Il trattamento può essere associato o meno a inibitori di SGLT-2.
Trattamento una volta al giorno con iniezioni di insulina glargine U100 =40 U/die =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.

E.4

Principal exclusion criteria

- 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.
- Potentially missed diagnosis of Type 1 diabetes (T1D) or latent autoimmune diabetes in adults (LADA) verified by C-peptide less than 0.5 nmol/L (1.5 ng/mL) or antibodies to glutamic acid decarboxylase (anti-GAD) greater than 5 units/mL, as measured by the central laboratory at screening.
- Presence or history(a) of pancreatitis (acute or chronic).
- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 mL/min/1.73 m2 at screening as defined by KDIGO 2012 classification.
- Any episodes(a) of diabetic ketoacidosis as declared by the participant or in the medical records within 90 days before screening.
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.

- 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
- Diagnosi potenzialmente mancata di T1D o LADA verificata mediante valori del peptide C <0,5 nmol/l (1,5 ng/ml) o anti-GAD >5 unità/ml, misurati dal laboratorio centrale allo screening.
- Presenza o anamnesi di pancreatite (acuta o cronica).
- Insufficienza renale misurata in termini di velocità di filtrazione glomerulare stimata (eGFR) con un valore <30 ml/min/1,73 m2 allo screening come definito secondo la classificazione KDIGO 2012-
- Qualsiasi episodio di chetoacidosi diabetica secondo quanto dichiarato dai partecipanti o nelle cartelle cliniche nei 90 giorni precedenti lo screening.
- Incapacità nota di riconoscere l’insorgenza di ipoglicemia, valutata dallo sperimentatore in base alla domanda n. 8 del questionario di Clarke.

E.5 End points

E.5.1

Primary end point(s)

Change in HbA1c

variazione dell' HbA1c

E.5.1.1

Timepoint(s) of evaluation of this end point

From baseline (week 0) to end of treatment (week 40)

Dal basale (Settimana 0) alla fine del trattamento (Settimana 40)

E.5.2

Secondary end point(s)

1. Change in body weight
2 Relative change in daily insulin dose
3. Change in HbA1c
4. Score of Diabetes Treatment Satisfaction Questionnaire – change version (DTSQc)
5. Participants achieving: Insulin dose = 0 U
6. Participants achieving: Insulin dose reduced from baseline by at least 50%
7. Participants achieving: HbA1c < 7%
8. Number of severe hypoglycaemic episodes (level 3)
9. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter)
10. 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)
11. Participants achieving all of the following targets:
- HbA1c reduced from baseline by at least 0.3%-points
- Insulin dose reduced from baseline
- No hypoglycaemic episodes (< 3.9 mmol/L (70 mg/dL) confirmed by BG meter)
- No weight gain
12. Change in score of Diabetes Treatment Satisfaction Questionnaire – status version (DTSQs)

1 Variazione del peso corporeo
2 Variazione relativa della dose giornaliera di insulina
3 Variazione dei livelli di HbA1c
4 Punteggio al questionario sulla soddisfazione rispetto al trattamento per il diabete – versione relativa al cambiamento (DTSQc)
5 Partecipanti che raggiungono il seguente obiettivo: Dose di insulina = 0 U
6 Partecipanti che raggiungono il seguente obiettivo: Dose di insulina ridotta di almeno il 50% rispetto al basale
7 Partecipanti che raggiungono il seguente obiettivo: HbA1c <7%
8 Numero di episodi ipoglicemici gravi (livello 3)
9 Numero di episodi ipoglicemici clinicamente significativi (livello 2) (<3,0 mmol/l [54 mg/dl], confermati mediante glucometro)
10 Numero di episodi ipoglicemici clinicamente significativi (livello 2) (<3,0 mmol/l [54 mg/dl], confermati mediante glucometro) o episodi ipoglicemici gravi (livello 3)
11 Partecipanti che raggiungono tutti i seguenti obiettivi:
• Riduzione della HbA1c di almeno 0,3 punti percentuali rispetto al basale
• Riduzione della dose di insulina rispetto al basale
• Nessun episodio ipoglicemico (<3,9 mmol/l [70 mg/dl] confermato mediante glucometro)
• Nessun aumento di peso
12 Variazione del punteggio al questionario sulla soddisfazione rispetto al trattamento per il diabete – versione relativa allo stato (DTSQs)

E.5.2.1

Timepoint(s) of evaluation of this end point

1.-3, 8-10. From baseline (week 0) to end of treatment (week 40)
4.-7, 11-12. At end of treatment (week 40)

1.-3, 8-10 Dal basale (Settimana 0) alla fine del trattamento (Settimana 40)
4.-7, 11-12 Alla fine del trattamento (Settimana 40)

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Insulin glargine (titrated)

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

South Africa

European Union

Russian Federation

Ukraine

United States

E.8.7

Trial has a data monitoring committee

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.8.9.1

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:

324

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

244

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

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

245

F.4.2.2

In the whole clinical trial

568

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

2022-02-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-01-20

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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