Clinical Trials Register

Summary
EudraCT Number:	2021-005484-53
Sponsor's Protocol Code Number:	D5671C00006
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:	2022-05-06
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

2021-005484-53

A.3

Full title of the trial

A Phase IIb/III Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Cotadutide in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis with Fibrosis

Studio di fase IIb/III, randomizzato, in doppio cieco, controllato con placebo per valutare la sicurezza e l’efficacia di cotadutide in partecipanti con steatoepatite non alcolica non cirrotica con fibrosi

A.3.1

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

A study to evaluate the safety and efficacy of cotadutide given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis

Studio per valutare la sicurezza e l’efficacia di cotadutide somministrata mediante iniezione sottocutanea in partecipanti adulti con steatoepatite non alcolica non cirrotica con fibrosi

A.3.2

Name or abbreviated title of the trial where available

PROXYMO-ADVANCE

A.4.1

Sponsor's protocol code number

D5671C00006

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	ASTRAZENECA AB
B.1.3.4	Country	Sweden
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca
B.5.2	Functional name of contact point	Clinical Study Information Center
B.5.3	Address:
B.5.3.1	Street Address	NA
B.5.3.2	Town/ city	NA
B.5.3.3	Post code	NA
B.5.3.4	Country	United States
B.5.6	E-mail	information.center@astrazeneca.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	Cotadutide
D.3.2	Product code	[NA]
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	Cotadutide
D.3.9.1	CAS number	1686108-82-6
D.3.9.2	Current sponsor code	MEDI0382
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	1
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	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	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	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	Cotadutide
D.3.2	Product code	[NA]
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	Cotadutide
D.3.9.1	CAS number	1686108-82-6
D.3.9.2	Current sponsor code	MEDI0382
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	5
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	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	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	Solution for injection in pre-filled pen
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection in pre-filled pen
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Non-cirrhotic non-alcoholic steatohepatitis with fibrosis

Steatoepatite non alcolica non cirrotica con fibrosi

E.1.1.1

Medical condition in easily understood language

Non-alcoholic steatohepatitis

Steatoepatite non alcolica

E.1.1.2

Therapeutic area

Diseases [C] - Symptoms and general pathology [C23]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	24.1
E.1.2	Level	LLT
E.1.2	Classification code	10086370
E.1.2	Term	NASH with fibrosis
E.1.2	System Organ Class	100000004871

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Part A:
To determine whether cotadutide is superior to placebo on resolution of NASH without worsening of liver fibrosis in participants with noncirrhotic NASH with fibrosis
Part B:
To determine whether cotadutide is superior to placebo on:
- Resolution of NASH without worsening of liver fibrosis
- Improvement of liver fibrosis by at least one stage without worsening of NASH

Parte A:
Determinare se il cotadutide è superiore al placebo nella risoluzione della NASH senza peggioramento della fibrosi epatica nei partecipanti con NASH non cirrotica con fibrosi
Parte B:
Per determinare se il cotadutide è superiore al placebo su:
- Risoluzione della NASH senza peggioramento della fibrosi epatica
- Miglioramento della fibrosi epatica di almeno uno stadio senza peggioramento della NASH

E.2.2

Secondary objectives of the trial

Part A:
1. To assess the effect of cotadutide versus placebo on improvement in fibrosis by at least one stage without worsening of NASH
2. To assess the effect of cotadutide versus placebo on resolution of NASH and improvement in fibrosis
3. To determine whether cotadutide is superior to placebo for weight reduction
4. To determine whether cotadutide is superior to placebo for glycemic control in participants with T2DM
5.To assess the effect of cotadutide versus placebo on triglycerides
Part B:
1. To assess the effect of cotadutide versus placebo on resolution of NASH and improvement in fibrosis
2. To determine whether cotadutide is superior to placebo for weight reduction
3. To determine whether cotadutide is superior to placebo for glycemic control in participants with T2DM
4. To assess the effect of cotadutide versus placebo on triglycerides

Parte A:
1. Valutare l'effetto di cotadutide rispetto al placebo sul miglioramento della fibrosi di almeno uno stadio senza peggioramento della NASH
2. Valutare l'effetto di cotadutide rispetto al placebo sulla risoluzione della NASH e sul miglioramento della fibrosi
3. Determinare se il cotadutide è superiore al placebo per la riduzione del peso
4. Determinare se il cotadutide è superiore al placebo per il controllo glicemico nei partecipanti con T2DM
5.Per valutare l'effetto di cotadutide rispetto al placebo sui trigliceridi
Parte B:
1. Valutare l'effetto di cotadutide rispetto al placebo sulla risoluzione della NASH e sul miglioramento della fibrosi
2. Determinare se il cotadutide è superiore al placebo per la riduzione del peso
3. Determinare se il cotadutide è superiore al placebo per il controllo glicemico nei partecipanti con T2DM
4. Per valutare l'effetto di cotadutide rispetto al placebo sui trigliceridi

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Other types of substudies
Specify title, date and version of each substudy with relative objectives: MRE/MRI sub-study as an integral part of clinical protocol.
Objective:
- To characterize the effect of cotadutide versus placebo on liver fat as determined by MRI-PDFF at Week 84
- To assess the effect of cotadutide versus placebo on liver stiffness as assessed by MRE at Week 84

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio MRE/MRI come parte integrante del protocollo clinico.
Obbiettivo:
- Per caratterizzare l'effetto di cotadutide rispetto al placebo sul grasso epatico come determinato da MRI-PDFF alla settimana 84
- Per valutare l'effetto di cotadutide rispetto al placebo sulla rigidità epatica valutata mediante MRE alla settimana 84

E.3

Principal inclusion criteria

1. Provision of informed consent
2. Males and female participants = 18 to = 75 years of age at the time of signing the informed consent.
3. Histologically confirmed non-alcoholic steatohepatitis (NASH) per NASH Clinical Research Network (CRN) criteria as diagnosed by liver biopsy fulfilling all of the following histological criteria:
(a) NAS (Non-alcoholic Fatty Liver Disease Activity Score) = 4 with a score of = 1 for each component: steatosis, lobular inflammation, and ballooning
(b) Presence of fibrosis stage F2 or F3
4. Women of childbearing potential, non-pregnant and nonbreastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study intervention.

1. Fornitura del consenso informato
2. Partecipanti maschi e femmine di età compresa tra = 18 e = 75 anni al momento della firma del consenso informato.
3. Steatoepatite non alcolica (NASH) confermata istologicamente secondo i criteri della rete di ricerca clinica (CRN) della NASH, come diagnosticata mediante biopsia epatica che soddisfa tutti i seguenti criteri istologici:
(a) NAS (Punteggio di attività della malattia epatica grassa non alcolica) = 4 con un punteggio = 1 per ciascuna componente: steatosi, infiammazione lobulare e rigonfiamento
(b) Presenza di fibrosi stadio F2 o F3
4. Donne in età fertile, non gravide e che non allattano al seno e che utilizzano un controllo delle nascite appropriato per evitare la gravidanza durante tutto lo studio e fino a 4 settimane dopo l'ultima dose di intervento dello studio.

E.4

Principal exclusion criteria

1 Chronic liver disease of other etiologies.
2 History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding.
3 Clinically significant cardiovascular or cerebrovascular disease within 90 days prior to screening, including but not limited to, myocardial infarction, acute coronary syndrome, unstable angina pectoris, transient ischemic attack, or stroke, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 90 days or who are due to undergo these procedures at the time of screening
4 History of malignant neoplasms within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or any in situ carcinoma.
5 Participation in another clinical study with an investigational product administered within the last 30 days or 5 half-lives of the therapy (whichever is longer) at the time of screening or the time of the historical biopsy or concurrent participation in another interventional study of any kind or prior randomization in this study.
6 Severe allergy/hypersensitivity to any of the proposed study treatments or excipients
7 Contraindication to liver biopsy (eg, bleeding diathesis, such as hemophilia, suspected hemangioma, or suspected echinococcal infection) or inability to safely obtain a liver biopsy as determined by the investigator
8 Severely uncontrolled hypertension defined as SBP = 180 mmHg or DBP = 110 mmHg on the average of 2 seated BP measurements after being at rest for at least 10 minutes at screening or randomization
9 Any positive results for human immunodeficiency virus infection, positive results for hepatitis B surface antigen or hepatitis C antibody test along with a positive HCV RNA test.

1 Malattia epatica cronica di altre eziologie.
2 Storia di cirrosi e/o scompenso epatico, inclusa ascite, encefalopatia epatica o sanguinamento da varici.
3 Malattie cardiovascolari o cerebrovascolari clinicamente significative entro 90 giorni prima dello screening, inclusi ma non limitati a infarto del miocardio, sindrome coronarica acuta, angina pectoris instabile, attacco ischemico transitorio o ictus o partecipanti che hanno subito un intervento coronarico percutaneo o un'arteria coronaria bypassare l'innesto negli ultimi 90 giorni o che devono sottoporsi a queste procedure al momento dello screening
4 Anamnesi di neoplasie maligne nei 5 anni precedenti lo screening, ad eccezione di carcinoma cutaneo a cellule basali, squamocellulari o qualsiasi carcinoma in situ adeguatamente trattato.
5 Partecipazione a un altro studio clinico con un prodotto sperimentale somministrato negli ultimi 30 giorni o 5 emivite della terapia (a seconda di quale sia il periodo più lungo) al momento dello screening o al momento della biopsia storica o partecipazione concomitante a un altro studio interventistico di qualsiasi tipo o precedente randomizzazione in questo studio.
6 Grave allergia/ipersensibilità a uno qualsiasi dei trattamenti o eccipienti proposti in studio
7 Controindicazione alla biopsia epatica (p. es., diatesi emorragica, come emofilia, sospetto emangioma o sospetta infezione echinococcica) o incapacità di ottenere in sicurezza una biopsia epatica come determinato dallo sperimentatore
8 Ipertensione gravemente non controllata definita come PAS = 180 mmHg o PAD = 110 mmHg sulla media di 2 misurazioni PA da seduto dopo essere stato a riposo per almeno 10 minuti allo screening o alla randomizzazione
9 Eventuali risultati positivi per l'infezione da virus dell'immunodeficienza umana, risultati positivi per l'antigene di superficie dell'epatite B o per il test degli anticorpi dell'epatite C insieme a un test positivo per l'RNA dell'HCV.

E.5 End points

E.5.1

Primary end point(s)

Part A:
• Proportion of participants with resolution of NASH without worsening of liver fibrosis based on biopsy at Week 48
Part B:
• Proportion of participants with resolution of NASH without worsening of liver fibrosis based on biopsy at Week 84
• Proportion of participants with improvement of liver fibrosis by at least one stage without worsening of NASH based on biopsy at Week 84

Parte A:
• Percentuale di partecipanti con risoluzione della NASH senza peggioramento della fibrosi epatica sulla base della biopsia alla settimana 48
Parte B:
• Percentuale di partecipanti con risoluzione della NASH senza peggioramento della fibrosi epatica sulla base della biopsia alla settimana 84
• Percentuale di partecipanti con miglioramento della fibrosi epatica di almeno uno stadio senza peggioramento della NASH sulla base della biopsia alla settimana 84

E.5.1.1

Timepoint(s) of evaluation of this end point

Part A:
At Week 48
Part B:
At week 84

Parte A:
Alla settimana 48
Parte B:
Alla settimana 84

E.5.2

Secondary end point(s)

Part A:
• Proportion of participants with improvement of liver fibrosis by at least one stage without worsening of NASH based on biopsy at Week 48
• Proportion of participants with both resolution of NASH and improvement in fibrosis by at least one stage based on biopsy at Week 48
• Absolute change from baseline in body weight at Week 48
• Change from baseline in HbA1c in participants with T2DM at Week 48
• Percent change from baseline in triglycerides at Week 48
Part B:
• Proportion of participants with both resolution of NASH and improvement in fibrosis by at least one stage based on biopsy at Week 84
• Absolute change from baseline in body weight at Week 84
• Change from baseline in HbA1c in participants with T2DM at Week 84
• Percent change from baseline in triglycerides at Week 84

Parte A:
• Percentuale di partecipanti con miglioramento della fibrosi epatica di almeno uno stadio senza peggioramento della NASH sulla base della biopsia alla settimana 48
• Percentuale di partecipanti con risoluzione della NASH e miglioramento della fibrosi di almeno uno stadio sulla base della biopsia alla settimana 48
• Variazione assoluta del peso corporeo rispetto al basale alla settimana 48
• Modifica rispetto al basale dell'HbA1c nei partecipanti con diabete di tipo 2 alla settimana 48
• Variazione percentuale rispetto al basale dei trigliceridi alla settimana 48
Parte B:
• Percentuale di partecipanti con risoluzione della NASH e miglioramento della fibrosi di almeno uno stadio sulla base della biopsia alla settimana 84
• Variazione assoluta del peso corporeo rispetto al basale alla settimana 84
• Variazione rispetto al basale dell'HbA1c nei partecipanti con diabete di tipo 2 alla settimana 84
• Variazione percentuale rispetto al basale dei trigliceridi alla settimana 84

E.5.2.1

Timepoint(s) of evaluation of this end point

Part A:
At Week 48
Part B:
At Week 84

Parte A:
Alla settimana 48
Parte B:
Alla settimana 84

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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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)

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

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

Yes

E.8.1.7.1

Other trial design description

Disegno di adattamento della dose

Dose adaptation design

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

Argentina

Australia

Brazil

Canada

China

Colombia

Hong Kong

Israel

Japan

Korea, Republic of

Malaysia

Mexico

New Zealand

Peru

Philippines

Singapore

South Africa

Taiwan

Thailand

United States

Viet Nam

Austria

France

Spain

Switzerland

Germany

Greece

Italy

Russian Federation

Turkey

United Kingdom

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

The end of the study (both Part A and Part B included) is defined as the date of the last visit of the last participant in the study.

La fine dello studio (compresa sia la Parte A che la Parte B) è definita come la data dell'ultima visita dell'ultimo partecipante allo studio.

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:

1300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

560

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

198

F.4.2.2

In the whole clinical trial

1860

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)

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

2022-07-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-04-28

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
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Clinical trials