Clinical Trials Register

Summary
EudraCT Number:	2021-005484-53
Sponsor's Protocol Code Number:	D5671C00006
National Competent Authority:	Spain - AEMPS
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

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

Ensayo fase IIb/III, aleatorizado, doble ciego, comparado con placebo para evaluar la seguridad y eficacia de la cotadutida en pacientes con esteatohepatitis no alcohólica no cirrótica con fibrosis. (Estudio PROXYMO-ADVANCE)

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

Ensayo para evaluar la seguridad y eficacia de cotadutida administrada mediante inyección intravenosa en pacientes adultos con esteatohepatitis no alcohólica no cirrótica con fibrosis.

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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca Farmacéutica Spain, S.A.
B.5.2	Functional name of contact point	Unidad de Investigación Clínica
B.5.3	Address:
B.5.3.1	Street Address	C/ Serrano Galvache, 56; Parque Norte, Ed. Álamo
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28033
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34900200444
B.5.6	E-mail	informacionEECC-Spain@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.3.4	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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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.3.4	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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

Esteatohepatitis no alcohólica no cirrótica con fibrosis

E.1.1.1

Medical condition in easily understood language

Non-alcoholic steatohepatitis

Esteatohepatitis no alcohólica

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	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 non-cirrhotic 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:

Determinar si la cotadutida es superior al placebo en la resolución de la EHNA sin empeoramiento de la fibrosis hepática en participantes con EHNA no cirrótica con fibrosis

Parte B:

Determinar si la cotadutida es superior al placebo en:
- Resolución de la EHNA sin empeoramiento de la fibrosis hepática
- Mejoría de la fibrosis hepática en al menos un estadio sin empeoramiento de la EHNA

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. Evaluar el efecto de la cotadutida frente al placebo en la mejoría de la fibrosis en al menos un estadio sin empeoramiento de la EHNA

2. Evaluar el efecto de la cotadutida frente al placebo en la resolución de la EHNA y la mejoría de la fibrosis

3. Determinar si la cotadutida es superior al placebo en la reducción del peso

4. Determinar si la cotadutida es superior al placebo en el control glucémico en participantes con DMT2

5. Evaluar el efecto de la cotadutida frente al placebo sobre los niveles de triglicéridos

Parte B:

1. Evaluar el efecto de la cotadutida frente al placebo en la resolución de la EHNA y la mejoría de la fibrosis

2. Determinar si la cotadutida es superior al placebo en la reducción del peso

3. Determinar si la cotadutida es superior al placebo en el control glucémico en participantes con DMT2

4. Evaluar el efecto de la cotadutida frente al placebo sobre los niveles de triglicéridos

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

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

Ensayo complementario de ERM/RM como parte integral del protocolo clínico.

Objetivo:
- Caracterizar el efecto de la cotadutida frente al placebo sobre la grasa hepática, determinada por FGDP-RM en la Semana 84
- Evaluar el efecto de la cotadutida frente al placebo en la rigidez hepática, evaluada mediante ERM en la Semana 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 non-breastfeeding 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. Provisión del consentimiento informado

2. Participantes de ambos sexos de ≥18 a ≤75 años de edad en el momento de firmar el consentimiento informado.

3. Esteatohepatitis no alcohólica (EHNA) confirmada histológicamente según los criterios de la Red de Investigación Clínica (CRN, por sus siglas en inglés) de la EHNA, diagnosticada mediante biopsi hepática que cumpla todos los criterios histológicos siguientes:

(a) NAS (índice de actividad de la esteatosis hepática no alcohólica) ≥4 con una puntuación ≥1 para cada uno de los componentes: esteatosis, inflamación lobulillar y degeneración vacuolar.

(b) Presencia de fibrosis en estadio F2 o F3

4. Mujeres fértiles, que no estén embarazadas ni amamantando y que usen un método anticonceptivo adecuado para evitar el embarazo durante todo el ensayo y hasta 4 semanas después de la última dosis de la intervención del ensayo.

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 Esteatosis hepática crónica de otras etiologías.

2 Antecedentes de cirrosis o descompensación hepática, incluyendo ascitis, encefalopatía hepática o hemorragia digestiva por rotura de varices esofágicas.

3 Enfermedad cardiovascular o cerebrovascular clínicamente significativa en los 90 días anteriores a la selección, incluidos, entre otros, infarto de miocardio, síndrome coronario agudo, angina de pecho inestable, accidente isquémico transitorio o ictus, o participantes que se hayan sometido a una intervención coronaria percutánea o a un injerto de derivación en una arteria coronaria en los últimos 90 días o que tengan previsto someterse a estos procedimientos en el momento de la selección.

4 Antecedentes de neoplasias malignas en los 5 años anteriores a la selección, excepto cáncer de piel basocelular o de células escamosas o cualquier carcinoma in situ tratado adecuadamente.

5 Participación en otro ensayo clínico con un producto en investigación administrado en los últimos 30 días o 5 semividas del tratamiento (el periodo que sea mayor) en el momento de la selección o en el momento en que se realizó la biopsia histórica o participación simultánea en otro ensayo de intervención de cualquier tipo o aleatorización previa en este ensayo.

6 Alergia/hipersensibilidad grave a cualquiera de los tratamientos propuestos del ensayo o excipientes.

7 Contraindicación para someterse a una biopsia hepática (p. ej., diátesis hemorrágica, como hemofilia, sospecha de hemangioma o sospecha de infección por equinococos) o imposibilidad de hacer una biopsia hepática de manera segura según lo determine el investigador.

8 Hipertensión grave no controlada definida como TAS ≥180 mm Hg o TAD ≥110 mm Hg en el promedio de 2 mediciones de la TA en sedestación después de estar en reposo durante al menos 10 minutos en el momento de la selección o la aleatorización.

9 Cualquier resultado positivo de infección por el virus de la inmunodeficiencia humana, resultado positivo indicativo de la presencia del antígeno de superficie del virus de la hepatitis B o resultado positivo en la prueba de detección de anticuerpos contra el virus de la hepatitis C junto con un resultado positivo en la prueba de detección del ARN del VHC.

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:

• Proporción de participantes con resolución de la EHNA sin empeoramiento de la fibrosis hepática, en base a la biopsia realizada en la Semana 48

Parte B:

• Proporción de participantes con resolución de la EHNA sin empeoramiento de la fibrosis hepática, en base a la biopsia realizada en la Semana 84
• Proporción de participantes con mejoría de la fibrosis hepática en al menos un estadio sin empeoramiento de la EHNA, en base a la biopsia realizada en la Semana 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:

En la Semana 48

Parte B:

En la Semana 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:

• Proporción de participantes con mejoría de la fibrosis hepática en al menos un estadio sin empeoramiento de la EHNA, en base a la biopsia realizada en la Semana 48
• Proporción de participantes con resolución de la EHNA y con mejoría de la fibrosis en al menos un estadio, en base a la biopsia realizada en la Semana 48
• Cambio absoluto con respecto a los valores de referencia en el peso corporal en la Semana 48
• Cambio con respecto a los valores de referencia en la HbA1c en participantes con DMT2 en la Semana 48
• Cambio porcentual con respecto a los valores de referencia en los triglicéridos en la Semana 48

Parte B:

• Proporción de participantes con resolución de la EHNA y con mejoría de la fibrosis en al menos un estadio, en base a la biopsia realizada en la Semana 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:

A la semana 48

Parte B:

A la semana 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

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

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.

El final del ensayo (ambas, Parte A y Parte B incluidas) se define como la fecha de última visita del último paciente en el estudio.

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)

None

Ninguno

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

2022-06-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-05-09

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

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