Clinical Trials Register

Summary
EudraCT Number:	2021-000169-34
Sponsor's Protocol Code Number:	M20-638
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:	2022-06-21
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

Spain - AEMPS

A.2

EudraCT number

2021-000169-34

A.3

Full title of the trial

A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with Rituximab and Lenalidomide (R2) compared to R2 in Subjects with Relapsed or Refractory Follicular Lymphoma (EPCORE™ FL-1)

Estudio de fase 3 abierto para evaluar la seguridad y la eficacia de epcoritamab en combinación con rituximab y lenalidomida (R2) en comparación con R2 en sujetos con linfoma folicular en recaída o resistente (EPCORE™ FL-1)

A.3.1

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

This study is to find out about the Safety and Efficacy of Epcoritamab in Combination with Rituximab and Lenalidomide (R2) compared to R2 in Subjects with Relapsed or Refractory Follicular Lymphoma

Este estudio pretende conocer la seguridad y la eficacia de epcoritamab en combinación con rituximab y lenalidomida (R2) en comparación con R2 en sujetos con linfoma folicular en recaída o resistente

A.3.2

Name or abbreviated title of the trial where available

EPCORE™ FL-1

A.4.1

Sponsor's protocol code number

M20-638

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

P/344/2021

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AbbVie Deutschland GmbH & Co. KG
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	AbbVie Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AbbVie Ltd.
B.5.2	Functional name of contact point	Global Clinical Trials Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	AbbVie House, Vanwall Business Park, Vanwall Road
B.5.3.2	Town/ city	Maidenhead
B.5.3.3	Post code	SL6 4UB
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+441628561090
B.5.5	Fax number	+441628461153
B.5.6	E-mail	global-clinical-trials@abbvie.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	Epcoritamab
D.3.2	Product code	ABBV-GMAB-3013
D.3.4	Pharmaceutical form	Concentrate for 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	Epcoritamab
D.3.9.1	CAS number	2134641-34-0
D.3.9.2	Current sponsor code	ABBV-GMAB-3013
D.3.9.4	EV Substance Code	SUB204090
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	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	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	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	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	Epcoritamab
D.3.2	Product code	ABBV-GMAB-3013
D.3.4	Pharmaceutical form	Concentrate for 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	Epcoritamab
D.3.9.1	CAS number	2134641-34-0
D.3.9.2	Current sponsor code	ABBV-GMAB-3013
D.3.9.4	EV Substance Code	SUB204090
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	60
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	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	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	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	Truxima
D.2.1.1.2	Name of the Marketing Authorisation holder	Celltrion Healthcare Hungary Kft.
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	Truxima
D.3.4	Pharmaceutical form	Concentrate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Rituximab
D.3.9.1	CAS number	174722-31-7
D.3.9.4	EV Substance Code	SUB12570MIG
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	10
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	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	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: 4
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	Revlimid
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Pharma EEIG
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	Revlimid
D.3.4	Pharmaceutical form	Capsule, hard
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	Lenalidomide
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
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	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	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: 5
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	Revlimid
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Pharma EEIG
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	Revlimid
D.3.4	Pharmaceutical form	Capsule, hard
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	Lenalidomide
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
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	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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Relapsed/Refractory Follicular Lymphoma

Linfoma folicular recidivante/refractario

E.1.1.1

Medical condition in easily understood language

Relapsed/Refractory Follicular Lymphoma

Linfoma folicular recidivante/refractario

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	24.0
E.1.2	Level	PT
E.1.2	Classification code	10085128
E.1.2	Term	Follicular lymphoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 purpose of this randomized Phase 3 study is to evaluate the efficacy, safety, and tolerability of epcoritamab 48 mg in combination with R2 compared to R2 alone in subjects with R/R FL.

El objetivo de este estudio aleatorizado de fase 3 es evaluar la eficacia, la seguridad y la tolerabilidad de 48 mg de epcoritamab en combinación con R2 en comparación con R2 solo en sujetos con LF R/R.

E.2.2

Secondary objectives of the trial

The secondary objectives are as follows:
• To evaluate whether epcoritamab 48 mg in combination with R2 compared to R2 alone can improve clinical outcomes as measured by key secondary endpoints (including CR, best overall response [BOR], overall survival [OS], and minimal residual disease [MRD] negativity) in subjects with R/R FL.
• To evaluate whether epcoritamab 24 mg in combination with R2 compared to R2 alone can improve PFS in subjects with relapsed/refractory (R/R) FL.
• To evaluate whether epcoritamab 24 mg in combination with R2 compared to R2 alone can improve clinical outcomes as measured by key secondary endpoints (including CR, BOR, OS, and MRD negativity) in subjects with R/R FL.

Evaluar si epcoritamab 48 mg en combinación con R2, en comparación con R2 solo, puede mejorar los resultados clínicos medidos por criterios de valoración secundarios clave (incluida la RC, la mejor respuesta global [MRG], la supervivencia global [SG] y la negatividad de la enfermedad mínima residual [ERM]) en sujetos con FL R/R.
- Evaluar si epcoritamab 24 mg en combinación con R2, en comparación con R2 solo, puede mejorar la SSP (supervivencia sin progresión) en sujetos con FL recidivante/refractario (R/R).
- Evaluar si epcoritamab 24 mg en combinación con R2 en comparación con R2 solo puede mejorar los resultados clínicos medidos por criterios de valoración secundarios clave (incluyendo RC, MRG, SG y negatividad de ERM) en sujetos con FL R/R.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subject must be at least 18 years old.
2. Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2.
3. Subject has:
• Fluorodeoxyglucose-positron emission tomography (FDG PET) scan demonstrating positive lesion
compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical
tumor sites AND
• ≥ 1 measurable nodal lesion (long axis ≥ 1.5 cm and short axis > 1.0 cm) or ≥ 1 measurable extra-nodal
lesion (long axis ≥ 1.0 cm) on CT scan or magnetic resonance image (MRI)
4. Subject must have histologically confirmed Grade 1 to 3a FL according to the World Health Organization (WHO) 2016 classification with no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy and CD20+ on a representative tumor biopsy based on the pathology report.
5. Subject must have R/R disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody in combination with (an)other anti-lymphoma agent(s). (Subject who received only prior anti-CD20 monoclonal antibody monotherapy is not eligible.)
6. Subject must be eligible to receive R2 per investigator determination

1. El sujeto debe tener al menos 18 años.
2. El sujeto debe tener una puntuación del estado funcional del ECOG (Eastern Cooperative Oncology Group) de 0 a 2.
3. El sujeto debe presentar:
- Tomografía por emisión de positrones con fluorodesoxiglucosa (PET FDG) que muestra una lesión positiva compatible con localizaciones tumorales anatómicas definidas por tomografía computarizada (TC) o resonancia magnética (RM) Y
- Al menos una lesión ganglionar mensurable (eje mayor ≥1,5 cm y eje menor >1,0 cm) o al menos una lesión extra ganglionar mensurable (eje mayor ≥1,0 cm) en la TC o la RM.
4. El sujeto debe tener un LF de grado 1 a 3a confirmado histológicamente según la clasificación de 2016 de la Organización Mundial de la Salud sin indicios de transformación histológica a un linfoma agresivo en la biopsia tumoral representativa más reciente y CD20+ en una biopsia tumoral representativa basándose en el informe anatomopatológico.
5. El sujeto debe presentar enfermedad R/R con al menos una pauta sistémica previa que incluyera un anticuerpo monoclonal (AcM) anti-CD20 en combinación con otros fármacos contra el linfoma. No podrán participar los sujetos que hayan recibido únicamente un AcM anti-CD20 en monoterapia.
6. El sujeto debe ser apto para recibir R2 según la determinación del investigador.

E.4

Principal exclusion criteria

1. Subject must not have documented refractoriness to lenalidomide, with refractoriness defined as:
o Best response to lenalidomide of stable disease or progressive disease, or
o Progressive disease within 6 months of completion of lenalidomide therapy
2. Subjects must not have had lenalidomide exposure within 12 months prior to randomization

1. El sujeto no debe presentar resistencia documentada a la lenalidomida, definida como:
- Mejor respuesta a la lenalidomida de enfermedad estable o progresión de la enfermedad.
- Progresión de la enfermedad en los 6 meses siguientes a la finalización del tratamiento con lenalidomida.
2. Los sujetos no podrán haber tenido exposición a la lenalidomida en los 12 meses previos a la aleatorización

E.5 End points

E.5.1

Primary end point(s)

Progression-Free Survival (PFS): duration from the date of randomization to the date of disease progression determined by Lugano criteria per Independent Review Committee (IRC), or death, whichever occurs first.

Supervivencia sin progresión (SSP): tiempo transcurrido entre la fecha de la aleatorización y la fecha de la progresión de la enfermedad, determinada por los criterios de Lugano según la evaluación del comité de revisión independiente (CRI), o la muerte, lo que ocurra antes.

E.5.1.1

Timepoint(s) of evaluation of this end point

Throughout the study. Survival follow-up will continue until death, withdrawal of the subject, lost to follow up, study discontinuation, or study termination by the Sponsor, whichever comes first

A lo largo del estudio. El seguimiento de la supervivencia continuará hasta la muerte, la retirada del sujeto, la pérdida de seguimiento, la interrupción del estudio o la terminación del estudio por parte del patrocinador, lo que ocurra primero

E.5.2

Secondary end point(s)

•Complete Response (CR) during the study, determined by Lugano criteria, as assessed by IRC
•Best overall response (BOR) of CR or partial response (PR), determined by Lugano criteria, as assessed by IRC
•Overall survival (OS)
•Minimal residual disease (MRD) negativity

• Respuesta completa (RC) durante el estudio, determinada mediante los criterios de Lugano, según la evaluación del CRI.
• Mejor respuesta global (MRG) de RC o respuesta parcial (RP), determinada mediante los criterios de Lugano, según la evaluación del CRI.
• Supervivencia global (SG).
• Negatividad de la enfermedad residual mínima (ERM)

E.5.2.1

Timepoint(s) of evaluation of this end point

-CR/BOR: Throughout the study.
-MRD: Throughout study till Post-Treatment Follow-up visits which will occur for a period of 5 years after the last subject has been randomized or until discontinuation, whichever comes first.
-Survival: Throughout the study until death, withdrawal of the subject, lost to follow up, study discontinuation, or study termination by the Sponsor, whichever comes first

-CR/MRG: Durante todo el estudio.
-CR/ERM: Durante todo el estudio hasta las visitas de seguimiento posteriores al tratamiento, que tendrán lugar durante un período de 5 años después de que el último sujeto haya sido aleatorizado o hasta la interrupción, lo que ocurra primero.
-Supervivencia: Durante todo el estudio hasta la muerte, la retirada del sujeto, la pérdida de seguimiento, la interrupción del estudio o la finalización del estudio por parte del promotor, lo que ocurra primero.

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

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

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

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

120

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

Israel

Japan

Korea, Republic of

New Zealand

Puerto Rico

South Africa

Taiwan

United States

Austria

France

Poland

Sweden

Netherlands

Spain

Switzerland

Czechia

Germany

Greece

Italy

Belgium

Denmark

Hungary

Slovakia

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 global end of this study shall be defined as the point at which all enrolled subjects have completed all study-specified follow-up (last subject, last visit in the last country where the study was conducted) or the last subject dies or withdraws from the study in the last country where the study was conducted. However, the maximum trial duration is 5 years after last subject has been enrolled.

El final global de este estudio se definirá como el punto en el que todos los sujetos inscritos hayan completado todo el seguimiento especificado en el estudio (último sujeto, última visita en el último país donde se realizó el estudio) o el último sujeto muera o se retire del estudio en el último país en el que se realizó el estudio. Sin embargo, la duración máxima del ensayo es de 5 años después de la inscripción del último sujeto.

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

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:

321

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

321

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

270

F.4.2.2

In the whole clinical trial

642

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

2022-09-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-09-07

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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