Clinical Trials Register

Summary
EudraCT Number:	2021-002301-10
Sponsor's Protocol Code Number:	I3Y-MC-JPEF
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:	2022-01-12
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

2021-002301-10

A.3

Full title of the trial

postMONARCH: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib plus Fulvestrant to Placebo plus Fulvestrant in Participants with HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy

postMONARCH: Estudio de fase 3, aleatorizado, con enmascaramiento doble ciego y controlado con placebo para comparar la eficacia de abemaciclib y fulvestrant con la del placebo y fulvestrant en participantes con cáncer de mama HR+ y HER2- en estadio avanzado o metastásico, tras la progresión durante un tratamiento con un inhibidor de las CDK4 y 6 y hormonoterapia

A.3.1

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

Abemaciclib plus Fulvestrant compared to Placebo plus Fulvestrant in HR+, HER2-, Advanced or Metastatic Breast Cancer previously treated with a CDK4/6 Inhibitor and Endocrine Therapy

Abemaciclib y fulvestrant comparado con un placebo y fulvestrant en participantes con cáncer de mama HR+ y HER2- en estadio avanzado o metastásico que anteriormente hayan recibido tratamiento con un inhibidor de las CDK4 y 6 y hormonoterapia

A.3.2

Name or abbreviated title of the trial where available

postMONARCH

A.4.1

Sponsor's protocol code number

I3Y-MC-JPEF

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	Lilly S.A.
B.1.3.4	Country	Spain
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	Eli Lilly and Company
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	Eli Lilly Cork Ltd
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Island House, Eastgate Road, Eastgate Business Park, Little Island
B.5.3.2	Town/ city	Co. Cork
B.5.3.3	Post code	T45 KD39
B.5.3.4	Country	Ireland
B.5.4	Telephone number	3491836 29 58
B.5.6	E-mail	ensayosclinicos@lilly.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	Yes
D.2.1.1.1	Trade name	Verzenios
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederlands B.V.
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	Abemaciclib
D.3.2	Product code	LY2835219
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LY2835219
D.3.9.3	Other descriptive name	Abemaciclib
D.3.9.4	EV Substance Code	SUB171907
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	50
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: 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	Yes
D.2.1.1.1	Trade name	Faslodex
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
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	Fulvestrant
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	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fulvestrant
D.3.9.3	Other descriptive name	Fulvestrant
D.3.9.4	EV Substance Code	SUB13933MIG
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	250
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: 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	Fulvestrant Mylan
D.2.1.1.2	Name of the Marketing Authorisation holder	Mylan
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	Fulvestrant
D.3.2	Product code	L02BA03
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	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fulvestrant
D.3.9.3	Other descriptive name	Fulvestrant
D.3.9.4	EV Substance Code	SUB13933MIG
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	250
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

HR+, HER2-, Advanced or Metastatic Breast Cancer

Cáncer de mama HR+ y HER2- en estadio avanzado o metastásico

E.1.1.1

Medical condition in easily understood language

Breast Cancer

Cáncer de mama

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10027475
E.1.2	Term	Metastatic breast cancer
E.1.2	System Organ Class	100000004864

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 compare the efficacy of fulvestrant with or without abemaciclib

Comparar la eficacia de fulvestrant con o sin abemaciclib

E.2.2

Secondary objectives of the trial

To further compare the efficacy of fulvestrant with or without abemaciclib
To further characterize the safety profile of abemaciclib in combination with fulvestrant
To compare PRO measures of fulvestrant with or without abemaciclib
To characterize the pharmacokinetics (PK) of abemaciclib in combination with fulvestrant

Comparar en mayor medida la eficacia de fulvestrant con o sin abemaciclib

Caracterizar en mayor medida el perfil de seguridad de abemaciclib en combinación con fulvestrant
Comparar los criterios de valoración de los RPP con fulvestrant, con o sin abemaciclib
Caracterizar la farmacocinética (FC) de abemaciclib en combinación con fulvestrant

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Have a diagnosis of HR+, HER2- breast cancer
-Have either advanced disease not amenable to curative surgical treatment or metastatic disease.
-Have radiologic evidence of disease progression or recurrence either On treatment with a CDK4 & 6 inhibitor (palbociclib, ribociclib, or abemaciclib) plus AI as initial therapy for advanced disease, or plus ET administered as adjuvant therapy for early-stage breast cancer
-Have either measurable disease or non-measurable but evaluable disease.
-Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale (Oken et al. 1982).
-Must be deemed appropriate for treatment with ET.
-Have discontinued previous treatments and recovered from the acute effects of therapy to at least Grade 1, except for residual alopecia and peripheral neuropathy.
-Have adequate organ function.
-Males and females may participate. Male participants must agree to use hormone suppression with a gonadotropin-releasing hormone agonist such as goserelin or leuprolide. Female participants must have postmenopausal status due to either surgical/natural menopause or ovarian suppression with a gonadotropin-releasing hormone agonist, such as goserelin or leuprolide.
- Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of childbearing potential (WOCBP) must test negative for pregnancy prior to initiation of treatment. WOCBP must agree to use 2 forms of effective contraception where at least one form must be highly effective to prevent pregnancy while receiving study treatment, and for 2 years after the last dose of fulvestrant (or according to local approved fulvestrant label).

- Tener un diagnóstico de cáncer de mama HR+, HER2-.
- Presentar enfermedad avanzada que no pueda tratarse quirúrgicamente con intención curativa, o enfermedad metastásica.
- Presentar signos radiológicos de progresión o recurrencia de la enfermedad durante el tratamiento con un inhibidor de la CDK4 y la CDK6 (palbociclib, ribociclib o abemaciclib) y un IA como tratamiento inicial para la enfermedad avanzada, o junto a hormonoterapia como tratamiento adyuvante para el cáncer de mama en fase precoz.
- Presentar enfermedad mensurable o enfermedad no mensurable, pero evaluable.
- Presentar una categoría funcional (CF) de 0 o 1 en la escala del Eastern Cooperative Oncology Group, (ECOG) (Oken et al. 1982).
- Debe considerarse que el paciente es tributario de hormonoterapia.
- Haber dejado de recibir definitivamente todos los tratamientos anteriores y haberse recuperado de los efectos inmediatos del tratamiento hasta al menos un grado 1, salvo los casos de alopecia residual y neuropatía periférica.
- Presentar una función orgánica aceptable.
- Pueden participar pacientes de ambos sexos. Los participantes masculinos deben estar de acuerdo en utilizar tratamientos de inhibición hormonal con un agonista de la hormona liberadora de gonadotropina, como goserelina o leuprolida. Las participantes femeninas deben ser posmenopáusicas, a consecuencia de menopausia quirúrgica/natural o un tratamiento de inhibición ovárica con un agonista de la hormona liberadora de gonadotropina, como goserelina o leuprolida.
- El uso de métodos anticonceptivos debe ser coherente con la normativa local relativa a dicho uso por parte de los participantes en estudios clínicos. Las mujeres que puedan quedarse embarazadas (MQPQE) deben presentar un resultado negativo en una prueba de embarazo antes del inicio del tratamiento. Las MQPQE deben estar de acuerdo en utilizar 2 métodos anticonceptivos eficaces, al menos uno de los cuales debe ser muy eficaz, durante el tratamiento del estudio y los 2 años posteriores a la última dosis de fulvestrant (o de acuerdo con la ficha técnica local aprobada de fulvestrant).

E.4

Principal exclusion criteria

-Have visceral crisis, lymphangitic spread or leptomeningeal carcinomatosis
-Have symptomatic or untreated central nervous system (CNS) metastasis.
-Have a history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
-Have serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study
- Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
-Have a known active systemic infection
-Have received any intervening line of systemic therapy between disease recurrence/progression and study screening or more than 1 line of therapy for advanced or metastatic disease.

- Presentar crisis visceral, diseminación linfangítica o carcinomatosis leptomeníngea.
- Presentar metástasis sintomáticas o sin tratar en el sistema nervioso central (SNC).
- Presentar antecedentes en el transcurso de los 12 meses anteriores de cualquiera de las enfermedades siguientes: síncope de causa cardiovascular, arritmia ventricular de origen patológico (entre otras, taquicardia ventricular y fibrilación ventricular) o paro cardíaco súbito.
- Presentar enfermedades preexistentes graves que, en opinión del investigador, podrían impedir su participación en este estudio.
- Presentar antecedentes de cualquier otro cáncer (excepto cáncer de piel no melanomatoso o carcinoma in situ de cuello uterino), a menos que haya estado en remisión completa al menos durante 3 años, sin ningún tipo de tratamiento.
- Presentar una infección sistémica activa.
- Haber recibido alguna línea intermedia de tratamiento sistémico entre la recurrencia/progresión de la enfermedad y la selección del estudio, o más de 1 línea de tratamiento para la enfermedad avanzada o metastásica.
- Haber recibido tratamiento previo con quimioterapia para el CMM, con cualquier tratamiento con un inhibidor de la CDK4 y la CDK6 distinto a los especificados, o con fulvestrant, cualquier otro tratamiento en investigación dirigido a los receptores de estrógenos (tanto degradantes selectivos de los receptores de estrógenos [DSRE] como de otro tipo) o cualquier inhibidor de PI3K, mTOR o AKT.
- Presentar mutaciones hereditarias patógenas tributarias de un inhibidor de la PARP, en regiones en las que estos tratamientos estén aprobados y disponibles, de acuerdo con el criterio del investigador.
- Haber comenzado a recibir bisfosfonatos o medicamentos aprobados dirigidos al ligando RANK (RANK-L) <7 días antes de la aleatorización.
- Estar recibiendo hormonoterapia reproductora exógena de forma concomitante.
- Haber recibido un alotrasplante o autotrasplante de hemocitoblastos.

E.5 End points

E.5.1

Primary end point(s)

To compare PFS of fulvestrant with or without abemaciclib as determined by investigator assessment using RECIST 1.1

Comparar la SSP con fulvestrant, con o sin abemaciclib, de acuerdo con la evaluación realizada por el investigador conforme a los criterios RECIST 1.1.

E.5.1.1

Timepoint(s) of evaluation of this end point

first occurrence of documented disease progression per RECIST 1.1, or death from any cause in the absence of documented progressive disease.

E.5.2

Secondary end point(s)

Efficacy endpoints: overall survival (OS), progression-free survival (PFS) by BICR, objective response rate (ORR), clinical benefit rate (CBR), disease control rate (DCR), duration of response (DoR)
Safety endpoint: including but not limited to TEAEs, SAEs, deaths and clinical laboratory abnormalities
Time to worsening in worst pain via the mBPISF worst pain item
Time to deterioration in physical function via the EORTC IL-19
Concentrations of abemaciclib

Criterios de valoración de la eficacia: supervivencia global (SG), supervivencia sin progresión (SSP) de acuerdo con una revisión centralizada e independiente de forma enmascarada (RCIE), tasa de respuestas objetivas (TRO), tasa de beneficio clínico (TBC), tasa de control de la enfermedad (TCE), duración de la respuesta (DdR).
Criterios de valoración de la seguridad: incluidos, entre otros parámetros, los AAAT, los AAG, las muertes y los resultados anómalos en los análisis clínicos.
Tiempo transcurrido hasta el empeoramiento del dolor más intenso, de acuerdo con el ítem de dolor más intenso del mBPISF.
Tiempo transcurrido hasta el deterioro en la función física de acuerdo con el EORTC IL-19.
Concentraciones de abemaciclib

E.5.2.1

Timepoint(s) of evaluation of this end point

first occurrence of documented disease progression per RECIST 1.1, or death from any cause in the absence of documented progressive disease.
At the end of the trial

Fecha en la que se documente por primera vez la progresión de la enfermedad de acuerdo con los criterios RECIST 1.1 o la muerte por cualquier causa (en ausencia de progresión documentada de la enfermedad).
Al final del estudio

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

E.6.10

Pharmacogenetic

Yes

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

Belgium

China

Czechia

Denmark

France

Greece

Hungary

Israel

Italy

Korea, Republic of

Mexico

Poland

Russian Federation

Spain

Sweden

Taiwan

Turkey

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

315

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

149

F.4.2.2

In the whole clinical trial

350

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)

After study completion, all patients who are on study treatment and who are eligible for the extension period will be unblinded.
Patients receiving study treatment and experiencing ongoing clinical benefit may continue to receive study treatment in the continued-access period until one of the criteria for discontinuation is met. Placebo will no longer be administered.

Tras la finalización del estudio, todos los pacientes que estén recibiendo el tratamiento del estudio y que se consideren idóneos para participar en el período de prolongación tendrán conocimiento del tratamiento asignado.
Los pacientes que estén recibiendo el tratamiento del estudio y continúen experimentando beneficio clínico podrán continuar recibiéndolo durante el período de acceso continuado, hasta que se constate uno de los criterios de interrupción.
Ya no se administrará placebo.

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

2022-01-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-01-03

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

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IMP with orphan designation in the indication
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