Clinical Trials Register

Summary
EudraCT Number:	2017-004851-22
Sponsor's Protocol Code Number:	B7451015
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:	2018-09-17
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

2017-004851-22

A.3

Full title of the trial

A phase 3 multi-center, long-term extension study investigating the efficacy and safety of PF-04965842, with or without topical medications, administered to subjects aged 12 years and older with moderate to severe atopic dermatitis

Estudio en fase III multicéntrico y de extensión a largo plazo para evaluar la eficacia y la seguridad de PF-04965842, en monoterapia o en combinación con medicamentos tópicos, administrado a pacientes de 12 años o más con dermatitis atópica moderada o grave

A.3.1

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

A study that allows patients from previous studies to continue on the medication. The aim of the study is to determine how safe and effective PF-04965842 are when taken as the treatment for moderate to severe atopic dermatitis in patients aged 12 years or older. Patients may also receive topical medications if needed.

Un estudio que permite a los pacientes de estudios previous seguir con la medicación. El objetivo del estudio es determiner como de seguro y eficaz es PF-04965842 para el tratamiento de dermatitis atópica moderada o grave en pacientes de 12 años o más. Los pacientes podran recibir también medicación tópica si lo precisan.

A.4.1

Sponsor's protocol code number

B7451015

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	Pfizer Inc., 235 East 42nd Street, New York, NY 10017
B.1.3.4	Country	United States
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	Pfizer Inc, 235 East 42nd Street, New York, NY 10017
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	Pfizer Inc.
B.5.2	Functional name of contact point	Clinical Trials.gov Call Centre
B.5.3	Address:
B.5.3.1	Street Address	235 East 42nd Street,
B.5.3.2	Town/ city	New York,
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	+1 800 7181021
B.5.6	E-mail	ClinicalTrials.gov_Inquiries@pfizer.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	PF-04965842 Tablets
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	PF-04965842
D.3.9.2	Current sponsor code	PF-04965842
D.3.9.3	Other descriptive name	PF-04965842
D.3.9.4	EV Substance Code	SUB177174
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	100
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

Moderate to severe atopic dermatitis

Dermatitis atópica moderada o grave

E.1.1.1

Medical condition in easily understood language

Atopic dermatitis is also known as atopic eczema. It is a type of inflammation of the skin that results in itchy, red, swollen, and cracked skin.

La dermatitis atópica se conoce también como eccema atópico. Se trata de un tipo de inflamación de la piel que provoca picor, enrojecimiento,
hinchazón y piel agrietada.

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

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	10003639
E.1.2	Term	Atopic dermatitis
E.1.2	System Organ Class	100000004858

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 estimate the long-term safety of 100 mg and 200 mg once daily (QD) of PF-04965842 with or without topical treatments in adult and adolescent subjects who previously participated in PF-04965842 atopic dermatitis (AD) Phase 3 trials.

Estimar la seguridad a largo plazo de la administración de 100 mg y 200 mg una vez al día (1 v/d) de PF-04965842 con o sin tratamientos tópicos en pacientes adultos y adolescentes que habían participado previamente en ensayos en fase III con PF-04965842 para la dermatitis atópica (DA).

E.2.2

Secondary objectives of the trial

To estimate the long-term efficacy of PF-04965842.

Estimar la eficacia a largo plazo de PF-04965842.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.
2. Male or female subjects of 12 years of age or older, at the time of informed consent and body weight ≥ 40 kg. Adolescent subjects below the age of 18 years old (or country-specific age of majority) will only be enrolled in this study if instructed by the sponsor and approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects aged 18 years (or country-specific age of majority) and older will be enrolled.
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
4. Must have completed the full treatment period of a qualifying Phase 3 study OR must have completed the full rescue treatment period of a qualifying Phase 3 study (if applicable). OR must have completed the full open-label run-in period in B7451014 and did not meet the protocol-specified response criteria at week 12.
5. Female subjects who are of childbearing potential (which includes all female subjects aged 12 years and older, regardless of whether they have experienced menarche) must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
a. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to allocation to treatment.
b. Female subjects of childbearing potential must agree to use a highly effective method of contraception (as per Section 4.4.1) for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
For Czech Republic only, 5 b. is revised and 5 c. is added to require:
Female subjects of childbearing potential ≥15 years of age who are at risk of pregnancy must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product;
c. Female subjects less than 15 years of age must not be sexually active, and abstinence per the below definition should be confirmed prior to enrollment.
NOTE: Sexual abstinence, defined as completely and persistently refraining from all heterosexual intercourse (including during the entire period of risk associated with the study treatments) may obviate the need for contraception ONLY if this is the preferred and usual lifestyle of the subject.
6. Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
a. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
b. Have medically confirmed ovarian failure; or
c. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state.
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
7. Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
8. Must agree to avoid use of prohibited medications throughout the duration of the study, as detailed in Appendix 2 and Appendix 3.

1.Constancia de un formulario de consentimiento informado firmado y fechado personalmente que indique que se ha informado al paciente o a su/sus progenitor/es o tutor legal, si procede, de todos los aspectos pertinentes del estudio.
2.Pacientes de ambos sexos de 12 años de edad o más en el momento del consentimiento informado y con un peso corporal ≥40 kg. Los pacientes adolescentes menores de 18 años (o edad de mayoría de edad específica de cada país) solo se incluirán en este estudio si así lo solicita el promotor y si lo aprueba la autoridad reguladora/sanitaria de cada país. Si no se han concedido estas aprobaciones, solo se incluirán pacientes de 18 años (o edad de mayoría de edad específica de cada país) o más.
3.Voluntad y capacidad de cumplir las visitas programadas, el plan de tratamiento, los análisis clínicos y otros procedimientos del estudio.
4.Debe haber completado el periodo de tratamiento completo de un estudio en fase III habilitante O debe haber completado el periodo de tratamiento de rescate completo de un estudio en fase III habilitante (si procede) O debe haber completado el periodo de preinclusión abierto completo de B7451014 y no cumplir los criterios de respuesta especificados en el protocolo en la semana 12
5.Mujeres con capacidad de concebir (entre las que se incluyen todas las pacientes de 12 años de edad o más con independencia de si han presentado la menarquia) que no tengan intención de quedarse embarazadas ni estén embarazadas en la actualidad ni en periodo de lactancia. Se aplican las siguientes condiciones:a.Las pacientes con capacidad de concebir deben tener un resultado negativo confirmado en la prueba de embarazo antes de la asignación al tratamiento.b:Las pacientes con capacidad de concebir deben estar de acuerdo en utilizar un método anticonceptivo altamente eficaz (de acuerdo con la sección 4.4.1 del protocolo) durante todo el periodo de tratamiento activo y durante al menos los 28 días siguientes a la administración de la última dosis del producto en investigación.
6.Las pacientes sin capacidad de concebir deben cumplir al menos 1 de los siguientes criterios:a.haberse sometido a una histerectomía y/o a una ovariectomía bilateral documentadas;
b.habérseles confirmado médicamente insuficiencia ovárica; o c.haber alcanzado el estado posmenopáusico, definido como: cese de la menstruación periódica durante al menos 12 meses seguidos sin ninguna otra causa patológica ni fisiológica y nivel de hormona foliculoestimulante (FSH) sérica que confirme este estado posmenopáusico. Se considera que todas las demás pacientes (incluidas las pacientes con ligadura de trompas) tienen capacidad de concebir.
7.Debe aceptar evitar una exposición prolongada a la luz solar y el uso de cabinas o lámparas de bronceado u otras fuentes de luz ultravioleta durante el estudio.
8.Debe aceptar evitar el uso de medicamentos prohibidos a lo largo de todo el estudio, como se indica en el Apéndice 2 y el Apéndice 3 del protocolo.

E.4

Principal exclusion criteria

1. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
2. Currently have active forms of other inflammatory skin diseases, ie, not AD.
3. Have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day -1 that would interfere with evaluation of atopic dermatitis or response to treatment.
4. Discontinued from treatment (or rescue treatment period/open-label run-in period, if applicable) early in a qualifying Phase 3 study OR triggered discontinuation criteria at any point during the qualifying Phase 3 study OR meets exclusion criteria from qualifying Phase 3 studies as detailed in Appendix 10 of the protocol.
5. Ongoing adverse event in the qualifying Phase 3 study which in the opinion of the investigator, or sponsor, is an ongoing safety concern OR the subject is currently triggering safety monitoring criteria in the qualifying Phase 3 study.
6. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.

1.Otras enfermedades o alteraciones psiquiátricas, agudas o crónicas, incluidos los comportamientos o las ideas suicidas recientes (en el último año) o activos, o anomalías de laboratorio que puedan aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación, o que puedan interferir con la interpretación de los resultados del estudio y que, según el criterio del investigador, hagan que el paciente no sea apto para incorporarse al estudio.
2.Pacientes que actualmente presentan formas activas de otras enfermedades inflamatorias de la piel, es decir, que no sean DA.
3.Pacientes que presentan signos de enfermedades cutáneas (p. ej., psoriasis, dermatitis seborreica, lupus) en el momento del Día −1 que pudieran interferir en la evaluación de la dermatitis atópica o en la respuesta al tratamiento.
4.Pacientes discontinuados del tratamiento (o del periodo de tratamiento de rescate/periodo de preinclusión abierto, si procede) en una etapa temprana de un estudio en fase III habilitante O pacientes que cumplieron los criterios de discontinuación en cualquier momento durante el estudio en fase III habilitante O que cumplen los criterios de exclusión del estudio en fase III habilitante, como se indica en el Apéndice 10 del protocolo.
5.Pacientes con un acontecimiento adverso en curso en el estudio en fase III habilitante que, en opinión del investigador o del promotor, sea un problema de seguridad en curso O pacientes que cumplan en la actualidad los criterios para la activación de la monitorización de la seguridad en el estudio en fase III habilitante.
6.Pacientes que sean miembros del personal del centro del investigador directamente implicados en la realización del estudio, así como sus familiares; miembros del personal del centro supervisados de alguna otra manera por el investigador o pacientes que sean empleados de Pfizer, incluidos los miembros de su familia, y que estén directamente implicados en la realización del estudio.

E.5 End points

E.5.1

Primary end point(s)

Primary (Safety) Endpoints
• The incidence of treatment emergent adverse events.
• The incidence of serious adverse events and adverse events leading to discontinuation.
• The incidence of clinical abnormalities and change from baseline in clinical laboratory values, electrocardiogram (ECG) measurements, and vital signs.

•La incidencia de los eventos adversos emergentes del tratamiento.
• La incidencia de eventos adversos graves y eventos adversos que conducen a la interrupción.
• La incidencia de anomalías clínicas y cambios en los valores clínicos de laboratorio, las mediciones del electrocardiograma (ECG) y los signos vitales des de el inicio.

E.5.1.1

Timepoint(s) of evaluation of this end point

Through out the study

Durante todo el estudio.

E.5.2

Secondary end point(s)

Baseline, for efficacy endpoints, is defined as pre-dose Day 1 in the qualifying Phase 3 study.
• Response based on achieving the Investigator’s Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥ 2 points at all scheduled time points.
• Response based on achieving ≥ 50%, ≥ 75% and ≥ 90% improvement from baseline in the Eczema Area and Severity Index (EASI) total score (EASI50, EASI75, and EASI90) at all scheduled time points.
• Response based on achieving an improvement ≥ 4 points from baseline in the severity of pruritus NRS at all scheduled time points.
• Change from baseline in the frequency of itching due to Atopic Dermatitis
• Change from baseline of Patient Global Assessment (PtGA) at all scheduled time points.
• Change from baseline in the percentage Body Surface Area (BSA) affected at all scheduled time points.
• Change from baseline in Dermatology Life Quality Index (DLQI) or Children’s DLQI (CDLQI) at all scheduled time points.
• Change from baseline in Patient Oriented Eczema Measure (POEM) at all scheduled time points.
• Change from baseline in Hospital Anxiety and Depression Scale (HADS) at all scheduled time points.
• Change from baseline of EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) or EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) at all scheduled time points.
• Steroid-free days.

Visita Basal, para los criterios de valoracion de eficacia, se define como pre-dosis Dia 1 en el estudio Fase III habilitante
-Respuesta basada en la puntuación de la evaluación global del investigador (EGI) de 0 o casi cero (1) (en una escala de 5 puntos) y una reducción des del principio de ≥ 2 puntos en todos los puntos temporales programados.
-Respuesta basada en alcanzar una mejoría de ≥ 50%, ≥ 75% y ≥ 90% des del principio en la área de eccema y puntuación total de EASI (EASI50, EASI75, and EASI90) en todos los puntos temporales programados
-Respuesta basada en alcanzar una mejoría de ≥ 4 puntos desde el principio en la severidad del prurito NRS en todos los puntos temporales programados
-Cambio desde visita basal en la frecuencia de picores debido a Dermatitis Atopica
-Cambio desde visita basal en la Evaluación Global del paciente (PtGA) en todos los puntos temporales programados
-Cambio desde visita basal en el porcentaje del Area de Superficie corporal afectada (ASC) en todos los puntos temporales programados
-Cambio desde visita basal en el índice Dermatologico de calidad de vida (DLQI) o en el DLQI pediátrico (CDLQI) en todos los puntos temporales programados
-Cambio desde visita basal en la Escala de medicion del eccema orientada al paciente (POEM) en todos los puntos temporales programados
-Cambio desde visita basal en la escala hospitalaria de ansiedad y depresión (HADS) en todos los puntos temporales programados
-Cambio desde visita basal en las escalas EuroQol de calidad de vida de 5 dimensiones y 5 niveles (EQ-5D-5L) y EuroQol de calidad de vida de 5 dimensiones-escala versión juvenil (EQ-5D-Y) en todos los puntos temporales programados
-Dias sin esteroides

E.5.2.1

Timepoint(s) of evaluation of this end point

At all scheduled timepoints

En todos los puntos temporales programados.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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)

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

Brazil

Bulgaria

Canada

Chile

China

Colombia

Czech Republic

France

Germany

Hungary

Israel

Italy

Japan

Korea, Republic of

Latvia

Mexico

Netherlands

Peru

Poland

Romania

Russian Federation

Serbia

Slovakia

Spain

Sweden

Switzerland

Taiwan

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

E.8.8

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

End of trial in a Member State of the EU is defined as the time at which it is deemed that a sufficient number of subjects have been recruited and completed the study as stated in the regulatory application (ie, clinical trial application [CTA]) and ethics application in the Member State. Poor recruitment (recruiting less than the anticipated number in the CTA) by a Member State is not a reason for premature termination but is considered a normal conclusion to the study in that Member State.

El final del ensayo en un Estado Miembro de la UE se define como el momento en el que se considera que se ha reclutado a un número suficiente de pacientes y estos han finalizado el estudio según lo declarado en el CTA presentado para la Agencia y para el CEIC del Estado Miembro. Un reclutamiento inferior al número previsto en el CTA por parte de un Estado miembro no es un motivo de terminación prematura, pero se considera una conclusión normal del estudio en ese Estado miembro.

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

Yes

F.1.1

Number of subjects for this age range:

290

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

290

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

1780

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

230

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Whenever consent is obtained from a subject's parent(s)/legal guardian, the subject's assent (affirmative agreement) must subsequently be obtained.

Siempre que se obtenga el consentimiento del/de los progenitor/es o tutor legal del paciente, deberá obtenerse posteriormente el asentimiento (acuerdo afirmativo) del paciente.

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

1800

F.4.2.2

In the whole clinical trial

2300

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

2018-11-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-22

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

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