Clinical Trials Register

Summary
EudraCT Number:	2013-004590-27
Sponsor's Protocol Code Number:	D3251C00003
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-07-04
Trial results	View 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

2013-004590-27

A.3

Full title of the trial

Randomised, double-blind, 56 week placebo-controlled, parallel group, multicentre, phase 3 study to evaluate the efficacy and safety of 2 doses of benralizumab in patients with moderate to very severe COPD with a history of exacerbations (GALATHEA)

Ensayo fase III, aleatorizado, doble ciego, de administración crónica (56 semanas) controlado con placebo, de grupos paralelos y multicéntrico para evaluar la eficacia y seguridad de dos dosis de benralizumab (MEDI-563) en pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC) de moderada a muy grave y antecedentes de exacerbaciones de EPOC (GALATHEA)

A.3.1

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

Efficacy and safety of 2 benralizumab doses in moderate to very severe COPD patients with prior exacerbation history

Eficacia y seguridad de dos dosis de benralizumab (MEDI-563) en pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC) de moderada a muy grave y antecedentes de exacerbaciones de EPOC

A.4.1

Sponsor's protocol code number

D3251C00003

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

P/020/2014

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AstraZeneca
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, Edificio Roble
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	900200444
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	benralizumab
D.3.2	Product code	Medi-563
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
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	benralizumab
D.3.9.1	CAS number	1044511-01-4
D.3.9.2	Current sponsor code	MEDI-563
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	100
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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal antibody
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	benralizumab
D.3.2	Product code	Medi-563
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
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	benralizumab
D.3.9.1	CAS number	1044511-01-4
D.3.9.2	Current sponsor code	MEDI-563
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	100
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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal antibody

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 syringe
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

Chronic Obstructive Pulmonary Disease

Enfermedad Pulmonar Obstructiva Crónica

E.1.1.1

Medical condition in easily understood language

Chronic Obstructive Pulmonary Disease that cause exacerbations which can no be fully controlled using standard care of treatment

Enfermedad Pulmonar Obstructiva Crónica que causa exacerbaciones y no puede ser controlada con el tratamiento estándar.

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

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 evaluate the effect of benralizumab on COPD exacerbations in subjects with moderate to very severe COPD

Evaluar el efecto de dos dosis de benralizumab sobre las exacerbaciones de la EPOC en sujetos con EPOC moderada a muy grave

E.2.2

Secondary objectives of the trial

To evaluate the effect of benralizumab:
- on health status/health-related quality of life
- on pulmonary function
- on respiratory symptoms
- on rescue medication use
- on nocturnal awakenings
- on the severity, frequency and duration of EXACT-PRO defined events
- on healthcare resource utilization due to COPD
- on general health status
- on blood eosinophil levels
To evaluate the pharmacokinetics parameters of benralizumab.
Assessment of the safety and tolerability of benralizumab.
To evaluate the immunogenicity of benralizumab

Evaluar el efecto de dos dosis de benralizumab sobre:
- el estado de salud / la calidad de vida relacionada con la salud
- sobre la función pulmonar
- sobre los síntomas respiratorios
- sobre el uso de medicación de rescate
- sobre los despertares nocturnos
- sobre la intensidad, frecuencia y duración de los acontecimientos definidos por EXACT-RCP.
- sobre otros parámetros asociados a exacerbaciones de la EPOC
- sobre el estado general de salud
- sobre los niveles sanguíneos de eosinófilos
Evaluar la farmacocinética y la inmunogenicidad de dos dosis de benralizumab.
Evaluar la seguridad y tolerabilidad de dos dosis de benralizumab.

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

Additional pulmonary function tests:

To evaluate the effect of two doses of
benralizumab in a subset of patients for lung
volumes.
To evaluate the effect of two doses of
benralizumab in a subset of patients for DLCO.
To evaluate the effect of two doses of
benralizumab in a subset of patients on exercise
endurance.

Sputum analysis:
To evaluate the effect of two doses of
benralizumab on sputum biomarkers/cell counts
in a subset of patients.

Pruebas de función pulmonar adicionales:

Evaluar el efecto de dos dosis de benralizumab sobre los volúmenes pulmonares en un subgrupo de pacientes.
Evaluar el efecto de dos dosis de benralizumab sobre la DLCO en un subgrupo de pacientes.
Evaluar el efecto de dos dosis de benralizumab sobre la resistencia al ejercicio en un subgrupo de pacientes.

Análisis de esputo:
Evaluar el efecto de dos dosis de benralizumab sobre biomarcadores/recuentos celulares y microbiología en el esputo en un subgrupo de pacientes.

E.3

Principal inclusion criteria

1.Informed consent.
2.Subjects 40-85 y.o.
3.Moderate to very severe COPD with post-BD FEV1>20% and ?65% .
4.?2 moderate or ?1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1.
5.mMRC score ?1 at Visit 1.
6.Treatment with double or triple therapy in the year prior to Visit 1, constant 2 weeks prior to Visit 1. 7.Tobacco history of ?10 pack-years.
8.Women of childbearing potential must use a highly effective form of birth control from Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result at Visit 1.
9.Male subjects who are sexually active must be surgically sterile one year prior to Visit 1 or use an adequate method of contraception from the first IP dose until 16 weeks after their last dose.
10.Compliance with maintenance therapy during run-in ?70%.

1. Firma del consentimiento informado.
2. Mujeres o varones de 40 a 85 años inclusive.
3. Antecedentes de EPOC moderada a muy grave con un FEV1/CVF después del broncodilatador de <0,70 y un FEV1 después del broncodilatador de >20% y ?65% del valor normal previsto en la selección.
4. Antecedentes de 2 o más exacerbaciones moderadas de la EPOC que han requerido tratamiento con corticosteroides sistémicos y/o antibióticos o 1 o más exacerbaciones graves de la EPOC que requirieron hospitalización (definida como un ingreso hospitalario estancia ?24 horas en un área de observación en el servicio de urgencias u otro servicio de salud equivalente dependiendo del país y del sistema sanitario) en las 2 a 52 semanas previas al reclutamiento.
5. Puntuación MRCm ?1 en la visita 1.
6. Tratamiento documentado de los sujetos con terapia doble (ICS/LABA o LABA/LAMA) o triple (ICS/LABA/LAMA) aprobada para la EPOC en un país dado en el año previo al reclutamiento (Visita 1). Se acepta que los sujetos hayan aumentado o disminuido la terapia (de doble a triple y viceversa), pero tienen que haber seguido siendo tratados sistemáticamente con sus medicaciones y dosis actuales durante un mínimo de 2 semanas antes del reclutamiento (Visita 1).
7. Fumadores o exfumadores con una historia de tabaquismo de ?10 paquete-años.
8. Las mujeres potencialmente fértiles deben usar un método anticonceptivo muy eficaz, según la definición anterior, desde el reclutamiento, durante todo el ensayo y hasta 16 semanas después de la última dosis del producto en investigación, y deben tener un resultado negativo en una prueba de embarazo en suero realizada en la visita 1.
9. Los pacientes varones que sean sexualmente activos deben haber sido esterilizados quirúrgicamente al menos un año antes de la visita 1 o deben usar un método anticonceptivo adecuado (preservativo con espermicida) desde la primera dosis del PI hasta 16 semanas después de su última dosis.
10. Al menos un 70% de cumplimiento con el tratamiento de mantenimiento del sujeto.

E.4

Principal exclusion criteria

1. Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
2. Any disorder or major physical impairment that is not stable by Investigator opinion and could affect: - subject safety?study findings or their interpretation or subject?s ability to complete the entire study duration.
3. Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator?s judgment may put the patient at risk or negatively affect the study outcome.
4. Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to Visit1.
5. Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 2 weeks prior to Visit1.
6. Pneumonia within 8 weeks prior to Visit1.
7. Pregnant, breastfeeding, or lactating women.
8. Risk factors for pneumonia
9. History of anaphylaxis to any other biologic therapy.
10. Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure.
11. Use of immunosuppressive medication within 28 days prior to randomisation.
12. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.
13. Evidence of active tuberculosis (TB), either treated or untreated, or latent TB without an appropriate course of treatment.
14. Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
15. Asthma as a primary or main diagnosis according to the GINA guidelines or other accepted guidelines.
16. Previous treatment with benralizumab.
17. Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.

1. Otra enfermedad pulmonar clínicamente importante aparte de la EPOC o haber sido diagnosticado alguna vez de una enfermedad pulmonar o sistémica que se asocie a una cifra elevada de eosinófilos y /o hallazgos radiológicos sugerentes de una enfermedad respiratoria diferente a la EPOC que está contribuyendo a los síntomas respiratorios del paciente.
2. Cualquier trastorno, como por ejemplo: cardiovascular, gastrointestinal, hepático, renal, neurológico, musculoesquelético, infeccioso, endocrino, metabólico, hematológico, psiquiátrico, o deterioro físico importante que no se encuentre estable en la opinión del investigador y que pudiera:
? Afectar a la seguridad del paciente durante el ensayo
? Influir en los resultados del ensayo o en su interpretación
? Impedir que el paciente pueda completar toda la duración del ensayo
3. Cardiopatía isquémica inestable, arritmia, miocardiopatía, o cualquier otro trastorno cardiovascular relevante a juicio del investigador pudiera suponer un riesgo para el paciente o dificultar las evaluaciones del ensayo.
4. Tratamiento con corticosteroides y/o antibióticos sistémicos y/o hospitalización para una exacerbación de la EPOC en las 2 semanas previas al reclutamiento (visita 1).
5. Infecciones agudas de las vías respiratorias superiores o inferiores que haya precisado antibióticos o antivíricos 2 semanas previas al reclutamiento (visita 1).
6. Neumonía en las 8 semanas antes del reclutamiento (visita 1).
7. Mujeres embarazadas o en período de lactancia.
8. Factores de riesgo de neumonía.
9. Antecedente de anafilaxia a cualquier otro tratamiento biológico.
10. Oxigenoterapia a largo plazo (OTLP) con signos y/o síntomas de cor pulmonale, y/o insuficiencia ventricular derecha.
11. Uso de medicación inmunodepresora, incluyendo corticosteroides rectales, corticosteroides tópicos de alta potencia y esteroides sistémicos en los 28 días previos a la aleatorización
12. Haber recibido cualquier producto no biológico experimental en los 30 días previos o en el período correspondiente a 5 semividas antes de la visita 1.
13. Sujetos que en opinión del investigador o una representante designado cualificado tengan signos de tuberculosis (TB) activa, tratada o no tratada, o TB latente sin haber completado un ciclo de tratamiento adecuado o tratamiento actual adecuado.
14. Sujetos con cirugía reductora del volumen pulmonar en los 6 meses previos a la visita 1. Sujetos con antecedentes de resección pulmonar parcial o total (se acepta de un lóbulo o la segmentectomía).
15. Asma como diagnóstico primario o principal de acuerdo con las directrices de la Global Initiative for Asthma (GINA) (GINA 2011) u otras directrices aceptadas.
16. Tratamiento previo con benralizumab (MEDI-563).
17. Infección parasitaria helmíntica diagnosticada en las 24 semanas anteriores a la visita 1.

E.5 End points

E.5.1

Primary end point(s)

Annual COPD exacerbation rate

Tasa anual de exacerbaciones

E.5.1.1

Timepoint(s) of evaluation of this end point

56 week

56 semanas

E.5.2

Secondary end point(s)

- SGRQ (St. George?s Respiratory Questionnaire)
-CAT (Chronic Obstructive Pulmonary Disease assessment tool)
- Pre-dose/pre-bronchodilator FEV1 at the study center
- BDI/TDI (Baseline/Transitional Dyspnea Index)
- Total rescue medication use (average puffs/day), recorded by patient using electronic diary
- Number of nights with awakening due to COPD, recorded by patient using electronic diary.
- EXACT-PRO (Exacerbations of Chronic Pulmonary Disease Tool ? Patient-reported Outcome) questionnaire
- COPD (Chronic Obstructive Pulmonary Disease) specific resource utilization (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other Chronic Obstructive Pulmonary Disease medications)
- PK (pharmacokinetics) - steady-state serum pre-dose concentration
- Adverse Events/ Serious Adverse Events (AE/SAE) - Laboratory variables - 12 lead ECG (Electrocardiogram) - Physical Examination - Vital Signs
- Determination of Anti-drug antibodies (ADA)
- EQ-5D-5L (European Quality of Life-5 Dimensions) questionnaire
- Blood eosinophils levels

- Cuestionario Respiratorio de St. George (SGRQ)
- Herramienta de evaluación de la EPOC (CAT)
- Volumen espiratorio forzado en un segundo (FEV1) pre-dosis/pre-broncodilatador en el centro de estudio
- Índice de disnea basal/transicional (BDI/TDI)
- Utilización total de medicamentos de rescate (media de inhalaciones/día)
- Número de noches con despertares debidos a EPOC
- Herramienta de Exacerbaciones de la Enfermedad Pulmonar Crónica - Resultado comunicado por el paciente (EXACT-RCP)
- Tasa anual de hospitalizaciones debidas a la EPOC; tasa anual combinada de hospitalizaciones y visitas a urgencias debidas a la EPOC; tasa anual de visitas a consultas externas no planificadas, incluidas visitas no planificadas a centros del ensayo debido a la EPOC y tasa anual de visitas al médico no planificadas debidas a la EPOC
- Parámetros farmacocinéticos (FC)
- Acontecimientos adversos/ Acontecimientos adversos graves (AA/AAG), Variables de laboratorio
Electrocardiograma (ECG) de 12 derivaciones, Exploración física,
Constantes vitales
- Anticuerpos contra el fármaco (ACF)
- Cuestionario Europeo de Calidad de Vida -5 Dimensiones (EQ-5D-5L)
- Eosinófilos en sangre

E.5.2.1

Timepoint(s) of evaluation of this end point

maximum of 60 weeks

Máximo de 60 semanas

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

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

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

150

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

Austria

Canada

Czech Republic

Germany

Hungary

Italy

Netherlands

Poland

Romania

Russian Federation

South Africa

Spain

Switzerland

United Kingdom

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

Última visita del último paciente

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

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:

872

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

871

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

1172

F.4.2.2

In the whole clinical trial

1743

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)

Standard of care

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

2014-09-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-09-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-04-10

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