Clinical Trials Register

Summary
EudraCT Number:	2017-004742-23
Sponsor's Protocol Code Number:	CRTH258B2301
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:	2018-04-20
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

2017-004742-23

A.3

Full title of the trial

A Two-Year, Three-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular Edema

Estudio de fase III, multicéntrico, aleatorizado, con doble enmascaramiento, de tres grupos y dos años de duración que evalúa la eficacia y seguridad de brolucizumab versus aflibercept en pacientes adultos con alteración visual debida a edema macular diabético

A.3.1

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

Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular Edema

Estudio que evalúa la eficacia y seguridad de brolucizumab versus aflibercept en pacientes adultos con alteración visual debida a edema macular diabético

A.4.1

Sponsor's protocol code number

CRTH258B2301

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	Novartis Farmacéutica, 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	Novartis Pharma AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Farmacéutica, S.A.
B.5.2	Functional name of contact point	Trial Monitoring Organization (TMo)
B.5.3	Address:
B.5.3.1	Street Address	Gran Vía de les Corts Catalanes, 764
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08013
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34900353036
B.5.5	Fax number	+34932479903
B.5.6	E-mail	eecc.novartis@novartis.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	RTH258
D.3.2	Product code	RTH258 formerly ESBA1008
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	Intravitreal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BROLUCIZUMAB
D.3.9.1	CAS number	1531589-13-5
D.3.9.2	Current sponsor code	RTH258 / ESBA1008
D.3.9.3	Other descriptive name	Anti-VGEF monoclonal antibody
D.3.9.4	EV Substance Code	SUB180753
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	120
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	No
D.IMP: 2
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	Eylea
D.2.1.1.2	Name of the Marketing Authorisation holder	Bayer Pharma AG
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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravitreal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	aflibercept
D.3.9.1	CAS number	862111-32-8
D.3.9.3	Other descriptive name	AFLIBERCEPT
D.3.9.4	EV Substance Code	SUB26987
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	40
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	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	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	RTH258
D.3.2	Product code	RTH258 formerly ESBA1008
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	Intravitreal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BROLUCIZUMAB
D.3.9.1	CAS number	1531589-13-5
D.3.9.2	Current sponsor code	RTH258 / ESBA1008
D.3.9.3	Other descriptive name	Anti-VGEF monoclonal antibody
D.3.9.4	EV Substance Code	SUB180753
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	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	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

diabetic macular edema

edema macular diabético

E.1.1.1

Medical condition in easily understood language

diabetic macular edema

edema macular diabético

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10057934
E.1.2	Term	Diabetic macular edema
E.1.2	System Organ Class	100000004853

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 demonstrate that brolucizumab is non-inferior to aflibercept with respect to the visual outcome after the first year of treatment

Demostrar que brolucizumab es no inferior a aflibercept con respecto al resultado visual tras el primer año de tratamiento.

E.2.2

Secondary objectives of the trial

To assess the efficacy and the ocular and systemic safety of brolucizumab:
• To demonstrate that brolucizumab is non-inferior to aflibercept with respect to visual outcome during the last 3 months of the first year of treatment
•To estimate the proportion of patients treated at q12w frequency with brolucizumab
•To estimate the predictive value of the first q12w cycle for maintenance of q12w treatment with brolucizumab
•To evaluate the functional and anatomical outcome with brolucizumab relative to aflibercept
•To evaluate the effect of brolucizumab relative to aflibercept on the Diabetic Retinopathy status
•To assess the safety of brolucizumab relative to aflibercept
•To evaluate the effect of brolucizumab relative to aflibercept on patient-reported outcomes (VFQ-25)

Evaluar la eficacia y seguridad ocular y sistémica de brolucizumab
-Demostrar que brolucizumab es no inferior a aflibercept con respecto al resultado visual durante los 3 últimos meses del primer año de tratamiento.
-Estimar la proporción de pacientes tratados a la frecuencia cada 12 semanas con brolucizumab.
-Estimar el valor predictivo del primer ciclo de c12c para el mantenimiento del tratamiento c12s con brolucizumab.
-Evaluar el resultado funcional y anatómico con brolucizumab respecto a aflibercept.
-Evaluar el efecto de brolucizumab respecto a aflibercept sobre el estado de la retinopatía diabética.
-Evaluar la seguridad y tolerabilidad de brolucizumab respecto a aflibercept.
-Evaluar el efecto de brolucizumab respecto a aflibercept sobre los resultados notificados por el paciente (VFQ-25).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

General
1.Patients must give written informed consent before any study related assessments are performed
2.Patients >=18 years of age at baseline
3.Patients with type 1 or type 2 diabetes mellitus and HbA1c of <=10% at screening
4.Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study
Study Eye
5.Visual impairment due to DME with:
•BCVA score between 78 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/320), at screening and baseline
•DME involving the center of the macula, with central subfield retinal thickness (measured from RPE to ILM inclusively) of >=340 µm on SD-OCT at screening
If both eyes are eligible, the eye with the worse visual acuity will be selected for study eye. However, the investigator may select the eye with better visual acuity, based on medical reasons or local ethical requirements.

General
1. El consentimiento informado por escrito se debe obtener antes de realizar cualquier evaluación.
2. Pacientes >= 18 años de edad en la basal.
3. Pacientes con diabetes mellitus tipo 1 o tipo 2 y HbA1c <= 10% en la selección.
4. La medicación para el control de la diabetes debe haber sido estable durante los 3 meses previos a la aleatorización y prever que permanezca estable durante el transcurso del estudio.
Ojo en studio
5. Alteración visual debida a EMD con:
• Puntuación MAVC entre 78 y 23 letras, ambas inclusive, utilizando gráficos de análisis de agudeza visual del ETDRS a una distancia de prueba de 4 metros (equivalente de Snellen aproximado de 20/32 a 20/320), en la selección y a nivel basal.
• EMD afectando el centro de la mácula, con grosor del subcampo central de la retina (medida desde EPR a MLI ambos inclusive) de >= 340 μm en OCT-DE en la selección.
Si ambos ojos son elegibles, el ojo con peor agudeza visual será seleccionado como ojo en estudio. No obstante, el investigador puede seleccionar el ojo con mejor agudeza visual, basándose en motivos clínicos o requisitos éticos locales.

E.4

Principal exclusion criteria

1.Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye
2.Active proliferative diabetic retinopathy in the study eye as per the investigator
3.Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the first 12-month study period (e.g., cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
4.Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline
5.Structural damage of the fovea in the study eye at screening likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques
6.Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication or according to investigator’s judgment, at screening or baseline
7.Neovascularization of the iris in the study eye at screening or baseline
8.Evidence of vitreomacular traction in the study eye at screening or baseline which, in the opinion of the investigator, affect visual acuity

1. Tratamiento previo con cualquier fármaco anti-VEGF o fármaco en investigación en el ojo en estudio.
2. Retinopatía diabética proliferativa activa en el ojo en estudio según el investigador.
3. Condiciones concomitantes o alteraciones oculares en el ojo en estudio en la selección o a nivel basal que podría, a criterio del investigador, impedir la respuesta al tratamiento del estudio o podría confundir la interpretación de los resultados del estudio, comprometer la agudeza visual o precisar intervención médica o quirúrgica durante el primer periodo de 12 meses del estudio (p.ej., cataratas, hemorragia vítrea, oclusión vascular retinal, desprendimiento de la retina, agujero macular, o neovascularización coroidea por cualquier causa).
4.Cualquier infección intraocular o periocular activa o inflamación intraocular activa (p.ej., conjuntivitis infecciosa, queratitis, escleritis, endoftalmitis, blefaritis infecciosa, uveítis) en el ojo en estudio en la selección o a nivel basal.
5.Daño estructural de la fóvea en el ojo en estudio en la selección que es probable que impida la mejoría en la agudeza visual tras la resolución del edema macular, incluyendo atrofia del epitelio pigmentario retiniano, fibrosis subretiniana, cicatrices del láser, membrana epirretiniana que afecta la fóvea o placas de exudados duros organizadas.
6.Glaucoma no controlado en el ojo en estudio definido como presión intraocular (PIO) > 25 mmHg con la medicación o a juicio del investigador, en la selección o a nivel basal.
7.Neovascularización del iris en el ojo en estudio en la selección o la basal.
8. Evidencia de tracción vitreomacular en el ojo en estudio o a nivel basal que, a juicio del investigador, afecta la agudeza visual.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in BCVA at Week 52

Cambio respecto a la basal en la MAVC en la semana 52.

E.5.1.1

Timepoint(s) of evaluation of this end point

@ week 52

@ semana 52

E.5.2

Secondary end point(s)

1. Change from baseline in BCVA averaged over a period Week 40 to Week 52
2. Proportion of patients maintained at q12w up to Weeks 52 & 100
3. Proportion of patients maintained at q12w up to Weeks 52 & 100, within those patients that qualified for q12w at week 36
4. Change from baseline by visit up to Week 100 in BCVA and in parameters derived from SD-OCT, Color fundus photography and Fluorescein angiography
5. Change in ETDRS Diabetic Retinopathy Severity Scale (DRSS) score up to Week 100
6. Incidence of Ocular and Non-ocular AEs, vital signs and laboratory values up to Week 100
7. Change in patient reported outcomes (VFQ-25) total and subscale scores from baseline up to Week 100

-Cambio respecto a la basal en la MAVC media de la semana 40 a la semana 52.
-Porcentaje de pacientes que se hayan mantenido en c12s hasta las semanas 52 y 100.
-Porcentaje de pacientes que se hayan mantenido en c12s hasta las semanas 52 y 100, entre aquellos pacientes que sean aptos para c12s en la semana 36.
-Cambio desde la basal por visita hasta la semana 100 en la MAVC y en parámetros derivados de OCT-DE, fotografía en color del fondo de ojo y angiografía con fluoresceína.
-Cambio en la puntuación de la escala de severidad de la retinopatía diabética ETDRS (DRSS) hasta la semana 100.
-Incidencia de AA oculares y no oculares, constantes vitales y valores de laboratorio hasta la semana 100.
-Cambio en la puntuación total y en las puntuaciones de las subescalas de los resultados comunicados por el paciente (VFQ-25) desde la basal hasta la semana 100.

E.5.2.1

Timepoint(s) of evaluation of this end point

@ weeks 40, 52 and/or 100

@ semanas 40, 52 y/o 100

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

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

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

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

Austria

Canada

Colombia

Israel

Italy

Japan

Netherlands

Portugal

Spain

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 - see protocol

Última visita, ultimo paciente - Ver protocolo

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:

400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

134

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

534

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)

A patient will be considered to have completed the study when the patient has completed the last visit planned in the protocol.
The investigator and/or referring physician will recommend the appropriate follow-up medical care, if needed, for all patients who are prematurely withdrawn from the study.

Se considerará que un paciente ha finalizado el estudio cuando haya realizado la última visita prevista en el protocolo.
El investigador o el médico responsable recomendará la asistencia médica de seguimiento adecuada, si es necesario, de todos los pacientes que se retiren de forma prematura del estudio.

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

2018-06-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-06-14

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

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