Clinical Trials Register

Summary
EudraCT Number:	2019-000716-28
Sponsor's Protocol Code Number:	CRTH258A2303
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:	2019-07-05
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

2019-000716-28

A.3

Full title of the trial

A 64-week, two-arm, randomized, double-masked, multi-center, phase IIIb study assessing the efficacy and safety of brolucizumab 6 mg compared to aflibercept 2 mg in a treat-to-control regimen in patients with neovascular age-related macular degeneration (TALON)

Estudio de fase IIIb, multicéntrico, aleatorizado, con doble enmascaramiento, de
dos grupos y 64 semanas de duración que evalúa la eficacia y seguridad de
brolucizumab 6 mg comparado con aflibercept 2 mg en una pauta de tratamiento
hasta control en pacientes con degeneración macular neovascular asociada a la
edad (TALON)

A.3.1

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

Study to evaluate the safety, efficacy, and the period between treatments of brolucizumab 6 mg compared with aflibercept 2 mg in neovascular Age-Related Macular Degeneration (nAMD), also commonly referred to as wet AMD

Estudio que evalúa la eficacia y seguridad de brolucizumab frente a aflibercept
en una pauta de tratamiento hasta control en pacientes con degeneración
macular neovascular asociada a la edad.

A.3.2

Name or abbreviated title of the trial where available

TALON

A.4.1

Sponsor's protocol code number

CRTH258A2303

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	3490 0353036
B.5.5	Fax number	3493 2479903
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.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

neovascular age-related macular degeneration

degeneración macular neovascular asociada a la edad

E.1.1.1

Medical condition in easily understood language

neovascular Age-Related Macular Degeneration (nAMD), also commonly referred to as wet AMD

degeneración macular neovascular asociada a la edad (DMAEn)

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10071129
E.1.2	Term	Neovascular age-related macular degeneration
E.1.2	System Organ Class	10015919 - Eye disorders

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 superior to aflibercept with respect to the duration of treatment intervals at Week 32
•To demonstrate that brolucizumab is non-inferior to aflibercept with respect to average change in BCVA from baseline at Weeks 28 and 32

1. Demostrar que brolucizumab es superior a aflibercept en cuanto a la duración de los intervalos de tratamiento en la semana 32.
2. Demostrar que brolucizumab no es inferior a aflibercept en cuanto al cambio medio en la mejor agudeza visual corregida (MAVC) respecto a la basal en las semanas 28 y 32.

E.2.2

Secondary objectives of the trial

•To evaluate the durability of brolucizumab relative to aflibercept
•To evaluate the functional outcomes with brolucizumab relative to aflibercept
•To evaluate the anatomical outcomes with brolucizumab relative to aflibercept
•To evaluate the effect of brolucizumab relative to aflibercept on Patient-Reported Outcomes (PRO)
•To assess the safety and tolerability of brolucizumab relative to aflibercept

-Evaluar la durabilidad de brolucizumab respecto a aflibercept.
-Evaluar los resultados funcionales con brolucizumab respecto a aflibercept.
-Evaluar los resultados anatómicos con brolucizumab respecto a aflibercept.
-Evaluar el efecto de brolucizumab respecto a aflibercept sobre los resultados
comunicados por el paciente (PRO).
-Evaluar la seguridad y tolerabilidad de brolucizumab respecto a aflibercept

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Signed informed consent must be obtained prior to participation in the study.
2.Male or female patients, ≥ 50 years of age at screening.
Study Eye:
3.Active CNV secondary to AMD that affects the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by fluorescein angiography and sequellae of CNV, e.g. pigment epithelial detachment (PED), subretinal or sub-retinal pigment epithelium (sub-RPE) hemorrhage, blocked fluorescence, macular edema.
4.Presence of intraretinal fluid (IRF) or subretinal fluid (SRF) that affects the central subfield, as seen by SD-OCT.
5.BCVA score must be ≤ 83 and ≥ 38 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximately Snellen equivalent of 20/25 and 20/200), at both screening and baseline.

1. Se deberá obtener el consentimiento informado firmado antes de la participación en el estudio.
2. Pacientes de ambos sexos >=50 años de edad en la selección que nunca hayan recibido tratamiento.
Ojo en estudio
3. Neovascularización coroidea (NVC) activa secundaria a una degeneración macular asociada a la edad (DMAE) que afecta al subcampo central, incluida una proliferación angiomatosa retiniana (RAP) con un componente de NVC, confirmada por la presencia de una fuga activa procedente de una NVC detectada mediante una angiografía con fluoresceína (AF) y secuelas de NVC, p. ej., desprendimiento del epitelio pigmentario (DEP), hemorragia subretiniana o del epitelio pigmentario subretiniano (EPSR), fluorescencia bloqueada y edema macular (ojo en estudio).
4. Presencia de fluido intrarretiniano (FIR) o fluido subretiniano (FSR) que afecta al subcampo central, detectada mediante una tomografía óptica de coherencia de dominio espectral (SD-OCT) (ojo en estudio).
5. Puntuación de la mejor agudeza visual corregida (MAVC) entre 83 y 38 letras, ambas inclusive, a los 4 metros, utilizando optotipos de agudeza visual del estudio del tratamiento precoz de la retinopatía diabética (ETDRS) (equivalente de Snellen aproximado de 20/25 a 20/200) tanto en la visita de selección como en la basal (ojo en estudio).

E.4

Principal exclusion criteria

1.Ocular conditions/disorders 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 planned medical or surgical intervention during the first 12-month study period, structural damage of the fovea, atrophy or fibrosis at the center of the fovea (study eye)
2.Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye)
3.Uncontrolled glaucoma defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator’s judgment, at screening or baseline (study eye)
4.Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 20/200 at screening (except when due to conditions which can lead to improved VA after surgery eg cataract)
5.Ocular treatments: previous treatment with any anti-vascular endothelial growth factor (VEGF) drugs or investigational drugs, intraocular or periocular steroids, macular laser photocoagulation, photodynamic therapy, vitreoretinal surgery, intraocular surgery (study eye)
6.Stroke or myocardial infarction during the 6-month period prior to baseline
7.Systemic anti-VEGF therapy at any time.

1. Enfermedades/trastornos oculares concomitantes en la selección o la basal
que podrían, según el criterio del investigador, impedir la respuesta al tratamiento del estudio, 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, daños estructurales de la fóvea, atrofia o fibrosis en el centro de la fóvea (ojo en estudio).
2. Cualquier infección intraocular o periocular activa o inflamación intraocular activa en la selección o la basal (ojo en estudio).
3. Glaucoma no controlado definido como presión intraocular (PIO) >25 mmHg con la medicación o a juicio del investigador, en la selección o la basal (ojo en estudio).
4. Presencia de ambliopía, amaurosis o trastornos oculares en el ojo
contralateral con MAVC <20/200 en la selección (excepto en caso de
enfermedades cuya cirugía pueda mejorar la agudeza visual [AV], p. ej., cataratas).
5. Tratamientos oculares: tratamiento previo con cualquier fármaco para el factor de crecimiento endotelial antivascular (anti-VEGF) o cualquier fármaco en investigación, esteroides intraoculares o perioculares, fotocoagulación macular con láser, terapia fotodinámica (TFD), cirugía vitreorretiniana o cirugía intraocular (ojo en estudio).
6. Ictus o infarto de miocardio durante el periodo de 6 meses antes de la basal.
7. Terapia sistémica anti-VEGF en cualquier momento.

E.5 End points

E.5.1

Primary end point(s)

1.Distribution of the last interval with no disease activity up to Week 32 (if there was disease activity, the last interval will be shortened by 4 weeks, down to a minimum of 4 weeks)
2.Average change in BCVA from baseline at Weeks 28 and 32

1.Distribución del último intervalo sin actividad de la enfermedad hasta la semana 32 (si hubo actividad de la enfermedad, el último intervalo se reducirá en 4 semanas, hasta un mínimo de 4 semanas)
2. Cambio promedio en BCVA desde el inicio en las semanas 28 y 32

E.5.1.1

Timepoint(s) of evaluation of this end point

1. up to week 32
2. at week 28 and 32

1. hasta semana 32
2. en las semanas 28 y 32

E.5.2

Secondary end point(s)

1. Distribution of the last interval with no disease activity up to Week 64 (if there was disease activity, the last interval will be shortened by 4 weeks down to a minimum of 4 weeks)
2. Distribution of the maximal intervals with no disease activity up to Week 64
3. Proportion of patients with no disease activity at Weeks 14 and 16
4. Time from the last loading injection to the first visit with no disease activity
5. Average change in BCVA from baseline at Weeks 60 and 64
6. Occurrence of BCVA improvements of ≥ 10 and ≥ 15 letters from baseline at Week 32, Week 64, and at the last injection visit
7. Occurrence of BCVA ≥ 69 letters at Week 32, at Week 64, and at the last injection visit
8. Average change from baseline in CSFT as assessed by SD-OCT at Weeks 28 and 32
9. Average change from baseline in CSFT as assessed by SD-OCT at Weeks 60 and 64
10. Number of visits with presence of IRF and/or SRF, and sub-RPE fluid in the central subfield, as assessed by SD-OCT at Weeks 28 and 32
11. Number of visits with presence of IRF and/or SRF, and sub-RPE fluid in the central subfield as assessed by SD-OCT at Weeks 60 and 64
12. Change in Visual Function Questionnnaire-25 (VFQ-25) total and subscale scores from baseline at Weeks 32 and 64
13. Incidence of Ocular and Non-ocular AEs, vital signs and laboratory values up to Week 64

1. Distribución del último intervalo sin actividad de la enfermedad hasta la semana 64 (si hay actividad de la enfermedad, el último intervalo se reducirá en fracciones de 4 semanas, hasta un mínimo de 4 semanas).
2. Distribución de los intervalos máximos sin actividad de la enfermedad hasta la semana 64.
3. Proporción de pacientes sin actividad de la enfermedad en las semanas 14 y 16.
4. Tiempo desde la última inyección de carga hasta la primera visita sin actividad de la enfermedad.
5. Cambio medio en la MAVC respecto a la basal en las semanas 60 y 64.
6. Presencia de mejoras en la MAVC ≥10 y ≥15 letras respecto a la basal en las semanas 32 y 64, y en la última visita de inyección.
7. Presencia de MAVC ≥69 letras en las semanas 32 y 64, y en la última visita de inyección.
8. Cambio medio respecto a la basal en el GSC evaluado mediante SD-OCT en las semanas 28 y 32.
9. Cambio medio respecto a la basal en el GSC evaluado mediante SD-OCT en las semanas 60 y 64.
10. Número de visitas con presencia de FIR y/o FSR, y fluido por debajo del EPR en el subcampo central, evaluados mediante SD-OCT en las semanas 28 y 32.
11. Número de visitas con presencia de FIR y/o FSR, y fluido por debajo del EPR en el subcampo central, evaluados mediante SD-OCT en las semanas 60 y 64.
12. Cambio en las puntuaciones total y de las subescalas del Visual Function Questionnaire-25 (VFQ-25) respecto a la basal en las semanas 32 y 64.
13. Incidencia de AA oculares y no oculares hasta la semana 64.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. up to Week 64
2. up to Week 64
3. at Weeks 14 and 16
4. Time from the last loading injection to the first visit with no disease activity
5. at Weeks 60 and 64
6. at Week 32, Week 64, and at the last injection visit
7. at Week 32, at Week 64, and at the last injection visit
8. at Weeks 28 and 32
9. at Weeks 60 and 64
10. at Weeks 28 and 32
11. at Weeks 60 and 64
12. at Weeks 32 and 64
13. up to Week 64

1. hasta la semana 64
2. hasta la semana 64
3. en las semanas 14 y 16
4. Tiempo desde la última inyección hasta la primera visita sin actividad de enfermedad
5. en las semanas 60 y 64
6. en la semana 32, semana 64, y en la última visita de inyección
7. en la semana 32, en la semana 64 y en la última visita de inyección
8. en las semanas 28 y 32
9. en las semanas 60 y 64
10. en las semanas 28 y 32
11. en las semanas 60 y 64
12. en las semanas 32 y 64
13. hasta la semana 64

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

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)

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

Australia

Austria

Belgium

Canada

Czech Republic

France

Germany

Israel

Italy

Korea, Republic of

Malaysia

Netherlands

Portugal

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

LVLS - see protocol

Última visita último 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

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:

346

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

346

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

276

F.4.2.2

In the whole clinical trial

692

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 completado el estudio cuando haya completado la última visita planeada en el protocolo.
El investigador y/o médico de referencia recomendarán los cuidados médicos de seguimiento apropiados, si fuera necesario, para todos los pacientes que se hubieran retirado del estudio de forma prematura.

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

2019-09-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-07-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-09-09

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Clinical trials