Clinical Trials Register

Summary
EudraCT Number:	2018-000031-28
Sponsor's Protocol Code Number:	CLKA651X2202
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:	2018-10-09
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

2018-000031-28

A.3

Full title of the trial

A randomized, active-controlled, patient and investigator-masked, multiple dose proof-of-concept study of intravitreal LKA651 in patients with diabetic macular edema

Estudio de prueba de concepto de dosis múltiples, aleatorizado, activo controlado, con paciente e investigador enmascarados, de LAK651 intravítreo, en pacientes con edema macular diabético.

A.3.1

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

A Proof of concept study of intravitreal LKA651 in patients with macular edema

Estudio de prueba de concepto de LKA651 intravitreo en pacientes con edema macular diabético

A.4.1

Sponsor's protocol code number

CLKA651X2202

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	LKA651
D.3.2	Product code	LKA651
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	LKA651
D.3.9.2	Current sponsor code	LKA651
D.3.9.3	Other descriptive name	LKA651
D.3.9.4	EV Substance Code	SUB177591
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	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	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	Lucentis
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Lucentis
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	RANIBIZUMAB
D.3.9.1	CAS number	347396-82-1
D.3.9.2	Current sponsor code	RFB002
D.3.9.4	EV Substance Code	SUB22314
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	10
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	Yes
D.2.1.1.1	Trade name	Lucentis
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Lucentis
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	RANIBIZUMAB
D.3.9.1	CAS number	347396-82-1
D.3.9.2	Current sponsor code	RBF002
D.3.9.4	EV Substance Code	SUB22314
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	10
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 evaluate the safety, tolerability, and efficacy, in reference to Lucentis® monotherapy, of three q4w intravitreal (IVT) doses of LKA651 in treating DME when administered as monotherapy and in combination with Lucentis®

Evaluar la seguridad, tolerabilidad y eficacia, en referencia a Lucentis® en monoterapia, de tres dosis intravítreas (IVT) de LKA651 administradas cada 4 semanas (c4s), para el tratamiento del EMD cuando se administra en monoterapia o en combinación con Lucentis®.

E.2.2

Secondary objectives of the trial

- To evaluate the serum pharmacokinetic (PK) profile of total LKA651 and Lucentis® following three q4w IVT doses of LKA651, or a combination of LKA651 and Lucentis,® in patients with DME

- To evaluate duration of effect of three q4w IVT doses of LKA651 in patients with DME.

- To evaluate the effect of IVT LKA651 on diabetic retinopathy (DR) progression in patients with DME.

-Evaluar el perfil farmacocinético (PK) sérico de LKA651 total y Lucentis® después de tres dosis IVT de LAK651 c4s, o una combinación de LKA651 y Lucentis® en pacientes con EMD.
-Evaluar la duración del efecto de tres dosis IVT de LAK651 c4s en pacientes con EMD.
-Evaluar el efecto de LAK651 IVT en la progresión de la retinopatía diabética (RD) en pacientes con EMD.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male and female patients age 18 to 90 years of age inclusive
• Diagnosis of type I or type II diabetes mellitus.
• The Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye must be between 24 and 70 letters (approximate Snellen equivalent of 20/40-20/320). The non-study eye (fellow eye) should be ≥34 letters or better (approximate Snellen equivalent of 20/200) at screening
• Presence of DME in the study eye, with decrease in vision due to foveal thickening of central macular thickness ≥ 275 µm in the central subfield, as assessed on spectral-domain ocular coherence tomography (SD-OCT) and confirmed by the central reading center
• Sufficiently clear ocular media and adequate pupil dilation in the study eye to permit fundus photographs of adequate clarity to measure diameters of retinal arteries and veins

-Pacientes hombres y mujeres con edad de 18 a 90 años inclusive.
-Diagnóstico de diabetes mellitus de tipo I o de tipo II.
-La puntuación de letras con el Estudio del tratamiento temprano de la retinopatía diabética (ETDRS) en el ojo de estudio deberá ser de entre 24 y 70 letras (equivalente aproximado de Snellen de 20/40-20/230). El ojo que no sea el de estudio (ojo contralateral) debería tener una visión >/=34 letras o más (equivalente aproximado de Snellen de 20/200) en la selección.
-Presencia de EMD en el ojo de estudio, con disminución de la visión debido a engrosamiento foveal del grosor macular central >/= 275 µm en el subcampo central, evaluado con tomografía de coherencia óptica de dominio espectral (SD-OCT) y confirmado por el centro de interpretación central.
-Medios oculares suficientemente transparentes y dilatación de la pupila adecuada en el ojo de estudio que permita fotografías de fondo de ojo con nitidez adecuada para medir los diámetros de las venas y arterias retinianas

E.4

Principal exclusion criteria

• Patient with history of IVT anti-vascular endothelial growth factor (VEGF) treatment, macular laser photocoagulation, or intravitreal or topical steroid treatment in the study eye. History of topical steroid >6 months from study start for treatment of non-DME condition is allowed. History of focal laser treatment outside 1000 µm of the fovea in the study eye is permitted. History or concurrent treatment with these medications/procedures in the non-study eye is permitted.
• Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than one disc area with no vitreous hemorrhage. Proliferative diabetic retinopathy in the study eye for which only focal, peripheral retinal areas were treated with photocoagulation with fewer than 30 laser burns performed at least 6 months preceding Day 1 is permitted.
• Patients, with type 1 or type 2 diabetes who have a hemoglobin A1C ≥ 12% at screening.
• Any progressive disease of the retina in the study eye (e.g. uveitis, rod-cone dystrophy) or optic nerve (e.g. glaucoma) other than those listed in the inclusion criteria.
• Area of retinal ischemia (as measured by the foveal avascular zone) ≥ 1000 μm. Any other retinal ischemia not involving the foveal center but located ≤ 1000 μm from the center of the macula of the study eye as assessed by fluorescein angiography (FA) at screening.
• Active intraocular inflammation (graded as trace or above) in either eye or active intraocular infection in the study eye.
• Current diagnosis of or laboratory evidence for anemia, defined as a hemoglobin <11 g/dL for women and <12 g/dL for men.

-Pacientes con antecedentes de tratamiento ITV con inhibidores del factor de crecimiento endotelial vascular del factor de crecimiento endotelial antivascular (VEGF), fotocoagulación macular con láser o tratamiento con esteroides tópicos o intravítreos en el ojo de estudio. Se permite antecedentes de esteroides tópicos > 6 meses desde el inicio del estudio para tratamiento de una afección no EMD. Se permite antecedentes de tratamiento focal con láser fuera de 1000 µm de la fóvea en el ojo de estudio. Se permite antecedentes o tratamiento concurrente con estas medicaciones/procedimientos en el ojo contralateral.
- Retinopatía diabética proliferativa en el ojo de estudio, con la excepción de microhemangiomas de neovascularización en menos de un área de disco sin hemorragia vítrea. Se permite retinopatía diabética proliferativa en el ojo de estudio para la que solo fueron tratadas áreas de la retina periférica, focales con fotocoagulación con menos de 30 quemaduras con laser por lo menos 6 meses antes del día 1.
-Pacientes con diabetes tipo 1 o tipo 2 con un valor de hemoglobina A1C >/=12% en la selección
-Cualquier enfermedad progresiva de la retina en el ojo de estudio (por ejemplo, uveítis, distrofia de conos y bastones) o nervio óptico (por ejemplo, glaucoma) que no sean las listadas en los criterios de inclusión.
-Área de isquemia retiniana (medida con la zona avascular foveal) >/=1000 μm. Cualquier otra isquemia retiniana que no afecte al centro de la fóvea pero que esté localizada </= 1000 μm del centro de la mácula del ojo de estudio, evaluada con angiografía fluoresceínica (FA) en la selección.
-Inflamación intraocular activa (clasificada como traza o superior) en cualquier ojo o infección intraocular activa en el ojo de estudio
-Diagnóstico actual o evidencia de laboratorio de anemia, definida como hemoglobina <11 g/dL para mujeres <12 g/dL para hombres.

E.5 End points

E.5.1

Primary end point(s)

1) Best Corrected Visual Acuity (BCVA) as assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity charts at week 12.

2) Central subfield retinal thickness as measured by SD-OCT at week 12

3) Ocular and systemic AEs

4) Vital signs (blood pressure, heart rate) and ECG intervals.

5) Safety laboratory measures (including reticulocyte count)

6) Complete ophthalmic exam, including :
• Intraocular Pressure (IOP)
• BCVA
• Macular thickness by spectral domain optical coherence tomography (SD-OCT)
• FA

1) Mejor agudeza visual corregida según lo evaluado con el Estudio del tratamiento temprano de la retinopatía diabética (ETDRS) por los gráficos de agudeza visual en la semana 12.
2) Espesor del subcampo central de la retina medido con SD-OCT en la semana 12
3)Acontecimientos adversos sistémicos u oculares
4) Constantes vitales (presión sanguínea, ritmo cardiaco) y Electrocardiograma (ECG)
5) Análisis de laboratorio de seguridad (incluido recuento de reticulocitos)
6) Examen oftálmico completo, incluyendo:
-Presión intraocular
-MAVC
-Espesor del subcampo central de la retina con SD-OCT
-FA

E.5.1.1

Timepoint(s) of evaluation of this end point

1) Best Corrected Visual Acuity as assessed by ETDRS visual acuity charts - week 12.

2) Central subfield retinal thickness as measured by SD-OCT - week 12

3) Ocular and systemic AEs - are evaluated on 1,2,8,15,29,43,57,85,113,141 and 169 days.

4) Vital signs are evaluated on
blood pressure and heart rate - 1,2,8,15,29,57,85,113,141 and 169 days
ECG intervals - 1,85 and 169 days

5) Safety laboratory measures (including reticulocyte count) are evaluated on 1,2,8,15,29,57,85 and 169 days

6) Complete ophthalmic exam is evaluated on :
• Intraocular Pressure (IOP) - 1,2,8,15,29,43,57,85,113,141 and 169 days
• BCVA and Macular thickness by spectral domain optical coherence tomography (SD-OCT) - 1,2,8,15,29,43,57,85,113,141 and 169 days
• FA - 29,57 and 169 days

Mejor agudeza visual corregida según lo evaluado ETDRS por los gráficos de agudeza visual en la semana 12.
Espesor del subcampo central de la retina medido con SD-OCT en la semana 12
AA sistémicos u oculares en los días: 1,2,8,15,29,43,57,85,113,141 y 169
Constantes vitales evaluadas en:
Presión sanguínea y ritmo cardiaco en los días: 1,2,8,15,29,57,85,113,141 y 169.
ECG en los días: 1,85 y 169
Análisis de laboratorio de seguridad (incluido recuento de reticulocitos) son evaluados en los días: 1,2,8,15,29,57,85 y 169.
6) Examen oftálmico completo es evaluado:
-Presión intraocular en los días ,2,8,15,29,43,57,85,113,141 y 169.
-MAVC y Espesor del subcampo central de la retina con SD-OCT en los días 1,2,8,15,29,43,57,85,113,141 y 169.
-FA en los días 29,57 y 169.

E.5.2

Secondary end point(s)

1) Time to retreatment with anti-VEGF (as determined by PI) after week 12 during an additional 12-week extension phase

2) Serum levels of total LKA651 (Maximum concentration (Cmax) and Area under the curve (AUC)0-28d in monotherapy or in combination with Lucentis® after the first dose

3) Serum levels of ranibizumab (Cmax and AUC0-28d) when administered in combination with LKA651 after the first dose

4) Patients with 2 and ≥3 step improvement in the diabetic retinopathy severity scale by color fundus photos at week 12 and week 24

1) Tiempo para un nuevo tratamiento con anti- VEGF (determinado por el PI) después de la semana 12 durante 12 semanas adicionales de fase de extensión.
2)Niveles en suero de LKA651 total (Concentración máxima (Cmax) y el Área bajo la curva (AUC) 0-28d en monoterapia o en combinación con Lucentis® después de la primera dosis.
3)Niveles en suero de ranibizumab total (Cmax y AUC0-28d) cuando se administra en combinación con LKA651 después de la primera dosis.
4)Pacientes con una mejoría de 2 y >/=3 pasos en la escala de severidad de la retinopatía diabética por fotos de fondo de color en la semana 12 y la semana 24

E.5.2.1

Timepoint(s) of evaluation of this end point

to 1) Time to retreatment with anti-VEGF (as determined by PI) after week 12 during an additional 12-week extension phase - week 12 and week 24

2) Serum levels of total LKA651 (Maximum concentration (Cmax) and Area under the curve (AUC)0-28d in monotherapy or in combination with Lucentis® after the first dose - day 85

3) Serum levels of ranibizumab (Cmax and AUC0-28d) when administered in combination with LKA651 after the first dose - day 85

4) Patients with 2 and ≥3 step improvement in the diabetic retinopathy severity scale by color fundus photos - week 12 and week 24

1) Tiempo para un nuevo tratamiento con anti- VEGF (determinado por el PI) después de la semana 12 durante 12 semanas adicionales de fase de extensión y semana 24.
2)Niveles en suero de LKA651 total (Concentración máxima (Cmax) y el Área bajo la curva (AUC) 0-28d en monoterapia o en combinación con Lucentis® después de la primera dosis - día 85.
3)Niveles en suero de ranibizumab total (Cmax y AUC0-28d) cuando se administra en combinación con LKA651 después de la primera dosis- día 85.
4)Pacientes con una mejoría de 2 y >/=3 pasos en la escala de severidad de la retinopatía diabética por fotos de fondo de color - semana 12 y la semana 24

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

Germany

Spain

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

LVLS- 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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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

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

2018-12-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-12-05

P. End of Trial
P.	End of Trial Status	Completed

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Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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