Clinical Trials Register

Summary
EudraCT Number:	2014-005663-32
Sponsor's Protocol Code Number:	CAIN457A2310
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-07-31
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

2014-005663-32

A.3

Full title of the trial

A randomized, double-blind, placebo- and active controlled multicenter trial to demonstrate efficacy of subcutaneous secukinumab compared to placebo and etanercept (in a single blinded arm) after twelve weeks of treatment, and to assess the safety, tolerability, and long-term efficacy in subjects from 6 to less than 18 years of age with severe chronic plaque psoriasis

Ensayo multicéntrico, aleatorizado, doble ciego, controlado con placebo y fármaco activo para demostrar la eficacia de secukinumab subcutáneo en comparación con placebo y etanercept (en un brazo simple ciego) después de doce semanas de tratamiento y evaluar la seguridad, la tolerabilidad y la eficacia a largo plazo en pacientes de 6 a menos de 18 años de edad con psoriasis en placas crónica grave

A.3.1

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

Study of efficacy and safety of secukinumab in pediatric patients with severe plaque psoriasis.

Estudio de la eficacia y la seguridad de secukinumab en pacientes pediátricos con psoriasis en placas grave.

A.4.1

Sponsor's protocol code number

CAIN457A2310

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/011/2015

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 Services 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	Departamento Médico
B.5.3	Address:
B.5.3.1	Street Address	Gran Via 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	Yes
D.2.1.1.1	Trade name	Cosentyx
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	secukinumab 150/1ml
D.3.2	Product code	AIN457
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	Secukinumab
D.3.9.1	CAS number	1229022-83-6
D.3.9.2	Current sponsor code	AIN457
D.3.9.3	Other descriptive name	SECUKINUMAB
D.3.9.4	EV Substance Code	SUB33242
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	150
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	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	Cosentyx
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	secukinumab 75mg /0,5 ml
D.3.2	Product code	AIN457
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	Secukinumab
D.3.9.1	CAS number	1229022-83-6
D.3.9.2	Current sponsor code	AIN457
D.3.9.3	Other descriptive name	SECUKINUMAB
D.3.9.4	EV Substance Code	SUB33242
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	150
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	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	Embrel 25 mg polvo y disolvente para solución inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	Wyeth Europa Ltd.
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	Powder for solution for injection
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	ETANERCEPT
D.3.9.1	CAS number	185243-69-0
D.3.9.4	EV Substance Code	SUB01984MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
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
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
D.8 Placebo: 2
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

Plaque Psoriasis

Psoriasis en placas

E.1.1.1

Medical condition in easily understood language

Psoriasis looks like red, raised, scaly areas of the skin

La psoriasis son como areas rojas, engrosadas y con escamas en la piel

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10050576
E.1.2	Term	Psoriasis vulgaris
E.1.2	System Organ Class	100000004858

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate superior efficacy of secukinumab versus placebo at Week 12, based on both PASI 75 and IGA mod 2011 0 or 1 response rates in children and adolescents aged 6 to less than 18 years with severe chronic plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to non-biologic systemic therapies.

El propósito de este estudio es demostrar la eficacia superior de secukinumab frente a placebo en la semana 12 basándose en las tasas de respuesta de PASI 75 e IGA mod. 2011 0 o 1 en niños y adolescentes de 6 a < 18 años de edad con psoriasis en placas crónica grave que no hayan respondido a tratamientos sistémicos no biológicos, que sean intolerantes a ellos o que estén contraindicados

E.2.2

Secondary objectives of the trial

To assess the long term safety and tolerability of secukinumab in this pediatric age group and will describe the efficacy and safety of secukinumab compared to etanercept.
To provide efficacy and safety data to support the extension of label of secukinumab to include children and adolescents (6 years to <18 years) with severe chronic plaque psoriasis

Other protocol-defined secondary objectives may apply.

Evaluar la seguridad y tolerabilidad a largo plazo de secukinumab en este grupo de edad pediátrica y describirá la eficacia y la seguridad de secukinumab en comparación con etanercept.
Proporcionar datos de eficacia y seguridad para respaldar la extensión de la ficha técnica de secukinumab para incluir niños y adolescentes (de 6 a < 18 años de edad) con psoriasis en placas crónica grave.
Referirse al protocolo para ver más objetivos secundarios

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Must be 6 to less than 18 years of age at the time of randomization
2) Severe plaque-type psoriasis meeting all of the following three criteria:
PASI score of 20 or greater,
Investigator's Global Assessment (IGA) score of 4 or greater
Total body surface area (BSA) affected of 10% or greater.
3) Subjects who failed to respond to, or have a contraindication or are intolerant to non-biologic systemic therapies

Other protocol-defined inclusion criteria may apply

1. Deben tener de 6 a < 18 años de edad en el momento de la aleatorización.
2. Psoriasis en placas grave, definida como una puntuación PASI ? 20 e IGA mod. 2011 ? 4, y afectación de la ASC ?10%.
3. Antecedentes de psoriasis en placas durante al menos 3 meses.
4. Pacientes que no hayan respondido a tratamientos sistémicos no biológicos, que sean intolerantes a ellos o que estén contraindicados.

E.4

Principal exclusion criteria

1) Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
2) Current drug-induced psoriasis.
3) Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
4) Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
5) History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
6) Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply.

1. Formas de psoriasis salvo psoriasis en placas crónica (p. ej., psoriasis pustulosa, eritrodérmica y gutata).
2. Psoriasis inducida por fármacos (es decir, nueva aparición o exacerbación actual por betabloqueantes, bloqueadores de los canales de calcio o litio).
3. Exposición previa a secukinumab o a cualquier otro fármaco biológico directamente dirigido contra IL-17 o el receptor de IL-17, o a etanercept
4. Enfermedades subyacentes (incluyendo entre otras enfermedades metabólicas, hematológicas, renales, hepáticas, pulmonares, neurológicas, endocrinas, cardíacas, infecciosas o gastrointestinales) que, según el criterio del investigador, inmunocomprometan de forma significativa al paciente y/o le coloca en una situación de riesgo inaceptable para recibir tratamiento inmunomodulador
5. Se deberá seguir el criterio del investigador en el caso de pacientes con trastornos desmielinizantes del sistema nervioso central o periférico preexistentes o de aparición reciente.
6. Mujeres embarazadas o en periodo de lactancia,

Referirse al protocolo para ver más criterios de exclusión

E.5 End points

E.5.1

Primary end point(s)

The percentage of Participants achieving a 75% Improvement from Baseline in PASI Score. The percentage of Participants who showed Investgator's Global Assessment (IGA) mod 2011 response of 0 or 1

? Porcentaje de pacientes que alcancen una mejoría (reducción) ?75% en la puntuación PASI en comparación con la basal. Porcentaje de pacientes que muestren una respuesta IGA 0 o 1

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12

semana 12

E.5.2

Secondary end point(s)

1. Percentage of Participants achieving a 90% Improvement from baseline in PASI score
2. Percentage of Participants achieving a 50%, 100% Improvement from baseline in PASI score
3. Percentage of Participants achieving a 50%, 75%, 90% or 100% Improvement from baseline in (PASI ) Score and an IGA mod 2011 score of 0 or 1
4. Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) score and IGA mod 2011 0 or 1 score
5. Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) score.
6. Percentage of participants achieving a Childrens' DLQI score of 0 or 1
7. Patients' safety. Clinical safety and tolerability as assessed by growth, weight gain, tolerability of s.c. injections, vital signs, clinical laboratory variables, ECGs, and adverse events monitoring

1. Porcentaje de pacientes que alcancen un PASI90 con respecto a la visita basal
2. Porcentaje de pacientes que alcancen un PASI50, PASI100 con respecto a la visita basal
3. Porcentaje de pacientes que alcancen un PASI50,75,90 o 100 PASI100 con respecto a la visita basal y un IGA mod 2011 de 0 o 1
4. Porcentaje de pacientes que alcancen un PASI y un IGA mod 2011 de 0 o 1
5. Cambio con respecto a visita basal del Children's Dermatology Life Quality Index (cDLQI)
6. Porcentaje de pacientes que alcancen DLQI de 0 o 1
7. Investigar la seguridad y tolerabilidad clínicas de secukinumab con respecto al crecimiento, el aumento de peso, la tolerabilidad a inyecciones s.c., las constantes vitales, las variables clínicas de laboratorio, los ECG y la monitorización de acontecimientos adversos en comparación con placebo.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. 12 weeks
2. 12 weeks
3. Weeks 1, 2, 3, 4, 6, 8, 12, 13, 14, 15, 16, 20, 24, 28, 32,36, 40, 44, 48 and 52
4. Baseline, week 1, 2, 3 ,4, 6, 8, 12, 13, 14, 15, 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52
5. Weeks 2, 4. 8, 12, 24, 36, 52
6. Weeks 2, 4. 8, 12, 24, 36, 52
7. from screening to Week 252

1-12 semanas
2-12 semanas
3-semanas1, 2, 3, 4, 6, 8, 12, 13, 14, 15, 16, 20, 24, 28, 32,36, 40, 44, 48 y 52
4. Basal, semana 1, 2, 3 ,4, 6, 8, 12, 13, 14, 15, 16, 20, 24, 28, 32, 36, 40, 44, 48, y 52
5. semanas 2, 4. 8, 12, 24, 36, 52
6. semanas 2, 4. 8, 12, 24, 36, 52
7. desde la selección hasta semana 52

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

Yes

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

Yes

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)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Belgium

Brazil

Colombia

Egypt

Estonia

France

Germany

Guatemala

Hungary

Israel

Italy

Japan

Latvia

Poland

Romania

Spain

United Kingdom

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

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

160

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

130

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Paediatric subjects that may require parental permission (depending on local regulations)

Pacientes pediátricos que requieran permiso paterno (dependiendo de la legislación local)

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

110

F.4.2.2

In the whole clinical trial

160

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)

When subject leaves the study the investigator will discuss the different medications or possible alternatives that are available to treat the subject's psoriasis.

Una vez finalizado el estudio el investigador comentará con el paciente los diferentes tratamientos o posibles alternativas disponibles para tratar la psoriasis del paciente

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

2015-09-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-08-14

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2023-03-30

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