Clinical Trials Register

Summary
EudraCT Number:	2017-004515-39
Sponsor's Protocol Code Number:	CAIN457A2311
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:	2018-06-21
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

2017-004515-39

A.3

Full title of the trial

A randomized, open-label, multicenter trial to assess the
efficacy of subcutaneous secukinumab after twelve weeks
of treatment, and to assess the long-term safety,
tolerability and efficacy in subjects from 6 to less than 18
years of age with moderate to severe chronic plaque
psoriasis.

Ensayo aleatorizado, abierto, multicéntrico para evaluar la eficacia de secukinumab subcutáneo después de doce semanas de tratamiento y evaluar la seguridad, tolerabilidad y eficacia a largo plazo en pacientes de 6 a menos de 18 años de edad con psoriasis crónica en placas de moderada a grave

A.3.1

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

Study to assess the long-term safety, tolerability and efficacy the in pediatric patients of age 6 to less than 18 years, with moderate to severe chronic plaque psoriasis

Estudio para evaluar la seguridad, tolerabilidad y eficacia a largo plazo en pacientes de 6 a menos de 18 años de edad con psoriasis crónica en placas de moderada a grave

A.4.1

Sponsor's protocol code number

CAIN457A2311

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/352/2017

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	+34 90 0353036
B.5.5	Fax number	+34 93 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	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
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 milligram(s)
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	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	secukinumab
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 milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	75
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

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 se ve como áreas rojas, elevadas y escamosas de 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	20.0
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 evaluate the efficacy of secukinumab in pediatric subjects aged 6 years to less than 18 years old with moderate to severe chronic plaque psoriasis with respect to PASI 75 and IGA mod 2011 0/1 response (coprimary endpoints) at Week 12, compared to placebo (historical control).

Evaluar la eficacia de secukinumab comparado con placebo (control histórico)en pacientes pediátricos de 6 a menos de 18 años de edad con psoriasis crónica en placas de moderada a grave con respecto a la respuesta PASI 75 e IGA mod. 2011 0 o 1 (variables co-principales) en la semana 12.

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of secukinumab in pediatric subjects aged 6 years to less than 18 years old with moderate to severe chronic plaque psoriasis with respect to PASI 90 at Week 12, compared to placebo (historical control).
To investigate the clinical safety and tolerability of secukinumab as assessed by growth, weight gain, vital signs, clinical laboratory variables, ECGs, and adverse event monitoring
To evaluate the pharmacokinetics of the two secukinumab doses in subjects.

Evaluar la eficacia de secukinumab comparado con placebo en pacientes pediátricos con respecto a PASI 90 en la semana 12 (control histórico).
Investigar la seguridad y tolerabilidad clínicas de secukinumab según la evaluación del crecimiento, aumento de peso, constants vitales, variables clínicas de laboratorio, ECG y monitorización de AA.
Evaluar la farmacocinética de secukinumab en pacientes pediátricos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written informed assent and parental permission (age as per local law) obtained at screening before any assessment is performed.
2. Must be 6 to less than 18 years of age at the time of randomization
3. Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IGA mod 2011 score of ≥ 3, and BSA involvement of ≥10%, at randomization.
4. History of plaque psoriasis for at least 3 months before randomization
5. Subject being regarded by the investigator to be a candidate for systemic therapy.

1. Asentimiento informado por escrito y autorización de los progenitores (según la legislación local) obtenido en la selección y antes de realizar ninguna evaluación.
2. Deben tener de 6 a menos de 18 años de edad en el momento de la aleatorización.
3. Psoriasis en placas de moderada a grave, definida como una puntuación PASI ≥ 12 e IGA mod. 2011 ≥ 3, y afectación del ASC ≥ 10 %.
4. Antecedentes de psoriasis en placas durante al menos 3 meses antes de la aleatorización.
5. Pacientes que el investigador considere candidatos para tratamiento sistémico

E.4

Principal exclusion criteria

Subjects fulfilling any of the following criteria:
1. Forms of psoriasis other than chronic plaque-type active at randomization
2. Drug-induced psoriasis
3. Ongoing use of prohibited treatments
4. Female subjects of childbearing potential defined as all women
physiologically capable of becoming pregnant, unless they are using
effective methods of contraception during dosing and for 16 weeks after
stopping study treatment
5. Pregnant or nursing (lactating) females
6. Subjects with total WBC count <2,500/μL, or platelets <100,000/μL
or neutrophils <1,500/μL or hemoglobin <8.5 g/dL at screening
7. Previous exposure to secukinumab or any other biologic drug directly
targeting IL-17 or the IL-17 receptor

pacientes que cumplan alguno de los siguientes criterios:
1. Formas de psoriasis salvo psoriasis crónica en placas activa en la aleatorización.
2. Psoriasis inducida por fármacos
3. Uso actual de tratamientos prohibidos
4. Pacientes mujeres en edad fértil definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, salvo que estén utilizando métodos anticonceptivos eficaces durante la administración de la dosis y las 16 semanas posteriores a la suspensión del tratamiento del studio
5. Mujeres embarazadas o en periodo de lactancia
6. Pacientes con un recuento total de leucocitos < 2500/μl, plaquetas < 100 000/μl, neutrófilos <1500/μl o hemoglobina <8,5 g/dl en la selección.
7. Exposición previa a secukinumab o a cualquier otro fármaco biológico directamente dirigido contra IL-17A o el receptor de IL-17.

E.5 End points

E.5.1

Primary end point(s)

PASI 75 and IGA mod 2011 0 or 1 response

PASI 75 y respuesta IGA mod. 2011 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. PASI 90
2. safety and tolerability
3. Pharmacokinetics

1. PASI90
2. Seguridad y tolerabilidad
3. Farmacocinética

E.5.2.1

Timepoint(s) of evaluation of this end point

1. week 12
2. up to week 224
3. up to week 224

1. Semana 12
2. hasta la semana 224
3. hasta la semana 224

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)

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

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

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

Belgium

Czech Republic

Estonia

Germany

Peru

Poland

Russian Federation

Spain

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

Ultimo paciente, última visita

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

Yes

F.1.1

Number of subjects for this age range:

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:

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 autorización de los progenitors (según 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

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. Patients can use standard available treatments to treat Psoriasis.

Ninguno. Los pacientes pueden usar tratamientos estándar disponibles para tratar la Psoriasis.

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

2018-08-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-08-16

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

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