Clinical Trials Register

Summary
EudraCT Number:	2013-001090-24
Sponsor's Protocol Code Number:	CAIN457F2314
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:	2013-11-12
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

2013-001090-24

A.3

Full title of the trial

A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis

Estudio multicéntrico, aleatorizado, doble ciego fase III de Secukinumab, controlado con placebo para demostrar la eficacia a las 16 semanas y evaluar la seguridad, tolerabilidad y eficacia a largo plazo en un periodo de 3 años en sujetos con espondilitis anquilosante activa

A.3.1

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

16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients

Eficacia a las 16 semanas y seguridad, tolerabilidad y eficacia en un periodo de 3 años de secukinumab en pacientes con espondilitis anquilosante activa

A.4.1

Sponsor's protocol code number

CAIN457F2314

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 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 Medico (ICRO)
B.5.3	Address:
B.5.3.1	Street Address	Gran Via 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	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	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous 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	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	Concentrate for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Ankylosing spondylitis

Espondilitis Anquilosante

E.1.1.1

Medical condition in easily understood language

Bechterev syndrom, Marie-Strümpell disease

Sindrome Bechterev, Enfermedad de Marie-Strümpell

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	PT
E.1.2	Classification code	10002556
E.1.2	Term	Ankylosing spondylitis
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue 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 the efficacy of at least one dose of secukinumab at Week 16 is superior to placebo based on the proportion of subjects achieving an ASAS 20 (Assessment of SpondyloArthritis International Society criteria) response in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF alpha therapy.

Demostrar que la eficacia de al menos una dosis de secukinumab en la semana 16 es superior a placebo en base a la proporción de sujetos que alcancen un ASAS 20 (criterios de la Sociedad Internacional de evaluación de la espondiloartritis) en sujetos con una EA activa a pesar de un tratamiento actual o previo con AINE, FAME y/o anti-TNF?.

E.2.2

Secondary objectives of the trial

-To demonstrate that the efficacy of at least one dose of secukinumab at Week 16 is superior to placebo based on:
1- the proportion of subjects achieving an ASAS 40 response
2- the change from baseline of hsCRP
3- the proportion of patients meeting the ASAS 5/6 response criteria
4- the change from baseline in total BASDAI
5- the change from baseline in the proportion of patients achieving ASAS partial remission
-To assess PFS usability utilizing the Self-Injection assessment checklist and Possible Hazard assessment checklist and to assess subject satisfaction with PFS utilizing the SIAQ
-Overall safety and tolerability of secukinumab LiV and PFS formulations compared to placebo as assessed by vital signs, clinical laboratory values and adverse events monitoring

Demostrar que la eficacia de al menos una dosis de secukinumab en la semana 16 es superior a placebo en base a:
1-la proporción de sujetos que logren una respuesta ASAS 40
2-al cambio de la PCRus desde la basal
3-la proporción de pacientes que logren una respuesta ASAS 5/6
4-al cambio de BASDAI total desde la basal
5-al cambio en la proporción de pacientes que logren una remisión parcial ASAS desde la basal
Evaluar la usabilidad de la JPC utilizando la lista de comprobación de evaluación de autoinyección y la lista de comprobación de evaluación de posibles riesgos, y evaluar la satisfacción del sujeto con las JPG mediante el cuestionario de evaluación de autoinyección (SIAQ)
La seguridad y tolerabilidad general de secukinumab en formulaciones LV y JPC comparadas con placebo evaluadas según las constantes vitales, los valores de laboratorio clínico y la monitorización de acontecimientos adversos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Moderate to severe AS
- Prior radiographic evidence according to the Modified NY Criteria (1984)
- Inadequate response to NSDAIDs
Other protocol-defined inclusion criteria may apply

-Diagnóstico de EA de moderada a grave
- evidencia con pruebas radiológicas documentadas previas que cumplan los criterios de New York modificados (1984)
-Pacientes tratados con AINEs y que hayan mostrado una respuesta inadecuada
Otros criterios de inclusion definidos en el protocolo

E.4

Principal exclusion criteria

- Pregnancy or lactation
- Ongoing infectious or malignant process on a chest X-ray or MRI
- Previous exposure to IL-17 or IL-17R targeting therapies
- Previous exposure to any biological immunomodulating agent excluding TNF antagonists
- Previous cell depleting therapy
Other protocol-defined exclusion critera may apply

- embarazo o periodo de lactancia
- Radiografía de tórax o RM con pruebas de un proceso infeccioso o maligno en curso
- Exposición previa terapias dirigidas contra la IL-17 o el receptor de la IL-17.
- Pacientes previamente tratados con cualquier agente biológico inmunomodulador, excepto los antagonistas al TNF?
- Tratamiento previo con cualquier terapia de destrucción celular
Otros criterios de exclusion definidos en el protocolo

E.5 End points

E.5.1

Primary end point(s)

Assessment of Spondyloarthritis International Society criteria / ASAS 20 response

Evaluación de los criterios de la Sociedad Internacional de evaluación de la espondiloartritis / respuesta ASAS 20

E.5.1.1

Timepoint(s) of evaluation of this end point

16 weeks

16 semanas

E.5.2

Secondary end point(s)

1- ASAS 40 response
2- Serum hsCRP
3- ASAS 5/6 response
4- Bath Ankylosing Spondylitis Disease Activity Index / BASDAI
5- Pre-filled syringe usability, possible hazard and patient satisfaction assessment
6- Overall safety and tolerability

1- respuesta ASAS 40
2- hsCRP sérica
3- respuesta ASAS 5/6
4- Índice de actividad para la espondilitis anquilosante de Bath / BASDAI
5- usabilidad de la jeringa precargada,evaluación de posibles riesgos y evaluación la satisfacción del sujeto
6- seguridad y tolerabilidad general

E.5.2.1

Timepoint(s) of evaluation of this end point

1 to 4: 16 weeks
5: Baseline to Week 16
6: 156 weeks

1 a 4: 16 semanas
5: desde la Basal hasta la Semana 16
6: 156 semanas

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

Yes

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)

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

Czech Republic

Germany

Greece

Portugal

Spain

Sweden

Mexico

Russian Federation

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

ultima visita del ultimo 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

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:

220

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

122

F.4.2.2

In the whole clinical trial

222

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)

The investigator must provide follow-up medical care for all subjects who are prematurely withdrawn from the study, or must refer them for appropriate ongoing care. This care may include initiating another treatment outside of the study as deemed appropriate by the investigator. This treatment may be any non-biologic DMARD. In case of a biologic treatment, a waiting period of 3 months before initiating the treatment is recommended.

El investigador debe proporcionar un seguimiento de la atencion medica a aquellos pacientes que se retiren del estudio prematuramente, o debe referirlos para que reciban asistencia medica apropiada. Esta asistencia médica puede incluir el iniciar otro tratamiento fuera del ensayo segun se considere apropiado por el investigador. Este tratamiento puede ser cualquier FAME no biologico. En caso de tratamiento biologico, se recomienda esperar 3 meses.

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

2013-12-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-12-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-12-11

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