Clinical Trials Register

Summary
EudraCT Number:	2014-005339-15
Sponsor's Protocol Code Number:	CAIN457A3302
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:	2015-03-03
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

2014-005339-15

A.3

Full title of the trial

Long term clear skin maintenance treatment optimization in patients with moderate to severe chronic plaque psoriasis: A randomized, multicenter, open-label with blinded-assessment, comparative, 52 week study to evaluate the efficacy, safety and tolerability of secukinumab 300 mg s.c.

Optimización del tratamiento de mantenimiento a largo plazo de la piel blanqueada en pacientes con psoriasis crónica en placas de moderada a grave: Estudio randomizado, multicéntrico, abierto con evaluación ciega, comparativo, de 52 semanas de seguimiento para evaluar la eficacia, seguridad y tolerabilidad de secukinumab 300 mg s.c.

A.3.1

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

Efficacy, safety and tolerability assessment of secukinumab 300 mg s.c. optimization in patients with moderate to severe chronic plaque psoriasis.

Evaluación de la eficacia, seguridad y tolerabilidad de secukinumab 300 mg s.c. en la optimización de pacientes con psoriasis crónica en placas de moderada a grave.

A.3.2

Name or abbreviated title of the trial where available

OPTIMISE

A.4.1

Sponsor's protocol code number

CAIN457A3302

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 Médico (LCO)
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	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/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.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 tiene la apariencia de áreas enrojecidas 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 in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.

El objetivo principal es demostrar, en el conjunto de pacientes con respuesta PASI 90 en la semana 24, la no inferioridad del tratamiento con 300 mg de secukinumab s.c. cada 6 semanas con respecto al tratamiento con 300 mg de secukinumab s.c. cada 4 semanas en el mantenimiento de una tasa de respuesta PASI 90 en la semana 52

E.2.2

Secondary objectives of the trial

To demonstrate in the patient pool of PASI 75 responders who do not reach a PASI 90 response at Week 24 that secukinumab 300 mg s.c. administered at a shorter dosing interval is superior to secukinumab 300 mg s.c. administered every 4 weeks at Week 52 based on the PASI 90 response rate.

Evaluate the proportion of PASI 50, PASI 75, PASI 100 and Novartis Investigator?s Global Assessment modified 2011 (IGA mod 2011) 0/1
responder rates at Week 52.

Evaluate the course of mean PASI over time from Week 24 to Week 52.

Evaluate the effect of different maintenance treatment frequencies on patient reported outcomes (PROs): Dermatology Life Quality Index (DLQI©), EuroQOL 5-Dimension Health Questionnaire (EQ-5D©), Work Productivity and Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), and the patient?s assessment of pain, itching and scaling.

El objetivo secundario principal es demostrar,en el conjunto de pacientes con una respuesta PASI 75 que no alcancen una respuesta PASI 90 en la semana 24,la superioridad en la semana 52 de la dosis de 300 mg de secukinumab s.c. administrado cada 2 semanas con respecto a la dosis de 300 mg de secukinumab s.c. administrado cada 4 semanas,en función de la tasa de respuesta PASI 90.
Otros:
?Evaluar el porcentaje de respuesta PASI 50, PASI 75, PASI 100 y las tasas de respondedores 0/1 en IGA mod 2011, en la semana 52
?Evaluar el cambio en la media de las puntuaciones PASI a lo largo del tiempo desde la semana 24 hasta la semana 52.
?Evaluar el efecto de diferentes frecuencias de administración del tratamiento de mantenimiento en los RNP:Índice de Calidad de Vida en Dermatología (DLQI©),EuroQoL 5D(EQ-5D©),Cuestionario de alteración de la actividad y productividad laboral específico para la psoriasis (WPAI-PSO) y evaluación del dolor, el prurito y la descamación por parte del paciente.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Chronic plaque-type psoriasis diagnosed for at least 6 months
prior to Screening and candidate for systemic therapy.
2. Moderate to severe psoriasis at Baseline as evidenced by:
3.PASI equal or major than 10 and
4. IGA mod 2011 score of 3 or higher (based on a scale of 0 to 4) and
5.BSA affected by plaque-type psoriasis equal or major than 10%.

1.Pacientes de ambos sexos de 18 años como mínimo en el momento de la selección.
2.Psoriasis crónica en placas diagnosticada como mínimo 6 meses antes de la selección y candidatos a tratamiento sistémico.
3.Psoriasis de moderada a grave en la visita basal, determinada por:
4.PASI mayor o igual 10 y
5.Puntuación IGA mod 2011 de 3 o superior (en una escala del 0 al 4) y
6.BSA afectada por la psoriasis en placas mayor o igual al 10 %.
4.Los pacientes deben ser capaces de entender al investigador y comunicarse con él, así como de cumplir con los requisitos del estudio y otorgar un consentimiento informado por escrito, firmado y fechado, antes de que se realice cualquier actividad relacionada con el estudio. En los casos pertinentes, se incluirá a un representante legal en la firma del CI, de conformidad con las leyes y demás normativas locales.

E.4

Principal exclusion criteria

1. History of exposure to any biologic drug taken for the treatment of chronic plaque psoriasis or any other indication including but not limited to anti-tumor necrosis factor (TNF) alpha, anti-interleukin (IL)12/23, or any anti-IL-17A or IL-17A receptor (IL 17AR) antibody.
2. History of hypersensitivity to any of the study drugs or to drugs of
similar chemical classes.
3. Forms of psoriasis other than chronic plaque-type (eg, pustular,
erythrodermic and guttate psoriasis).
4. Drug-induced psoriasis (ie, new onset or current exacerbation
from beta-blockers, calcium channel inhibitors or lithium).
5. Ongoing use of prohibited psoriasis treatments (eg, topical or
systemic corticosteroids, ultraviolet (UV) therapy).
6. Ongoing use of other non-psoriasis prohibited treatments.
Washout periods detailed in the protocol have to be adhered to.
All other prior non-psoriasis concomitant treatments must be at a stable dose as detailed in the protocol before initiation of study
drug.
7. Pregnant or nursing (lactating) women, where pregnancy is
defined as the state of a female after conception and until the
termination of gestation, confirmed by a positive human chorionic
gonadotropin (hCG) laboratory test (major 5 mIU/mL).
8. Women of child-bearing potential, defined as all women
physiologically capable of becoming pregnant, unless they are
using effective methods of contraception during dosing of study
drug and for 16 weeks after stopping study drug.
9. Active ongoing inflammatory diseases other than psoriasis that
might confound the evaluation of the benefit of secukinumab
therapy.
10. Underlying condition (including, but not limited to metabolic,
hematologic, renal, hepatic, pulmonary, neurologic, endocrine,
cardiac, infectious or gastrointestinal conditions) which, in the opinion of the Investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.

Other protocol-defined exclusion criteria may apply.

1.Antecedentes de exposición a cualquier fármaco biológico que se haya administrado para el tratamiento de la psoriasis crónica en placas o para cualquier otra indicación, incluidos, entre otros, anticuerpos frente al factor de necrosis tumoral (TNF) alfa, anticuerpos anti-IL 12/23 o cualquier anticuerpo anti-IL 17A o anticuerpo frente al receptor IL 17A (IL 17AR).
2.Administración de cualquier otro fármaco en fase investigación clínica en las 4 semanas previas a la visita basal o en un período de 5 semividas del fármaco en fase de investigación clínica, lo que sea mayor.
3.Antecedentes de hipersensibilidad a cualquiera de los fármacos del estudio o a fármacos de clase química similar.
4.Formas de psoriasis distintas de la psoriasis crónica en placas (p. ej., psoriasis pustulosa, psoriasis eritrodérmica o psoriasis en gotas).
5.Psoriasis inducida por fármacos (es decir, de nuevo inicio o reagudización actual por el uso de betabloqueantes, inhibidores de los canales del calcio o litio).
6.Uso actual de tratamientos prohibidos para la psoriasis (p. ej., corticosteroides tópicos o sistémicos, tratamiento con rayos ultravioleta [UV]).
7.Uso actual de tratamientos prohibidos para otras afecciones. Deben respetarse los períodos de lavado que se detallan en el protocolo (tabla 5-2). Todos los demás tratamientos concomitantes previos no relacionados con la psoriasis deben permanecer en una dosis estable, tal como se detalla en el protocolo, antes del inicio del fármaco de estudio.
8.Mujeres embarazadas o en período de lactancia, definiéndose el embarazo como el estado de la mujer después de la concepción y hasta el fin de la gestación, confirmado por un resultado positivo (mayor 5 mUI/ml) en las pruebas analíticas de gonadotropina coriónica humana (GCH).
9.Mujeres fértiles, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, a menos que utilicen métodos anticonceptivos eficaces durante la administración del tratamiento del estudio y durante las 16 semanas posteriores a la finalización del fármaco de estudio. Los métodos anticonceptivos eficaces son:
Abstinencia total (cuando está en consonancia con el estilo de vida preferido y habitual del paciente). La abstinencia periódica (p. ej., métodos del calendario, ovulación, sintotérmico, post-ovulación) y la marcha atrás no son métodos anticonceptivos aceptables.
Esterilización en mujeres (haberse sometido a ooforectomía quirúrgica bilateral con o sin histerectomía) o ligadura de trompas como mínimo 6 semanas antes de recibir el fármaco de estudio.
En caso de ooforectomía únicamente, solo cuando el estado reproductivo de la mujer se haya confirmado con una evaluación de seguimiento de los niveles hormonales.
Esterilización en varones (como mínimo 6 meses antes de la selección). En el caso de las mujeres en el estudio, la pareja masculina vasectomizada debe ser la única pareja de la paciente.
Métodos anticonceptivos de barrera: preservativo o tapón oclusivo (diafragma o capuchón cervical) con espuma/gel/película/crema espermicida o supositorio vaginal.
Uso de métodos de anticoncepción hormonal orales, inyectados o implantados u otras formas de anticoncepción hormonal con eficacia similar (tasa de error menor 1 %), por ejemplo anillo vaginal hormonal o anticonceptivo hormonal transdérmico.
Colocación de un dispositivo intrauterino (DIU) o sistema intrauterino (SIU).
En caso de que se utilicen anticonceptivos orales, las mujeres deben haber estado usando la misma píldora durante un mínimo de 12 semanas antes de que se les administre el fármaco de estudio.
Se considerará que las mujeres son posmenopáusicas y no pueden quedarse embarazadas si han tenido un período de 12 meses de amenorrea natural (espontánea) con un perfil clínico apropiado (p. ej., edad apropiada, antecedentes de síntomas vasomotores) o se les ha practicado ooforectomía quirúrgica bilateral (con o sin histerectomía) o ligadura de trompas al menos 6 semanas antes. En caso de ooforectomía únicamente, solo cuando el estado reproductivo de la mujer se haya confirmado con una evaluación de seguimiento de los niveles hormonales se considerará que no puede quedarse embarazada.
10.Enfermedades inflamatorias activas en curso distintas de la psoriasis que puedan inducir a error en la evaluación del efecto beneficioso del tratamiento con secukinumab.
11.Enfermedad preexistente (incluidas, entre otras, metabolopatías, hemopatías, nefropatías, hepatopatías, neumopatías, neuropatías, endocrinopatías, cardiopatías, infecciones o gastroenteropatías) que, en opinión del investigador puede inmunocomprometer de modo significativo al paciente y/o ponerle en una situación de riesgo inaceptable para recibir un tratamiento inmunomodulador.

... Ver Protocolo para más información

E.5 End points

E.5.1

Primary end point(s)

Psoriasis Area and Severity Index 90 response rate

Tasa de respuesta PASI 90 (índice de severidad y extensión de la psoriasis )

E.5.1.1

Timepoint(s) of evaluation of this end point

52 weeks

52 semanas

E.5.2

Secondary end point(s)

1) Psoriasis Area and Severity Index 90 response rate
2) Psoriasis Area and Severity Index 50 response rate
3) Psoriasis Area and Severity Index 75 response rate
4) Psoriasis Area and Severity Index 100 response rate
5) Investigator's Global Assessment modified 2011 0/1 responder rates
6) mean Psoriasis Area and Severity Index
7) Dermatology Life Quality Index
(DLQI©)
8) EuroQOL 5-Dimension Health Questionnaire (EQ-5D©)
9) Work Productivity and Activity Impairment Questionnaire-Psoriasis
(WPAI-PSO)
10) patient?s assessment of pain, itching and
scaling.

1) Tasa de respuesta PASI 90 (PASI : Índice de severidad y extensión de la psoriasis )
2) Tasa de respueta PASI 50 (PASI : Índice de severidad y extensión de la psoriasis )
3) Tasa de respuesta PASI 75 (PASI : Índice de severidad y extensión de la psoriasis )
4) Tasa de respuesta PASI 100 (PASI : Índice de severidad y extensión de la psoriasis )
5) Tasas de respondedores 0/1 IGA mod 2011 (Evaluación global del investigador modificada en 2011)
6) Media del PASI (PASI : Índice de severidad y extensión de la psoriasis )
7 DLQI (Índice de Calidad de Vida en Dermatología)

E.5.2.1

Timepoint(s) of evaluation of this end point

1) week 52
2) week 52
3) week 52
4) week 52
5) week 52
6) From week 24 to Week 52
7) week 52
8) week 52
9) week 52
10) week 52

1) semana 52
2) semana 52
3) semana 52
4) semana 52
5) semana 52
6) de semana 24 a semana 52
7) 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

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

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

Yes

E.8.1.7.1

Other trial design description

Evaluación ciega

Blinded-Assessment

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

Yes

E.8.2.3.1

Comparator description

300 mg dose of secukinumab every 4 weeks

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

275

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

Austria

Belgium

Bulgaria

Croatia

Czech Republic

Denmark

Finland

France

Germany

Greece

Hungary

Israel

Italy

Latvia

Lithuania

Netherlands

Norway

Poland

Portugal

Romania

Russian Federation

Serbia

Slovakia

Spain

Sweden

Switzerland

United Kingdom

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

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:

1422

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

158

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

250

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1450

F.4.2.2

In the whole clinical trial

1580

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.

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

2015-04-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-04-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-05-22

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