Clinical Trials Register

Summary
EudraCT Number:	2018-002521-30
Sponsor's Protocol Code Number:	CAIN457F2304E1
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-15
Trial 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

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-002521-30

A.3

Full title of the trial

An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis

Uno studio di estensione che valuta l’efficacia a lungo termine, la sicurezza e la tollerabilità fino a 4 anni di secukinumab per via sottocutanea in pazienti con Artrite Idiopatica Giovanile, sottotipi Artrite Psoriasica Giovanile e Artrite Entesite Relata

A.3.1

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

An extension study of subcutaneous secukinumab in patients with Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)

Uno studio di estensione di secukinumab per via sottocutanea in pazienti con Artrite Idiopatica Giovanile e Artrite Entesite Relata

A.3.2

Name or abbreviated title of the trial where available

Secukinumab long-term safety, tolerability and efficacy in JPsA and ERA up to 4 years

Sicurezza, tollerabilità e efficacia di secukinumab fino a 4 anni in JPsA e ERA

A.4.1

Sponsor's protocol code number

CAIN457F2304E1

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 PHARMA AG
B.1.3.4	Country	Switzerland
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 Farma S.p.A.
B.5.2	Functional name of contact point	Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Largo Umberto Boccioni 1
B.5.3.2	Town/ city	Origgio (VA)
B.5.3.3	Post code	21040
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390296541
B.5.5	Fax number	0039029659066
B.5.6	E-mail	info.studiclinici@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.2.1.1.1	Trade name	COSENTYX - 150 MG - SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA -USO SOTTOCUTANEO - SIRINGA (VETRO) 1 ML (150MG/ML)- 2 SIRINGHE PRERIEMPITE
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS EUROPHARM 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.3.1	Product name	-
D.3.2	Product code	[-]
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	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis

Artrite Psoriasica Giovanile e Artrite Entesite Relata

E.1.1.1

Medical condition in easily understood language

Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis

Artrite Psoriasica Giovanile e Artrite Entesite Relata

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10072745
E.1.2	Term	Enthesitis related arthritis
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10076674
E.1.2	Term	Juvenile psoriatic arthritis
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 evaluate the long-term efficacy of secukinumab (provided as pre-filled syringes) with respect to JIA ACR30 response over time up to Week 308 in patients with active JPsA and ERA subtypes of JIA and who completed the Phase III study CAIN457F2304.

Valutare l’efficacia a lungo termine di secukinumab (fornito in siringhe pre-riempite) amministrato per via sottocutanea, in merito a risposte JIA ACR30 fino alla settimana 308 di trattamento, in pazienti con JIA in fase attiva, sottotipi JPsA e ERA, e che hanno completato lo studio di fase III CAIN457F2304.

E.2.2

Secondary objectives of the trial

1. To evaluate the long-term safety, tolerability and immunogenicity of secukinumab as assessed by vital signs, clinical laboratory variables and adverse events monitoring over time up to Week 308.
2. To evaluate the long-term effect of secukinumab treatment for all patients and each JIA category with respect to:
-JIA ACR/50/70/90/100 and inactive disease status
-Each JIA ACR core component
-Change from baseline of core study CAIN457F2304
-Juvenile Arthritis Disease Activity Score (JADAS)
-Total Enthesitis count
-Total Dactylitis count
3. To evaluate Pharmacokinetics (PK) of secukinumab.

1. Valutare sicurezza, tollerabilità e immunogenicità a lungo termine di secukinumab, tramite il monitoraggio di parametri vitali e variabili cliniche di laboratorio e il monitoraggio degli eventi avversi fino alla settimana 308 di trattamento.
2. Valutare l’effetto a lungo termine del trattamento con secukinumab in tutti i pazienti e tutte le categorie JIA in merito a:
• Risposte JIA ACR 50/70/90/100 e stato di malattia inattivo
• Ciascun componente dello score JIA ACR
• Modifiche rispetto al baseline dello studio core CAIN457F2304
• Juvenile Arthritis Disease Activity Score (JADAS)
• Conta delle entesiti
• Conta delle dattiliti
3. Valutare la farmacocinetica di secukinumab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patient must have participated in core study CAIN457F2304, and must have completed the entire treatment period up to and including Week 104.
2. Patients must be deemed by the investigator to benefit from continued secukinumab therapy.

Other protocol-defined inclusion criteria apply.

1. I pazienti devono aver partecipato allo studio core CAIN457F2304, e devono aver completato l’intero periodo di trattamento fino (ed inclusa) alla settimana 104.
2. Il medico deve giudicare che il paziente abbia tratto beneficio dalla terapia continuativa con secukinumab.
3. Per pazienti che non abbiano l’età per dare il consenso (18 anni): il consenso scritto dei genitori o del rappresentante legale e l’assenso del bambino, se appropriato, devono essere ottenuti prima della partecipazione allo studio e prima dello svolgimento di qualsiasi procedura correlata allo studio. Inoltre, se il paziente raggiunge l’età del consenso (18 anni) durante lo studio, dovrà firmare il modulo per il consenso informato.
4. Per pazienti che abbiamo l’età per dare il consenso (18 anni): il consenso scritto deve essere ottenuto prima della partecipazione allo studio e prima dello svolgimento di qualsiasi procedura correlata allo studio.

E.4

Principal exclusion criteria

1. Plans for administration of live vaccines during the extension study period.
2. Any patient taking other concomitant biologic immunomodulating agent(s) except secukinumab.
3. Any patient who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms.

Other protocol-defined exclusion criteria apply.

1. Programma di esecuzione di vaccini vivi durante il periodo di estensione dello studio.
2. Terapia concomitante con altri farmaci biologici immunomodulanti, con l’eccezione di secukinumab.
3. Paziente che non ha avuto beneficio durante lo studio core, ovvero ci sia stata mancanza di miglioramento dei sintomi o peggioramento degli stessi.
4. Donne in gravidanza o allattamento, con la gravidanza definita come lo stato di una donna dopo il concepimento e fino al termine della gestazione, confermato da un test di laboratorio positivo per gonadotropina corionica umana (hCG).
5. Donne in età fertile (menarca avvenuto in precedenza o nel corso dello studio) che non acconsentano all’astinenza o, se sessualmente attive, non acconsentano all’uso di terapia anticoncezionale.

E.5 End points

E.5.1

Primary end point(s)

JIA ACR30 response

Risposte JIA ACR30

E.5.1.1

Timepoint(s) of evaluation of this end point

Until Week 308 visit.

Fino alla visita della settimana 308

E.5.2

Secondary end point(s)

AEs, lab values, vital signs, Anti-Drug Antibodies (ADAs).
JIA ACR 50/70/90/100, JIA ACR Core Components, Inactive Disease Status, JADAS Score, Total Enthesitis count, Total Dactylitis count.
Secukinumab serum concentrations and derived PK parameters.

AEs, valori di laboratorio, segni vitali, Anti-Drug Antibodies (ADAs).
JIA ACR 50/70/90/100, JIA ACR Core Components, Status di malattia inattiva, punteggio JADAS, conteggio totale di entesite, conteggio totale della dattilite.
Concentrazioni sieriche di Secukinumab e parametri PK dei derivati.

E.5.2.1

Timepoint(s) of evaluation of this end point

Until Week 308 visit.

Fino alla visita della settimana 308

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

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

Immunogenicità

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

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

Yes

E.8.2.3.1

Comparator description

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

Information not present in EudraCT

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

Russian Federation

South Africa

Turkey

United States

Belgium

Germany

Italy

Poland

Spain

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

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.1.1.1

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)

Yes

F.1.2.1

Number of subjects for this age range:

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.

Soggetti pediatrici che possono richiedere l'autorizzazione dei genitori, in base alle normative locali.

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)

The Investigator must provide follow-up medical care for all patients 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.

Lo sperimentatore deve fornire assistenza medica di follow-up per tutti i pazienti che vengono ritirati prematuramente dallo studio, o devono indirizzarli per cure appropriate attualmente in uso. Questa cura può includere l'avvio di un altro trattamento al di fuori dello studio come ritenuto appropriato dallo sperimentatore. Questo trattamento può essere qualsiasi DMARD non biologico. In caso di trattamento biologico, si raccomanda un periodo di attesa di 3 mesi prima di iniziare il trattamento

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

2019-04-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-02-25

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

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IMP with orphan designation in the indication
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