Clinical Trials Register

Summary
EudraCT Number:	2014-005339-15
Sponsor's Protocol Code Number:	CAIN457A3302
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:	2018-02-22
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

Italy - Italian Medicines Agency

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.

Ottimizzazione della terapia di mantenimento a lungo termine di una cute esente da lesioni in pazienti con psoriasi a placche cronica da moderata a severa: studio
multicentrico, randomizzato, comparativo, in aperto, con
valutazione del PASI in cieco, della durata di 52 settimane per determinare l’efficacia, la sicurezza e la tollerabilità del 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.

Ottomizzazione della valutazione dell'efficacia, della sicurezza e della tollerabilità di secukinumab 300 mg s.c. in pazienti con psoriasi a placche cronica da moderata a severa.

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 FARMA S.P.A.
B.1.3.4	Country	Italy
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 FARMA S.p.A.
B.5.2	Functional name of contact point	Drug Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Largo U. 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	Yes
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	Italy
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	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
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.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

Psoriasi a placche

E.1.1.1

Medical condition in easily understood language

Psoriasis looks like red, raised scaly areas of the skin

Psoriasi con aree di cute ispessita, arrossata e ricoperta di squame

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 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.

L’obiettivo primario è di dimostrare, nel gruppo di pazienti che ottengono una risposta PASI 90 alla Settimana 24, che il trattamento con secukinumab
300 mg s.c. ogni 6 settimane non è inferiore al trattamento con secukinumab 300 mg s.c. ogni 4 settimane rispetto al mantenimento di un tasso di risposta PASI 90 alla Settimana 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 (WPAIPSO), and the patient's assessment of pain, itching and scaling.

- Dimostrare, nel gruppo di pazienti che ottengono una risposta PASI 75 ma che non raggiungono una risposta PASI 90 alla Settimana 24, che secukinumab 300 mg s.c. somministrato ogni 2 settimane è superiore a secukinumab 300 mg s.c. somministrato ogni 4
settimane alla Settimana 52 in base al tasso di risposta PASI 90.
- Valutare la proporzione dei tassi di risposta PASI 50, PASI 75, PASI 100 e IGA mod 2011 0/1 alla Settimana 52
- Valutare l’andamento medio dell’indice PASI nel tempo dalla Settimana 24 alla Settimana 52
- Valutare l’effetto di diverse frequenze di somministrazione del trattamento di mantenimento sugli esiti riportati dai pazienti (PRO): (DLQI®), (EQ-5D®), (WPAIPSO), e la valuvalutazione da parte del paziente del dolore, del prurito e della desquamazione.

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:
• PASI ≥ 10 and
• IGA mod 2011 score of 3 or higher (based on a scale of 0 to 4) and
• BSA affected by plaque-type psoriasis of ≥ 10%.

1. Uomini o donne di almeno 18 anni di età al momento dello screening.
2. Pazienti affetti da psoriasi a placche cronica diagnosticata almeno 6 mesi prima dello screening e candidati a terapia sistemica.
3. Psoriasi da moderata a severa, come evidenziato da:
· PASI ≥10 e
· Punteggio IGA mod 2011 di 3 o superiore (in base ad una scala da 0 a 4) e
· BSA colpita da psoriasi a placche ≥10%.
4. Pazienti in grado di comprendere e di comunicare con lo sperimentatore, e in grado di aderire alle richieste dello studio e che hanno fornito un consenso informato scritto firmato e datato prima dell’effettuazione di qualsiasi attività correlata allo studio.

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 (> 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. Anamnesi di esposizione a qualsiasi farmaco biologico assunto per il trattamento della psoriasi a placche cronica o per qualsiasi altra indicazione compresi, ma non limitati a, fattore di necrosi anti-tumorale (anti-tumor necrosi factor – TNF) alfa, anti-interleuchina (IL)12/23, o anticorpi anti-IL-17A o anti - recettore di IL-17/A (IL-17AR).
2. Anamnesi di ipersensibilità ad uno qualsiasi dei trattamenti in studio o a farmaci di classi chimiche simili.
3.Forme di psoriasi diverse dalla psoriasi cronica a placche (ad es. psoriasi pustolosa, etritrodermica e guttata).
4. Psoriasi farmaco-indotta (ovvero, insorgenza o attuale esacerbazione da beta-bloccanti, inibitori del canale del calcio o litio).
5.Attuale uso di trattamenti proibiti per la psoriasi (ad es. corticosteroidi topici o sistemici, terapia ad ultravioletti – UV).
6 Attuale uso di altri trattamenti proibiti non per la psoriasi. Devono essere rispettati i periodi di washout dettagliati nel protocollo. Tutti i trattamenti
concomitanti precedenti per la psoriasi devono essere a dose stabile come dettagliato nel protocollo prima dell’inizio del farmaco in studio.
7. 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 (hGC) (>5 mlU/mL).
8.Donne potenzialmente fertili, definite come tutte le donne fisiologicamente in grado di iniziare una gravidanza, a meno che non utilizzino metodi contraccettivi efficaci durante la somministrazione del farmaco in studio e per le 16 settimane successive all’interruzione del farmaco in studio.
9.Patologie infiammatorie attive in corso diverse dalla psoriasi che potrebbero confondere la valutazione del beneficio della terapia con il
secukinumab.
10.Condizioni di base (comprese, ma non limitate a, condizioni metaboliche, ematologiche, renali, epatiche, polmonari, neurologiche, endocrine, cardiache, infettive o gastrointestinali) che, a giudizio dello sperimentatore, immunocompromettono il paziente in modo
significativo e/o lo espongono ad un rischio inaccettabile nel ricevere una terapia immunomodulante.

E.5 End points

E.5.1

Primary end point(s)

PASI 90 response rate

Tasso di risposta PASI 90

E.5.1.1

Timepoint(s) of evaluation of this end point

52 weeks

52 settimane

E.5.2

Secondary end point(s)

Patient's assessment of pain, itching and
scaling.

Valutazione da parte del paziente del dolore, del prurito e della desquamazione

E.5.2.1

Timepoint(s) of evaluation of this end point

week 52

settimana 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

Valutazione in cieco

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

secukinumab 300 mg s.c. ogni 4 settimane

300 mg s.c. 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

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

Austria

Belgium

Bulgaria

Croatia

Czech Republic

Denmark

Finland

France

Germany

Greece

Hungary

Ireland

Israel

Italy

Latvia

Lithuania

Netherlands

Norway

Poland

Portugal

Romania

Russian Federation

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

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

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

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

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.

Al termine dello studio lo sperimentatore informerà il paziente dei farmaci e delle terapie disponibili per il trattamento della psoriasi.

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

2015-09-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-07-09

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

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