Clinical Trials Register

Summary
EudraCT Number:	2011-000276-34
Sponsor's Protocol Code Number:	CAIN457F2306
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:	2011-12-29
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-000276-34

A.3

Full title of the trial

Studio multicentrico, randomizzato, in doppio cieco, controllato verso placebo, per dimostrare l’efficacia di secukinumab a 24 settimane e per valutare la sicurezza, la tollerabilita' e l’efficacia a lungo termine fino a 2 anni in pazienti con artropatia psoriasica attiva

A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active psoriatic arthritis

A.3.1

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

2 year study of secukinumab (AIN457) treatment in patients with active Psoriatic Arthritis

Studio di 2 anni con secukinumab (AIN457) nel trattamento di pazienti con artropatia psoriasica attiva

A.4.1

Sponsor's protocol code number

CAIN457F2306

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
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 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
B.5.2	Functional name of contact point	Drug Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Largo Umberto Boccioni, 1
B.5.3.2	Town/ city	ORIGGIO
B.5.3.3	Post code	21040
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 02 96541
B.5.5	Fax number	+39 02 9659066
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.2.5	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	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Secukinumab
D.3.9.2	Current sponsor code	AIN457
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.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	Powder for solution for injection
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	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

Psoriatic arthritis

Artrite psoriasica

E.1.1.1

Medical condition in easily understood language

Psoriatic arthritis

Artrite psoriasica

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10037160
E.1.2	Term	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 demonstrate the efficacy of secukinumab 75 or 150 mg at Week 24 is superior to placebo in patients with active PsA based on the proportion of patients achieving an ACR20 response in the subgroup of subjects who are TNFα inhibitor naïve.

dimostrare che la proporzione di pazienti che raggiungono i criteri di risposta ACR 20 a 24 settimane è maggiore con secukinumab rispetto al placebo nel sottogruppo di soggetti naïve al trattamento con un inibitore del TNFα.

E.2.2

Secondary objectives of the trial

• The efficacy of secukinumab 75 or 150 mg at Week 24 is superior to placebo based on the proportion of subjects achieving an ACR20 response in the entire study population. • The improvement (change) from baseline on secukinumab 75 or 150 mg is superior to placebo for the HAQ-DI at Week 24 in the subgroup of subjects who are TNFα inhibitor naïve. • The improvement (change) from baseline to Week 24 on secukinumab 75 and 150 mg is superior to placebo for joint/bone structural damage (van der Heijde modified total Sharp score) in the subgroup of subjects who are TNFα inhibitor naïve. • Secukinumab 75 or 150 mg is superior to placebo (as originally randomized) with regards to the proportion of subjects achieving Major Clinical Response at Week 52 in the subgroup of subjects who are TNFα inhibitor naïve.

1.La proporzione di pazienti che raggiungono i criteri di risposta ACR 20 a 24 sett. è maggiore con secukinumab rispetto al placebo nell’intera popolazione di studio. 2. Il miglioramento(variazione)rispetto al basale con secukinumab è superiore al placebo nella valutazione HAQ-DI dopo 24 sett. di trattamento nel sottogruppo di soggetti naïve al trattamento con un inibitore del TNFα. 3.Il miglioramento(variazione)rispetto al basale a 24 sett. con secukinumab è superiore al placebo per il danno strutturale articolare/osseo nel sottogruppo di soggetti naïve al trattamento con un inibitore del TNFα. 4.Il trattamento per 12 mesi con secukinumab è superiore al trattamento ritardato con placebo di secukinumab/ secukinumab,relativamente alla proporzione di soggetti che raggiungono una risposta clinica maggiore nel sottogruppo di soggetti naïve al trattamento con un inibitore del TNFα

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or non-pregnant, non-lactating female subjects at least 18 years of age 2. Diagnosis of PsA classified by CASPAR criteria (see Appendix 2) and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen joints out of 76 (dactylitis of a digit counts as one joint each) 3. RF and anti-CCP antibodies negative. 4. Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2 cm diameter (but not in intertriginous areas such as armpits, or chest between breasts, or groin) or nail changes consistent with psoriasis or a documented history of plaque psoriasis. SEE PROTOCOL FOR MORE DETAILS

1. Uomini o donne, non in gravidanza o in allattamento, di età maggiore o uguale a 18 anni 2. Diagnosi di PsA classificata secondo i criteri CASPAR con sintomi da almeno 6 mesi di PsA da moderata a severa, con presenza al Basale di almeno 3 articolazioni doloranti su 78 e di almeno 3 articolazioni gonfie su 76 (la dattilite di un dito conta come una articolazione) 3. Fattore reumatoide e anticorpi anti-CCP negativi 4. Diagnosi di psoriasi a placche attiva, con almeno una placca psoriasica di diametro ≥2 cm (ma non alle ascelle, o al torace tra i seni o all’inguine) o modifiche delle unghie compatibili con psoriasi o una storia documentata di psoriasi a placche. CONSULTARE IL PROTOCOLLO PER MAGGIORI DETTAGLI

E.4

Principal exclusion criteria

1. Chest X-ray with evidence of ongoing infectious or malignant process, obtained within 3 months of screening and evaluated by a qualified physician. 2. Subjects who have previously been treated with more than 3 different TNFα inhibitors (investigational or approved). 3 Subjects taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine). 4 Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα, investigational or approved. 5 Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor. 6 Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 and investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)

1. Radiografia al torace con evidenza di processi infettivi o neoplasie in atto, effettuata nei 3 mesi prima dello screening e valutata da un medico qualificato 2. Pazienti precedentemente trattati con più di 3 differenti farmaci diretti contro il TNFα (in corso di sviluppo o già approvati) 3. Soggetti che assumono analgesici oppiacei ad alta potenza (ad es. metadone, idromorfone o morfina) 4. Soggetti che hanno già ricevuto farmaci biologici immunomodulatori, con l’eccezione di quelli diretti verso il TNFα, in sviluppo o già approvati. 5. Precedente esposizione a secukinumab o a qualsiasi altro farmaco biologico diretto verso l’IL-17 o il recettore dell’L-17 6. Qualsiasi precedente terapia in grado di determinare deplezione cellulare, inclusi ma non limitati a anti-CD20, farmaci in sviluppo (ad es. CAMPATH, anti-CD4, anti-CD5, anti-CD3, e anti-CD19)

E.5 End points

E.5.1

Primary end point(s)

ACR 20

E.5.1.1

Timepoint(s) of evaluation of this end point

24 weeks

24 settimane

E.5.2

Secondary end point(s)

- HAQ-DI, and van der Heijde modified total Sharp Score - Major clinical response

- HAQ-DI, e punteggio totale Sharp modificato secondo van der Heijde - Maggiore risposta clinica

E.5.2.1

Timepoint(s) of evaluation of this end point

Respectively: - 16 weeks - 52 weeks

Rispettivamente: - 16 settimane - 52 settimane

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

Yes

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

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

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

Argentina

Australia

Brazil

Canada

Israel

Peru

Philippines

Russian Federation

Singapore

Thailand

Turkey

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

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

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:

568

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

249

F.4.2.2

In the whole clinical trial

600

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)

Extension study is planned

E' prevista l'estensione dello studio

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

2011-07-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-07-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-10-21

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials