Clinical Trials Register

Summary
EudraCT Number:	2010-024529-18
Sponsor's Protocol Code Number:	CAIN457F2305
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2010-024529-18

A.3

Full title of the trial

A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis

Studio multicentrico, randomizzato, in doppio cieco, controllato verso placebo per dimostrare l'efficacia di secukinumab a 16 settimane e per valutare la sicurezza, la tollerabilita' e l'efficacia a lungo termine fino a 2 anni in pazienti con spondilite anchilosante attiva

A.3.1

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

2-year study of secukinumab treatment in patients with active Ankylosing Spondylitis

Studio di 2 anni di trattamento con secukinumab in pazienti con spondilite anchilosante attiva

A.4.1

Sponsor's protocol code number

CAIN457F2305

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 injection
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

Spondilite anchilosante

E.1.1.1

Medical condition in easily understood language

Bechterev syndrome, Marie-Strümpell disease

Sindrome di Bechterev, malattia di 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	14.1
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 each secukinumab regimen at Week 16 is superior to placebo in patients with active Ankylosing Spondylitis based on the proportion of patients achieving an ASAS 20 (Assessment of Spondyloarthritis International Society criteria) response in the subgroup of patients who are TNFα inhibitor naïve

Dimostrare che l’efficacia di ciascun regime di secukinumab a 16 settimane è superiore al placebo in pazienti con AS attiva basata sulla proporzione di pazienti che raggiungono la risposta ASAS 20 (criteri di valutazione da parte della Società Internazionale sulla Spondiloartrite) nel sottogruppo di pazienti che non hanno mai ricevuto un trattamento con inibitori del TNFα.

E.2.2

Secondary objectives of the trial

1. To demonstrate the efficacy of each secukinumab regimen at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response in the whole study population. 2. To demonstrate the efficacy of each secukinumab regimen at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 40 response in patients who are TNFα inhibitor naïve. 3. To demonstrate the efficacy of each secukinumab regimen at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 40 response in the whole study population.

1. Dimostrare che l’efficacia di ciascun regime di secukinumab a 16 settimane è superiore al placebo in pazienti con AS attiva basata sulla proporzione di pazienti che raggiungono la risposta ASAS 20 nell’intera popolazione in studio; 2. dimostrare che l’efficacia di ciascun regime di secukinumab a 16 settimane è superiore al placebo in pazienti con AS attiva basata sulla proporzione di pazienti che raggiungono la risposta ASAS 40 nei pazienti che non hanno mai ricevuto un trattamento con inibitori del TNFα. 3. Dimostrare che l’efficacia di ciascun regime di secukinumab a 16 settimane è superiore al placebo in pazienti con AS attiva basata sulla proporzione di pazienti che raggiungono la risposta ASAS 40 nell’intera popolazione in studio; Per maggiori dettagli consultare il capitolo 2 del protocollo originale.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male or non-pregnant, non-lactating female patients at least 18 years of age; • Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984); • Patients should have been on NSAIDs with an inadequate response; • Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose; • Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response. Other protocol-defined inclusion criteria may apply.

• Uomini o donne, non in gravidanza o in allattamento, di età maggiore o uguale a 18 anni; • Diagnosi di AS da moderata a severa, con documentata precedente evidenza radiologica, in grado di soddisfare i criteri di New York modificati per la AS (1984); • I pazienti devono essere stati trattati con FANS con risposta inadeguata; • I pazienti che stanno assumendo regolarmente FANS come parte della loro terapia per la AS, dovranno assumerli in dose stabile; • I pazienti che sono stati in terapia con un farmaco anti-TNFα (non più di uno) devono avere evidenziato una risposta inadeguata. Per maggiori dettagli consultare il paragrafo 4.1 del protocollo originale.

E.4

Principal exclusion criteria

• Chest X-ray with evidence of ongoing infectious or malignant process; • Patients with total ankylosis of the spine; • Patients previously treated with any biological immunomodulating agents except for those targeting TNFα; • Previous treatment with any cell-depleting therapies. Other protocol-defined exclusion criteria may apply.

• Radiografia al torace con evidenza di processi infettivi o neoplasie in atto; • Pazienti con anchilosi totale della colonna vertebrale; • Pazienti precedentemente trattati con qualsiasi altro farmaco immunomodulante con l’eccezione di farmaci diretti contro il TNFα; • Qualsiasi precedente terapia in grado di determinare deplezione cellulare. Per maggiori dettagli consultare il paragrafo 4.2 del protocollo originale.

E.5 End points

E.5.1

Primary end point(s)

ASAS 20

E.5.1.1

Timepoint(s) of evaluation of this end point

16 weeks

16 settimane

E.5.2

Secondary end point(s)

ASAS 20 and ASAS 40

ASAS 20 e ASAS 40

E.5.2.1

Timepoint(s) of evaluation of this end point

16 weeks

16 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

Canada

Mexico

Peru

Russian Federation

Taiwan

Turkey

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:

332

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

166

F.4.2.2

In the whole clinical trial

350

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	2014-12-17

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