Clinical Trials Register

Summary
EudraCT Number:	2017-000679-10
Sponsor's Protocol Code Number:	CAIN457K2340
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-09-22
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2017-000679-10

A.3

Full title of the trial

A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis

Étude multicentrique, randomisée, partiellement en aveugle et contrôlée contre traitement actif, du sécukinumab, destinée à démontrer la réduction de la progression radiographique versus GP2017 (biosimilaire adalimumab) à 104 semaines et évaluer à long terme la sécurité d'emploi, la tolérance et l'efficacité jusqu'à 2 ans, chez les patients atteints d'une spondylarthrite ankylosante active

A.3.1

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

Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)

A.3.2

Name or abbreviated title of the trial where available

SURPASS

A.4.1

Sponsor's protocol code number

CAIN457K2340

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 Pharma S.A.S
B.5.2	Functional name of contact point	Information&Communication Médicales
B.5.3	Address:
B.5.3.1	Street Address	2 et 4 rue Lionel Terray
B.5.3.2	Town/ city	Rueil-Malmaison
B.5.3.3	Post code	92500
B.5.3.4	Country	France
B.5.4	Telephone number	+33 1 5547 6600
B.5.5	Fax number	+33 1 5547 6100
B.5.6	E-mail	icm.phfr@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
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.3.4	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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	adalimumab
D.3.2	Product code	GP2017
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	ADALIMUMAB
D.3.9.1	CAS number	331731-18-1
D.3.9.2	Current sponsor code	GP2017
D.3.9.4	EV Substance Code	SUB20016
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	50
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	Solution for injection in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous 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

E.1.1.1

Medical condition in easily understood language

Bechterew`s syndrome

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	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 the proportion of subjects on secukinumab (combined 150 mg s.c. and 300 mg s.c.) with no radiographic progression as measured by mSASSS at Week 104 is superior to subjects on GP2017 (adalimumab biosimilar 40 mg s.c.).

De démontrer que la proportion de patients sans progression radiographique, mesurée par le score mSASSS à la semaine 104, est supérieure sous sécukinumab (150 mg s.c. et 300 mg s.c. combinés) versus GP2017 (biosimilaire adalimumab 40 mg s.c.).

E.2.2

Secondary objectives of the trial

-To demonstrate the proportion of subjects on AIN457 (150mg sc or 300mg sc) with no radiographic progression at W104 is superior to subjects on GP2017
-To demonstrate the change from baseline in mSASSS in subjects on AIN457 (150mg sc or 300mg sc) is superior to GP2017 at W104
-To demonstrate the proportion of subjects with a syndesmophyte at baseline with no new syndesmophytes at W104 on AIN457 (150mg sc or 300mg sc) is superior to GP2017
-To evaluate the Berlin SI joint edema score in subjects on AIN457 (150mg sc and 300mg sc) at W104 versus GP2017 (in a subset of subjects at selected sites)
-To evaluate the ASspiMRI-a Berlin modification score in subjects on AIN457 (150mg sc and 300mg sc) at W104 versus GP2017 (in a subset of subjects at selected sites)
-To evaluate ASAS20 response, ASAS40 response, ASAS partial remission and ASDAS inactive disease in subjects on AIn457 150mg sc compared to AIN457 300mg sc at W104
-Overall safety and tolerability of AIN457

-démontrer que la proportion de patients sans progression radiographique à Semaine 104(S104) est > sous AIN457(150mg sc ou 300mg sc) VS GP2017.-Démontrer que l’efficacité mesurée par la variation du score mSASSS à S104 par rapport à baseline, est > chez patients sous AIN457(150mg sc ou 300mg sc) vs GP2017.-Démontrer que la proportion de patients avec au moins un syndesmophyte à la baseline sans nouveau syndesmophyte à S104 est > sous AIN457(150mg sc ou 300mg sc) vs GP2017.-Evaluer le score d’œdème SI de Berlin chez patients sous AIN457(150mg sc et 300mg sc) VS GP2017 à S104 (sous-ensemble de patients de sites sélectionnés).-Evaluer le score de Berlin modifié ASspiMRI chez patients sous AIN457(150mg sc et 300mg sc) VS GP2017 à S104 (sous-ensemble de patients de sites sélectionnés).-Évaluer la réponse ASAS 20, réponse ASAS 40, la rémission partielle ASAS et la maladie inactive ASDAS chez patients sous AIN457 150mg sc VS 300mg sc à S104.-Sécurité d'emploi et tolérance globales du AIN457.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Male or non-pregnant, non-nursing female patients at least 18 years of age.
- Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/non biologic DMARD therapy.
- Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10.
- Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10).
- Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm).
- hsCRP ≥ 5mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray.

Other protocol-defined inclusion criteria may apply,

-Homme ou femme (hors grossesse et allaitement) d'au moins 18 ans
-Diagnostic de SA modérée à sévère avec des signes radiologiques de la maladie (relecture centralisée) répondant aux critères de New York modifiés pour la SA malgré traitement antérieur ou en cours par des AINS/DMARD non biologiques
-SA active déterminée par un score BASDAI total ≥ 4 (0-10)
-Douleur rachidienne mesurée par question n°2 du BASDAI≥ 4 (0-10)
-Rachialgie totale mesurée sur l'échelle visuelle analogique EVA ≥ 40 mm (0-100 mm)
-hs-CRP ≥ 5 mg/l OU présence d'au moins un syndesmophyte sur la radiographie rachidienne interprétée par le laboratoire centralisé.

D'autres critères d'inclusion définis dans le protocole peuvent s'appliquer

E.4

Principal exclusion criteria

- Patients with total ankylosis of the spine.
- Pregnant or nursing (lactating) women.
- Evidence of ongoing infectious or malignant process.
- Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFα.
- Subjects taking high potency opioid analgesics.
- Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents.

Other protocol-defined exclusion criteria may apply,

-Patients avec ankylose totale de la colonne vertébrale.
-Femmes enceintes ou allaitant
-signes d'un processus infectieux ou cancéreux en cours
-Exposition antérieure à tout autre agent immunomodulateur biologique, y compris ceux ciblant l'IL-17, le récepteur de l'IL-17 ou le TNFα.
-Utilisation d'analgésiques opioïdes très puissants
-Traitement antérieur par toute thérapie induisant une déplétion des cellules, notamment anti-CD20

D'autres critères d'exclusion définis dans le protocole peuvent s'appliquer

E.5 End points

E.5.1

Primary end point(s)

No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) for combined 150 mg sc and 300 mg sc secukinumab versus GP2017)

E.5.1.1

Timepoint(s) of evaluation of this end point

104 weeks

E.5.2

Secondary end point(s)

- No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) (150 mg sc or 300 mg sc secukinumab versus GP2017).
- Change from baseline in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS).
- No new syndesmophyte as measured by mSASSS.
- Assessment of SpondyloArthritis International Society 20 (ASAS20).
- ASAS 40.
- ASAS partial remission.
- Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease.
- Berlin sacroiliac (SI) joint edema score.
- Ankylosing Spondylitis Spine Magnetic Resonance Imaging - activity (ASspiMRI-a) Berlin modification score.

E.5.2.1

Timepoint(s) of evaluation of this end point

104 weeks

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

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

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Pts know if they receive PR1 or PR2;but they don`t know the dose of PR1 (150 or 300mg) they receive

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

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

101

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

Belgium

Canada

Chile

Colombia

Czech Republic

Denmark

Finland

France

Germany

Israel

Korea, Republic of

Mexico

Netherlands

Peru

Philippines

Poland

Portugal

Romania

Russian Federation

Slovakia

South Africa

Spain

Taiwan

Turkey

United Kingdom

United States

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

LPLV

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.1.1.1

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:

753

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

379

F.4.2.2

In the whole clinical trial

837

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 subjects 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 Bx treatment,a waiting period of 3 mos for a subject previously on AIN457 & 4 mos for a subject previously on GP2017 before initiating the treatment is recommended.

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

2018-01-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-11-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-11-29

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