Clinical Trials Register

Summary
EudraCT Number:	2019-001177-90
Sponsor's Protocol Code Number:	CAIN457P12301
National Competent Authority:	Greece - EOF
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-11-13
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

Greece - EOF

A.2

EudraCT number

2019-001177-90

A.3

Full title of the trial

A randomized, double-blind, placebo-controlled, parallel group, phase III
multicenter study of intravenous secukinumab to compare efficacy at 16
weeks with placebo and to assess safety and tolerability up to 52 weeks in
subjects with active Ankylosing Spondylitis or non-radiographic axial
SpondyloArthritis

Τυχαιοποιημένη, διπλά τυφλή, ελεγχόμενη με εικονικό φάρμακο, παράλληλων ομάδων, πολυκεντρική μελέτη φάσης ΙΙΙ του ενδοφλέβιου secukinumab για τη σύγκριση της αποτελεσματικότητας στις 16 εβδομάδες με το εικονικό φάρμακο, και την εκτίμηση της ασφάλειας και της ανεκτικότητας έως και τις 52 εβδομάδες σε άτομα με ενεργό αγκυλοποιητική σπονδυλαρθρίτιδα ή μη ακτινογραφική αξονική σπονδυλαρθρίτιδα

A.3.1

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

Study to demonstrate the efficacy, safety and tolerability of an intravenous
(i.v.) regimen of secukinumab compared to placebo in subjects with active
axSpA

A.4.1

Sponsor's protocol code number

CAIN457P12301

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 (Hellas) S.A.C.I.
B.5.2	Functional name of contact point	Veronique Schaaf
B.5.3	Address:
B.5.3.1	Street Address	12th Klm National Road Athens-Lamia, No1
B.5.3.2	Town/ city	Metamorphosis
B.5.3.3	Post code	14451
B.5.3.4	Country	Greece
B.5.4	Telephone number	0030 210 2897152
B.5.5	Fax number	0030 210 2835053
B.5.6	E-mail	veronique.schaaf@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	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous 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	25
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	Concentrate for 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

Axial Spondyloarthritis

E.1.1.1

Medical condition in easily understood language

Axial Spondyloarthritis

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10071400
E.1.2	Term	Axial spondyloarthritis
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 i.v. secukinumab at Week 16 is
superior to placebo in subjects with active axSpA (AS and nr-axSpA)
based on the proportion of subjects achieving an ASAS40 (Assessment of
SpondyloArthritis International Society criteria) response.

E.2.2

Secondary objectives of the trial

-To demonstrate that the efficacy of i.v. secukinumab at Week 16 is
superior to placebo based on:
the proportion of subjects achieving:
1- ASDAS-CRP major improvement
2- BASDAI
3- ASAS 5/6
4- BASFI
5 - SF-36 PCS
6 - ASQoL
7 - hsCRP
8 - ASAS 20
9- ASDAS-CRP inactive disease
10 - ASAS partial remission
11 - Pittsburgh Sleep Quality Indiex
12- Overall safety and tolerability of secukinumab compared to placebo
as assessed by vital signs, clinical laboratory values and adverse events
monitoring

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Diagnosed with axSpA according to ASAS criteria (inflammatory back
pain for at least 6 months; onset before 45 years of age)
- For subjects with AS: Diagnosis of AS with prior documented radiologic
evidence (x-ray or radiologist's report) fulfilling the Modified New York
criteria for AS
- For subjects with nr-axSpA: X-ray of SIJ negative (centrally read) for
AS by Modified NY criteria AND
a. Sacroiliitis on MRI (centrally read) with ≥ 1 SpA feature OR HLA-B-27
positive with ≥2 SpA features AND
b. Objective signs of inflammation at screening, evident by either MRI
with SIJ inflammation (centrally read) AND / OR hsCRP > ULN (as
defined by the central lab)
- Active axial SpA assessed by BASDAI ≥4 cm (0-10 cm) at Baseline
- Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at
Baseline
- Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at Baseline
- Inadequate response to NSDAIDs
Other protocol-defined inclusion criteria may apply

E.4

Principal exclusion criteria

- Pregnancy or lactation
- Ongoing infectious or malignant process on a chest X-ray or MRI
- Previous exposure to IL-17 or IL-17R targeting therapies
- Previous exposure to any biological immunomodulating agent
excluding TNF antagonists
Other protocol-defined exclusion critera may apply

E.5 End points

E.5.1

Primary end point(s)

Assessment of SpondyloArthritis International Society criteria 40
(ASAS40) response

E.5.1.1

Timepoint(s) of evaluation of this end point

16 weeks

E.5.2

Secondary end point(s)

1- ASDAS-CRP major improvement
2- BASDAI
3- ASAS 5/6
4- BASFI
5 - SF-36 PCS
6 - ASQoL
7 - hsCRP
8 - ASAS 20
9- ASDAS-CRP inactive disease
10 - ASAS partial remission
11 - Pittsburgh Sleep Quality Indiex
12- Overall safety and tolerability of secukinumab compared to placebo
as assessed by vital signs, clinical laboratory values and adverse events
monitoring

E.5.2.1

Timepoint(s) of evaluation of this end point

1 - 11: Week 16
12: 60 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

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

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability

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

Brazil

Colombia

Egypt

Guatemala

India

Korea, Republic of

Malaysia

Philippines

Russian Federation

Thailand

Turkey

United States

Belgium

Bulgaria

Italy

Poland

Sweden

Czechia

Greece

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

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:

450

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

152

F.4.2.2

In the whole clinical trial

500

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)

If, at study completion, the investigator determines that a patient could
benefit from continued secukinimab treatment, the physician may
request access from Novartis, at no cost to the patient, if not
commercially available and accessible.

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

2020-01-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-01-17

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-12-20

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