Clinical Trials Register

Summary
EudraCT Number:	2017-000401-21
Sponsor's Protocol Code Number:	CAIN457H3301
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-04-19
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

Spain - AEMPS

A.2

EudraCT number

2017-000401-21

A.3

Full title of the trial

SKIPPAIN (Speed of onset of SecuKinumab-Induced relief from Pain in Patients with Axial SpoNdyloarthritis)
A 24-week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of secukinumab in controlling spinal pain in patients with axial spondyloarthritis

SKIPPAIN (Rapidez en el alivio del dolor en pacientes con espondiloartritis axial inducido por secukinumab), Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de 24 semanas de duración para evaluar la eficacia y seguridad de secukinumab en el control del dolor espinal en pacientes con espondiloartritis axial

A.3.1

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

Efficacy and safety of secukinumab in controlling spinal pain in patients with axial spondyloarthritis

Eficacia y seguridad del secukinumab en el control del dolor espinal en pacientes con espondiloartritis axial

A.3.2

Name or abbreviated title of the trial where available

SKIPPAIN (Speed of onset of SecuKinumab-Induced relief from Pain in Patients with Axial SpoNdyloarth

SKIPPAIN – Rapidez en el alivio del dolor en pacientes con espondiloartritis axial inducido por secu

A.4.1

Sponsor's protocol code number

CAIN457H3301

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 Farmacéutica, S.A.
B.1.3.4	Country	Spain
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 Farmacéutica, S.A.
B.5.2	Functional name of contact point	Departamento Médico
B.5.3	Address:
B.5.3.1	Street Address	Gran Vía de les Corts Catalanes, 764
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08013
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34 90 0353036
B.5.5	Fax number	+34 93 2479903
B.5.6	E-mail	eecc.novartis@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.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

Axial Spondyloarthritis

espondiloartritis axial

E.1.1.1

Medical condition in easily understood language

Axial Spondyloarthritis

espondiloartritis axial

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	19.1
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 assess the superiority of secukinumab 150 mg compared to placebo in achieving a spinal pain score < 4 on a 0-10 numerical rating score (NRS) at Week 8.

Evaluar la superioridad de secukinumab 150 mg en comparación con placebo en alcanzar una puntuación de dolor espinal < 4 en una escala NRS de 0-10 en la semana 8.

E.2.2

Secondary objectives of the trial

To assess the superiority of secukinumab 150 mg compared to placebo in achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score < 4 at Week 8.

Evaluar la superioridad de secukinumab 150 mg en comparación con placebo en alcanzar una puntuación del Índice de actividad de Bath para la espondilitis anquilosante (BASDAI) < 4 en la semana 8.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Diagnosis of axial spondylarthritis (AxSpA, either ankylosing spondylitis or non radiographic axial spondylarthritis) according to ASAS AxSpA classification criteria.
- Patients with back pain for at least 3 months and age of onset less than 45 years.
- Active AxSpA as assessed by total BASDAI score of at least 4 at Baseline.
- Spinal pain numeric rating scale score of more than 4 at Baseline.
- Inadequate response to or failure to respond to at least 2 different NSAIDs at the highest recommended dose for at least 4 weeks in total prior to randomization.

Other protocol-defined inclusion criteria may apply.

-Diagnóstico de espondiloartritis axial(EspAax, espondilitis anquilosante o EspAax no radiográfica) según los criterios de clasificación ASAS.
-Pacientes con dolor de espalda durante al menos 3 meses y edad de inicio menor de 45 años
-EspAax activa evaluada mediante una puntuación del BASDAI total > = 4 en la basal.
-Puntuación de la NRS del dolor espinal > 4 en la basal.
-Los pacientes deben de haber tomado al menos dos AINE diferentes en la dosis más alta recomendada durante al menos 4 semanas en total antes de la aleatorización con una respuesta inadecuada o ninguna respuesta.
Por favor vease el resumen de protocolo para el resto de criterios

E.4

Principal exclusion criteria

- Chest X-ray or MRI with evidence of ongoing infectious or malignant process.
- Patients previously treated with any biological immunomodulating agents, except those targeting tumor necrosis factor alpha.
- Patients who have been exposed to more than one anti-tumor necrosis factor alpha agent.
- Active ongoing inflammatory diseases other than axial spondyloarthritis.
- Other ongoing mechanical diseases affecting the spine.

Other protocol-defined exclusion criteria may apply.

-Radiografía de tórax o resonancia magnética (RM) con evidencia de proceso infeccioso o maligno en curso,
-Pacientes que hayan sido tratados previamente con cualquier fármaco inmunomodulador biológico, salvo aquellos que actúan contra el TNFα.
-Pacientes que hayan estado expuestos a más de un fármaco antagonista del factor de necrosis tumoral alfa (anti-TNF-α).
-Enfermedades inflamatorias activas en curso, salvo EspAax
-Otras enfermedades mecánicas en curso que afecten a la columna vertebral
Por favor vease el resumen de protocolo para el resto de criterios

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients with a spinal pain NRS score below 4

Proporción de pacientes que alcancen una puntuación de dolor espinal < 4 en una escala NRS

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 8

Semana 8

E.5.2

Secondary end point(s)

Proportion of patients with a Bath ankylosing spondylitis disease activity index score below 4

Proporción de pacientes con una puntuación del Índice de actividad de Bath para la espondilitis anquilosante (BASDAI) < 4

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 8

Semana 8

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

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

Belgium

Bulgaria

Croatia

Czech Republic

Estonia

Finland

Germany

Greece

Ireland

Israel

Italy

Latvia

Lithuania

Poland

Romania

Russian Federation

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

Ultimo paciente última visita

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:

334

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

310

F.4.2.2

In the whole clinical trial

352

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 patients 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. Based on the individual risk/benefit profile of a patient, treatment options may include DMARDs. In case of a biologic treatment, a waiting period of 3 months before initiating the treatment is recommended.

El investigador proporcionará asistencia médica de seguimiento a todos los pacientes que se retiren prematuramente del estudio o los derivará para que reciban la asistencia adecuadaEsta asistencia puede incluir el inicio de otro tratamiento fuera del estudio según consideración del investigadorSegún relación beneficio/riesgo del paciente las opciones de tratamiento podrán incluir los FAMEEn caso de un tratamiento biológico se recomienda periodo de espera de 3meses antes de iniciar el tratamiento

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

2017-05-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-04-25

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-02-15

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