Clinical Trials Register

Summary
EudraCT Number:	2012-005772-34
Sponsor's Protocol Code Number:	CL2-78989-010
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:	2013-06-10
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

Spain - AEMPS

A.2

EudraCT number

2012-005772-34

A.3

Full title of the trial

A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease

Estudio aleatorizado, doble ciego, controlado frente a placebo, de prueba de concepto, de eficacia de 60 mg de gevokizumab subcutáneo administrado cada 4 semanas durante 24 semanas en el tratamiento de pacientes con polimiositis o dermatomiositis

A.3.1

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

A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis disease

Estudio controlado frente a placebo, de prueba de concepto de la eficacia de gevokizumab subcutáneo durante 24 semanas en el tratamiento de pacientes con polimiositis o dermatomiositis

A.4.1

Sponsor's protocol code number

CL2-78989-010

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1139-6207

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	Laboratorios Servier S.L
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	Laboratorios Servier, S.L.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Laboratorios Servier S.L
B.5.2	Functional name of contact point	Loreto TABOADA
B.5.3	Address:
B.5.3.1	Street Address	Avda de los Madroños, 33
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28043
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34917489630178
B.5.5	Fax number	+34913003249NA
B.5.6	E-mail	loreto.taboada@es.netgrs.com
B.Sponsor: 2
B.1.1	Name of Sponsor	Institut de Recherches Internationales Servier (IRIS)
B.1.3.4	Country	France
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	ADIR
B.4.2	Country	France
B.4.1	Name of organisation providing support	Servier Research and Development Ltd
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Institut de Recherches Internationales Servier (IRIS)
B.5.2	Functional name of contact point	Clinical Studies Department
B.5.3	Address:
B.5.3.1	Street Address	50 rue Cranot
B.5.3.2	Town/ city	Suresnes Cedex
B.5.3.3	Post code	92284
B.5.3.4	Country	France
B.5.4	Telephone number	+33155 72436
B.5.5	Fax number	+33155 72541
B.5.6	E-mail	clinicaltrials@servier.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	Gevokizumab
D.3.2	Product code	S78989
D.3.4	Pharmaceutical form	Solution for injection
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	gevokizumab
D.3.9.1	CAS number	1129435-60-4
D.3.9.2	Current sponsor code	S78989
D.3.9.3	Other descriptive name	XOMA 052
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	60
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
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

Polymyositis / Dermatomyositis

Polimiositis/Dermatomiositis

E.1.1.1

Medical condition in easily understood language

Polymyositis / Dermatomyositis

Polimiositis/Dermatomiositis

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	16.0
E.1.2	Level	PT
E.1.2	Classification code	10012503
E.1.2	Term	Dermatomyositis
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	PT
E.1.2	Classification code	10036102
E.1.2	Term	Polymyositis
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

The objective of this study is to evaluate the efficacy and safety of gevokizumab in adult patients with polymyositis or dermatomyositis intolerant or resistant or dependent to systemic oral corticosteroids.

El objetivo de este estudio es evaluar la eficacia y seguridad de gevokizumab en pacientes adultos con polimiositis o dermatomiositis intolerantes o resistentes o dependientes de los corticoides sistémicos orales.

E.2.2

Secondary objectives of the trial

Not applicable

No aplicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Active polymyositis or dermatomyositis intolerant or resistant or dependent to systemic oral corticosteroids,
- Disease diagnosis duration ? 6 years,
- With a stable background treatment of oral corticosteroid if any and / or a stable dose of immunosuppressive agent if any.
- Male or female, age ? 18 (or legal age of majority in the country),
- Weight ?40 kg and ? 125 kg at selection,
- For subjects with reproductive potential, a willingness to use highly effective contraceptive measures.

-Polimiositis activa o dermatomiositis intolerante o resistente o dependiente de corticoides sistémicos orales.
- Duración del diagnóstico de la enfermedad ? 6 años.
- En caso de tratamiento de base con corticoides orales , éste tiene que ser estable y /o en caso de tratamiento con agente inmunosupresor éste tiene que ser a dosis estables
-Hombre o mujer, edad ? 18 años (o mayoría de edad legal en el país)
-Peso ? 40 kg y ? 125 kg en la selección
-Para sujetos con potencial reproductivo, el compromiso de utilizar medidas anticonceptivas de elevada efectividad.

E.4

Principal exclusion criteria

- Juvenile dermatomyositis, drug induced myositis, severity criteria such as severe cardiovascular or pulmonary involvement or myositis damage, necrotizing myopathy, inclusion body myositis, cancer- associated myositis or DM diagnosed for less than 1 year,
- Impossibility to perform muscle biopsy for PM patients (if required),
- Non-ambulatory patients,
- Fibromyalgia of type I,
- Joint disease or other musculoskeletal condition,
- Active TB disease,
- History of severe allergic or anaphylactic reactions to monoclonal antibodies,
- History of malignancy within 5 years prior to selection,
- Known immunodeficiency,
- Infectious disease,
- Pregnancy, breastfeeding or possibility to become pregnant during the study

- Dermatomiositis juvenil, miositis inducida por fármacos, criterios de severidad como afectación severa cardiovascular o pulmonar o daño por miositis, miopatía necrotizante, miositis por cuerpos de inclusión, cáncer asociado con la miositis o DM diagnosticado hace menos de 1 año,
-Imposibilidad de realizar biopsia muscular en los pacientes con PM si es requerida
- Pacientes no ambulatorios
-Fibromialgia tipo I
-Enfermedad articular u otra condición musculoesquelética
-Enfermedad TBC activa
-Antecedentes de alergia severa o reacciones anafilácticas a los anticuerpos monoclonales.
- Antecedentes de malignidad dentro de los 5 años previos a la selección
-Inmunodeficiencia conocida.
- Enfermedad infecciosa
- Embarazo, lactancia o posibilidad de quedarse embarazada durante el estudio

E.5 End points

E.5.1

Primary end point(s)

-Clinical improvement according to Manual Muscle Testing (MMT-8) score
-Clinical improvement according to IMACS group's myositis disease activity core set
-Specific dermatologic testing: modified CDASI for DM patients
-SF36
-Biomarkers

-Mejoría clínica de acuerdo con la puntuación del Manual Muscle Testing (MMT-8)
-Mejoría clínica de acuerdo con la escala de puntuación de la actividad en la miositis del grupo IMACS
-Pruebas dermatológicas específicas: CDASI modificado para pacientes con DM
-SF36
-Biomarcadores

E.5.1.1

Timepoint(s) of evaluation of this end point

MMT-8 and biomarkers : at selection and every 4 weeks until week 24
Others : every 4 weeks form week 0 to week 24

MMT-8 y biomarcadores: en la selección y cada 4 semans hasta la semana 24
Otros: cada 4 semanas desde la semana 0 hasta la semana 24

E.5.2

Secondary end point(s)

Not Applicable

No aplicable

E.5.2.1

Timepoint(s) of evaluation of this end point

Not Applicable

No aplicable

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

E.6.11

Pharmacogenomic

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

Brazil

Czech Republic

Denmark

France

Germany

Hungary

Italy

Norway

Spain

Sweden

United Kingdom

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

Última visita del último participante

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:

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

F.4.2.2

In the whole clinical trial

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)

After the end of the study, as gevokizumab is not licensed, study drug will not be available. The subject will continue his/her other treatment and/or have access to other appropriate care by his doctor.

Después del final del estudio, teniendo en cuenta que gevokizumab no está comercializado, el fármaco del estudio no estará disponible. El sujeto recibirá otro tratamiento y/o tendrá acceso a unos cuidados apropiados por su médico.

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

2013-06-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-17

P. End of Trial
P.	End of Trial Status	Completed

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