Clinical Trials Register

Summary
EudraCT Number:	2013-002778-38
Sponsor's Protocol Code Number:	CL2-78989-012
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:	2013-10-18
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

2013-002778-38

A.3

Full title of the trial

A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis

Estudio aleatorizado, doble siego, controlado con placebo, de prueba de concepto sobre la eficacia y seguridad del gevokizumab en el tratamiento de pacientes con arteritis de células gigantes

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 and safety of gevokizumab in the treatment of patients with giant cell arteritis

Estudio controlao frente a placebo, prueba de concepto sobre la seguridad y la eficacia de gevokizumab en el tratameitno de pacientes con arteritis de células gigantes

A.4.1

Sponsor's protocol code number

CL2-78989-012

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1144-7133

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 SL
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 SL
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 SL
B.5.2	Functional name of contact point	Loreto TABOADA
B.5.3	Address:
B.5.3.1	Street Address	Avenida 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	0034917489630178
B.5.5	Fax number	0034913003249NA
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 Servier
B.4.2	Country	France
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
B.5.2	Functional name of contact point	Clinical Studies Department
B.5.3	Address:
B.5.3.1	Street Address	50 rue carnot
B.5.3.2	Town/ city	Suresnes
B.5.3.3	Post code	92284
B.5.3.4	Country	France
B.5.4	Telephone number	0033155 72 43 6
B.5.5	Fax number	0033155 72 54 1
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

Giant cell arteritis

Arteritis de células gigantes

E.1.1.1

Medical condition in easily understood language

Giant cell arteritis

Arteritis de células gigantes

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10018250
E.1.2	Term	Giant cell arteritis
E.1.2	System Organ Class	100000004866

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 on symptoms of giant cell arteritis (GCA) in relapsing patients receiving systemic oral corticosteroids (CS)

El objetivo de este estudio es evaluar la eficacia y seguridad de gevokizumab en los síntomas de la arteritis de células gigantes ( ACG ) de pacientes con recaída que reciban corticoterapia sistémica oral

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Relapsing GCA with systemic symptoms,
- Diagnosis of GCA according to ACR criteria and at least one previous GCA relapse,
- Oral CS therapy,
- Male or female, age ? 50 years,
- Weight > 40 kg at selection,
- For subjects with reproductive potential, a willingness to use highly effective contraceptive measures.

- ACG recidivantes con síntomas sistémicos
- Diagnóstico de ACG de acuerdo con los criterios ACR y con al menos una recaída previa,
- Corticoterapia oral
- Hombres o mujeres de edad > 50 años ,
- Peso > 40 kg en la selección
- Para sujetos fértiles, la voluntad de utilizar métodos anticonceptivos altamente eficaces

E.4

Principal exclusion criteria

- relapse of GCA with symptoms indicative of a risk of ischemic event,
- History of recent, permanent or transient visual loss due to GCA and the presence of any specific visual abnormality,
- History of major ischemic event, unrelated to GCA,
- History of fibromyalgia,
- Evidence of active pulmonary infection, active TB disease, or malignancy, or suspicion of active or latent TB, or exposition to TB,
- 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

- recaída de ACG cuyos síntomas denoten riesgo de isquemia
- Antecedentes de ceguera reciente, permanente o transitoria debida a ACG y la presencia de cualquier anomalía visual específica
- Episodio isquémico importante, no relacionado con la CGA
- Antecedentes de fibromialgia
- Evidencia de infección pulmonar activa, tuberculosis activa o neoplasia o sospecha de TB activa o latente o exposición a la TB .
- Antecedentes de reacción alérgica o anafilactica grave a los anticuerpos monoclonales
- Antecedentes de neoplasis maligna en los 5 años anteriores a la selección
- Inmunodeficiencia conocida
- Embarazo, lactancia o posibilidad de quedar embarazada durante el estudio

E.5 End points

E.5.1

Primary end point(s)

- Proportion of responders to treatment,
- Physician Global Assessment,
- Patient Global Assessment,
- PMR activity score (PMR-AS),
- Quality of life (SF-36),
- Inflammation markers,
- Corticosteroids use.

- Proporción de respondedores al tratamiento
- Evaluación global del médico
- Evaluación global del paciente
- Indice de actividad PMR ( PMR-AS)
- Calidad de vida ( SF-36 )
- Marcadores inflamatorios
- uso de corticoides

E.5.1.1

Timepoint(s) of evaluation of this end point

Response to treatment: at week 4,
Physician/Patient Global Assessment, PMR-AS, inflammation markers, remission, CS use: at each visit from selection to end of study visit,
SF-36 : at week 0, week 4, week 12, week 24, week 36 and end of study visit

Respuesta al tratamiento: en W4,
Evaluación global del paciente /médico, PMR-AS, marcadores inflamatorios, remisión, uso de CS: en cada visita desde seleción hasta el final de las visitas de estudio,
SF-36: en semana 0, semana 4, semana 12, semana 24, semana 36 y al final del estudio

E.5.2

Secondary end point(s)

Not Applicable

E.5.2.1

Timepoint(s) of evaluation of this end point

Not Applicable

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

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

Canada

Australia

Russian Federation

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

Ultima visita del ultimo paciente

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, y dado que gevokizumab no estará comercializado, el fármaco no estará disponible. El sujeto deberá continuar su otro tratameinto y/o acceder o otro cuidado adecuado de 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

2014-01-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-12-13

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

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IMP with orphan designation in the indication
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