Clinical Trials Register

Summary
EudraCT Number:	2012-001125-27
Sponsor's Protocol Code Number:	CL3-78989-002
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-09-21
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2012-001125-27

A.3

Full title of the trial

A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet’s Disease uveitis. The EYEGUARD B study.

Studio randomizzaato, in doppio cieco, controllato verso placebo, dell`efficacia di gevokizumab nel trattamento di pazienti affetti da uveite di Behcet- Lo studio EYEGUARD B

A.3.1

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

Efficacy of gevokizumab in the treatment of patients with Behcet`s disease uveitis

Efficacia di gevokizumab nel trattamento di pazienti affetti da malattia di Behçet

A.3.2

Name or abbreviated title of the trial where available

THE EYEGUARD TM B STUDY

STUDIO EYEGUARD TM B

A.4.1

Sponsor's protocol code number

CL3-78989-002

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	INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
B.1.3.4	Country	Italy
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.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ISTITUTO DI RICERCA SERVIER SRL
B.5.2	Functional name of contact point	PROJECT MANAGER CHIARA PERTICA
B.5.3	Address:
B.5.3.1	Street Address	VIA LUCA PASSI, 85
B.5.3.2	Town/ city	ROMA
B.5.3.3	Post code	00166
B.5.3.4	Country	Italy
B.5.4	Telephone number	06-669081
B.5.5	Fax number	06-66908738
B.5.6	E-mail	infoirs@it.netgrs.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	Yes
D.2.5.1	Orphan drug designation number	EU/3/10/796
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 infusion
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

Behçet's disease uveitis

Uveite nella malattia di Behçet

E.1.1.1

Medical condition in easily understood language

Behçet's disease uveitis

Uveite nella malattia di Behçet

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10021428
E.1.2	Term	Immune system disorders
E.1.2	System Organ Class	10021428 - Immune system disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10046851
E.1.2	Term	Uveitis
E.1.2	System Organ Class	10015919 - Eye 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 demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of Behçet’s disease uveitis exacerbations

L’obiettivo di questo studio è dimostrare la superiorità di gevokizumab verso placebo in aggiuta alla corrente terapia medica nella riduzione del rischio di esacerbazione dell’uveite nella malattia di Behçet

E.2.2

Secondary objectives of the trial

The secondary objectives are to assess the effect of gevokizumab on the other efficacy endpoints and to evaluate its safety.

Gli obiettivi secondari sono valutare gli effetti di gevokizumab sugli altri endopoints di efficacia e valutare la sua sicurezza

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Behçet’s disease diagnosis fulfilling the International Study Group Classification Criteria. - History of Behçet’s disease uveitis with ocular involvement of the posterior segment. - Patients with a stable backgroud treatment of oral corticosteroid and at least one immunosuppressive drug. - Male or female, age ≥18 (or legal age of majority in the country) at selection - For subjects with reproductive potential, a willingness to use highly effective contraceptive measures

Diagnosi di malattia di Behçet che soddisfa i criteri di classificazione del gruppo di studio internazionale – storia di uveite nella malattia di Behcet con coinvolgimento oculare del segmento posteriore.- pazienti con terapia di base stabile con corticosteroidi orali e almeno un farmaco immunosoppressore.—Uomini e Donne, età > a 18 anni alla selezione- per soggetti potenzialmente fertili volontà all’uso di efficaci metodi contraccettivi.

E.4

Principal exclusion criteria

- Infectious uveitis, uveitis due to causes other than Behçet’s disease. - Monocular vision - Presence of severe cataract or severe posterior capsular opacification. - Contraindication to mydriasis or presence of posterior synechiae. - Active TB disease. - History of severe allergic or anaphylactic reactions to monoclonal antibodies - History of malignancy within 5 years prior to Selection. - Infectious disease. - Known immunodeficiency.

Uveite infettiva, uveite dovuta a cause diverse dalla malattia di Behçet. – Visione monoculare – presenza di cataratta grave od opacizzazione capsulare posteriore grave. – controindicazioni alla midriasi o presenza di sinechia posteriore.- Tubercolosi attiva. Storia di allergia grave o reazione anafilattica agli anticorpi monoclonali - storia di tumori maligni nei 5 anni precedenti la selezione- Malattie infettive, Immunodeficienza conosciuta

E.5 End points

E.5.1

Primary end point(s)

Time to first acute ocular exacerbation (number of days)

Tempo di occorrenza della prima esacerbazione oculare acuta (espresso in numero di giorni)

E.5.1.1

Timepoint(s) of evaluation of this end point

Time to first acute ocular exacerbation (number of days).

Tempo di occorrenza della prima esacerbazione oculare acuta (numero di giorni).

E.5.2

Secondary end point(s)

Ocular exacerbations - Visual acuity - Vitreous haze - Retinal infiltrates or acute retinal vasculitis - Anterior chamber - Safety measurements (adverse events, non ocular manifestations of Behçet's Disease, vital signs, chest X rays, standard 12-lead ECG, laboratory parameters,...)

Esacerbazione oculare- acuità visiva -offuscamento del Corpo Vitreo – Infiltrazione retinica o vasculite retinica acuta- Cellule della Camera anteriore- Valutazione della sicurezza (eventi avversi , manifestazioni non oculari della malattia di Behçet, segni vitali, raggi X del torace, EGC standard a 12 derivazioni- Parametri di laboratorio,…)

E.5.2.1

Timepoint(s) of evaluation of this end point

Ocular exacerbations : from inclusion to the end of the trial, -Vitreous haze, retinal infiltrates, acute retinal vasculitis, anterior chamber, visual acuity : at each visit of Part 1. Part 2 : at month 4 and end of trial, -Safety measurements : from selection to the end of the trial.

Esacerbazione oculare: dall’inclusione alla fine dello studio, - offuscamento del Corpo Vitreo - Infiltrazione retinica, vasculite retinica acuta- Cellule della camera anteriore, acuità visiva: a ciascuna visita della Parte 1. Parte 2: alla visita al Mese 4 e alla fine dello studio, valutazione della sicurezza: dalla selezione alla fine dello studio

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

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)

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

Yes

E.8.1.7.1

Other trial design description

Valutaz.comparsa esacerbazioni oculari ed estensione doppi cieco+parte in aperto

Occurence of ocular execerbation and double blind extention+ open part

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

China

Hong Kong

India

Korea, Republic of

Russian Federation

Saudi Arabia

Tunisia

Turkey

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

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

Number of subjects for this age range:

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

110

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 receive other treatment and/or have access to other appropriate care by his doctor

Dopo la fine dello studio poichè gevokizumab non è autorizzato, il farmaco dello studio non sarà disponibile. Il soggetto riceverà altri trattamenti e/o avrà accesso ad altre appropriate cure da parte del suo medico.

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

2012-11-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-09-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-09-29

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IMP with orphan designation in the indication
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