Clinical Trials Register

Summary
EudraCT Number:	2017-002698-20
Sponsor's Protocol Code Number:	OPT-302-1002
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:	2020-12-11
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

2017-002698-20

A.3

Full title of the trial

A dose-ranging study of intravitreal OPT-302 in combination with
ranibizumab, compared with ranibizumab alone, in participants with
neovascular age-related macular degeneration (wet AMD)

Studio a dosi variabili di OPT-302 intravitreale in combinazione con ranibizumab, confrontato con ranibizumab in monoterapia, in partecipanti con degenerazione maculare neovascolare correlata all¿et¿ (DMS umida).

A.3.1

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

A clinical study of OPT-302 with ranibizumab compared to ranibizumab
alone in patients with neovascular age-related macular degeneration

Studio clinico di OPT-302 con ranibizumab, confrontato con ranibizumab in monoterapia, in pazienti con degenerazione maculare neovascolare correlata all¿et¿.

A.3.2

Name or abbreviated title of the trial where available

A clinical study of OPT-302 with ranibizumab compared to ranibizumab alone in patients with neovasc

Studio clinico di OPT-302 con ranibizumab, confrontato con ranibizumab in monoterapia, in pazienti c

A.4.1

Sponsor's protocol code number

OPT-302-1002

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN00000000

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03345082

A.5.3

WHO Universal Trial Reference Number (UTRN)

U0000-0000-0000

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	OPTHEA LIMITED
B.1.3.4	Country	Australia
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	Opthea Ltd
B.4.2	Country	Australia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Opthea Ltd
B.5.2	Functional name of contact point	Clinical Development
B.5.3	Address:
B.5.3.1	Street Address	650 Chapel Street
B.5.3.2	Town/ city	South Yarra
B.5.3.3	Post code	VIC 3141
B.5.3.4	Country	Australia
B.5.4	Telephone number	61398260399
B.5.5	Fax number	61398240083
B.5.6	E-mail	clare.price@opthea.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	OPT-302
D.3.2	Product code	-
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	Intravitreal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Vascular endothelial growth factor receptor-3 (VEGFR-3) derivative fused to a human immunoglobulin (IgG)1 Fc fragment (no proposed INN at this stage)
D.3.9.2	Current sponsor code	OPT-302
D.3.9.3	Other descriptive name	Vascular endothelial growth factor receptor-3 (VEGFR-3) derivative fused to a human immunoglobulin (IgG)1 Fc fragment (no proposed INN at this stage)
D.3.9.4	EV Substance Code	-
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	40
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	LUCENTIS - 10MG/ML - SOLUZIONE INIETTABILE - USO INTRAVITREO - SIRINGA PRERIEMPITA 0,165 ML - 1 SIRINGA PRERIEMPITA
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS EUROPHARM LTD
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	-
D.3.2	Product code	-
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	Intravitreal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RANIBIZUMAB
D.3.9.1	CAS number	347396-82-1
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB22314
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	10
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Neovascular age-related macular degeneration (wet AMD)

Degenerazione maculare neovascolare correlata all'età (DMS umida)

E.1.1.1

Medical condition in easily understood language

Chronic eye disease that causes blurred vision or a blind spot in one¿s
visual field caused by abnormal blood vessels leaking fluid or blood into
the part of the retina responsible for central vision

Degenerazione maculare neovascolare correlata all'età (DMS umida)

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10071129
E.1.2	Term	Neovascular age-related macular degeneration
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10067791
E.1.2	Term	Wet macular degeneration
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10015919
E.1.2	Term	Eye disorders
E.1.2	System Organ Class	10015919 - Eye 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

Determine the efficacy of two different doses of intravitreal OPT-302
when administered in combination with ranibizumab in participants with
wet AMD

Determinare l¿efficacia di due differenti dosi di OPT-302 intravitreale quando somministrato in combinazione con ranibizumab in partecipanti affetti da DMS umida.

E.2.2

Secondary objectives of the trial

* Determine the proportion of participants gaining 15 or more ETDRS
BCVA letters from Baseline to Week 24;
* Determine the area under the ETDRS BCVA over time curve;
* Determine the change in central subfield thickness (CST) on spectral
domain optical coherence tomography (SD-OCT) from Baseline to Week
24;
* Determine the change in sub-retinal fluid on SD-OCT from Baseline to
Week 24;
* Determine the presence or absence of intra-retinal fluid on SD-OCT
from Baseline to Week 24;
* Determine the proportion of participants losing 15 or more letters (on
ETDRS BCVA chart) from Baseline to the Week 24 Visit;
* Determine the safety of OPT-302 in combination with ranibizumab;
* Determine the pharmacokinetic parameters of OPT-302;
* Determine the incidence of anti-OPT-302 antibody (ADA) formation.

* Determinare la percentuale di partecipanti che acquisiscono 15 o pi¿ lettere alla BCVA ETDRS dalla baseline alla Settimana 24;
* Determinare l¿area sotto la curva BCVA ETDRS nel tempo;
* Determinare la variazione dello spessore nel settore centrale (CST) rilevata dalla tomografia a coerenza ottica ad alta definizione nel dominio spettrale (SD-OCT) dalla baseline alla Settimana 24;
* Determinare la variazione del fluido sottoretinico rilevata da SD-OCT dalla baseline alla Settimana 24;
* Determinare la presenza o l¿assenza di fluido intraretinico rilevata da SD-OCT dalla baseline alla Settimana 24;
* Determinare la percentuale di partecipanti che perdono 15 o pi¿ lettere (sulla tavola per la BCVA ETDRS) dalla baseline alla Visita della Settimana 24;
* Determinare la sicurezza di OPT-302 in combinazione con ranibizumab;
* Determinare i parametri farmacocinetici di OPT-302;
* Determinare l¿incidenza della formazione di anticorpi anti-OPT-302 (ADA)

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Other types of substudies
Specify title, date and version of each substudy with relative objectives: Pharmacokinetic Sub-Study
* Objective: To gather further pharmacokinetic data for OPT-302 to build
on the population PK (PopPK) model developed using the PK data from
study OPT-302-1001

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio di farmacocinetica
Obiettivo: Raccogliere ulteriori dati di farmacocinetica per OPT-302 per estendere il modello relativo alla popolazione PK (PopPK) sviluppato utilizzando i dati di PK provenienti dallo studio OPT-302-1001

E.3

Principal inclusion criteria

STUDY EYE
1. Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal
CNV lesion (1-199 µm from the fovea) with subfoveal involvement
(demonstrated by leakage on fluorescein angiography (FA) and/or intraretinal
or sub-retinal fluid on spectral-domain optical coherence
tomography
[SD-OCT]) secondary to age-related macular degeneration
(AMD).
Active CNV as measured on FA must constitute at least 50% of
the
lesion area, with a total lesion size of = 30.5 mm2. The lesion may
contain
classic and/or occult CNV, but any occult CNV present must
measure
< 10 mm2 on the FA. The characteristics of each lesion must be
confirmed
by the Independent Reading Centre.
2.
A best corrected (ETDRS) visual acuity (BCVA) score between 60 and
25
(inclusive) letters (Snellen equivalent of 20/63 (feet) or 6/21
(metres)
and 20/320 (feet) or 6/96 (metres) respectively).
GENERAL
1. Willing and able to provide written informed consent.
2. Male or female participants at least 50 years of age.
3. Able to understand and willing to comply with study protocol
procedures and restrictions.
4. If female and of child-bearing potential: Pregnancy test at Screening
is negative, and agrees to use a highly effective method of contraceptive
for the duration of the study and for at least 3 months following the last
dose of study medication.

OCCHIO IN STUDIO
1. Lesione con neovascolarizzazione coroideale (CNV) subfoveale attiva o lesione CNV iuxtafoveale (1-199 µm dalla fovea) con coinvolgimento subfoveale (dimostrato da perdite rilevate da angiografia con fluoresceina (FA) e/o fluido intraretinico o sottoretinico rilevato da tomografia a coerenza ottica ad alta definizione nel dominio spettrale [SD-OCT]) secondaria alla degenerazione maculare neovascolare correlata all’età (DMS). La CNV attiva misurata da FA deve costituire almeno il 50% dell'area della lesione, con una dimensione totale della lesione di = 30,5 mm2. La lesione può contenere CNV classica e/o occulta, ma eventuale CNV occulta presente deve misurare < 10 mm2 dall’FA. Le caratteristiche di ciascuna lesione devono essere confermate dal Centro di lettura indipendente.
2. Un punteggio della miglior acuità visiva corretta (BCVA) (ETDRS) compreso tra 60 e 25 (incluso) lettere (equivalente snellen di 20/63 piedi o 6/21 metri, e 20/320 piedi o 6/96 metri rispettivamente).
GENERALI
1. Volontà e capacità di fornire un consenso informato scritto.
2. Partecipanti di sesso maschile o femminile di almeno 50 anni.
3. Capacità di comprendere e volontà di rispettare le procedure e le restrizioni del protocollo dello studio.
4. Se di sesso femminile ed in età fertile: Test di gravidanza negativo allo Screening e consenso all’utilizzo di un metodo contraccettivo altamente efficace per la durata dello studio e per almeno 3 mesi dopo l’ultima dose di farmaco in studio.

E.4

Principal exclusion criteria

STUDY EYE
1 Any previous treatment for wet AMD

2 Clinically significant ocular disorders other than wet

3 Haemorrhage measuring more than 50% of total lesion area

4 Fibrosis involving either the fovea centre or measuring more than
25% of the total lesion area and/or juxtafoveal or sub-foveal geographic
Atrophy

5 Choroidal neovascularisation due to causes other than AMD

6 Cloudy ocular media, or inadequate pupillary dilatation

7 Presence of intraocular inflammation (= trace cell or flare), significant
epiretinal membrane or vitreomacular traction, macular hole or vitreous
haemorrhage

8 Aphakia or absence of the posterior capsule

9 History of idiopathic or autoimmune-associated uveitis
10. Any current ocular or periocular infection

11 Intraocular pressure of greater than 25 mmHg

12 Myopia, or known former myopia, with a spherical equivalent of
Greater than 8 dioptres

13 Intraocular surgery within 6 months prior to screening, except for
Cataract surgery that is excluded within 3 months of Screening.

14 History of any of the following conditions or procedures:
Rhegmatogenous retinal detachment, filtering surgery
glaucoma drainage device, or corneal transplant.

15 Prior pars plana vitrectomy.

16 Presence of an intravitreal device.
17 Retinopathy

NON-STUDY EYE
History of idiopathic, autoimmune-associated, or infectious uveitis

GENERAL
1 diabetes mellitus
2 Administration of systemic steroids within 3 months of screening
3 Symptoms of heart failure
4 Unstable angina, myocardial infarction or coronary artery revascularisation within 6 months of screening.
5 Ventricular tachyarrhythmia requiring ongoing treatment
6 Vascular stenting within 6 months of screening
7 Cerebrovascular event
8 Diastolic blood pressure > 100 mmHg at screening.
9 Renal failure requiring dialysis or transplant.
10. ALT or AST = 2 x upper limit of normal or total bilirubin = 1.5
x ULN unless due to genetically confirmed Gilbert's disease
11 Any major surgical procedure
12 Active systemic infection
13 Malignancy within 5 years of screening, with the exception of
carcinoma in situ, non-melanoma skin cancers and prostate cancer not
requiring treatment or on stable (> 6 months) treatment with hormone
therapy
14 Known serious allergies to the fluorescein or hypersensitivity to
any of the listed excipients in the OPT-302 formulation or components of
the ranibizumab formulation
15 Pregnant, within 3 months after the end of pregnancy, planning to
become pregnant, or lactating.
16 Previous administration of anti-VEGF-A therapies except by intravitreal injection in the non-Study Eye
17 Administration of an investigational drug or ocular device within 30
days of screening, or 5 half-livesor any prior
treatment with OPT-302
18 Any social or medical condition that, in the Investigator's opinion,
would preclude enrolment into the study

OCCHIO IN STUDIO
1 Eventuale trattamento precedente per la DMS umida
2 Disturbi oculari clinicamente significativi diversi dalla DMS umida
3 Emorragia che misura più del 50% dell’area totale della lesione
4 Fibrosi che coinvolge il centro della fovea o che misura più del 25% dell’area totale della lesione e/o atrofia geografica subfoveale o iuxtafoveale
5 Neovascolarizzazione coroideale dovuta a cause diverse dalla DMS
6 Media oculare non chiara o dilatazione delle pupille inadeguata
7 Presenza di infiammazione intraoculare, membrana epiretinica o trazione vitreomaculare significativa, perforazione maculare o emorragia del corpo vitreo
8 Afachia o assenza di capsula posteriore
9 Anamnesi di uveite idiopatica o auto-immune
10 Eventuale infezione oculare o perioculare attuale
11 Pressione intraoculare superiore a 25 mmHg
12 Miopia con equivalente sferico superiore a 8 diottrie.
13 Intervento chirurgico intraoculare nei 6 mesi precedenti lo screening, ad eccezione di intervento chirurgico per cataratta che è escluso entro 3 mesi dallo Screening
14 Anamnesi di qualsiasi delle seguenti condizioni e procedure:
Distacco regmatogeno della retina, chirurgia filtrante, dispositivo di drenaggio del glaucoma o trapianto della cornea
15 Precedente vitrectomia della pars plana
16 Presenza di dispositivo intravitreale
17 Retinopatia

OCCHIO NON IN STUDIO
Anamnesi di uveite idiopatica, auto-immune o infettiva

INFORMAZIONI GENERALI
1 Diabete mellito
2 Somministrazione di steroidi sistemici entro 3 mesi dallo screening
3 Sintomi di insufficienza cardiaca
4 Angina instabile, infarto miocardico o rivascolarizzazione arteriosa coronarica entro 6 mesi dallo screening
5 Tachiaritmia ventricolare che richiede trattamento in corso
6 Stenting vascolare entro 6 mesi dallo screening
7 Evento cerebrovascolare
8. Pressione sanguigna diastolica > 100 mmHg allo screening
9 Insufficienza renale che richiede dialisi o trapianto.
10. ALT o AST = 2 x il limite superiore della norma o bilirubina totale = 1,5 x ULN salvo se dovuta a malattia di Gilbert confermata geneticamente
11 Eventuale intervento chirurgico importante
12 Infezione sistemica attiva
13 Tumore maligno entro 5 anni dallo screening, con l’eccezione di carcinoma in situ, carcinomi cutanei non melanomatosi e carcinoma prostatico che non richiedono trattamento o che sono in trattamento stabile (> 6 mesi) con terapia ormonale
14 Note allergie serie alla fluorescina o ipersensibilità a uno qualsiasi degli eccipienti elencati nella formulazione di OPT-302 o dei componenti della formulazione di ranibizumab
15 Gravidanza, entro 3 mesi dopo la fine della gravidanza, intenzione di iniziare una gravidanza, allattamento al seno
16 Somministrazione precedente di terapie anti-VEGF-A ad eccezione di iniezione intravitreale nell’occhio non in studio
17 Somministrazione di un farmaco sperimentale o di un dispositivo oculare entro 30 giorni dallo screening o 5 emivite o eventuale trattamento precedente con OPT-302
18 Qualsiasi condizione sociale o medica che precluderebbe l’arruolamento nello studio

E.5 End points

E.5.1

Primary end point(s)

Mean change from Baseline in Early Treatment Diabetic Retinopathy
Study (ETDRS) best corrected visual acuity (BCVA) letters to Week 24
(Visit 8)

Variazione media dalla baseline delle lettere della miglior acuità visiva corretta (BCVA) nell’ambito dello studio del trattamento precoce della retinopatia diabetica (ETDRS - Early Treatment Diabetic Retinopathy Study) alla Settimana 24 (Visita 8).

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24 (Visit 8)

Settimana 24 (Visita 8)

E.5.2

Secondary end point(s)

The proportion of participants gaining 15 or more ETDRS BCVA letters
from Baseline to the Week 24 Visit;
* Area under the ETDRS BCVA-over-time curve;
* Change in CST on SD-OCT from Baseline to Week 24;
* Change in sub-retinal fluid on SD-OCT from Baseline to Week 24;
* Presence or absence of intra-retinal fluid determined by the presence
or absence of intra-retinal cysts on SD-OCT from Baseline to Week 24;
* Proportion of participants losing 15 or more letters (on ETDRS BCVA
chart) from Baseline to the Week 24 Visit;
* Incidence of ocular and non-ocular adverse events (AEs);
* OPT-302 pharmacokinetic parameters;
* Participant incidence of ADA formation.

* Percentuale di partecipanti che acquisiscono 15 o pi¿ lettere alla BCVA ETDRS dalla baseline alla Visita della Settimana 24;
* Area sotto la curva BCVA ETDRS nel tempo;
* Variazione del CST rilevata da SD-OCT dalla baseline alla Settimana 24;
* Variazione del fluido sottoretinico rilevata da SD-OCT dalla baseline alla Settimana 24;
* Presenza o assenza di fluido intraretinico determinata dalla presenza o assenza di cisti intraretiniche rilevata da SD-OCT dalla baseline alla Settimana 24;
* Percentuale di partecipanti che perdono 15 o pi¿ lettere (sulla tavola per la BCVA ETDRS) dalla baseline alla Visita della Settimana 24;
* Incidenza di eventi avversi (AE) oculari e non oculari;
* Parametri farmacocinetici di OPT-302;
* Incidenza della formazione di ADA nei partecipanti.

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 24 (Visit 8)

Settimana 24 (Visita 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

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

Yes

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)

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

iniezione sham

Sham injection

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

Information not present in EudraCT

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

Czechia

France

Hungary

Israel

Italy

Latvia

Poland

Spain

United Kingdom

United States

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.1.1.1

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:

326

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

164

F.4.2.2

In the whole clinical trial

351

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)

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

2018-01-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-18

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:
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