Clinical Trials Register

Summary
EudraCT Number:	2018-002673-21
Sponsor's Protocol Code Number:	35RC17_8841_EFFICACI
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-07-06
Trial 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

France - ANSM

A.2

EudraCT number

2018-002673-21

A.3

Full title of the trial

EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial.

EFFICACI : Efficacité de l'Infliximab versus le vedolizumab après échec d'un traitement par anti-TNF sous-cutané chez des patients atteints de rectocolite hémorragique : essai clinique randomisé contrôlé en double aveugle

A.3.1

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

EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial.

A.3.2

Name or abbreviated title of the trial where available

EFFICACI

A.4.1

Sponsor's protocol code number

35RC17_8841_EFFICACI

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	Centre Hospitalier Universitaire de Rennes
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	PHRC National 2017
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	Centre Hospitalier Universitaire de Rennes
B.5.2	Functional name of contact point	Diection de la Recherche
B.5.3	Address:
B.5.3.1	Street Address	2 rue Henri Le Guilloux
B.5.3.2	Town/ city	Rennes cedex 9
B.5.3.3	Post code	35033
B.5.3.4	Country	France
B.5.4	Telephone number	0033299282555
B.5.5	Fax number	0033299283999
B.5.6	E-mail	violaine.benoit@chu-rennes.fr

D. IMP Identification
D.IMP: 1
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	Remicade
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Biologics B.V.
D.2.1.2	Country which granted the Marketing Authorisation	France
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	infliximab
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INFLIXIMAB
D.3.9.1	CAS number	170277-31-3
D.3.9.4	EV Substance Code	SUB02681MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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.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	Inflectra
D.2.1.1.2	Name of the Marketing Authorisation holder	Hospira UK Limited
D.2.1.2	Country which granted the Marketing Authorisation	France
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	infliximab
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INFLIXIMAB
D.3.9.1	CAS number	170277-31-3
D.3.9.4	EV Substance Code	SUB02681MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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.IMP: 3
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	Flixabi
D.2.1.1.2	Name of the Marketing Authorisation holder	Samsung Bioepis UK Limited
D.2.1.2	Country which granted the Marketing Authorisation	France
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	infliximab
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INFLIXIMAB
D.3.9.1	CAS number	170277-31-3
D.3.9.4	EV Substance Code	SUB02681MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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.IMP: 4
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	Remsima
D.2.1.1.2	Name of the Marketing Authorisation holder	Celltrion Healthcare Hungary Kft.
D.2.1.2	Country which granted the Marketing Authorisation	France
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	infliximab
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INFLIXIMAB
D.3.9.1	CAS number	170277-31-3
D.3.9.4	EV Substance Code	SUB02681MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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.IMP: 5
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.2.1.1.1	Trade name	Entyvio
D.2.1.1.2	Name of the Marketing Authorisation holder	Takeda Pharma A/S
D.2.1.2	Country which granted the Marketing Authorisation	France
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	Vedolizumab
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	943609-66-3
D.3.9.3	Other descriptive name	VEDOLIZUMAB
D.3.9.4	EV Substance Code	SUB30452
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Ulcerative colitis

rectocolite hémorragique

E.1.1.1

Medical condition in easily understood language

Ulcerative colitis

rectocolite hémorragique

E.1.1.2

Therapeutic area

Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

MedDRA Classification

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	10045365
E.1.2	Term	Ulcerative colitis
E.1.2	System Organ Class	100000004856

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 determine whether a non-TNF-targeted biologic (vedolizumab) is superior to infliximab to treat patient with UC losing response or with a primary failure to a first subcutaneous anti-TNF drug at week 14.

Déterminer si une biothérapie ne ciblant pas le TNF (vedolizumab) est supérieure à l'infliximab pour traiter un patient présentant une perte de réponse ou un échec primaire à un premier médicament anti-TNF sous-cutané

E.2.2

Secondary objectives of the trial

₋ To assess the rate of clinical response and remission at Week 54 in each group of treatments and the time to clinical response and remission from baseline ;
₋ To assess the changes in faecal calprotectin levels from baseline to week 14 and 54 according to treatment ;
₋ To assess the rate of colectomy and hospitalization in each treatment group ;
₋ To assess the rate of mucosal healing at week 14 and 54 in each group of treatments ;
To assess the rate of loss of response
To assess the changes of quality of life indexes and the disability index
To determine the safety profile
To characterize the response according to drug monitoring of the first anti-TNF agent
To describe the pharmacokinetics of infliximab and vedolizumab and explore the sources of pharmacokinetic inter-individual variability
To identify predictive factors of response to the treatment, including pharmacokinetic features

₋ Évaluer le taux de réponse clinique et de rémission aux semaines 14, et 54 dans chaque groupe de traitements et le délai de réponse clinique et de rémission
₋ Évaluer les variations de la calprotectine fécale entre le début et les semaines 14 et 54 selon le traitement administré
₋ Évaluer le taux de colectomie et d'hospitalisation dans chaque groupe de traitement
₋ Évaluer le taux de cicatrisation muqueuse aux semaines 14 et 54 dans chaque groupe de traitements
Évaluer le taux de perte de réponse
Evaluer les variations de qualité de vie
Déterminer le profil de sécurité
Caractériser la réponse en fonction des données pharmacocinétique à l’arrêt du premier agent anti-TNF
Décrire la pharmacocinétique de l'infliximab et du vedolizumab et explorer les sources de la variabilité interindividuelle pharmacocinétique
Identifier les facteurs prédictifs de réponse au traitement, incluant les caractéristiques pharmacocinétiques

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

₋ Male or non-pregnant female, non-lactating female;
₋ 18 years of age or older and less than 75 years ;
₋ Documented diagnosis of UC for at least 6 months ;
₋ Left side colitis or pancolitis ;
₋ Moderate to severe disease according to a Mayo score equal or above 6 with a Mayo endoscopic sub-score of 2 or 3 ;
₋ Active disease despite ongoing treatment with adalimumab or golimumab for at least 12 weeks (inadequate response, failure, loss of response or intolerance) ;
₋ Ability of the subject to participate fully in all aspects of this clinical trial ;
₋ Written informed consent must be obtained and documented ;
₋ Naïve to JAK inhibitor ;
₋ Affiliation to the national health insurance.

- Homme ou femme, âgés de 18 ans inclus à 75 ans exclus
- Diagnostic de RCH depuis au moins 6 mois;
- Extension colique gauche ou pancolique de la RCH
- Maladie modérée à sévère selon le score de Mayo (supérieur ou égal à 6 avec un sous-score endoscopique de Mayo de 2 ou 3
- Maladie active malgré un traitement par adalimumab ou golimumab utilisé pendant au moins 12 semaines (réponse inadéquate, échec, perte de réponse ou intolérance)
- Capacité du sujet à comprendre et participer pleinement à tous les aspects de cet essai clinique
- Après obtention du consentement éclairé et signé
- Naïf d’un traitement inhibiteur des Janus Kinases.
- Affiliation à un régime de sécurité sociale

E.4

Principal exclusion criteria

₋ Contraindication to continue TNF antagonist (ongoing abscess(es), clinical suspicion of tuberculosis, past allergic reaction) ;
₋ Contraindication to vedolizumab treatment ;
₋ Steroid treatment > 20 mg/day for at least two weeks before baseline ;
₋ Proctitis ;
₋ Stoma ;
₋ Proctocolectomy or subtotal colectomy ;
₋ Planned surgery within the year of the trial ;
₋ Previous exposure to vedolizumab or infliximab ;
₋ History of cancer during the past 5 years ;
₋ Pregnancy or breastfeeding
₋ Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.
₋ Ongoing participation to another interventional study

- Contre-indication pour continuer un traitement anti-TNF (suspicion clinique de tuberculose)
- Contre-indication au traitement par vedolizumab
- Traitement par corticostéroïdes à une dose supérieure à 20 mg par jour pendant les deux semaines précédant l’inclusion
- Rectite
- Stomie
- Antécédent de proctocolectomie ou colectomie subtotale;
- Chirurgie prévue dans l'année de l'essai
- Exposition antérieure au vedolizumab ou à l'infliximab
- Antécédents de cancer sur les 5 dernières années
- Femmes enceintes ou allaitantes
- Personnes majeures faisant l'objet d'une protection légale (sauvegarde de justice, curatelle, tutelle) et personnes privées de liberté.
- Participation à une autre recherche impliquant la personne humaine interventionnelle

E.5 End points

E.5.1

Primary end point(s)

The rate of patients with clinical and endoscopic steroid free-remission (Mayo score ≤ 2 without subscore > 1) at week 14.

Le taux de patient présentant une rémission clinique et endoscopique sans corticoïdes (score de Mayo ≤2 sans sous-score >1) à la semaine 14

E.5.1.1

Timepoint(s) of evaluation of this end point

week 14

semaine 14

E.5.2

Secondary end point(s)

₋ Mayo score at week 54 ;
₋ Faecal calprotectine level at week 14 and 54 ;
₋ Colectomy or hospitalization for disease flare during the study period ;
₋ Endoscopic subscore of the mayo Score at week 14 and 54 ;
₋ Partial Mayo score at week 2, 6, 14, 54 ;
₋ IBDQ index, IBD-Disk and IBD-DI at baseline week 14 and 54
₋ Rate and type of adverse events during the study period ;
₋ Last trough concentration of the first subcutaneous agent at the time of the loss of response and anti-drug antibodies concentration ;
₋ Trough concentration of infliximab or vedolizumab at each visit and anti-drug antibodies concentration.

₋ Score de Mayo à la semaine 54
₋ Concentration de la calprotectine fécale aux semaines 14 et 54
₋ Colectomie et hospitalisation pour une poussée de la maladie pendant la période de l’essai
₋ Sous score endoscopique du score de Mayo et Ulcerative colitis Endoscopic Index of severity (UCEIS) aux semaines 14 et 54
₋ Score de Mayo partiel aux semaines 2, 6, 14, 54
₋ Taux et types d’effets indésirables pendant la période de l’essai
₋ Concentration résiduelle et anticorps anti-médicament au moment de la perte de réponse au premier anti-TNF
₋ Concentration résiduelle et anticorps anti-médicament avant chaque perfusion d’infliximab et de vedolizumab

E.5.2.1

Timepoint(s) of evaluation of this end point

week 2, 6, 14 and 54

semaines 2, 6, 14 et 54

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

E.6.5

Efficacy

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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)

Yes

E.8.2.2

Placebo

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

last visit of the last person who is a subject in the study

Dernière visite du dernier sujet participant à l'étude

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 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:

150

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

150

F.4.2

For a multinational trial

F.4.2.1

In the EEA

150

F.4.2.2

In the whole clinical trial

150

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)

As usual care

Selon la prise en charge habituelle

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

2018-09-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-08-27

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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