Clinical Trials Register

Summary
EudraCT Number:	2017-004496-31
Sponsor's Protocol Code Number:	CNTO148UCO3003
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-17
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-004496-31

A.3

Full title of the trial

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

Uno studio di fase III randomizzato in aperto per valutare l’efficacia, la sicurezza e la farmacocinetica del trattamento con golimumab, un anticorpo monoclonale umano anti-TNFa, somministrato per via sottocutanea in partecipanti pediatrici con colite ulcerosa ad attività moderata-severa

A.3.1

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

A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

Uno studio sull'efficacia e la sicurezza di Golimumab in partecipanti pediatrici con colite ulcerosa ad attività moderata-severa

A.3.2

Name or abbreviated title of the trial where available

PURSUIT 2

A.4.1

Sponsor's protocol code number

CNTO148UCO3003

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/065/2018

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Janssen Biologics B.V.
B.1.3.4	Country	Netherlands
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	Janssen Research & Development
B.4.2	Country	United States
B.4.1	Name of organisation providing support	Janssen Biologics BV
B.4.2	Country	Netherlands
B.4.1	Name of organisation providing support	Janssen Cilag SpA
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Janssen Biologics BV
B.5.2	Functional name of contact point	Clinical Registry Group
B.5.3	Address:
B.5.3.1	Street Address	Janssen Biologics BV - Archimedesweg 29
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 CM
B.5.3.4	Country	Netherlands
B.5.6	E-mail	ClinicalTrialsEU@its.jnj.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	Yes
D.2.1.1.1	Trade name	Simponi
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Biologics BV - EU/1/09/546
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Golimumab
D.3.2	Product code	[CNTO148]
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	GOLIMUMAB
D.3.9.1	CAS number	476181-74-5
D.3.9.2	Current sponsor code	CNTO148
D.3.9.4	EV Substance Code	SUB25638
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	50
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	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	Yes
D.2.1.1.1	Trade name	SIMPONI
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Biologic NV EU/1/09/546
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Golimumab
D.3.2	Product code	[CNTO148]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Yes
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	GOLIMUMAB
D.3.9.1	CAS number	476181-74-5
D.3.9.2	Current sponsor code	CNTO148
D.3.9.3	Other descriptive name	D.3.6.2.1 - valore: 45 / 0.45 mg/ml
D.3.9.4	EV Substance Code	SUB25638
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	45
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: 3
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	Yes
D.2.1.1.1	Trade name	Simponi
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Biologics BV - EU/1/09/546
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Golimumab
D.3.2	Product code	[CNTO148]
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	GOLIMUMAB
D.3.9.1	CAS number	476181-74-5
D.3.9.2	Current sponsor code	CNTO148
D.3.9.4	EV Substance Code	SUB25638
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	100
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: 4
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	Yes
D.2.1.1.1	Trade name	Remicade
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Biologics BV - EU/1/99/116
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.2	Product code	[CNTO312]
D.3.4	Pharmaceutical form	Concentrate 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.3.9.2	Current sponsor code	CNTO312
D.3.9.3	Other descriptive name	D.3.6.2.1 - valore: 5 o 10 mg/kg
D.3.9.4	EV Substance Code	SUB02681MIG
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	100
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

Ulcerative Colitis

Colite Ulcerosa

E.1.1.1

Medical condition in easily understood language

Ulcerative Colitis

Colite Ulcerosa

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

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 evaluate the efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active UC.
•To evaluate the safety profile of golimumab, in pediatric participants with moderately to severely active UC.

•Valutare l’efficacia di golimumab in termini di induzione della remissione clinica valutata dal punteggio Mayo in partecipanti pediatrici con colite ulcerosa ad attività moderata-severa.
•Valutare il profilo di sicurezza di golimumab in pazienti pediatrici con colite ulcerosa ad attività moderata-severa.

E.2.2

Secondary objectives of the trial

•To evaluate the efficacy of golimumab in inducing clinical response as assessed by the Mayo Score and clinical remission as measured by the PUCAI Score.
•To evaluate the efficacy of golimumab on endoscopic healing.
•To evaluate the efficacy of golimumab during the long-term phase.
•To evaluate the effect of golimumab on additional efficacy and quality of life (QOL) measures
•To evaluate the PK and exposure response of golimumab during shortand long-term phases.

•Valutare l’efficacia di golimumab in termini di induzione della risposta clinica valutata dal punteggio Mayo e della remissione clinica misurata dal punteggio PUCAI (Pediatric Ulcerative Colitis Activity Index).
•Valutare l’efficacia di golimumab in termini di guarigione endoscopica.
•Valutare l’efficacia di golimumab durante la fase a lungo termine.
•Valutare l’effetto di golimumab su altre misure relative all’efficacia e alla qualità di vita.
•Valutare la PK e la risposta all’esposizione di golimumab durante le fasi a breve e lungo termine.

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: Usability Assessment Substudy (see appendix 18 of the CNTO148UCO3003 protocol). The Usability Assessment Substudy will be conducted at US sites only. The objective of the Substudy is to provide supportive data that the prefilled syringe as designed, together with the approriate training and written Instructions for Use, is suitable for at home administration by pediatric participants or their caregivers.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio di valutazione dell’usabilità (vedere appendice 18 del Protocollo CNTO148UCO3003) Il sottostudio di valutazione dell’usabilità sarà condotto solo in centri degli Stati Uniti. L'obiettivo del sottostudio è quello di fornire dati a supporto del potenziale utilizzo della siringa preriempita, insieme ad un appropriato training e a delle istruzioni per l'uso scritte, nella somministrazione a casa da parte dei partecipanti pediatrici o dei loro caregivers.

E.3

Principal inclusion criteria

-Must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies: oral corticosteroids, 6-mercaptopurine, methotrexate or azathioprine OR must either have or have had a history of corticosteroid dependency OR required more than 3 courses of corticosteroids in the past year
-Moderately to severely active UC
-If receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to the first administration of study intervention at Week 0. Partecipants who receive parenteral nutrition are not permitted to enroll in the trial.
-No history of latent or active tuberculosis prior to screening
-Acceptable evidence of immunity to measles, mumps, rubella, and varicella

- Devono essere in attuale trattamento con, o avere una storia di mancata risposta, o una controindicazione medica ad almeno una delle seguenti terapie: corticosteroidi per via orale, 6 mercaptopurina, metotrexato or azatioprina o avere un attuale o precedente dipendenza da corticosteroidi o devono avere assunto oltre 3 cicli di corticosteroidi nell’ultimo anno
-Devono avere una colite ulcerosa ad attività moderata-severa
-In caso di nutrizione enterale, devono ricevere un regime stabile da almeno 2 settimane prima della prima somministrazione del farmaco dello studio alla Settimana 0. Partecipanti che ricevono una nutrizione parenterale non possono essere arruolati nello studio.
-Nessuna storia di latente o attiva tubercolosi prima dello screening
-Evidenza accettabile dell’immunità a morbillo, parotite, rosolia e varicella

E.4

Principal exclusion criteria

- History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric (including suicidality), or metabolic disturbances
- History of malignancy or macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)
- Have UC limited to the rectum only or to <20 percent (%) of the colon
- Presence of a stoma
- Presence or history of a fistula
- Contraindications to the use of golimumab or infliximab or anti-tumor necrosis factor (TNF-alpha) therapy per local prescribing information

- Storia di insufficienza epatica o renale; significativi disturbi cardiaci, vascolari, polmonari, gastrointestinali, endocrini, neurologici, ematologici, reumatologici, psichiatrici (compresa la suicidalità) o metabolici.
- Storia di neoplasia maligna o sindrome da attivazione macrofagica (MAS) o linfoistiocitosi emofagocitica (HLH)
- Colite ulcerosa limitata al solo retto o al <20% del colon
- Presenza di uno stoma
- Presenza o storia di fistola
- Controindicazioni all’utilizzo della terapia con golimumab o infliximab o anti-TNFa conformemente alle informazioni di prescrizione locali

E.5 End points

E.5.1

Primary end point(s)

Clinical remission as assessed by the Mayo score.

Remissione clinica misurata dal punteggio Mayo

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 6

Settimana 6

E.5.2

Secondary end point(s)

1. Clinical response as assessed by the Mayo score.
2. Clinical remission as assessed by the PUCAI score.
3. Endoscopic healing.
4. Clinical remission as assessed by the PUCAI score.
5. Endoscopic healing.
6. Symptomatic remission
7. Clinical remission as assessed by the Mayo score.

1. Risposta clinica misurata dal punteggio Mayo
2. Remissione clinica misurata dal punteggio PUCAI
3. Guarigione endoscopica
4. Remissione clinica misurata dal punteggio PUCAI
5. Guarigione endoscopica
6. Remissione sintomatica
7. Remissione clinica misurata dal punteggio Mayo.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Week 6
2. Week 6
3. Week 6
4. Week 54
5. Week 54

1. Settimana 6
2. Settimana 6
3. Settimana 6
4. Settimana 54
5. Settimana 54
6. Settimana 54
7. Settimana 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

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

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

controllo con placebo storico

historical placebo control

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

Brazil

Israel

Korea, Republic of

Taiwan

United States

Belgium

France

Italy

Netherlands

Poland

Spain

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

The end of study is defined as the date of the Last Subject Last Visit, or the last follow-up contact, whichever is longer.

La fine dello studio è definita come la data dell'ultima visita dell'ultimo soggetto, o l'ultimo contatto di follow-up, a seconda di quale sia la data più recente

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

Yes

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Parental consent

Consenso dei genitori/tutore legale

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

125

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)

Upon completion of the study, the subjects will be treated in accordance with the Investigator's clinical judgement.

Al completamento dello studio, i soggetti saranno trattati in accordo con il giudizio clinico dello Sperimentatore.

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

2019-02-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-11-08

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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