Clinical Trials Register

Summary
EudraCT Number:	2018-002253-30
Sponsor's Protocol Code Number:	INCB39110-120
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-11-10
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

2018-002253-30

A.3

Full title of the trial

An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Pediatric Subjects

Studio in aperto, a braccio singolo, di fase 1/2 volto a valutare la sicurezza e l’efficacia di Itacitinib in combinazione con i corticosteroidi per il trattamento della malattia del trapianto contro l’ospite acuta in soggetti pediatrici naïve agli steroidi

A.3.1

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

A study evaluating safety and efficacy of Itacitinib in combination with corticosteroids for the treatment of first-line acute graft versus-host disease in children

Studio che valuta la sicurezza e l'efficacia di Itacitinib in combinazione con corticosteroidi per il trattamento della malattia del trapianto contro l'ospite acuta in bambini

A.3.2

Name or abbreviated title of the trial where available

INCYTE_INCB39110-120

A.4.1

Sponsor's protocol code number

INCB39110-120

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/208/2018

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	INCYTE CORPORATION
B.1.3.4	Country	United States
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	Incyte Corporation
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Incyte Corporation
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	1801 Augustine Cut-Off
B.5.3.2	Town/ city	Wilmington
B.5.3.3	Post code	DE 19803
B.5.3.4	Country	United States
B.5.6	E-mail	RA@incyte.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	EMA/OD/169/17
D.3 Description of the IMP
D.3.1	Product name	Itacitinib
D.3.2	Product code	[INCB039110]
D.3.4	Pharmaceutical form	Modified-release granules
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ITACITINIB ADIPATE
D.3.9.1	CAS number	1334302-63-4
D.3.9.2	Current sponsor code	INCB039110 ADIPATE
D.3.9.3	Other descriptive name	ITACITINIB ADIPATE
D.3.9.4	EV Substance Code	SUB184194
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	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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	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	EMA/OD/169/17
D.3 Description of the IMP
D.3.1	Product name	Itacitinib
D.3.2	Product code	[INCB039110]
D.3.4	Pharmaceutical form	Modified-release granules
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ITACITINIB ADIPATE
D.3.9.1	CAS number	1334302-63-4
D.3.9.2	Current sponsor code	INCB039110 ADIPATE
D.3.9.3	Other descriptive name	ITACITINIB ADIPATE
D.3.9.4	EV Substance Code	SUB184194
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	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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

Male or female, 28 days to less than 18 years of age, who have received an allogeneic hematopoietic stem cell transplant (allo-HSCT) and have developed Grade II to IV acute GVHD

Maschio o femmina, di età compresa tra 28 giorni e 18 anni, che hanno ricevuto un trapianto di cellule staminali ematopoietiche allogeniche (allo- HSCT) e hanno sviluppato la malattia del trapianto contro l'ospite (GVHD) acuta di grado II-IV

E.1.1.1

Medical condition in easily understood language

Acute graft versus host disease after allogeneic stem cell transplantation

Malattia del trapianto del trapianto contro l'ospite acuta dopo un trapianto di cellule staminali ematopoietiche allogeniche

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

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	10021428
E.1.2	Term	Immune system disorders
E.1.2	System Organ Class	10021428 - Immune system 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

Phase 1:
- To assess the safety and tolerability of itacitinib in combination with corticosteroids in pediatric subjects with Grade II to IV steroid-naive (SN) acute graft-versus-host disease (aGVHD).
- To evaluate the pharmacokinetics (PK) of itacitinib when administered in combination with corticosteroids.
Phase 2:
- To assess the efficacy of itacitinib in combination with corticosteroids in terms of overall response rate (ORR) at Day 28 in pediatric subjects with aGVHD.

Fase 1:
- Valutare la sicurezza e la tollerabilità di itacitinib in combinazione con corticosteroidi in soggetti pediatrici con malattia del trapianto contro l’ospite acuta (acute Graft-Versus-Host Disease, aGVHD) di grado II a IV, naïve agli steroidi (Steroid-Naïve, SN).
- Valutare la farmacocinetica (Pharmacokinetics, PK) di itacitinib quando somministrato in combinazione con corticosteroidi.
Fase 2:
- Valutare l’efficacia di itacitinib in combinazione con corticosteroidi in termini di tasso di risposta complessiva (Overall Response Rate, ORR) al Giorno 28 in soggetti pediatrici con aGVHD.

E.2.2

Secondary objectives of the trial

Phase 1:
- To assess the efficacy of itacitinib in combination with corticosteroids in terms of ORR at Day 28 in pediatric subjects with aGVHD.
Phase 2:
- To evaluate the PK of itacitinib when administered in combination with corticosteroids.
Phase 1 and 2:
- To evaluate additional efficacy and longer-term efficacy outcomes.
- To assess the incidence and severity of AEs and SAEs.
- To evaluate the incidence of secondary graft failure.
- To evaluate the use and discontinuation of corticosteroids.
- To evaluate the use and discontinuation of immunosuppressive medications.
- To evaluate the incidence of aGVHD flares.
- To evaluate the incidence of cGVHD.

Fase 1:
- Valutare l’efficacia di itacitinib in combinazione con corticosteroidi in termini di ORR al Giorno 28 in soggetti pediatrici con aGVHD.
Fase 2:
- Valutare la PK di itacitinib quando somministrato in combinazione con corticosteroidi
Fase 1 e 2:
- Valutare l’efficacia aggiuntiva e gli esiti di efficacia a lungo termine.
- Valutare l’incidenza e la gravità di EA e SAE.
- Valutare l’incidenza di fallimento secondario del trapianto
- Valutare l’uso e l’interruzione del trattamento con corticosteroidi.
- Valutare l’uso e l’interruzione del trattamento con farmaci immunosoppressori.
- Valutare l’incidenza di riacutizzazioni dell’aGVHD
- Valutare l’incidenza di cGVHD.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

. Male and female subjects from 28 days to < 18 years old
• Undergone 1 allo-HSCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
• Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT and any GVHD prophylactic medication. Efforts should be made to obtain biopsies to pathologically confirm aGVHD. In cases where a biopsy is negative, unable to be obtained, or clinically contraindicated, clinical suspicion of aGVHD by the treating physician is sufficient, provided that alternative diagnoses of drug effects or infection are adequately ruled out.
• Evidence of myeloid engraftment (eg, absolute neutrophil count [ANC] = 0.5 × 109/L for 3 consecutive assessments if ablative therapy was previously used). Use of growth factor supplementation is allowed.
• Glomerular filtration rate (GFR) >50 mL/mln/1.73 m2 as estimated using modified Schwartz formula.

- Soggetti di sesso maschile e femminile da 28 giorni fino a < 18 anni
- Soggetti sottoposti a 1 allo-HSCT da qualsiasi donatore e tipo HLA (correlato o no al donatore con qualunque grado di compatibilità con HLA) con utilizzo di qualsiasi fonte di trapianto (midollo osseo, cellule staminali da sangue periferico o da sangue cordonale). Sono considerati idonei i riceventi regimi di condizionamento mieloablativi e a ridotta intensità.
- Sospetto clinico di aGVHD di grado da II a IV secondo i criteri MAGIC, insorta dopo allo-HSCT e qualsiasi trattamento farmacologico per la profilassi della GVHD. È necessario compiere ogni sforzo per ottenere biopsie finalizzate alla conferma patologica dell’aGVHD. Qualora la biopsia sia negativa, non possa essere ottenuta o sia clinicamente controindicata, è sufficiente il sospetto clinico di aGVHD da parte del medico curante, purché si escludano adeguatamente diagnosi alternative di effetti farmaco-correlati o infezione.
- Evidenza di attecchimento mieloide (ad es. conta assoluta dei neutrofili [Absolute Neutrophil Count, ANC] =0,5 × 109/l per 3 valutazioni consecutive in caso di uso precedente di una terapia ablativa). È consentito il ricorso all’integrazione con fattore di crescita.
- Velocità di vibrazione glomerulare (GFR) >50 mL/mln/1.73 m2 stimata tramite la formula modificata di Schwartz.

E.4

Principal exclusion criteria

• More than 1 allo-HSCT.
• Received more than 2 days of systemic corticosteroids for aGVHD before the first study drug administration.
• Presence of GVHD overlap syndrome.
• Presence of an active uncontrolled infection, defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection.

• Più di 1 allo-HSCT.
• Più di 2 giorni di trattamento con corticosteroidi sistemici per aGVHD prima della prima somministrazione del farmaco dello studio.
• Presenza di sindrome da sovrapposizione con GVHD.
• Presenza di un’infezione attiva non controllata, definita come instabilità emodinamica attribuibile a sepsi o come insorgenza di nuovi sintomi, peggioramento dei segni fisici o risultati radiologici attribuibili a infezione. Una febbre persistente senza segni o sintomi non sarà interpretata come infezione attiva non controllata.

E.5 End points

E.5.1

Primary end point(s)

Phase 1:
• Frequency, duration, and severity of adverse events (AEs) and serious adverse events (SAEs)
• Changes in vital signs and clinical evaluations.
• Changes in clinical laboratory blood samples.
• Cmax, Cmin, Tmax, AUC, and Cl/F assessed at Day 1, 7, and 28.
Phase 2:
• ORR at Day 28, defined as the proportion of subjects demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).

Fase 1:
• Frequenza, durata e gravità degli eventi avversi (EA) e degli eventi avversi seri (Serious Adverse Events, SAE).
• Variazioni nei segni vitali e nelle valutazioni cliniche.
• Variazioni nei campioni di sangue per gli esami clinici di laboratorio.
• Cmax, Cmin, Tmax, AUC (Area Under the Curve [area sotto la curva]) e Cl/F valutati al Giorno 1, 7 e 28
Fase 2:
• ORR al Giorno 28, definito come proporzione di soggetti che presentano una risposta completa (Complete Response, CR), una risposta parziale molto buona (Very Good Partial Response, VGPR) o una risposta parziale (PR).

E.5.1.1

Timepoint(s) of evaluation of this end point

Day1 , 7, 14, 21, 28, 35, 42, 49, 56, 100, 180, 365

Giorno 1 , 7, 14, 21, 28, 35, 42, 49, 56, 100, 180, 365

E.5.2

Secondary end point(s)

Phase 1:
• ORR at Day 28, defined as the proportion of subjects demonstrating a CR, VGPR, or PR.
Phase 2:
• Cmax, Cmin, Tmax, AUC, and Cl/F assessed at Day 7.
• ORR, defined as the proportion of subjects demonstrating a CR, VGPR, or PR, at Days 14, 56, and 100.
• Nonrelapse mortality (NRM) rate, defined as the proportion of subjects who died due to causes other than underlying hematological disorders at Months 6, 9, 12, and 24.
• Duration of response (DOR) for responders will be calculated. The DOR is defined from the time of the onset of response to either progression or death. Subjects who died or discontinued will be censored at the death date or the previous assessment.
• Time to response, defined as the interval from treatment initiation to first response.
• Relapse rate of malignant and non-malignant disorders, defined as the proportion of subjects whose underlying disease relapses.
• Malignant and non-malignant disorders relapse–related mortality rate, defined as the proportion of subjects whose underlying disease relapses and has a fatal outcome.
• Failure-free survival rate at timepoint , defined as the proportion of subjects who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic graft versus-host disease (cGVHD).
• Overall survival, defined as the interval from treatment initiation to death due to any cause.
• Clinical safety data (eg, AEs, infections) will be tabulated and listed.
• Incidence rate of secondary graft failure, defined as > 95% recipient cells any time after engraftment with no signs of relapse OR retransplantation because of secondary neutropenia (< 0.5 × 109/L) and/or thrombocytopenia (< 20 × 109/L) within 2 months of transplant.
• Average and cumulative corticosteroid dose at Days 28, 56, 100, and 180; proportion of subjects who discontinue corticosteroids at Days 56 and 100.
• Proportion of subjects who discontinue immunosuppressive medication at Days 56 and 100.
• Incidence rate of aGVHD flares through Day 100.
• Incidence rate of cGVHD at Days 180 and 365.

Fase 1:
• ORR al Giorno 28, definito come proporzione di soggetti che presentano una CR, una VGPR o una PR.
Fase 2:
• Cmax, Cmin, Tmax, AUC e Cl/F valutati al Giorno 7.
• ORR, definito come proporzione di soggetti che presentano una CR, una VGPR o una PR ai Giorni 14, 56 e 100.
• Tasso di mortalità non correlata a recidiva (Nonrelapse Mortality, NRM), definita come proporzione di soggetti deceduti per cause diverse dai disturbi ematologici di base ai Mesi 6, 9, 12 e 24.
• Durata della risposta (Duration Of Response, DOR) per i soggetti responsivi. La DOR è definita come intervallo di tempo dall’insorgenza della risposta alla progressione o al decesso.
• Tempo alla risposta, definito come intervallo di tempo dall’inizio del trattamento alla prima risposta.
• Tasso di recidiva dei disturbi ematologici maligni e non maligni, definito come proporzione di soggetti con recidiva della malattia di base.
• Tasso di mortalità correlata a recidiva dei disturbi ematologici maligni e non maligni, definito come proporzione di soggetti la cui malattia di base recidiva e ha un esito fatale.
• Tasso di sopravvivenza libera da fallimento ad un punto temporale, definita come proporzione di soggetti che sono ancora in vita, non hanno sviluppato recidiva, non hanno richiesto ulteriore terapia per aGVHD e non hanno manifestato segni o sintomi di malattia del trapianto contro l’ospite cronica (chronic GVHD, cGVHD).
• Sopravvivenza complessiva, definita come intervallo di tempo dall’inizio del trattamento al decesso per qualsiasi causa.
• I dati clinici di sicurezza (es. EA, infezioni) saranno riportati in tabelle ed elencati.
• Tasso di incidenza di fallimento secondario del trapianto, definito come presenza di >95% delle cellule del ricevente in qualsiasi momento dopo l’attecchimento senza segni di recidiva, OPPURE ritrapianto dovuto a neutropenia (<0,5 × 109/l) e/o trombocitopenia (<20 × 109/l) secondaria entro 2 mesi dal trapianto.
• Dose media e cumulativa di corticosteroidi ai Giorni 28, 56, 100 e 180; proporzione di soggetti che interrompono il trattamento con corticosteroidi ai Giorni 56 e 100
• Proporzione di soggetti che interrompono il trattamento con farmaci immunosoppressori ai Giorni 56 e 100.
• Tasso di incidenza di riacutizzazioni dell’aGVHD fino al Giorno 100.
• Tasso di incidenza di cGVHD ai Giorni 180 e 365.

E.5.2.1

Timepoint(s) of evaluation of this end point

Day1 , 7, 14, 21, 28, 35, 42, 49, 56, 100, 180, 365 - Months 9 and 24.

Giorno 1 , 7, 14, 21, 28, 35, 42, 49, 56, 100, 180, 365 - Monti 9 e 24.

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

Yes

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)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Safety and PK

Sicurezza e PK

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

E.8.1.1

Randomised

E.8.1.2

Open

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

Yes

E.8.1.7.1

Other trial design description

studio in aperto_approccio scaglionato per coorte di età

open study_staggered approach by age cohort

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

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

Belgium

France

Germany

Italy

Spain

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

The study will end once 75% of subjects have died or are lost to followup

Lo studio avrà termine quando il 75% dei soggetti sarà deceduto oppure perso al follow-up

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

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

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

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)

None

Nessuno

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

2019-02-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-03-07

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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