Clinical Trials Register

Summary
EudraCT Number:	2018-002932-26
Sponsor's Protocol Code Number:	D9108C00002
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:	2021-02-04
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

2018-002932-26

A.3

Full title of the trial

A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Neoadjuvant Durvalumab Alone or in Combination with Novel Agents in Subjects with Resectable, Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer (NeoCOAST)

Studio di fase 2 in aperto, multicentrico, randomizzato, con piattaforma multifarmaco su durvalumab neoadiuvante in monoterapia o in combinazione con nuovi agenti in soggetti con carcinoma polmonare non a piccole cellule resecabile allo stadio iniziale (da I [> 2 cm] a IIIA) (NeoCOAST)

A.3.1

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

Durvalumab neoadiuvante da solo o in combinazione con nuovi agenti nel carcinoma polmonare non a piccole cellule resecabile

Neoadjuvant Durvalumab Alone or in Combination with Novel Agents in Resectable Non-Small Cell Lung Cancer

A.3.2

Name or abbreviated title of the trial where available

NeoCOAST

A.4.1

Sponsor's protocol code number

D9108C00002

A.5.4

Other Identifiers

Name:

IND number

Number:

140575

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	MEDIMMUNE, LLC
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	MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
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	MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
B.5.2	Functional name of contact point	Clinical Trial Enquiries
B.5.3	Address:
B.5.3.1	Street Address	One MedImmune Way 0
B.5.3.2	Town/ city	Gaithersburg, Maryland
B.5.3.3	Post code	20878
B.5.3.4	Country	United States
B.5.4	Telephone number	0013013980000
B.5.5	Fax number	00000000000000000
B.5.6	E-mail	clinicaltrialenquiries@medimmune.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	durvalumab
D.3.2	Product code	[MEDI4736]
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	Durvalumab
D.3.9.1	CAS number	1428935-60-7
D.3.9.2	Current sponsor code	MEDI4736
D.3.9.3	Other descriptive name	Immunoglobulin G1, anti-human CD antigen
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	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	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	oleclumab
D.3.2	Product code	[MEDI9447]
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	Oleclumab
D.3.9.2	Current sponsor code	MEDI9447
D.3.9.3	Other descriptive name	human IgG1¿ monoclonal antibody
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	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: 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	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	monalizumab
D.3.2	Product code	[IPH2201]
D.3.4	Pharmaceutical form	Lyophilisate for solution for injection
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	monalizumab
D.3.9.2	Current sponsor code	IPH2201
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	375
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	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	danvatirsen
D.3.2	Product code	[AZD9150]
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	Danvatirsen
D.3.9.1	CAS number	1402100-56-4
D.3.9.2	Current sponsor code	AZD9150
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	50
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

Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer

Carcinoma polmonare non a piccole cellule allo stadio iniziale (da I [> 2 cm] a IIIA)

E.1.1.1

Medical condition in easily understood language

Carcinoma polmonare non a piccole cellule allo stadio iniziale

Early-stage Non-small Cell Lung Cancer

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10029517
E.1.2	Term	Non-small cell lung cancer stage I
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10029518
E.1.2	Term	Non-small cell lung cancer stage II
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10029520
E.1.2	Term	Non-small cell lung cancer stage IIIA
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Efficacy
- Assess the antitumor activity of durvalumab alone and/or in combination with novel agents

Efficacia
- Valutare l’attività antitumorale di durvalumab in monoterapia e/o in combinazione con nuovi agenti

E.2.2

Secondary objectives of the trial

Safety
- Assess the feasibility of receiving the planned surgical resection
- Assess the safety and tolerability of durvalumab alone and/or in combination with novel agents
Efficacy
- Assess the antitumor activity of durvalumab alone and/or in combination with novel agents
Pharmacokinetics
- To describe the PK of durvalumab alone and/or in combination with novel agents
Immunogenicity
(a) To assess the immunogenicity of durvalumab alone or in combination with novel agents
(b) To assess the immunogenicity of novel biologic agents in combination with durvalumab

Sicurezza
- Valutare la fattibilità di eseguire la resezione chirurgica programmata
- Valutare la sicurezza e la tollerabilità di durvalumab in monoterapia e/o in combinazione con nuovi agenti
Efficacia
- Valutare l’attività antitumorale di durvalumab in monoterapia e/o in combinazione con nuovi agenti
Farmacocinetica
-Descrivere la PK di durvalumab in monoterapia e/o in combinazione con nuovi agenti
Immunogenicità
- (a) Valutare l’immunogenicità di durvalumab in monoterapia o in combinazione con nuovi agenti
- (b) Valutare l’immunogenicità di nuovi agenti biologici in combinazione con durvalumab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Cytologically and/or histologically-documented NSCLC
(a) Stage I (> 2 cm) to IIIA (For subjects with N2 disease, only those
with 1 single nodal station = 3 cm are eligible) NSCLC
(b) Amenable to complete surgical resection
(c) Have not received any other therapy for this condition
2. Age =18 years old
3. Predicted FEV1 = 50%
4. Predicted DLCO = 50%
5. ECOG 0 or 1
6. Adequate organ function

1. NSCLC documentato con esame citologico e/o istologico
(a) NSCLC di Stadio da I (> 2 cm) a IIIA (nei casi di malattia N2, sono idonei solo i soggetti con 1 singola stazione nodale = 3 cm)
(b) Suscettibile di resezione chirurgica completa
(c) Nessuna terapia pregressa per il trattamento di questa condizione
2. Età =18 anni
3. FEV1 = 50% del valore predetto
4. DLCO = 50% del valore predetto
5. ECOG 0 o 1
6. Funzionalità organica adeguata

E.4

Principal exclusion criteria

1. Subjects with small-cell lung cancer or mixed small-cell lung cancer
2. Subjects who require or may require pneumonectomy
3. Prior treatment with PD-L1, PD-L1, or CTLA-4 inhibitors
4. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
5. Active or prior documented autoimmune or inflammatory disorders.
The following are exceptions to this criterion:
a. Subjects with vitiligo or alopecia
b. Subjects with hypothyroidism on hormone replacement
c. Any chronic skin condition that does not require systemic therapy
d. Subjects without active disease in the last 5 years may be included
but only after consultation with the study physician
e. Subjects with celiac disease controlled by diet alone
6. Pregnant or breast-feeding female
7. Major surgical procedure within prior 30 days
8. History of active primary immunodeficiency
9. Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV
10. QTc interval (QTc) = 470 ms
11. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent
12. Receipt of live attenuated vaccination within 30 days prior to study entry
13. History of another primary malignancy except for:
a. Curative-treated malignancy with no known active disease > 2 years before enrollment on the study
b. Curative-treated non-melanoma skin cancer and/or carcinoma in-situ

1. Soggetti con carcinoma polmonare a piccole cellule o carcinoma polmonare misto a piccole cellule
2. Soggetti (potenzialmente) necessitanti di pneumonectomia
3. Pregresso trattamento con inibitori di PD-L1, PD-L1 o CTLA-4
4. Impiego attuale o pregresso di farmaci immunosoppressori nei 14 giorni precedenti alla somministrazione della prima dose del farmaco in studio
5. Patologie autoimmuni o infiammatorie attive o pregresse.
Fanno eccezione a questo criterio:
a. Soggetti con vitiligine o alopecia
b. Soggetti con ipotiroidismo in terapia ormonale sostitutiva
c. Qualsiasi patologia cutanea cronica non necessitante di terapia sistemica
d. I soggetti senza malattia attiva negli ultimi 5 anni possono essere inclusi, ma solo dopo consultazione con il medico dello studio
e. Soggetti con malattia celiaca controllati con sola dieta
6. Donne in gravidanza o allattamento
7. Intervento di chirurgia maggiore nei 30 giorni precedenti
8. Anamnesi di immunodeficienza primaria attiva
9. Infezione attiva, tra cui tubercolosi, epatite B, epatite C o HIV
10. Intervallo QTc (QTc) = 470 ms
11. Malattia intercorrente non controllata, che limiterebbe la conformità ai requisiti dello studio, determinerebbe un sostanziale aumento del rischio di EA o comprometterebbe la capacità del soggetto di fornire il consenso informato scritto
12. Trattamento con vaccino vivo attenuato nei 30 giorni precedenti all’ingresso in studio
13. Anamnesi di altra malignità primaria, ad eccezione di:
a. Neoplasia maligna sottoposta a trattamento curativo senza malattia attiva nota > 2 anni prima dell’arruolamento nello studio
b. Carcinoma cutaneo non melanoma e/o carcinoma in situ sottoposto a trattamento curativo

E.5 End points

E.5.1

Primary end point(s)

Clinical activity
- Major Pathological Response (MPR) rate

Attività clinica
- Tasso di MPR

E.5.1.1

Timepoint(s) of evaluation of this end point

MPR will be done in the resected specimen. Surgery is planned to take place within 14 days after the 4 weeks treatment period

L’analisi della MPR sarà eseguita sul campione resecato. L’intervento chirurgico è programmato per svolgersi entro 14 giorni dal termine del periodo di 4 settimane di trattamento.

E.5.2

Secondary end point(s)

Safety
- Feasibility, defined as having the planned surgical resection within Day 29 to Day 42 after Week 1, Day 1
- Presence of AEs, SAEs, laboratory abnormalities, and vital signs
Efficacy
- Pathological Complete Response (pCR) rate
Pharmacokinetics
- Concentration of durvalumab or novel agents in plasma or serum
Immunogenicity
- ADA incidence of durvalumab or novel biologic agents

Sicurezza
- Fattibilità definita come programmazione della resezione chirurgica dal Giorno 29 al Giorno 42 dopo il Giorno 1 della Settimana 1
- Presenza di eventi avversi (EA), eventi avversi gravi (EAG), anomalie nei valori di laboratorio e segni vitali
Efficacia
- Tasso pCR
Farmacocinetica
- Concentrazione di durvalumab o dei nuovi agenti nel plasma o nel siero
Immunogeniticità
- Incidenza di ADA di durvalumab o nuovi agenti biologici

E.5.2.1

Timepoint(s) of evaluation of this end point

Safety
- Feasibility - Surgery is planned to take place within 14 days after the 4 weeks treatment period.
- AEs, SAEs, laboratory abnormalities, and vital signs - Up to 126 days after C1D1
Efficacy
- pCR will be done in the resected specimen. Surgery is planned to take place within 14 days after the 4 weeks treatment period.
Pharmacokinetics and Immunogenicity
- Up to 126 days after C1D1

Sicurezza
- Fattibilità - L’intervento chirurgico è programmato per svolgersi entro 14 giorni a partire dal termine delle 4 settimane del periodo di trattamento.
- EA, SAE, anomalie di laboratorio e segni vitali - Fino a 126 giorni dopo C1D1
Efficacia
- L’analisi della pCR sarà eseguita sul campione resecato. L’intervento chirurgico è programmato per svolgersi entro 14 giorni dal termine del periodo di 4 settimane di trattamento.
Farmacocinetica e immunogenicità
- Fino a 126 giorni dopo C1D1

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

Immunogenicità

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Studio piattaforma

Platform study

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

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

Canada

United States

France

Italy

Portugal

Spain

Switzerland

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

The end of the study ("study completion") is defined as the date of the last protocol-specified visit/assessment for the last subject in the study. This date will be 1 year after the final subject is entered into the study or when the sponsor stops the study, whichever occurs first.

Con fine dello studio (“completamento dello studio”) si denota la data dell’ultima valutazione/visita specificata nel protocollo per l’ultimo soggetto partecipante allo studio. Tale data sarà 1 anno dopo l’ingresso dell’ultimo soggetto o quando lo sponsor interrompe lo studio, in base all’evento che si verifica prima.

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:

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

160

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

2019-08-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-07-15

P. End of Trial
P.	End of Trial Status	Completed

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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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