Clinical Trials Register

Summary
EudraCT Number:	2020-001759-42
Sponsor's Protocol Code Number:	214094
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:	2021-06-07
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

2020-001759-42

A.3

Full title of the trial

A randomized, double-blind, placebo-controlled, study evaluating the efficacy and safety of otilimab IV in patients with severe pulmonary COVID-19 related disease.

Studio randomizzato, in doppio cieco, controllato verso placebo, per valutare l’efficacia e la sicurezza di otilimab IV in pazienti con malattia polmonare severa correlata a COVID-19.

A.3.1

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

Investigating otilimab in patients with severe coronavirus related lung disease.

Studio con otilimab in pazienti con grave malattia polmonare correlata al coronavirus

A.3.2

Name or abbreviated title of the trial where available

OSCAR

A.4.1

Sponsor's protocol code number

214094

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	GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
B.1.3.4	Country	United Kingdom
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	GlaxoSmithKline LLC
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	GlaxoSmithKline Research & Development Ltd
B.5.2	Functional name of contact point	GSK Clinical Support HelpDesk
B.5.3	Address:
B.5.3.1	Street Address	980 Great West Road
B.5.3.2	Town/ city	Brentford, Middlesex
B.5.3.3	Post code	TW8 9GS
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	4402089904466
B.5.5	Fax number	4402089904968
B.5.6	E-mail	GSKClinicalSupportHD@gsk.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	OTILIMAB
D.3.2	Product code	[GSK3196165]
D.3.4	Pharmaceutical form	Solution for injection/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	OTILIMAB
D.3.9.1	CAS number	1638332-55-4
D.3.9.2	Current sponsor code	GSK3196165
D.3.9.3	Other descriptive name	Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody
D.3.9.4	EV Substance Code	SUB198008
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	150
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Concentrate for solution for injection/infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Severe pulmonary COVID-19 related disease

Grave malattia polmonare correlata a COVID-19

E.1.1.1

Medical condition in easily understood language

Severe coronavirus related lung disease

Grave malattia polmonare correlata al coronavirus

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	LLT
E.1.2	Classification code	10053983
E.1.2	Term	Corona virus infection
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Part 1
To compare the efficacy of otilimab IV versus placebo.

Part 2
To compare the efficacy of otilimab IV versus placebo

Parte 1
Confrontare l’efficacia di otilimab 90 mg per via endovenosa (IV) rispetto a placebo

Parte 2
Confrontare l’efficacia di otilimab 90 mg per via endovenosa (IV) rispetto a placebo

E.2.2

Secondary objectives of the trial

Part 1
To compare the efficacy of otilimab IV versus placebo.
To compare the safety and tolerability of otilimab IV versus placebo.

Part 2
To compare the efficacy of otilimab IV versus placebo
To compare the safety and tolerability of otilimab IV versus placebo

Parte 1
Confrontare l’efficacia di otilimab 90 mg IV rispetto a placebo
Confrontare la sicurezza e tollerabilità di otilimab 90 mg IV rispetto a placebo

Parte 2
Confrontare l’efficacia di otilimab 90 mg IV rispetto a placebo
Confrontare la sicurezza e tollerabilità di otilimab 90 mg IV rispetto a placebo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Part 1
1. Age =18 years and =79 years at the time of obtaining informed consent.
2. Participants must:
a. have positive SARS-CoV-2 result (any validated test, e.g. RT-PCR [performed on an appropriate specimen; e.g. respiratory tract sample])
b. AND be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan consistent with COVID-19)
c. AND be developing new onset of oxygenation impairment requiring any of the following
- high-flow oxygen (=15L/min)
- non-invasive ventilation (NIV, CPAP, BIPAP)
- mechanical ventilation =48h prior to dose
d. AND have increased biological markers of systemic inflammation (either CRP >ULN or serum ferritin >ULN).
3. No gender restriction.
4. Female participants must meet and agree to abide by the contraceptive criteria detailed in the protocol.
5. Capable of giving written informed consent. If participants are not capable of giving written informed consent, alternative consent procedures will be followed.

Part 2
1. Age 70 years or above at the time of obtaining informed consent.
2. Participants must:
a. have positive SARS-CoV-2 result (any validated test, e.g. RT-PCR [performed on an appropriate specimen; e.g. respiratory tract sample])
b. AND be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan consistent with COVID-19)
c. AND be developing new onset of oxygenation impairment requiring any of the following
- high-flow oxygen (=15L/min)
- non-invasive ventilation (NIV, CPAP, BIPAP)
- mechanical ventilation =48h prior to dose
d. AND have increased biological markers of systemic inflammation (either CRP >ULN or serum ferritin >ULN).
3. No gender restriction
4. Capable of giving written informed consent. If participants are not capable of giving written informed consent, alternative consent procedures will be followed.

Criteri inclusione PARTE 1 dello STUDIO
ETA’
1. Età ¿18 anni e ¿79 anni al momento dell’ottenimento del consenso informato.
TIPO DI PARTECIPANTI E CARATTERISTICHE DELLA MALATTIA
2. I partecipanti devono:
a. Avere un risultato positivo per SARS-CoV-2 (qualsiasi test validato, ad esempio RT-PCR [effettuato su un campione adeguato; ad esempio, campione di tratto respiratorio])
b. E essere ospedalizzati con diagnosi di polmonite (radiografia toracica o tomografia computerizzata [TAC] coerente con COVID-19)
c. E presentare nuova insorgenza di riduzione dell’ossigenazione che necessita di uno dei seguenti:
1. Ossigeno ad alto flusso (¿15L/min)
2. Ventilazione non invasiva (ad esempio CPAP, BiPAP)
3. Ventilazione meccanica ¿ 48 ore prima della somministrazione
E presentare un aumento degli indicatori biologici di infiammazione sistemica (CRP >ULN1 o ferritina sierica >ULN1). 1In base al range di rif.loc.È consentita la ripetizione dei test per CRP o ferritina.
SESSO
3. Nessuna restrizione di genere.
4. Le partecipanti di sesso femminile devono soddisfare e rispettare i criteri relativi alla contraccezione dettagliati nell’Appendice 4 del Protocollo. Per maggiori dettagli fare riferimento al Protocollo e alla sinossi.
CONSENSO INFORMATO
5. Pazienti in grado di dare il proprio consenso informato scritto come descritto alla Sezione 9.1.3 del Protocollo. Se i partecipanti non sono in grado di dare il proprio consenso scritto, saranno seguite procedure alternative come descritto alla Sezione 9.1.3 del Protocollo.Parte 2

Criteri inclusione PARTE 2 dello STUDIO

ETA’
1. Età uguale o superiore a 70 anni al momento dell’ottenimento del consenso informato.
TIPO DI PARTECIPANTI E CARATTERISTICHE DELLA MALATTIA
2. I partecipanti devono:
a. Avere un risultato positivo per SARS-CoV-2 (qualsiasi test validato, ad esempio RT-PCR
[effettuato su un campione adeguato; ad esempio, campione di tratto respiratorio])
b. E essere ospedalizzati per diagnosi di polmonite (radiografia toracica o tomografia
computerizzata [TAC] coerente con COVID-19)
c. E presentare nuova insorgenza di riduzione dell’ossigenazione che necessita di uno dei
seguenti:
1. Ossigeno ad alto flusso (>15L/min)1
2. Ventilazione non invasiva (ad esempio CPAP, BiPAP)
3. Ventilazione meccanica < 48 ore prima della somministrazione
d. E presentare un aumento degli indicatori biologici di infiammazione sistemica (CRP >ULN2
o ferritina sierica >ULN2).1o equivalente, come dettagliato nel manuale di riferimento dello studio (SRM).
2In base al range di riferimento locale. È consentita la ripetizione dei test per CRP o ferritina.
SESSO
3.Nessuna restrizione di genere.
CONSENSO INFORMATO
4. Pazienti in grado di dare il proprio consenso informato scritto come descritto alla Sezione 9.1.3 del Protocollo. Se i partecipanti non sono in grado di dare il proprio consenso scritto, saranno seguite procedure alternative come descritto alla Sezione 9.1.3 del Protocollo.

E.4

Principal exclusion criteria

Exclusion criteria Part 1: please see Protocol

Part 2
1. Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator.
2. Multiple organ failure according to the investigator’s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU.
3. Extracorporeal membrane oxygenation (ECMO) haemofiltration/dialysis, or more than one inotrope/vasopressor of any class.
4. Current serious or uncontrolled medical condition (e.g. significant pulmonary disease [such as severe COPD or pulmonary fibrosis], heart failure [NYHA class III or higher], severe renal dysfunction, acute myocardial infarction or acute cerebrovascular accident within the last 3 months), severe dementia, severe disability or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.
5. Untreated systemic bacterial, fungal, viral, or other infection (other than SARS-CoV-2).
6. Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB.
7. Known HIV regardless of immunological status.
8. Known HBsAg and/or anti-HCV positive.
9. Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy.
10. Received monoclonal antibody therapy (e.g. tocilizumab, sarilumab) within the past 3 months prior to randomization, including intravenous immunoglobulin or planned to be received during the study.
11. Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, JAK inhibitors (e.g. baricitinib, tofacitinib, upadacitinib), nintedanib, DMARDs (e.g. methotrexate) within the last 3 months prior to randomization or planned to be received during the study.
History of allergic reaction, including anaphylaxis to any previous treatment with an anti- GM-CSF therapy.
12. Received COVID-19 convalescent plasma within 48 hours of randomization.
13. Currently receiving chronic oral corticosteroids for a non-COVID-19 related condition in a dose higher than prednisone 10 mg or equivalent per day.
14. Treatment with an investigational drug within 30 days of randomization.
15. Participating in other drug clinical trials, including for COVID-19.

A complete list of Exclusion criteria for Part 2 can be found in the protocol Section 5.4

Criteri di esclusione Parte 1 dello Studio: Vedasi Protocollo e/o Sinossi.
Criteri di esclusione Parte 2 dello Studio
RELATIVI ALLA MALATTIA POLMONARE SEVERA CORRELATA A COVID-19
1. La progressione al decesso è imminente e inevitabile entro le 48 successive, indipendentemente dalla somministrazione di trattamenti, a discrezione dello sperimentatore.
2. Insufficienza d’organo multipla a giudizio dello sperimentatore o una valutazione del punteggio SOFA (Sequential Organ Failure Assessment) > 10 se intubato in ICU.
3. Ossigenazione per membrana extracorporea (ECMO), emofiltrazione/dialisi, o più di un inotropo/vasopressore di qualsiasi classe.
CONDIZIONI MEDICHE CONCOMITANTI
4. Attuale condizione medica seria o non controllata (ad esempio, malattia polmonare significativa [come BPCO severa o fibrosi polmonare], scompenso cardiaco [classe NYHA III o superiore], disfunzione renale, infarto miocardico acuto o accidente cerebrovascolare acuto nei 3 mesi precedenti), demenza severa, disabilità severa o anomalie dei test di laboratorio clinico che, a giudizio dello sperimentatore, preclude la partecipazione sicura del partecipante allo studio e il completamento dello studio stesso.
5. Infezione sistemica batterica, micotica, virale o altra infezione non trattata (diversa da SARS-CoV-2).
6. Tubercolosi (TB) nota attiva, anamnesi di TB non trattata o trattata in modo non completo attiva o latente, sospetta o nota TB extra polmonare.
7. HIV noto indipendentemente dallo stato immunologico.
8. Positività nota per HbsAg e/o anti-HCV (i pazienti che mostrano una risposta virologica sostenuta [Sustained Virological Response – SVR] non sono esclusi dalla partecipazione).
Pazienti attualmente sottoposti a radioterapia, chemioterapia (le terapie a base ormonale sono consentite) o immunoterapia per neoplasia maligna.
FARMACI/TRATTAMENTI PREGRESSI
10. Pazienti sottoposti a terapia con anticorpi monoclonali (ad esempio, tocilizumab, sarilumab) nei 3 mesi precedenti la randomizzazione, comprese immunoglobuline per via endovenosa, o con la somministrazione di tali trattamenti pianificata durante lo studio.
11. Pazienti sottoposti a terapia immunosoppressiva compresi, a titolo esemplificativo e non esaustivo, ciclosporina, azatioprina, tacrolimus, micofenolato, inibitori JAK (ad esempio, baricitinib, tofacitinib, upadacitinib), nintedanib, DMARD (ad es. metotrexato) nei 3 mesi precedenti la randomizzazione o con la somministrazione di tali trattamenti pianificati durante lo studio.
Nota: i partecipanti con un trapianto d’organo sono pertanto esclusi (ad eccezione dei pazienti con trapianti di cornea che non richiedono immunosoppressione).
12. Anamnesi di reazione allergica, compresa anafilassi, a qualsiasi trattamento pregresso con una terapia anti-GM-CSF.
13. Pazienti che hanno ricevuto plasma da convalescenti da COVID-19 entro 48 ore dalla randomizzazione.
Nota: Per diventare eleggibili per lo studio, i partecipanti che hanno ricevuto plasma da convalescenti da COVID-19 devono, a giudizio dello sperimentatore, continuare a peggiorare da un punto di vista clinico per almeno 48 ore dopo l’infusione di plasma convalescente.
FARMACI PROIBITI
14. Pazienti attualmente in trattamento con corticosteroidi orali cronici per una condizione non correlata a COVID-19 ad una dose superiore a prednisone 10 mg o equivalente al giorno.
15. Trattamento con un farmaco sperimentale entro 30 giorni dalla randomizzazione, a meno che non approvato dal Medical Monitor.
ESPERIENZA CONCOMITANTE/PREGRESSA IN STUDI CLINICI
16. Pazienti partecipanti ad altri studi clinici con farmaco, compresi studi per COVID-19.
VALUTAZIONI DIAGNOSTICHE
17. Aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) >5x limite superiore di normalità (Upper Limit of Normal - ULN).
18. Piastrine <50,000/mm3.
19. Emoglobina ¿9 g/dL.
20. Conta assoluta dei neutrofili (Absolute Neutrophil Count - ANC) <1.0 x 109/L (neutropenia ¿ Grado 3).
21. GFR stimata ¿30 mL/min/1.73m2.

E.5 End points

E.5.1

Primary end point(s)

Part 1 and Part 2
Participants alive and free of respiratory failure

Parte 1 e Parte 2
Partecipanti in vita e liberi da insufficienza respiratoria

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 28

Giorno 28

E.5.2

Secondary end point(s)

Part 1
• All-cause mortality
• Time to last dependence on supplementary oxygen
• Participants alive and independent of supplementary oxygen
• ICU admission
• Time to final ICU discharge
• Time to final hospital discharge
• Time to all-cause mortality,
• Time to recovery from respiratory failure
• Time to last dependence on supplementary oxygen
• Occurrence of adverse events (AEs)
• Occurrence of serious adverse events (SAEs)

Part 2
• All cause mortality
• Time to all-cause mortality
• Participants alive and free of respiratory failure
• Time to recovery from respiratory failure
• Participants alive and independent of supplementary oxygen
• Time to last dependence on supplementary oxygen
• Time to final ICU discharge
• Time to first discharge from investigator site
• Time to first discharge to non-hospitalized residence
• Occurrence of adverse events (AEs)
• Occurrence of serious adverse events (SAEs)

Parte 1
• Mortalità per qualsiasi causa al Giorno 60
• Tempo alla mortalità per qualsiasi causa fino al Giorno 60
• Partecipanti in vita e liberi da insufficienza respiratoria ai Giorni 7, 14, 42 e 60
• Tempo alla guarigione dall’insufficienza respiratoria fino al Giorno 28
• Partecipanti in vita e indipendenti dalla supplementazione con ossigeno ai Giorni 7, 14, 28, 42 e 60
• Tempo all’ultima dipendenza da supplementazione con ossigeno fino al Giorno 28
• Ricovero in terapia intensiva (Intensive Care Unit – ICU) fino al Giorno 28
• Tempo alla dimissione finale dalla ICU fino al Giorno 28
• Tempo alla dimissione finale dall’ospedale fino al Giorno 28
• Insorgenza di eventi avversi (Adverse Event – AE) [fino al Giorno 60]
• Insorgenza di eventi avversi seri (Serious Adverse Event – SAE) [fino al Giorno 60]

Parte 2
• Mortalità per qualsiasi causa al Giorno 28
• Mortalità per qualsiasi causa al Giorno 60
• Tempo alla mortalità per qualsiasi causa fino al Giorno 60
• Partecipanti in vita e senza insufficienza respiratoria ai Giorni 7, 14, 42 e 60
• Tempo alla guarigione dall’insufficienza respiratoria fino al Giorno 28
• Partecipanti in vita e indipendenti dalla supplementazione con ossigeno ai Giorni 7, 14, 28, 42 e 60
• Tempo all’ultima dipendenza da supplementazione con ossigeno fino al Giorno 28
• Tempo alla dimissione finale dalla ICU fino al Giorno 28
• Tempo alla prima dimissione dal centro sperimentale fino al Giorno 60
• Tempo alla prima dimissione ad una residenza non ospedaliera fino al Giorno 60
• Insorgenza di eventi avversi (Adverse Event – AE) [fino al Giorno 60]
• Insorgenza di eventi avversi seri (Serious Adverse Event – SAE) [fino al Giorno 60]

E.5.2.1

Timepoint(s) of evaluation of this end point

Various timepoints up to Day 60.

Vari timepoints fino al Giorno 60

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

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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

Yes

E.8.1.7.1

Other trial design description

Parte 2 dello studio

2 Part Study

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

Brazil

Canada

Chile

India

Japan

Mexico

Peru

Russian Federation

South Africa

United States

Belgium

France

Netherlands

Poland

Spain

United Kingdom

Argentina

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

A participant is considered to have completed the study if he/she has completed all visits of the study through to Day 60 or has died prior to Day 60. The end of the study is defined as the date of the last contact of the last participant in this additional cohort in Part 2 (or any future additional cohorts) in the study.

Si considera che un partecipante abbia completato lo studio se ha completato tutte le visite dello studio fino al giorno 60 o è morto prima del giorno 60. La fine dello studio è definita come la data dell'ultimo contatto dell'ultimo partecipante in questa coorte aggiuntiva nella Parte 2 (o in qualsiasi futura coorte aggiuntiva) nello studio.

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:

440

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

710

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

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

If participants are not capable of giving informed consent, consent maybe obtained from a legal representative.

Se i partecipanti non sono in grado di fornire il consenso informato, il consenso può essere ottenuto da un rappresentante 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

520

F.4.2.2

In the whole clinical trial

1150

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

2021-05-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-08-16

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