Clinical Trials Register

Summary
EudraCT Number:	2021-002566-40
Sponsor's Protocol Code Number:	20200491
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:	2022-01-26
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

2021-002566-40

A.3

Full title of the trial

Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 757 in Subjects with Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment

Studio di fase 2 volto a valutare l’efficacia, la sicurezza, la tollerabilità e la farmacocinetica di AMG 757 in soggetti con tumore del polmone a piccole cellule recidivante/refrattario dopo due o più linee di trattamento precedenti

A.3.1

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

A Phase 2 Study of AMG 757 in Patients with Small Cell Lung Cancer (SCLC)

Studio di fase II su AMG 757 in pazienti con tumore del polmone a piccole cellule (SCLC)

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

20200491

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	AMGEN INC.
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	Amgen Inc.
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	Amgen S.r.l. a socio unico
B.5.2	Functional name of contact point	Medical Information
B.5.3	Address:
B.5.3.1	Street Address	Via E. Tazzoli 6
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20154
B.5.3.4	Country	Italy
B.5.4	Telephone number	0039026241121
B.5.5	Fax number	0039026241121
B.5.6	E-mail	medicalinformationitaly@amgen.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	AMG 757
D.3.2	Product code	[AMG 757]
D.3.4	Pharmaceutical form	Powder for 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	Tarlatamab
D.3.9.2	Current sponsor code	AMG 757
D.3.9.4	EV Substance Code	SUB189746
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	6
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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Desametasone
D.3.2	Product code	[Desametasone]
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DESAMETASONE
D.3.9.1	CAS number	50-02-2
D.3.9.2	Current sponsor code	Desametasone
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	4
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

Relapsed/Refractory Small Cell Lung Cancer

Tumore del polmone a piccole cellule recidivante/refrattario

E.1.1.1

Medical condition in easily understood language

Relapsed/Refractory Small Cell Lung Cancer

Tumore del polmone a piccole cellule recidivante/refrattario

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	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10029104
E.1.2	Term	Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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

Part 1 only
•To evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of AMG 757
All part
•Evaluate anti-tumor activity of AMG 757 as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR)

Solo Parte 1:
- valutare la sicurezza e l’efficacia (in base al giudizio dello sperimentatore secondo i criteri di valutazione della risposta nei tumori solidi versione 1.1 [RECIST 1.1]) di 2 livelli di dose di AMG 757
Tutte le Parti:
- Valutare l’attività antitumorale di AMG 757 secondo quanto determinato dal tasso di risposta obiettiva (ORR) in base ai criteri RECIST 1.1 mediante revisione centralizzata indipendente in cieco (BICR)

E.2.2

Secondary objectives of the trial

• Evaluate anti-tumor activity of AMG 757 as determined by other measures per RECIST 1.1 by BICR
• Evaluate anti-tumor activity of AMG 757 as assessed by ORR and other measures per RECIST 1.1 by investigator
• Evaluate the safety and tolerability of AMG 757
• Characterize the pharmacokinetics (PK) of AMG 757
• Evaluate the immunogenicity of AMG 757

• Valutare l’attività antitumorale di AMG 757 secondo quanto determinato da altre misure in base ai criteri RECIST 1.1 mediante BICR
• Valutare l’attività antitumorale di AMG 757 secondo quanto determinato dallo sperimentatore tramite ORR e altre misure in base ai criteri RECIST 1.1
• Valutare la sicurezza e la tollerabilità di AMG 757
• Caratterizzare la farmacocinetica (PK) di AMG 757
• Valutare l’immunogenicità di AMG 757

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

101 Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
102 Male and female subjects >= 18 years of age (or legal adult age within country) at the time of signing the informed consent.
103 Histologically or cytologically confirmed relapsed/refractory SCLC
104 Subjects who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy
Note: (1) re-treatment with a platinum-based regimen is considered a second line of therapy; (2) platinum-based regimen followed by checkpoint inhibitor/anti-programmed death ligand 1 (PD-L1) as maintenance therapy is considered 1 line of therapy; (3) in countries where standard of care first line systemic treatment includes platinum containing chemotherapy in combination with PD-L1 inhibitor, it is required that patients to have failed PD-L1 inhibitor as part of their first
line systemic treatment or not have access to.
105 Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded [FFPE] sample) or willing to undergo pretreatment tumor biopsy. Subjects who do not have archived tumor tissue available and are unable to undergo a pretreatment tumor biopsy due to extenuating circumstances (eg, cannot be performed safely or inaccessible, as determined by the investigator) may be allowed to enroll without a tumor biopsy upon agreement between the investigator and Amgen medical monitor.
106 Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
107 Minimum life expectancy of 12 weeks.
108 Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of AMG 757.
109 Subjects with treated brain metastases are eligible provided they meet the following criteria:
- Definitive therapy was completed at least 2 weeks prior to the first dose of AMG 757.
- There is no evidence of radiographic central nervous system (CNS) progression following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.
- Any CNS disease is asymptomatic for at least 7 days (unless symptoms are deemed irreversible by the investigator), the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the subject is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days.

PLEASE REFERE TO THE PROTOCOL FOR THE FULL LIST.

101 Il soggetto ha fornito il consenso informato prima dell'inizio di qualsiasi attività/procedura specifica dello studio.
102 Soggetti maschi e femmine >= 18 anni di età (o età legale adulta nel paese) al momento della firma del consenso informato.
103 SCLC recidivato/refrattario confermato istologicamente o citologicamente
104 Soggetti che sono progrediti o recidivati dopo 1 regime a base di platino e almeno 1 altra linea di terapia precedente
Nota: (1) il ritrattamento con un regime a base di platino è considerato una seconda linea di terapia; (2) il regime a base di platino seguito da un inibitore del checkpoint/anti-programmato ligando 1 della morte (PD-L1) come terapia di mantenimento è considerato una linea di terapia; (3) nei paesi in cui il trattamento sistemico standard di prima linea include la chemioterapia contenente platino in combinazione con l'inibitore PD-L1, è richiesto che i pazienti non abbiano risposto all'inibitore PD-L1 come parte del loro primo trattamento sistemico di prima linea o non abbiano avuto accesso al trattamento.
105 Soggetti disposti a fornire campioni di tessuto tumorale archiviati (campione fissato in formalina e incluso in paraffina [FFPE]) o disposti a sottoporsi a biopsia tumorale pretrattamento. I soggetti che non hanno a disposizione tessuto tumorale archiviato e non sono in grado di sottoporsi a una biopsia tumorale pretrattamento a causa di circostanze attenuanti (per esempio, non può essere eseguita in modo sicuro o non è accessibile, come determinato dallo sperimentatore) possono essere autorizzati ad essere arruolati senza una biopsia tumorale previo accordo tra lo sperimentatore e il monitor medico di Amgen.
106 Eastern Cooperative Oncology Group (ECOG) performance status di 0-1.
107 Aspettativa di vita minima di 12 settimane.
108 Lesioni misurabili secondo la definizione RECIST 1.1 entro 21 giorni prima della prima dose di AMG 757.
109 I soggetti con metastasi cerebrali trattate sono eleggibili a condizione che soddisfino i seguenti criteri:
- La terapia definitiva è stata completata almeno 2 settimane prima della prima dose di AMG 757.
- Non c'è evidenza di progressione radiografica del sistema nervoso centrale (SNC) dopo la terapia definitiva e al momento dello screening dello studio. I pazienti che manifestano progressione in lesioni precedentemente trattate con radiochirurgia stereotassica possono ancora essere eleggibili se la pseudoprogressione può essere dimostrata con mezzi appropriati e dopo discussione con il monitor medico.
- Qualsiasi malattia del SNC è asintomatica per almeno 7 giorni (a meno che i sintomi siano considerati irreversibili dallo sperimentatore), il paziente è senza steroidi per almeno 7 giorni (dosi fisiologiche di steroidi sono consentite), e il soggetto è senza, o con dosi stabili di farmaci antiepilettici per la malattia maligna del SNC per almeno 7 giorni.

SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO PER LA LISTA COMPLETA.

E.4

Principal exclusion criteria

201 Untreated or symptomatic brain metastases and leptomeningeal disease.
202 Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
203 Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
204 Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible(defined as having been present and stable for > 21 day) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen.
205 History of other malignancy within the past 2 years, with the following exceptions:
- malignancy treated with curative intent and with no known active disease present for >= 2 years before enrollment and felt to be at low risk for recurrence by the treating physician.
- adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- adequately treated cervical carcinoma in situ without evidence of disease.
- adequately treated breast ductal carcinoma in situ without evidence of disease.
- prostatic intraepithelial neoplasia without evidence of prostate cancer.
- adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
206 Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 757 (Section 11.9).
207 History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of AMG 757.
208 Presence of fungal, bacterial, viral, or other infection requiring oral or IV antimicrobials for management within 7 days of first dose AMG 757.
NOTE: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. Subjects requiring oral antibiotics who have been afebrile > 24 hours, have no leukocytosis or have any clinical signs of infection are eligible. Subjects who meet these criteria and who were previously on IV antimicrobials should have been off IV antimicrobials for > 48 hours.
209 Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter).
NOTE: A pleural catheter or dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted.

PLEASE REFERE TO THE PROTOCOL FOR THE FULL LIST.

201 Metastasi cerebrali non trattate o sintomatiche e malattia leptomeningea.
202 Ha evidenza di malattia polmonare interstiziale o polmonite attiva non infettiva.
203 Soggetti che hanno sperimentato una polmonite ricorrente (grado 2 o superiore) o eventi avversi immuno-mediati gravi e pericolosi per la vita o reazioni correlate all'infusione, comprese quelle che portano all'interruzione permanente del trattamento con agenti immuno-oncologici.
204 Tossicità irrisolte da precedenti terapie antitumorali, definite come non risolte al Common Terminology Criteria for Adverse Events (CTCAE) versione 5.0 grado 1, o ai livelli dettati nei criteri di ammissibilità ad eccezione dell'alopecia o delle tossicità da precedenti terapie antitumorali che sono considerate irreversibili (definite come presenti e stabili da > 21 giorni) che possono essere consentite se non sono altrimenti descritte nei criteri di esclusione E c'è l'accordo di consentire sia il ricercatore che Amgen.
205 Storia di altri tumori maligni negli ultimi 2 anni, con le seguenti eccezioni:
- tumore maligno trattato con intento curativo e senza malattia attiva nota presente per >= 2 anni prima dell'arruolamento e ritenuto a basso rischio di recidiva dal medico curante.
- cancro della pelle non melanoma adeguatamente trattato o lentigo maligna senza evidenza di malattia.
- carcinoma cervicale in situ adeguatamente trattato senza evidenza di malattia.
- carcinoma duttale della mammella in situ adeguatamente trattato senza evidenza di malattia.
- neoplasia prostatica intraepiteliale senza evidenza di cancro alla prostata.
- carcinoma papillare uroteliale non invasivo o carcinoma in situ adeguatamente trattato.
206 Infarto miocardico e/o insufficienza cardiaca congestizia sintomatica (New York Heart Association > classe II) entro 12 mesi dalla prima dose di AMG 757 (paragrafo 11.9).
207 Storia di trombosi arteriosa (es. ictus o attacco ischemico transitorio) entro 12 mesi dalla prima dose di AMG 757.
208 Presenza di infezioni fungine, batteriche, virali o di altro tipo che richiedono antimicrobici per via orale o endovenosa per la gestione entro 7 giorni dalla prima dose di AMG 757.
NOTA: L'infezione semplice del tratto urinario (UTI) e la faringite batterica non complicata sono consentite se rispondono al trattamento attivo e dopo aver consultato lo sponsor. I soggetti che necessitano di antibiotici per via orale che sono stati afebrili > 24 ore, non hanno leucocitosi o hanno qualsiasi segno clinico di infezione sono ammissibili. I soggetti che soddisfano questi criteri e che erano precedentemente in trattamento con antimicrobici per via endovenosa devono aver sospeso gli antimicrobici per > 48 ore.
209 Presenza di qualsiasi linea o drenaggio indwelling (es. tubo per nefrostomia percutanea, catetere Foley indwelling, drenaggio biliare, o catetere pleurico/peritoneale/pericardico).
NOTA: Sono consentiti un catetere pleurico o cateteri di accesso venoso centrale dedicati come un catetere Port-a-Cath o Hickman.

SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO PER LA LISTA COMPLETA.

E.5 End points

E.5.1

Primary end point(s)

Part 1 only
•objective response (OR) (complete response [CR] and partial response [PR])
•incidence of treatment-emergent adverse events (TEAEs)
•serum concentrations of AMG 757

All parts
•OR (CR and PR)

Solo parte 1
-risposta obiettiva (OR) (risposta completa [CR] e risposta parziale [PR])
-incidenza di eventi avversi emergenti dal trattamento (TEAEs)
-Concentrazioni nel siero di AMG 757

Tutte le parti
-OR (CR e PR)

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary analysis is planned when all subjects have been enrolled and have had the opportunity to have at least 6 months of follow up from the first post-baseline tumor ssessment.

The final analysis will occur when enrollment is complete and each subject completes the study, including long-term follow up.

L'analisi primaria è prevista quando tutti i soggetti sono stati arruolati e hanno avuto l'opportunità di avere almeno 6 mesi di follow up dalla prima valutazione post-basale del tumore.

L'analisi finale avverrà quando l'arruolamento sarà completo e ogni soggetto completerà lo studio, compreso il follow up a lungo termine.

E.5.2

Secondary end point(s)

•duration of response (DOR)
•disease control (DC)
•duration of DC
•progression-free survival (PFS)
•DOR
•overall survival (OS)
•incidence of TEAEs
•serum concentrations of AMG 757
•incidence of anti-AMG 757 antibody formation

-durata della risposta (DOR)
-controllo della malattia (DC)
-durata della DC
-sopravvivenza libera da progressione (PFS)
-DOR
-Sopravvivenza totale (OS)
-Incidenza di TEAE
-Concentrazioni nel siero di AMG 757
-Incidenza della formazione di anticorpi anti-AMG 757

E.5.2.1

Timepoint(s) of evaluation of this end point

The primary analysis is planned when all subjects have been enrolled and have had the opportunity to have at least 6 months of follow up from the first post-baseline tumor assessment.

The final analysis will occur when enrollment is complete and each subject completes the study, including long-term follow up.

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

Yes

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)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

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

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

Japan

Korea, Democratic People's Republic of

Singapore

Switzerland

Taiwan

United Kingdom

United States

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

LSLV

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

2021-10-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-10-19

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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