Clinical Trials Register

Summary
EudraCT Number:	2020-005532-29
Sponsor's Protocol Code Number:	A0001B
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:	2021-04-29
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

2020-005532-29

A.3

Full title of the trial

Randomized, placebo-controlled, double-blind, multicenter, seamless adaptive phase II-III clinical trial to select the dose and evaluate safety and efficacy of MAD0004J08 monoclonal antibody in adult patients with recently diagnosed asymptomatic to moderately severe COVID-19.

Studio clinico randomizzato, controllato verso placebo, in doppio cieco, multicentrico, di fase II-III senza soluzione di continuità per selezionare la dose e valutare la sicurezza e l'efficacia dell'anticorpo monoclonale MAD0004J08 in pazienti adulti con diagnosi recente di COVID-19 da asintomatico a moderatamente severo.

A.3.1

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

Clinical trial to select the dose and evaluate safety and efficacy of MAD0004J08 monoclonal antibody in adult patients with recently diagnosed asymptomatic to moderately severe COVID-19.

Studio clinico per selezionare la dose e valutare la sicurezza e l'efficacia dell'anticorpo monoclonale MAD0004J08 in pazienti adulti con diagnosi recente di COVID-19 da asintomatico a moderatamente severo.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

A0001B

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	Toscana Life Sciences Sviluppo
B.1.3.4	Country	Italy
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	Toscana Life Sciences e Sviluppo S.r.l.
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	AchilleS Vaccines S.r.l.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Toscana Life Sciences e Sviluppo S.r.l.
B.5.2	Functional name of contact point	Sarah Nosari
B.5.3	Address:
B.5.3.1	Street Address	Via di Città, 43
B.5.3.2	Town/ city	Siena
B.5.3.3	Post code	53100
B.5.3.4	Country	Italy
B.5.4	Telephone number	05771517858
B.5.5	Fax number	05771517858
B.5.6	E-mail	s.nosari@achillesvaccines.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	MAD0004J08
D.3.2	Product code	[MBHX0120]
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	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	MAD0004J08
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	MAD0004J08
D.3.2	Product code	[MBHX0120]
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	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	MAD0004J08
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection/infusion
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

SARS-CoV2 treatment.

Trattamento SARS-CoV2.

E.1.1.1

Medical condition in easily understood language

COVID-19 treatment.

Trattamento COVID-19.

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	PT
E.1.2	Classification code	10084268
E.1.2	Term	COVID-19
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	PT
E.1.2	Classification code	10084268
E.1.2	Term	COVID-19
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	PT
E.1.2	Classification code	10084460
E.1.2	Term	COVID-19 treatment
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Safety:
- To assess the safety and tolerability of MAD0004J08 as determined by severe and serious adverse events.

Efficacy:
- To demonstrate that MAD0004J08 shortens the time to clearance of SARS-CoV-2 from the URT.

Sicurezza:
- Valutare la sicurezza e la tollerabilità di MAD0004J08 determinate dall’insorgenza di eventi avversi severi e seri.

Efficacia:
- Dimostrare che MAD0004J08 riduce i tempi di clearance di SARS-CoV-2 dall'URT.

E.2.2

Secondary objectives of the trial

Safety:
- To assess the overall safety and tolerability, local reactogenicity, and production of anti-drug antibodies of MAD0004J08.

Efficacy:
- To demonstrate that MAD0004J08 reduces the proportion of participants who experience one of the clinically outcomes that are part of the composite endpoint.
- To assess the impact of MAD0004J08 on SARS-CoV-2 virus in the URT and on the clinical course of COVID-19.

Sicurezza:
- Valutare la sicurezza e la tollerabilità complessive, la reattogenicità locale e la produzione di anticorpi antifarmaco MAD0004J08.

Efficacia:
- Dimostrare che MAD0004J08 riduce la proporzione di partecipanti che presentano uno degli esiti clinici che fanno parte dell'endpoint composito.
- Valutare l’impatto di MAD0004J08 sul virus SARS-CoV-2 nell’URT e sul decorso clinico di COVID-19.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed written informed consent taken before any study procedure from any patient capable of giving consent, or, when the patient is incapable of doing so, by his or her legal/authorized representative.
2. Age = 18 years.
3. First nasopharyngeal swab testing positive for SARS-CoV-2 by RT-PCR taken no more than 3 days before randomization (Visit 1). Results of “rapid” semiquantitative tests are not acceptable.
4. Asymptomatic to moderately symptomatic outpatients with no need for immediate hospitalization: grade 1, or grade 2 or grade 3 of Clinical Severity Scale.
5. No childbearing potential (post-menopause, surgically-induced, or pharmacologicallyinduced sterility) or, if of childbearing potential, negative urinary pregnancy test (women) and commitment to use at least 2 forms of contraception for at least 168 days from administration of study drug (men and women).

1. Consenso informato scritto ottenuto prima dell’effettuazione di qualsiasi procedura dello studio da qualsiasi paziente in grado di dare il consenso o, quando il paziente non è in grado di farlo, dal suo rappresentante legale/autorizzato.
2. Età = 18 anni.
3. Primo tampone nasofaringeo con esito positivo per SARS-CoV-2 da RT-PCR effettuato non più di 3 giorni prima della randomizzazione (Visita 1). I risultati dei test semiquantitativi "rapidi" non sono accettabili.
4. Pazienti ambulatoriali asintomatici o moderatamente sintomatici senza necessità di ricovero immediato: grado 1, grado 2 o grado 3 della scala Clinical Severity Scale.
5. Non potenzialmente fertili (fase di post-menopausa, sterilità indotta chirurgicamente o farmacologicamente) o, se potenzialmente fertili, test di gravidanza sulle urine negativo (donne) e impegno a utilizzare almeno 2 forme di contraccezione per almeno 168 giorni dalla somministrazione del farmaco in studio (uomini e donne).

E.4

Principal exclusion criteria

1. Severe or critical COVID-19: grade 4 or grade 5 of clinical severity scale.
2. Current hospitalization and/or hospitalization or emergency room visit in the past 14 days.
3. Need for immediate hospitalization for any reason in the investigator’s opinion.
4. Severe liver disease as determined by values of ALT and/or AST >5x upper limit of normal (ULN) and/or history of liver cirrhosis.
5. Severe renal disease as determined by estimated creatinine clearance (CcCl) <30 mL/min or serum creatinine >2 mg/dL (>176.8 µmol/L) or ongoing renal dialysis.
6. Absolute neutrophil count (ANC) < 1000/µL.
7. Demyelinating and connective tissue disease.
8. Active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
9. Any condition that in the Investigator’s opinion may be negatively affected by the study treatments and/or study procedures.
10. Any condition, including psychiatric disorders, alcohol, or substance abuse, which in the Investigator’s opinion may interfere with completion of the study procedures.
11. Any condition with life expectancy <6 months in the Investigator’s opinion.
12. Ongoing or planned pregnancy.
13. Ongoing breast feeding.
14. History of life-threatening event in the 1 month before Visit 1.
15. History of surgery in the 1 month before Visit 1.
16. History of treatment with blood components in the 6 months before Visit 1.
17. History of cancer treated with chemotherapy in the 6 months before Visit 1.
18. History of solid organ transplant at any time before Visit 1.
19. History of severe and/or serious allergic reaction to monoclonal antibodies or any component of MAD0004J08, including anaphylaxis at any time before Visit 1.
20. Treatment with an investigational drug or vaccine within 5 half-lives or 30 days (whichever is longer) of randomization.
21. Treatment at any time with monoclonal antibodies bamlanivimab, bamlanivimab + etesevimab combination, and casiribimab + imdevimab combination .

Receipt of an approved vaccine vs. COVID-19 is NOT an exclusion criterion, i.e. is compatible with enrolment in the study if all inclusion and exclusion criteria are met.

1. COVID-19 severo o critico: grado 4 o grado 5 della scala di severità clinica.
2. Attuale ospedalizzazione e/o ospedalizzazione o visita al pronto soccorso nei 14 giorni precedenti.
3. Necessità di ospedalizzazione immediata per qualsiasi motivo a giudizio dello sperimentatore.
4. Patologia epatica severa determinata da valori di ALT e/o AST >5 ULN (Upper Normal Limit – limite superiore di normalità) e/o anamnesi di cirrosi epatica.
5. Patologia renale severa determinata da clearance creatinina (Creatinine Clearance – CcCl) stimata <30 mL/min o creatinina sierica >2 mg/dL (>176.8 µmol/L) o dialisi renale in corso.
6. Conta assoluta dei neutrofili (Absolute Neutrophil Count – ANC) < 1000/µL.
7. Patologia demielinizzante e del tessuto connettivo.
8. Tubercolosi attiva o sospetta infezione attiva batterica, micotica, virale o altra infezione (oltre a COVID-19).
9. Qualsiasi condizione che, a giudizio dello sperimentatore, possa subire un impatto negativo dai trattamenti in studio e/o dalle procedure dello studio.
10. Qualsiasi condizione, compresi disturbi psichiatrici, abuso di alcol o di sostanze che a giudizio dello sperimentatore possono interferire con il completamento delle procedure dello studio.
11. Qualsiasi condizione con un’aspettativa di vita <6 mesi a giudizio dello sperimentatore.
12. Gravidanza in corso o pianificata.
13. Allattamento in corso.
14. Anamnesi di evento potenzialmente letale nel mese precedente la Visita 1.
15. Anamnesi di intervento chirurgico nel mese precedente la visita 1.
16. Anamnesi di trattamento con component ematici nei 6 mesi precedenti la Visita 1.
17. Anamnesi di cancro trattato con chemioterapia nel 6 mesi precedenti la Visita 1.
18. Anamnesi di trapianto d’organo solido in qualsiasi momento prima della Visita 1.
19. Anamnesi di reazione allergica severa e/o seria ad anticorpi monoclonali o a qualsiasi componente di MAD0004J08, compresa anafilassi, in qualsiasi momento prima della Visita 1.
20. Trattamento con un farmaco o un vaccino sperimentale entro 5 emivite o 30 giorni (scegliere l’intervallo più lungo) dalla randomizzazione.
21. Trattamento in qualsiasi momento con gli anticorpi monoclonali bamlanivimab, la combinazione bamlanivimab + etesevimab e la combinazione casiribimab + imdevimab.

La somministrazione di un vaccino approvato per COVID-19 NON costituisce un criterio di esclusione, ovvero è compatibile con l’arruolamento nello studio se sono soddisfatti tutti i criteri di inclusione ed esclusione.

E.5 End points

E.5.1

Primary end point(s)

Safety:
- Proportion of participants with severe (Grade 3) unsolicited AEs and/or serious unsolicited AEs (SAEs).

Efficacy:
- Time to SARS-CoV-2 clearance in the URT.

Sicurezza:
- Proporzione di partecipanti con eventi avversi (Adverse Event -AE) severi (Grado 3) non sollecitati e/o eventi avversi seri (Serious Adverse Event - SAE) non sollecitati.

Efficacia:
- Tempo alla clearance di SARS-CoV-2 dall'URT.

E.5.1.1

Timepoint(s) of evaluation of this end point

Safety and efficacy endpoints will be analyzed as appropriate in two target populations and three time windows:
- Primary populations: 1) all randomized participants (ALL), and 2) seronegative randomized participants (SEROneg).
- Time windows (defined at an individual participant level): 1) baseline (Visit 1) to end of Stage-1 or dropout (interim analysis), 2) baseline (Visit 1) to end of Stage-2 or dropout (primary analysis), 3) baseline (Visit 1) to end of study (Visit 12) or dropout (final analysis).

Gli endpoint di sicurezza ed efficacia verranno opportunamente lizzati in due popolazioni target ed in tre finestre temporali:
- Popolazioni primarie: 1) tutti i partecipanti randomizzati (ALL), e 2) partecipanti randomizzati sieronegativi (SEROneg).
- Finestre temporali (definite a livello del singolo partecipante): 1) dal basale (Visita 1) fino alla fine dello Stadio 1 o all’uscita anticipata dallo studio (dropout) (analisi ad interim), 2) dal basale (Visita 1) fino alla fine dello Stadio 2 o all dropout (analisi primaria), 3) dal basale (Visita 1) alla fine dello studio (Visita 12) o al dropout (analisi finale).

E.5.2

Secondary end point(s)

Safety:
- Proportion of participants with unsolicited AEs, including clinically relevant laboratory and ECG abnormalities, and with solicited local AEs at the injection site; proportion of tested participants who develop ADA (ADA testing limited to the first 60 randomized participants).

Efficacy:
- Proportion of patients experiencing at least one of the following events: peripheral capillary oxygen saturation (SpO2) < 94%, newly established or increased dose home oxygen therapy, hospitalization, death (clinical composite endpoint);
- Viral clearance and viral load in the URT and SpO2% by visit, COVID-19 clinical symptoms, newly established or increased dose home oxygen therapy, proportion of patients requiring hospitalization, hospital oxygen therapy, admission to intensive care unit (ICU) and deaths; duration of hospital and ICU stay and of oxygen therapy.

Sicurezza:
- Proporzione di partecipanti con AE non sollecitati, compresi risultati di laboratorio clinicamente rilevanti ed anomalie dell’ECG e con AE sollecitati locali in corrispondenza del sito di iniezione; proporzione di pazienti testati che sviluppano ADA (il test per ADA è limitato ai primi 60 partecipanti randomizzati).

Efficacia:
- Proporzione di pazienti che manifestano almeno uno dei seguenti eventi: saturazione capillare periferica dell'ossigeno (SpO2) < 94%, inizio o aumento dell’ossigenoterapia a domicilio, ospedalizzazione, decesso (endpoint composito clinico);
- Clearance virale e carico virale nell’URT e SpO2% per visita, sintomi clinici di COVID-19, inizio o aumento dell’ossigenoterapia a domicilio, proporzione di pazienti ospedalizzati, con ossigenoterapia ospedaliera, ricoverati in terapia intensiva (Intensive Care Unit – ICU) e deceduti; durata dell’ospedalizzazione, della permanenza in ICU e dell’ ossigeno terapia.

E.5.2.1

Timepoint(s) of evaluation of this end point

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

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

Studio stratificato e adattivo senza soluzione di continuità.

Stratified and seamless adaptive study.

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of the study is defined as the date of last scheduled procedure shown in the Schedule of Activities for the last participant in the trial globally.
The participation of the patient in the study regularly ends:
- At the end of the follow-up (Visit 12)
- In case of death.

La fine dello studio è definita come la data dell'ultima procedura programmata indicata nello Schedule of Activities per l'ultimo partecipante alla sperimentazione a livello globale.
La partecipazione del paziente allo studio termina regolarmente:
- Alla fine del follow-up (Visita 12)
- In caso di morte.

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:

600

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

206

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

806

F.4.2

For a multinational trial

F.4.2.1

In the EEA

806

F.4.2.2

In the whole clinical trial

806

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

2021-04-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-04-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-05-26

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