Clinical Trials Register

Summary
EudraCT Number:	2017-001431-39
Sponsor's Protocol Code Number:	TCD14906
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:	2021-01-05
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

2017-001431-39

A.3

Full title of the trial

A Phase 1/2 study to evaluate safety, pharmacokinetics and efficacy of isatuximab in combination with cemiplimab in patients with relapsed/refractory multiple myeloma

Studio di Fase 1/2 per valutare la sicurezza, la farmacocinetica e l¿efficacia di isatuximab in combinazione con cemiplimab in pazienti con mieloma multiplo recidivante/refrattario

A.3.1

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

Isatuximab in Combination with Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Isatuximab in combinazione con cemiplimab in pazienti con mieloma multiplo recidivante/refrattario (RRMM)

A.3.2

Name or abbreviated title of the trial where available

Isatuximab in Combination with Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Isatuximab in combinazione con Cemiplimab in pazienti con Mieloma Multiplo recidivante/refrattario (

A.4.1

Sponsor's protocol code number

TCD14906

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1189-4706

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	SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
B.1.3.4	Country	France
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	SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SANOFI S.p.A.
B.5.2	Functional name of contact point	CONTACT POINT
B.5.3	Address:
B.5.3.1	Street Address	VIALE L. BODIO 37/B
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20158
B.5.3.4	Country	Italy
B.5.4	Telephone number	800226343
B.5.5	Fax number	0239394168
B.5.6	E-mail	informazioni.medicoscientifiche@sanofi.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/14/1268
D.3 Description of the IMP
D.3.1	Product name	isatuximab
D.3.2	Product code	[SAR650984]
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	Isatuximab
D.3.9.2	Current sponsor code	SAR650984
D.3.9.4	EV Substance Code	SUB119676
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	20
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	cempilimab
D.3.2	Product code	[REGN2810]
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	Cemiplimab
D.3.9.2	Current sponsor code	REGN2810
D.3.9.4	EV Substance Code	SUB179369
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.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

Cancer

Cancro

E.1.1.1

Medical condition in easily understood language

Cancer

cancro

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	10035226
E.1.2	Term	Plasma cell myeloma
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

-To evaluate the safety and tolerability of the combination of Isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory multiple myeloma.

-To compare the overall response of the combination of Isatuximab and cemiplimab versus isatuximab alone in patients with RRMM based on International Myeloma Working Group (IMWG) criteria.

- Determinare la sicurezza e la tollerabilit¿ della combinazione di Isatuximab (SAR650984) e Cemiplimab (REGN2810) in pazienti con mieloma multiplo recidivante/refrattario
- Confrontare il tasso di risposta complessiva della combinazione di isatuximab e cemiplimab rispetto a isatuximab in monoterapia in pazienti con MMRR in base ai criteri dell¿International Myeloma Working Group (IMWG) (Gruppo internazionale di lavoro sul mieloma)

E.2.2

Secondary objectives of the trial

-To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of response (DOR),
time to response (TTR), progression free survival (PFS), and overall survival (OS).

-To assess the pharmacokinetics (PK) of Isatuximab and cemiplimab when given in combination.

-To assess the immunogenicity of isatuximab and cemiplimab when given in combination.

- Determinare l¿efficacia in termini di tasso di beneficio clinico (CBR), durata della risposta (DOR), tempo alla risposta (TTR), sopravvivenza libera da progressione (PFS), sopravvivenza globale (OS);
- Determinare il profilo farmacocinetico (PK) di isatuximab e cemiplimab se somministrati in combinazione.
- Valutare l¿immunogenicit¿ di isatuximab e cemiplimab se somministrati in combinazione.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients must have a known diagnosis of multiple myeloma with evidence of measurable disease, as defined below:
-> Serum M-protein =1 g/dL (=0.5 g/dL in case of IgA disease),
AND/OR
-> Urine M-protein =200 mg/24 hours,
OR
-> In the absence of measurable m-protein, serum immunoglobulin free light chain =10 mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio (<0.26 or >1.65).

- Patients must have received prior treatment with an IMiD (for =2 cycles or =2 months of treatment) and a proteasome inhibitor (for =2 cycles or =2 months of treatment).

- Patients must have received at least 3 prior lines of therapy (Note: Induction therapy and stem cell transplant ± maintenance will be considered as one line)

- Patient must have achieved MR or better with any anti-myeloma therapy (ie, primary refractory disease is not eligible).

- I pazienti devono disporre di una diagnosi nota di mieloma multiplo con evidenza di malattia misurabile, come definito di seguito:
• proteina M nel siero =1 g/dL (=0,5 g/dl in caso di malattia a IgA);
E/O
• proteina M nelle urine =200 mg/24 ore;
OPPURE
• in assenza di livelli misurabili di proteina M, catena leggera libera delle immunoglobuline nel siero =10 mg/dl e rapporto catena leggera libera kappa/lambda delle immunoglobuline nel siero anormale (<0,26 o >1,65);
- I pazienti devono aver ricevuto un precedente trattamento con un farmaco immunomodulatore (IMiD) (per =2 cicli o =2 mesi di trattamento) e un inibitore del proteasoma (PI) (per =2 cicli o =2 mesi di trattamento);
- I pazienti devono aver ricevuto almeno 3 linee precedenti di terapia (Nota: la terapia di induzione e il trapianto di cellule staminali ± mantenimento saranno considerati come un’unica linea);
- I pazienti devono aver ottenuto una risposta MR o migliore con qualsiasi terapia anti-mieloma (ossia, la malattia refrattaria primaria non è eleggibile).

E.4

Principal exclusion criteria

- Prior exposure to isatuximab or participated clinical studies with isatuximab.
- Prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1 pathway.
- Evidence of other immune related disease /conditions.
- History of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation.
- Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
- Has allogenic haemopoietic stem cell (HSC) transplant.
- Prior treatment with idelalisib (a PI3K inhibitor).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2.
- Poor bone marrow reserve.
- Poor organ function.

- Precedente esposizione a:
• isatuximab (o partecipazione a studi clinici con isatuximab);
• qualsiasi agente (approvato o sperimentale) che blocca il pathway del recettore 1 della morte programmata (PD-1)/ligando 1 della morte programmata (PD-L1).
- Evidenza di altre malattie/condizioni immuno-correlate
- Anamnesi di polmonite non infettiva che necessita di steroidi oppure polmonite in atto; anamnesi di radioterapia toracica.
- Ricevimento di una vaccinazione con vaccino vivo nei 30 giorni precedenti l’inizio programmato del trattamento. I vaccini antinfluenzali stagionali che non contengono virus vivo sono consentiti.
- Trapianto allogenico di cellule staminali ematopoietiche (HSC).
- Precedente trattamento con idelalisib (inibitore della fosfatidilinositolo-3-chinasi [PI3K]).
- Performance Status (PS) secondo l’Eastern Cooperative Oncology Group (ECOG) (Gruppo cooperativo orientale di oncologia) >2.
-Ridotta riserva midollare.
-Ridotta funzionalità d’organo.

E.5 End points

E.5.1

Primary end point(s)

1 - Dose Limiting Toxicities (DLTs) DLTs are following AEs in Cycle 1 unless due to disease progression or an obviously unrelated cause: Grade (G) 4 neutropenia >7 days; G 3 to 4 neutropenia with fever or documented infection; G 3 to 4 thrombocytopenia with bleeding requiring intervention; G 4 non hematological AE; G =2 uveitis; G 3 non-hematological AE >3 days despite supportive care (with defined exceptions); Delay in initiation of the 2nd cycle >14 days for related laboratory abnormalities/AEs 2 - Adverse events (AEs) and changes in laboratory tests and vital signs Number of patients with AEs and changes in laboratory tests and vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 Grade scaling 3 - Overall Response Rate (ORR) ORR is defined as the proportion of patients with complete response (CR) (including sCR [stringent complete response]), very good partial response (VGPR) and partial response (PR)

1 - Tossicità Dose Limitante (DLT)
Le DLT seguono gli eventi avversi nel Ciclo 1 a meno che non siano dovuti alla progressione della malattia o a cause indubbiamente non correlate: Neutropenia di grado 4 di durata superiore a 7 giorni; Neutropenia di grado da 3 a 4 complicata da febbre o infezione documentata; Trombocitopenia di grado da 3 a 4 associata a emorragia che necessita di intervento clinico; EA non ematologico di grado 4; Uveite di grado =2; EA non ematologico di grado 3, che dura >3 giorni malgrado cure di supporto ottimali (con eccezioni definite); Ritardo nell’inizio del Ciclo 2 di più di 14 giorni a causa di alterazioni degli esami di laboratorio/EA correlati al trattamento.
2- Eventi avversi (EA) e cambiamenti negli esami di laboratorio e nei segni vitali. La gravità degli EA sarà valutata utilizzando la versione 4.03 dei Criteri terminologici comuni per gli eventi avversi (CTCAE) del National Cancer Institute (NCI) (Istituto nazionale del cancro).
3 - Tasso di risposta complessiva (ORR)
L' ORR è definito come la percentuale di pazienti con risposta completa (CR) (inclusa la risposta completa stringente [sCR]), risposta parziale molto buona [VGPR] e risposta parziale (PR)

E.5.1.1

Timepoint(s) of evaluation of this end point

1 - Up to 4 weeks 2 - Up to 90 days following the last administration of study treatment for ongoing related AE, ongoing serious AE and new related AE until resolution or stabilization 3 - Up to 6 months from last patient in for primary efficacy analysis, and up to 12 months from last patient in (LPI) for the final analysis

1- fino a 4 settimane
2- fino a 90 giorni dopo l'ultima somministrazione del trattamento in studio per Evento avverso (EA) correlato in corso, EA grave in corso e nuovo EA correlato fino a risoluzione o stabilizzazione
3- Fino a 6 mesi dall’ultimo paziente incluso nello studio (LPI) per le analisi primarie di efficacia e fino a 12 mesi dall’ultimo paziente incluso nello studio (LPI) per le analisi finali

E.5.2

Secondary end point(s)

1 - Clinical Benefit Rate (CBR) CBR is defined as the proportion of patients with CR (including sCR), VGPR, PR and minimalresponse (MR) 2 - Duration of Response (DOR) DOR is defined as the time from the date of the first response (=PR) that is subsequently confirmed to the date of first confirmed disease progression or death, whichever happens first 3 - Time to Response (TTR) TTR is defined as time from first study treatment administration to first response (=PR) that is subsequently confirmed 4 - Progression Free Survival (PFS) PFS is defined as time from the first study treatment administration to the date of first documentation of progressive disease that is subsequently confirmed or the date of death from any cause 5 - Overall Survival (OS) OS defined as the time from the first study treatment administration to death from any cause 6 - Assessment of PK parameter: partial AUC AUC is area under the drug concentration versus time curve 7 - Assessment of PK parameter: Cmax is maximum drug concentration observed 8 - Antibodies to isatuximab Levels of anti isatuximab antibodies in plasma samples will be determined 9 - Antibodies to cemiplimab Levels of anti cemiplimab antibodies in serum samples will be determined

1- Tasso di Beneficio Clinico (CBR) definito come la percentuale di pazienti con CR (inclusa la sCR), VGPR, PR e risposta minima (MR)
2- Durata della Risposta (DOR) definita come il tempo dalla data della prima risposta (=PR) successivamente confermata alla data della prima progressione della malattia confermata o di decesso, a seconda di quale circostanza si verifichi per prima.
3- Tempo di Risposta (TTR) definito come il tempo dalla prima somministrazione del trattamento in studio alla prima risposta (= PR) che venga successivamente confermata
4- Sopravvivenza Libera da Progressione (PFS) definita come il tempo dalla prima somministrazione del trattamento dello studio alla data della prima documentazione di progressione della malattia che venga successivamente confermata o alla data di decesso da qualsiasi causa.
5-Sopravvivenza Globale (OS) definita come il tempo dalla prima somministrazione del trattamento dello studio al decesso da qualsiasi causa.
6- Valutazione dei parametri di farmacocinetica (PK): AUC parziale, dove AUC rappresenta l¿Area Sotto la Curva di Concentrazione del farmaco rispetto al Tempo
7- Valutazione dei parametri di farmacocinetica (PK): Cmax, dove Cmax rappresenta la concentrazione massima di farmaco osservata
8- Anticorpi contro Isatuximab: valutazione dei livelli di anticorpi contro isatuximab rilevati nei campioni di plasma
9- Anticorpi contro Cemiplimab: valutazione dei livelli di anticorpi contro cemiplimab rilevati nei campioni di siero

E.5.2.1

Timepoint(s) of evaluation of this end point

1 to 4: Up to 6 months from last patient in for primary efficacy analysis, and up to 12 months from LPI for the final analysis 5: Up to 12 months from LPI for the final analysis 6 and 7: Up to 4 weeks 8 and 9: Up to 12 months from LPI for the final analysis

Da 1 a 4: fino a 6 mesi da LPI per le analisi primarie di efficacia, e fino a 12 mesi da LPI per l¿analisi finale;
5: fino a 12 mesi da LPI per l¿analisi finale;
6-7: fino a 4 settimane;
8-9: fino a 12 mesi da LPI per l¿analisi finale

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

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)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Study Phase I/II. Italy will partecipate to phase II only

Studio di fase I/II. Italia partecipa solo alla fase II

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Brazil

Canada

United States

Czechia

France

Greece

Hungary

Italy

Spain

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

LVLS

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

123

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

2018-05-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-05-15

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

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