Clinical Trials Register

Summary
EudraCT Number:	2017-002454-36
Sponsor's Protocol Code Number:	2125-MEL-301
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-01-25
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

2017-002454-36

A.3

Full title of the trial

A Randomized Phase 3 Comparison of IMO-2125 with Ipilimumab versus Ipilimumab Alone in Subjects with Anti-PD-1 Refractory Melanoma

Confronto randomizzato di fase 3 di IMO-2125 con ipilimumab rispetto a ipilimumab in monoterapia in soggetti affetti da melanoma refrattario a terapia anti-PD1

A.3.1

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

A Clinical Trial to compare the effectiveness of the study drug IMO-2125 given in combination with Ipilimumab (a drug indicated for the treatment of advanced melanoma) compared to Ipilimumab given alone in subjects with Refractory Melanoma

Un trial clinico per confrontare l'efficacia del farmaco in studio IMO-2125 somministrato in combinazione con Ipilimumab (un farmaco indicato per il trattamento del melanoma avanzato) rispetto a Ipilimumab somministrato da solo in soggetti con melanoma refrattario

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

2125-MEL-301

A.5.4

Other Identifiers

Name:

IND number

Number:

125515

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	IDERA PHARMACEUTICALS, 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	Idera Pharmaceuticals, 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	Idera Pharmaceuticals, Inc.
B.5.2	Functional name of contact point	Jennessa Martin
B.5.3	Address:
B.5.3.1	Street Address	505 Eagleview Boulevard, Suite 212
B.5.3.2	Town/ city	Exton, PA
B.5.3.3	Post code	19341
B.5.3.4	Country	United States
B.5.4	Telephone number	0014843481607
B.5.5	Fax number	000000
B.5.6	E-mail	jmartin@iderapharma.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	IMO-2125
D.3.2	Product code	[IMO-2125]
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	Intratumoral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Tilsotolimod
D.3.9.4	EV Substance Code	SUB31305
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	8
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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.2.1.1.1	Trade name	YERVOY®
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Pharma EEIG
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Ipilimumab
D.3.2	Product code	[LO1XC11]
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	ipilimumab
D.3.9.2	Current sponsor code	N/A
D.3.9.4	EV Substance Code	SUB29397
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	5
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

Refractory melanoma is a malignant tumor of melanocytes which originates predominantly from skin.

Il melanoma refrattario è un tumore maligno di melanociti che origina prevalentemente dalla pelle.

E.1.1.1

Medical condition in easily understood language

Refractory melanoma is a type of cancer mainly found on the skin, which may not respond to available treatments.

Il melanoma refrattario è un tipo di cancro localizzato principalmente sulla pelle, che potrebbe non rispondere ai trattamenti disponibili.

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10027481
E.1.2	Term	Metastatic melanoma
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Compare the efficacy measured by overall survival [OS] and overall response rate [ORR] of intratumoral IMO-2125 in combination with ipilimumab versus ipilimumab alone.

Confrontare l’efficacia (misurata mediante sopravvivenza complessiva [OS] e il tasso di risposta complessiva [overall response rate, ORR]) di IMO-2125 intratumorale in combinazione con ipilimumab rispetto a ipilimumab in monoterapia.

E.2.2

Secondary objectives of the trial

Assess other measures of clinical benefit, safety, pharmacokinetics (PK), and patient-reported outcomes (PROs).
Investigate potential biomarkers and the incidence of anti-IMO-2125 antibodies.

Valutare altri parametri di beneficio clinico, sicurezza, farmacocinetica (pharmacokinetics, PK) e gli esiti riferiti dal paziente (patient-reported outcomes, PRO).
Indagare potenziali biomarcatori e l’incidenza degli anticorpi anti-IMO-2125.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subjects must be willing and able to sign the informed consent and comply with the study protocol.
2. Must be =18 years of age.
3. Histologically confirmed metastatic melanoma with measurable (by RECIST v1.1), stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease that is accessible for injection.
4. Confirmed progression during or after treatment with PD-1 inhibitor (cannot be part
of a bi-specific antibody), e.g., either nivolumab or pembrolizumab. Confirmed progression is defined as:
• Radiological progression (confirmed at least 4 weeks after the initial scan showing PD); or
• For progression based solely on worsening of non-target or new, non-measurable disease, confirmation by an additional scan at least 4 weeks after the initial scan unless progression is accompanied by correlative symptoms.
In addition, all the following must hold:
a) No intervening anti-cancer therapy between the last course of PD-1 inhibitor
treatment and the first dose of study treatment is allowed except for local measures (e.g., surgical excision or biopsy, focal radiation therapy).
b) The interval between last PD-1 inhibitor and start of study treatment should be at least 21 days with no residual anti-PD-1-related immune toxicities in excess of Grade 1 severity.
c) Subjects who had adjuvant anti-PD-1 treatment are eligible if they have either disease recurrence after the end of adjuvant treatment or on-treatment disease recurrence after =12 weeks of adjuvant treatment.
d) If subject BRAF mutation status is unknown, before randomization the subject must have BRAF testing performed using an approved assay method.
e) Patients with BRAF-positive tumor(s) are eligible for the study if they received prior treatment with a BRAF inhibitor (alone or in combination with a MEK inhibitor) or declined targeted therapy.
5. ECOG Performance Status =1.
6. Adequate baseline organ function as defined by:
a) Absolute neutrophil count (ANC) =1.5 x 109/L (1500/mm3)
b) Platelet count =75 x 109/L (75,000/mm3)
c) Hemoglobin =8.0 g/dL (4.96 mmol/L)
d) Serum creatinine =1.5 x upper limit of normal (ULN) or calculated creatinine clearance =60 mL/minute (=Grade 1)
e) Aspartate aminotransferase (AST) =2.5 x ULN; alanine aminotransferase (ALT) =2.5 x ULN; AST/ALT <5 x ULN if liver involvement (=Grade 1)
f) Serum bilirubin =1.5 x ULN, except in subjects with Gilbert’s Syndrome who must have a total bilirubin <3 mg/dL (=Grade 1)
7. Women of childbearing potential (WOCBP) and men must agree to use effective contraceptive methods from screening until at least 90 days after the last dose of either ipilimumab or IMO-2125, whichever is later.
8. WOCBP must have a negative pregnancy test (serum or urine) according to the Schedule of Evaluations described in the study Protocol.

1. I soggetti devono essere disposti e in grado di firmare il consenso informato e rispettare il protocollo di studio.
2. Devono avere almeno 18 anni d’età.
3. Melanoma metastatico confermato istologicamente con malattia misurabile (secondo i criteri di valutazione della risposta nei tumori solidi [Response Evaluation Criteria in Solid Tumors, RECIST] v1.1), allo stadio III (linfonodi o lesioni di transito) o allo stadio IVA, IVB o IVC, accessibile per l’iniezione.
4. Progressione confermata durante o dopo il trattamento con inibitore PD-1 (non può
far parte di un anticorpo bi-specifico), ad es. nivolumab o pembrolizumab. Si definisce progressione della malattia:
• Progressione radiologica (confermata almeno 4 settimane dopo la diagnosi di malattia progressiva alla scansione iniziale); o
• Per la progressione basata esclusivamente sul peggioramento della malattia non misurabile, non target o nuova, conferma mediante scansione aggiuntiva effettuata almeno 4 settimane dopo la scansione iniziale a meno che la progressione non sia accompagnata da sintomi correlativi.
Inoltre, devono verificarsi tutte le seguenti condizioni:
a) Non è ammessa alcuna terapia antitumorale intercorrente tra l’ultimo trattamento di inibitore PD-1 e la prima dose del trattamento dello studio, ad eccezione delle misure locali (ad esempio, escissione chirurgica o biopsia, radioterapia focale).
b) L’intervallo tra l’ultima dose di inibitore PD-1 e l’avvio del trattamento dello studio dovrebbe essere di almeno 21 giorni senza tossicità immunitarie residue associate agli anti-PD-1 di gravità superiore al Grado 1.
c) I soggetti già sottoposti a trattamento adiuvante anti-PD-1 sono idonei se presentano una recidiva di malattia al termine del trattamento adiuvante oppure durante il trattamento, dopo = 12 settimane di trattamento adiuvante.
d) Se lo stato mutazionale di BRAF non è noto, prima della randomizzazione il soggetto deve essere sottoposto al test di BRAF eseguito mediante un metodo di analisi approvato.
e) I pazienti con tumore/i BRAF-positivo/i sono idonei allo studio se sono stati sottoposti a un precedente trattamento con inibitore di BRAF (in monoterapia o in combinazione con un inibitore di MEK) o una terapia mirata ridotta.
5. Valutazione secondo la scala ECOG (Eastern Cooperative Oncology Group [Gruppo cooperativo orientale dell’oncologia]) =1.
6. Adeguata funzionalità organica basale definita come segue:
a) Conta assoluta dei neutrofili (Absolute neutrophil count, ANC) =1,5 x 109/L (1.500/mm3)
b) Conta piastrinica =75 x 109/L (75.000/mm3)
c) Emoglobina =8,0 g/dL (4,96 mmol/L)
d) Creatinina sierica =1,5 x limite superiore dell’intervallo normale (upper limit of normal, ULN) o clearance della creatinina calcolata =60 mL/minuto (=Grado 1)
e) Aspartato aminotransferasi (AST) =2,5 x ULN; alanina aminotransferasi (ALT) =2,5 x ULN; AST/ALT <5 x ULN in caso di coinvolgimento del fegato (=Grado 1)
f) Bilirubina sierica =1,5 x ULN, eccetto nei soggetti con sindrome di Gilbert, che devono presentare una bilirubina totale <3 mg/dL (=Grado 1)
7. Tutte le donne in età fertile (Women of childbearing potential, WOCBP) e gli uomini devono accettare di utilizzare metodi contraccettivi efficaci dallo screening fino ad almeno 90 giorni dopo l’ultima dose di ipilimumab o IMO-2125, a seconda di quale evento si verifica più tardi.
8. Le donne in età fertile devono avere un test di gravidanza negativo (urine o siero) secondo il Programma delle Valutazioni descritto nel protocollo.

E.4

Principal exclusion criteria

1. Ocular melanoma.
2. Prior therapy with a TLR agonist, excluding topical agents.
3. Prior ipilimumab with the exception of adjuvant treatment completed =6 months prior to enrollment.
4. Systemic treatment with IFN-a within the previous 6 months.
5. Known hypersensitivity to any oligodeoxynucleotide.
6. Active autoimmune disease requiring disease modifying therapy at the time of screening.
7. Subjects with a requirement for systemic steroids receiving >10 mg/day of prednisone (or equivalent) for the 2 weeks preceding start of study treatment.
8. Subjects with another primary malignancy that has not been in remission for at least 3 years with the exception of non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic).
9. Active systemic infections requiring antibiotics.
10. Known active, hepatitis A, B, or C infection.
11. Known diagnosis of human immunodeficiency virus (HIV) infection.
12. Women who are pregnant or breast-feeding.
13. Prior anaphylactic or other severe infusion reaction associated with human antibody administration that cannot be managed with standard supportive measures.
14. Presence of known central nervous system, meningeal, or epidural metastatic disease. However, subjects with known brain metastases are allowed if the brain metastases are stable for =4 weeks before the first dose of study treatment. Stable is defined as neurological symptoms not present or resolved to baseline, no radiologic evidence of progression, and steroid requirement of prednisone =10 mg/day or equivalent.
15. Impaired cardiac function or clinically significant cardiac disease.

1. Melanoma oculare.
2. Precedente terapia con un agonista del TLR, esclusi gli agenti topici.
3. Precedente trattamento con ipilimumab con l’eccezione del trattamento adiuvante completato =6 mesi prima dell’arruolamento.
4. Trattamento sistemico con IFN-a nei 6 mesi precedenti.
5. Ipersensibilità nota a qualsiasi oligodeossinucleotide.
6. Malattia autoimmune in fase attiva che richiede una terapia modificante la malattia al momento dello screening.
7. I soggetti che richiedono una terapia steroidea sistemica e che ricevono >10 mg/giorno di prednisone (o equivalente) nelle 2 settimane prima dell’inizio del trattamento dello studio.
8. Soggetti con un altro tumore maligno primario che non è stato in remissione per almeno 3 anni, ad eccezione di: tumore cutaneo che non sia melanoma; tumore prostatico localizzato con livelli non rilevabili di antigene specifico per la prostata e trattato in modo curativo; carcinoma cervicale in situ identificato mediante biopsia o lesione intraepiteliale squamosa identificata mediante test di Papanicolaou (Pap test); tumore della tiroide (ad eccezione della forma anaplastica).
9. Infezioni sistemiche attive che richiedono antibiotici.
10. Infezione da epatite A, B o C attiva.
11. Diagnosi nota di infezione da virus dell’immunodeficienza umana (HIV).
12. Soggetti di sesso femminile in stato di gravidanza o in fase di allattamento.
13. Precedente reazione anafilattica o altra reazione grave all’infusione, associate alla somministrazione di un anticorpo umano e che non possono essere gestite mediante misure di supporto standard.
14. Presenza di malattia metastatica nota del sistema nervoso centrale, meningea o epidurale. Tuttavia i soggetti con metastasi cerebrali note sono ammessi se le metastasi cerebrali rimangono stabili per =4 settimane prima della somministrazione della prima dose di trattamento dello studio. Il termine “stabile” viene usato quando i sintomi neurologici non sono presenti o risolti al basale, non c’è alcuna evidenza radiologica di progressione e la necessità di somministrazione dello steroide prednisone è =10 mg/giorno o equivalente.
15. Funzionalità cardiaca compromessa o cardiopatia clinicamente significativa.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint family (see FDA Guidance for Industry, 2017) includes:
• OS, defined as the time to death from any cause measured from the
date of randomization.
• ORR by blinded independent review using RECIST v1.1

La famiglia di endpoint primario (vedere Guida FDA per l'industria, 2017) include:
• OS, definito come il tempo di morte per qualsiasi causa misurata dalla data di randomizzazione.
• ORR per revisione indipendente in cieco utilizzando RECIST v1.1

E.5.1.1

Timepoint(s) of evaluation of this end point

Tumor assessments will be performed at Screening and Week 12, then every 8 weeks for the first year and every 12 weeks during subsequent years.

Le valutazioni del tumore verranno eseguite allo screening e alla settimana 12, quindi ogni 8 settimane per il primo anno e ogni 12 settimane negli anni successivi.

E.5.2

Secondary end point(s)

• ORR by blinded independent review using modified immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
• ORR by investigator assessment using RECIST v1.1 and irRECIST
• Durable response rate (DRR) by blinded independent review and investigator assessment (using RECIST v1.1 and irRECIST), defined as the rate of CR or partial response (PR) lasting =6 months with onset during the first 12 months of treatment
• Time to response, defined as time to a complete or partial response (using RECIST v1.1 and irRECIST) measured from the date of randomization, by blinded independent review and investigator
assessment
• Progression-free survival (PFS), defined as the time to disease progression or death from any cause measured from the date of randomization, by investigator assessment (using RECIST v1.1 and irRECIST)
• PFS, by investigator assessment (using RECIST v1.1 and irRECIST) and OS at 1 and 2 years
• PRO using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
• Safety, including AEs, laboratory and vital sign tests,
electrocardiograms (ECGs), ECOG, and physical examination
• Plasma PK of IMO 2125

• ORR mediante revisione indipendente in cieco utilizzando i criteri di valutazione della risposta immuno-correlati modificati nei tumori solidi (irRECIST)
• ORR mediante valutazione dello sperimentatore utilizzando RECIST v1.1 e irRECIST
• Tasso di risposta durevole (DRR) mediante revisione indipendente in cieco e valutazione dello sperimentatore (utilizzando RECIST v1.1 e irRECIST), definita come la velocità di CR o risposta parziale (PR) della durata di =6 mesi con insorgenza durante i primi 12 mesi di trattamento
• Tempo di risposta, definito come tempo per una risposta completa o parziale (utilizzando RECIST v1.1 e irRECIST) misurato dalla data della randomizzazione, da una revisione indipendente in cieco e dalla valutazione dello sperimentatore
• Sopravvivenza libera da progressione (PFS), definita come il tempo necessario alla progressione della malattia o alla morte per qualsiasi causa misurata dalla data della randomizzazione, mediante valutazione dello sperimentatore (utilizzando RECIST v1.1 e irRECIST)
• PFS, mediante valutazione dello sperimentatore (utilizzando RECIST v1.1 e irRECIST) e OS a 1 e 2 anni
• PRO utilizzando l'Organizzazione europea per la ricerca e il trattamento del cancro Questionario sulla qualità della vita-Core 30 (EORTC QLQ-C30)
• Sicurezza, compresi esami di laboratorio, test di laboratorio e dei segni vitali, elettrocardiogrammi (ECG), ECOG ed esame fisico
• Plasma PK di IMO 2125

E.5.2.1

Timepoint(s) of evaluation of this end point

Various, refer to information in E.5.2.

Varie, fare riferimento alle informazioni in E.5.2.

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)

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

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

Australia

Canada

United States

Czechia

France

Germany

Italy

Netherlands

Spain

Sweden

United Kingdom

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 study is complete when 397 randomized subjects have died.

Lo studio è completo quando 397 soggetti randomizzati sono morti.

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:

206

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

248

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

369

F.4.2.2

In the whole clinical trial

454

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

2018-07-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-04-04

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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