Clinical Trials Register

Summary
EudraCT Number:	2014-004523-51
Sponsor's Protocol Code Number:	SS0004
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:	2017-12-15
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

2014-004523-51

A.3

Full title of the trial

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OFCONCEPT
STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJӦGREN'S SYNDROME

STUDIO PILOTA RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO PER VALUTARE L’EFFICACIA E LA SICUREZZA DI UCB5857 SU 12 SETTIMANE IN SOGGETTI AFFETTI DA SINDROME DI SJӦGREN PRIMARIA

A.3.1

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

UCB PROOF OF CONCEPT STUDY IN PATIENTS WITH PRIMARY SJӦGREN'S SYNDROME

UCB STUDIO PILOTA IN PAZIENTI AFFETTI DA SINDROME DI SJӦGREN PRIMARIA

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

SS0004

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	UCB CELLTECH (UK BRANCH OF UCB PHARMA SA)
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	UCB Celltech, UK
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	UCB BIOSCIENCES GmbH
B.5.2	Functional name of contact point	Clin Trial Reg & Results disclosure
B.5.3	Address:
B.5.3.1	Street Address	Alfred-Nobel-Strasse 10
B.5.3.2	Town/ city	Monheim
B.5.3.3	Post code	40789
B.5.3.4	Country	Germany
B.5.4	Telephone number	49 2173 481515
B.5.5	Fax number	49 2173 4815 73
B.5.6	E-mail	clinicaltrials@ucb.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	UCB5857
D.3.2	Product code	UCB5857
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	UCB5857
D.3.9.1	CAS number	1362850-20-1
D.3.9.2	Current sponsor code	UCB5857
D.3.9.3	Other descriptive name	UCB5857
D.3.9.4	EV Substance Code	SUB122669
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	5
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	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	UCB5857
D.3.2	Product code	UCB5857
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	UCB5857
D.3.9.1	CAS number	1362850-20-1
D.3.9.2	Current sponsor code	UCB5857
D.3.9.3	Other descriptive name	UCB5857
D.3.9.4	EV Substance Code	SUB122669
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	10
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: 3
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	UCB5857
D.3.2	Product code	UCB5857
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	UCB5857
D.3.9.1	CAS number	1362850-20-1
D.3.9.2	Current sponsor code	UCB5857
D.3.9.3	Other descriptive name	UCB5857
D.3.9.4	EV Substance Code	SUB122669
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	30
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Primary Sjӧgren's Syndrome

Sindrome di Sjӧgren primaria

E.1.1.1

Medical condition in easily understood language

Primary Sjӧgren's Syndrome

Sindrome di Sjӧgren primaria

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10040767
E.1.2	Term	Sjogren's syndrome
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of the study is to evaluate the efficacy on overall disease activity and safety of UCB5857 added to current treatment relative to placebo in subjects with Primary Sjogren's Syndrome.

L’obiettivo principale di questo studio è quello di valutare l’effetto sull’attività complessiva della malattia e la sicurezza del nuovo farmaco, UCB5857, aggiunto al trattamento attuale del paziente in confronto con il placebo in soggetti affetti da SSp.

E.2.2

Secondary objectives of the trial

1) The efficacy of UCB5857 on changes:
- in salivary function
- in tear function
- patient reported outcomes
- cost effectiveness
2)PK profile of UCB5857 in subjects with pSS

Gli obiettivi secondari:
1) efficacia di UCB5857 sui cambiamenti:
- funzione salivare
- funzione lacrimale
- esito riportato dal paziente
- convenienza
2) profilo farmacocinetico (PK) di UCB5857 in pazienti con pSS

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

finale-Wed Feb 18 00:00:00 CET 2015-NA-Collection of samples for mRNA and DNA to allow for potential exploratory analyses of transcriptome biomarkers and protein biomarkers relevant to inflammatory and immune response processes or
relevant to the mechanism of action of UCB5857

finale-Wed Feb 18 00:00:00 CET 2015-NA-Raccolta di campioni di mRNA e DNA per permettere potenziali analisi esplorative di biomarkers del trascrittoma e biomarkers proteici rilevanti nei processi di risposta immune e infiammtoria o rilevanti nel meccanismo di azione di UCB5857.

E.3

Principal inclusion criteria

•Subject must be between 18 years and 75 years of age •Women of childbearing potential must agree to use an acceptable method of birth control during the study and for a period of 3 months after their final dose of study drug. Women not agreeing to use birth
control must be surgically sterile (hysterectomy/oophorectomy or tubal ligation) or postmenopausal for at least 2 years prior to Screening (Visit 1) Women of childbearing potential are required to have a serum pregnancy test taken at Screening (Visit 1), which is confirmed to be
negative by urine testing prior to the first dose of study drug at Week 0 (Visit 2) •Subject must meet the 2002 AECG criteria for Primary Sjogren's Syndrome •Subject must have a serum test positive for anti-SSA/Ro (Ro-52 and Ro-60) and/or anti SSB/La autoantibodies
•Subject must have an ESSDAI score of ≥5
•Subject must have an unstimulated salivary flow rate of > 0mL/5 minutes

- Il soggetto deve essere di età compresa tra 18 e 75 anni.
- Le donne in età fertile devono acconsentire all’utilizzo di metodi contraccettivi accettabili durante lo studio e per un periodo di 3 mesi successivi alla somministrazione dell’ultima dose del farmaco sperimentale. Le donne che non acconsentono a utilizzare tali metodi devono essere chirurgicamente sterili (isterectomia/ovariectomia o legatura tubarica) o in post-menopausa per almeno 2 anni prima dello screening (Visita 1). Le donne in età fertile sono tenute a sottoporsi a un test di gravidanza sierologico durante lo screening (Visita 1), che deve essere confermato negativo mediante un’analisi delle urine precedente alla prima somministrazione della dose del farmaco sperimentale durante la Settimana 0 (Visita 2).
- Il soggetto deve soddisfare i criteri AECG (American-European Consensus Group) pubblicati nel 2002 relativamente alla SSp.
- Il soggetto deve sottoporsi a un test sierologico con risultato positivo per la presenza di autoanticorpi anti SSA/Ro (Ro-52 e Ro-60) e/o anti SSB/La.
-Il soggetto deve avere un punteggio ESSDAI ≥5.
- Il soggetto deve avere una velocità di flusso salivare non stimolato >0 ml/5 minuti.

E.4

Principal exclusion criteria

•Subject has a diagnosis of any other autoimmune disease, ie, secondary Sjögren's syndrome (eg, rheumatoid arthritis, systemic lupus
erythematosus)
•Subject has a diagnosis of any other sicca syndrome (eg, history of head and neck radiation treatment, sarcoidosis chronic graft-versus-host
disease)
•Subject has, in the opinion of the Investigator, significant fibromyalgia syndrome
•Subject has, in the opinion of the Investigator, significant depression
•Subject has oral candidiasis
•Subject is female and is breast-feeding, pregnant, or plans to become pregnant or to start breastfeeding during the study or within 3 months
after the final dose of the investigational medicinal product (IMP)
•Subject has evidence of an immunosuppressive state, including human immunodeficiency virus (HIV) infection, hypogammaglobulinemias, Tcell
deficiencies, or human T-cell leukemia virus type 1 (HTLV-1)
•Subject has a history of chronic infections, including but not limited to concurrent acute or chronic viral hepatitis B or C. A subject with a
history of a recent serious or life-threatening infection or any current signs or symptoms that may indicate a significant infection at Screening
(Visit 1) to randomization, as per the Investigator's clinical judgment is also excluded. Subject must have completed any prior anti-infective
therapy prior to the first dose of study drug with the exception of antiinfectives taken specifically for the treatment of acne, rosacea, onychomycosis, or vaginal yeast infections; for the prophylaxis of
urinary tract infections; or prophylaxis for pre-surgical or pre-procedural reasons (including dental procedures). Note: minocycline may not be
used for these purposes
•Subject is, in the opinion of the Investigator, at a particularly high risk of significant infection due to their lifestyle and/or occupation
•Subject has received intranasal influenza vaccine within the 8 weeks prior to Screening (Visit 1)
•Subject has significant hematologic abnormalities of hemoglobin <8.0g/dL, or white blood cell (WBC) <2000/mm3, or absolute neutrophil
count <1000/mm3, or platelets <30,000/mm3 at Screening (Visit 1)
•Subject has a history of cancer, except the following treated cancers:
Sjögren's syndrome associated lymphoma, cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma

- Al soggetto sono state diagnosticate eventuali altre malattie autoimmuni, ovvero la Sindrome di Sjögren secondaria (ad esempio, artrite reumatoide, lupus eritematoso sistemico).
- Al soggetto sono state diagnosticate eventuali altre sindromi da secchezza (ad esempio, secondarie a pregresso trattamento radioterapico di testa e collo, sarcoidosi, malattia cronica del trapianto contro l’ospite).
- Il soggetto è affetto, secondo il parere dello Sperimentatore, da sindrome fibromialgica significativa.
- Il soggetto è affetto, secondo il parere dello Sperimentatore, da depressione significativa.
- Il soggetto è affetto da candidosi orale.
- Il soggetto è di sesso femminile e sta allattando, è incinta o sta programmando una gravidanza o l’inizio dell’allattamento durante lo studio o entro 3 mesi dalla somministrazione dell’ultima dose del prodotto medicinale sperimentale (IMP).
- Il soggetto esibisce segni di immunosoppressione, tra cui infezione da virus dell’immunodeficienza umana (HIV), ipogammaglobulinemie, deficienze delle cellule T o virus umano della leucemia a cellule T di tipo 1 (HTLV-1).
- Il soggetto ha anamnesi di infezioni croniche, comprese, in via non limitativa, epatiti B o C acute concomitanti o croniche di natura virale. Verrà inoltre escluso un soggetto che, in base al giudizio clinico dello Sperimentatore, abbia di recente avuto un’infezione grave o potenzialmente letale, o che presenti eventuali segni o sintomi che potrebbero indicare un’infezione grave tra il momento dello screening (Visita 1) e la randomizzazione alla Visita 2. Il soggetto deve aver completato tutte le terapie anti-infettive precedenti prima di assumere la prima dose del farmaco sperimentale, ad eccezione degli anti-infettivi assunti in modo specifico per il trattamento di acne, acne rosacea, onicomicosi o infezioni da candida vaginale, oppure per la profilassi delle infezioni delle vie urinarie o per la profilassi precedente a interventi chirurgici o procedure (comprese le procedure odontoiatriche). Nota: la minociclina non può essere utilizzata per questi scopi.
- Il soggetto è, secondo il parere dello Sperimentatore, a rischio particolarmente alto di grave infezione a causa del suo stile di vita e/o della sua professione.
- Al soggetto è stato somministrato il vaccino antinfluenzale intranasale nelle 8 settimane precedenti allo screening (Visita 1).
- Al momento dello screening (Visita 1), il soggetto evidenzia significative anomalie a livello ematologico per quanto riguarda emoglobina (<8,0 g/dl), globuli bianchi (<2.000/mm3), conta assoluta dei neutrofili (<1.000/mm3) o piastrine (<30.000/mm3).
- Il soggetto ha avuto un cancro, ad eccezione dei seguenti tumori trattati: linfoma associato alla Sindrome di Sjögren, carcinoma della cervice in situ, carcinoma a cellule basali o dermatologico a cellule squamose.

E.5 End points

E.5.1

Primary end point(s)

Change from Baseline in the European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI)

variazione dal basale dell’indice EULAR Sjӧgren’s Syndrome Patient Reported Index (ESSPRI)

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12

12 settimane

E.5.2

Secondary end point(s)

1) Change from Baseline in the European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI)
2) Change from Baseline in the EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)
3) Change from Baseline in the stimulated salivary flow
4)Change from Baseline in the unstimulated salivary flow
5)Change from Baseline in Schirmer I test (without anesthesia)

1) variazione dal basale dell’indice EULAR Sjӧgren’s Syndrome Patient Reported Index (ESSPRI)
2) variazione dal basale dell’indice EULAR Sjӧgren’s Syndrome Patient Reported Index (ESSPRI)
3) variazione dal basale del flusso salivare stimolato
4) variazione dal basale del flusso salivare non stimolato
5) variazione dal basale test di Schirmer I (senza anestesia)

E.5.2.1

Timepoint(s) of evaluation of this end point

1) Week 4 and 8
2) Week 4, 8 and 12
3) Week 4, 8 and 12
4) Week 4, 8 and 12
5) Week 12

1) settimana 4 e 8
2) settimana 4, 8 e 12
3) settimana 4, 8 e 12
4) settimana 4, 8 e 12
5) settimana 12

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

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

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

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

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

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

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

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

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

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

2015-08-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-06-10

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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