Clinical Trials Register

Summary
EudraCT Number:	2014-004633-96
Sponsor's Protocol Code Number:	D3461C00005
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:	2020-01-21
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

2014-004633-96

A.3

Full title of the trial

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3
Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in
Adult Subjects with Active Systemic Lupus Erythematosus

Studio multicentrico, randomizzato, in doppio cieco, controllato con placebo, di fase 3, per la valutazione dell'efficacia e della sicurezza di due dosi di Anifrolumab in soggetti adulti con lupus eritematoso sistemico attivo

A.3.1

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

A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

Studio per valutare l'efficacia e la sicurezza di due dosi di Anifrolumab in confronto a placebo in pazienti adulti con lupus eritematoso sistemico attivo

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

D3461C00005

A.5.4

Other Identifiers

Name:

Number:

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	ASTRAZENECA AB
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	Astra Zeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Astra Zeneca AB
B.5.2	Functional name of contact point	Clinical Trial Transparency
B.5.3	Address:
B.5.3.1	Street Address	Karlebyhus, Astraallén
B.5.3.2	Town/ city	Södertälje
B.5.3.3	Post code	151 85
B.5.3.4	Country	Sweden
B.5.4	Telephone number	NA
B.5.5	Fax number	NA
B.5.6	E-mail	ClinicalTrialTransparency@astrazeneca.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	Anifrolumab
D.3.2	Product code	NA
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Anifrolumab
D.3.9.2	Current sponsor code	NA
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	150
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	Anifrolumab
D.3.2	Product code	NA
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Anifrolumab
D.3.9.2	Current sponsor code	NA
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	150
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Concentrate for solution for infusion

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Systemic Lupus Erythematosus

Lupus eritematoso sistemico

E.1.1.1

Medical condition in easily understood language

Lupus, an autoimmune disease

Lupus, malattia autoimmune

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10042945
E.1.2	Term	Systemic lupus erythematosus
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

To evaluate the effect of anifrolumab 300 mg compared to placebo on disease activity as
measured by the difference in the proportion of subjects who achieve an SLE Responder Index of ≥4 (SRI[4]) at Week 52

Valutare l’effetto di anifrolumab 300 mg rispetto al placebo sull’attività della malattia misurata con la differenza nella percentuale di soggetti che ottengono un indice di Responder LES (SLE Responder Index, SRI) ≥4 (SRI[4]) in Settimana 52

E.2.2

Secondary objectives of the trial

1. To evaluate the effect of anifrolumab 300mg compared to placebo on:
a. The proportion of subjects with SRI(4) at Week 52 in the IFN testhigh
sub-group
b. The proportion of subjects who achieve an OCS dose ≤7.5 mg/day at
Week 40, which is maintained through Week 52 in the sub-group of
subjects with baseline OCS ≥10 mg/day
c. The proportion of subjects with a ≥50% reduction in CLASI activity
score at Week 12 in the sub-group of subjects with baseline CLASI
activity score ≥10
d. The proportion of subjects with SRI(4) at Week 24
e. The annualised flare rate through 52 weeks
2. To evaluate the effect of anifrolumab 150 mg compared to placebo on
disease activity as
measured by the difference in the proportion of subjects who achieve
SRI(4) at Week 52
3. To evaluate the safety and tolerability of anifrolumab

1.Valutare l’effetto di anifrolumab 300 mg rispetto al placebo su:
a.La percentuale di soggetti con SRI(4) in Settimana 52 nel sottogruppo con risultati elevati al test IFN
b.La percentuale di soggetti che raggiunge una dose di corticosteroidi orali ≤7,5 mg/die in Settimana 40, che viene mantenuta fino alla Settimana 52 nel sottogruppo di soggetti con corticosteroidi orali al basale ≥10 mg/die
c.La percentuale di soggetti con una riduzione ≥50% nel punteggio delCLASI, in Settimana 12 nel sottogruppo di soggetti con un punteggio dell’attività CLASI al basale ≥10
d.La percentuale di soggetti con SRI(4) in Settimana 24
e.il tasso di riesacerbazione annualizzato nelle 52 settimane
2.Valutare l’effetto di anifrolumab 150 mg rispetto al placebo sull’attività della malattia misurata con la differenza nella percentuale di soggetti che raggiungono (SRI[4]) in Settimana 52
3.Valutare la sicurezza e la tollerabilità di anifrolumab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Aged 18 through 70 years at the time of screening
2. Diagnosis of paediatric or adult SLE with a diagnosis of SLE according
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to the ACR 1982 revised criteria ≥24 weeks prior to signing the Informed
Consent form (ICF)
3. Currently receiving at least 1 of the following:
(a) A dose of oral prednisone (≤40 mg/day) for a minimum of 2 weeks
prior to signing of the ICF.
(b) Any of the following medications administered for a minimum of 12
weeks prior to signing the informed consent, and at a stable dose for a
minimum of 8 weeks prior to signing the informed consent and until Day
1:
(i) Azathioprine ≤200 mg/day
(ii) Antimalarial (eg, chloroquine, hydroxychloroquine, quinacrine)
(iii) Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day
(iv) Oral, subcutaneous (SC), or intramuscular methotrexate ≤25
mg/week
(v) Mizoribine ≤150 mg/day
4. Fulfils at least 4 of the 11 ACR modified 1982 classification criteria for
SLE, at least 1 of which must be:
(a) Positive antinuclear antibody (ANA) test at screening by
immunofluorescent assay (IFA) at the central laboratory with titre ≥
1:80; OR
(b) Elevated anti-dsDNA antibodies OR anti-Smith (anti-Sm) antibody at
screening as determined by the central laboratory
5. At Screening, Disease Activity Adjudication Group confirmation of:
SLEDAI-2K Criteria: SLEDAI-2K score ≥6 points and "Clinical" SLEDAI-2K
score ≥4 points. The "Clinical" SLEDAI-2K is the SLEDAI-2K assessment
score without the inclusion of points attributable to any urine or
laboratory results including immunologic measures:
6. Must not have active or latent TB on either chest radiograph or by
quantiferon gold test
7. Day 1 "Clinical" SLEDAI-2K score ≥4 points
8. OCS dose stable for at least 2 weeks
9. Stable SLE SOC treatment
10. Women of child-bearing potential must have a negative serum β-hCG
test at screening and negative urine pregnancy test prior to
administration of investigational product

1. Età tra i 18 e i 70 anni al momento dello screening
2. Diagnosi di LES adulto o pediatrico con diagnosi di LES secondo i criteri ACR 1982 rivisti ≥24 settimane prima della firma del Modulo di consenso informato (ICF)
3. Assume attualmente almeno 1 dei farmaci seguenti:
(a) una dose di prednisone orale (≤40 mg/die) per almeno 2 settimane prima della firma del ICF
(b) Uno dei seguenti farmaci assunti per almeno 12 settimane prima della firma del consenso informato e a una dose stabile per almeno 8 settimane prima della firma del consenso informato e fino al Giorno 1:
(i) azatioprina ≤200 mg/die
(ii) antimalarico (ad esempio clorochina, idrossiclorochina, quinacrina)
(iii) micofenolato mofetile ≤2 g/die o acido micofenolico ≤1,44 g/die
(iv) metotrexato orale, sottocutaneo (SC) o intramuscolare ≤25 mg/settimana
(v) mizoribina ≤150 mg/die
4. Soddisfa almeno 4 degli 11 criteri di classificazione ACR 1982 modificati per il LES, almeno 1 dei quali deve essere:
(a) test anticorpi antinucleo (ANA) positivo allo screening con il test di immunofluorescenza (IFA) presso il laboratorio centrale con un titolo ≥1:80; OPPURE
(b) elevati anticorpi anti-dsDNA OPPURE anticorpi anti-Smith (anti-Sm) allo screening in base alla determinazione del laboratorio centrale
5. Allo screening, conferma dal gruppo di valutazione (Adjudication Group) dell’attività della malattia di: Criteri SLEDAI-2K: punteggio SLEDAI-2K ≥6 punti e punteggio SLEDAI-2K “clinico” ≥4 punti. Lo SLEDAI-2K “clinico” è il punteggio di valutazione dello SLEDAI-2K senza l’inclusione di punti attribuibili a risultati delle urine o di laboratorio inclusi i parametri immunologici.
6. Non deve avere TB attiva o latente alla radiografia toracica o al Quantiferon Gold Test
7. Giorno 1 SLEDAI-2K “clinico” ≥4 punti
8. Dose di OCS stabile per almeno 2 settimane
9. Trattamento SOC stabile per il LES
10. Le donne potenzialmente fertili devono avere un test sierico β-hCG negativo allo screening e un test di gravidanza urinario negativo prima della somministrazione del prodotto sperimentale

E.4

Principal exclusion criteria

1. Receipt of any investigational product (small molecule or biologic
agent) within 4 weeks or 5 half-lives prior to signing of the ICF,
whichever is greater
2. Receipt of any of the following:
(a) Intra-articular, intramuscular or IV glucocorticosteroids within 6
weeks
prior to Day 1
3. History of, or current diagnosis of, a clinically significant non SLErelated
vasculitis syndrome. 4. Active severe or unstable
neuropsychiatric SLE
5. Active severe SLE-driven renal disease
6. Diagnosis (within 1 year of signing the ICF) of mixed connective
tissue disease or any history of overlap syndromes of SLE or SSc.
7. History of, or current, inflammatory joint or skin disease other than
SLE
8. History of any non-SLE disease that has required treatment with oral
or parenteral corticosteroids for more than 2 weeks within the 24 weeks
prior to enrollment
9. Confirmed positive test for hepatitis B or hepatitis C
10. Any severe herpes infection at any time prior to Week 0 (Day 1)
11. Opportunistic infection requiring hospitalisation or parenteral
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antimicrobial treatment within 3 years prior to randomization
12. History of cancer, apart from:
(a) Squamous or basal cell carcinoma of the skin that has been
successfully treated
(b) Cervical cancer in situ that has been successfully treated

1. Assunzione di qualunque prodotto sperimentale (piccola molecola o agente biologico) durante le 4 settimane o 5 emivite prima della firma del ICF, dei due il periodo più lungo.
2. Aver assunto uno dei seguenti farmaci:
(a) glucocorticosteroidi intraarticolari, intramuscolari o EV durante le 6 settimane precedenti al Giorno 1
3. Anamnesi di, o attuale diagnosi di, una sindrome di vasculite clinicamente significativa non correlata al LES.
4. LES neuropsichiatrico attivo severo o instabile
5. Malattia renale indotta dal LES severo attivo
6. Diagnosi (nell’anno precedente alla firma del ICF) di malattia del tessuto connettivo misto o anamnesi di sindrome da sovrapposizione di LES o sclerosi sistemica (SSc)
7. Anamnesi di, o attuale, patologia infiammatoria delle articolazioni o della cute diversa dal LES
8. Anamnesi di qualunque patologia non LES che abbia richiesto il trattamento con corticosteroidi orali o parenterali per più di 2 settimane durante le 24 settimane precedenti all’arruolamento
9. Test positivo confermato per l’epatite B o per l’epatite C
10. Qualunque infezione erpetica grave in qualunque momento prima della Settimana 0 (Giorno 1)
11. Infezione opportunistica che richiede il ricovero ospedaliero o trattamento antimicrobico parenterale nei 3 anni precedenti alla randomizzazione
12. Anamnesi di cancro, esclusi:
(a) carcinoma a cellule squamose o carcinoma basocellulare della cute trattato con successo
(b) cancro della cervice in situ trattato con successo

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the difference in proportions of subjects
achieving Systemic Lupus Erythematosus Responder Index SRI(4) at
Week 52 comparing anifrolumab 300mg to placebo

L’endpoint primario è la differenza nelle percentuali di soggetti che raggiungono lo SRI(4) in Settimana 52 confrontando anifrolumab 300 mg al placebo

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 52

Settimana 52

E.5.2

Secondary end point(s)

1a. The composite endpoint SRI4 will be the measure of this objective.
1b. Maintained OCS reduction defined by the following criteria:
- Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by
Week 40 and
- Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from
Week 40 to Week 52 and
- No discontinuation of investigational product or use of restricted
medications beyond the protocol-allowed threshold before assessment
1c. 50% reduction in CLASI activity score compared to baseline defined
by the following criteria:
- Achieve ≥50% reduction of CLASI activity score at Week 12 compared
to baseline and
- No discontinuation of investigational product or use of restricted
medications beyond the protocol-allowed threshold before assessment
1d. The composite endpoint SRI4 will be the measure of this objective
1e. Annualised flare rate with flare defined as either 1 or more new
BILAG-2004 A or 2 or more new BILAG-2004 B items compared to the
previous visit
2. The composite endpoint SRI4 will be the measure of this objective
3. The following safety data will be collected: vital signs, physical
examination, 12-lead ECG, haematology, clinical chemistry, urinalysis, CSSRS,
PHQ-8, modified SLEDAI Flare Index based flares, and reported
AEs

1a.lL'Endpoint composito SRI(4) sarà la misura di questo obiettivo
1b.Mantenimento della riduzione dei corticosteroidi orali definito dai criteri seguenti:
- raggiungimento di una dose di corticosteroidi orali ≤7,5 mg/die di prednisone o equivalente entro la Settimana 40 e
- mantenimento di una dose di corticosteroidi orali ≤7,5 mg/die di prednisone o equivalente dalla Settimana 40 alla Settimana 52 e
- nessuna sospensione del prodotto sperimentale o uso di farmaci soggetti a restrizione oltre la soglia consentita dal protocolloa prima della valutazione
1c.50% di riduzione nel punteggio dell’attività CLASI rispetto al basale definito dai criteri seguenti:
- raggiungimento di una riduzione ≥50% nel punteggio dell’attività CLASI in Settimana 12 rispetto al basale e
- nessuna sospensione del prodotto sperimentale o uso di farmaci soggetti a restrizione oltre la soglia consentita dal protocolloa prima della valutazione
1d.L'Endpoint composito SRI(4) sarà la misura di questo obiettivo
1.e Il tasso di riesacerbazione annualizzato ove riesacerbazione viene definita come 1 o più nuove voci BILAG-2004 A oppure 2 o più nuove voci BILAG-2004 B rispetto alla visita precedente
2.L'Endpoint composito SRI(4) sarà la misura di questo obiettivo
3.sarannor accolti is eguenti dati sulal sicurezza:parametri vitali, esame obiettivo, elettrocardiogrammi a 12 derivazioni,(ematologia, clinica chimica, esame delle urine,C-SSRS, PHQ-8,sull’Indice di riesacerbazione SLEDAI modificato ed eventi avversi

E.5.2.1

Timepoint(s) of evaluation of this end point

1a. - Week 52
1b. - Week 52
1c. - Week 12
1d. - Week 24
1e. - Weeks 0- 52
2. - Week 52
3. - Weeks 0-52

1a. - Settimana 52
1b. - Settimana 52
1c. - Settimana12
1d. - Settimana 24
1e. - Settimane0- 52
2. - Settimana 52
3. - Settimane 0-52

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

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

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

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

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

Argentina

Australia

Brazil

Chile

Colombia

Germany

Israel

Italy

Korea, Republic of

New Zealand

Peru

Poland

Romania

Taiwan

Ukraine

United Kingdom

United States

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

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:

338

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

112

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

131

F.4.2.2

In the whole clinical trial

450

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)

Subjects who participate in this study may have the option of entering
a separate long-term extension study, if eligible.

I pazienti che partecipano a questo studio possono avere l'opzione di partecipare ad uno studio di estensione a lungo termine separato, se elegibili

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

2015-09-16

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

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Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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