Clinical Trials Register

Summary
EudraCT Number:	2019-002713-19
Sponsor's Protocol Code Number:	VIB4920.P2.S2
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-17
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

2019-002713-19

A.3

Full title of the trial

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects with Sjögren's Syndrome (SS)

Studio proof of concept di fase 2, randomizzato, in doppio cieco, controllato con placebo, per valutare l’efficacia e la sicurezza di VIB4920 in soggetti affetti da sindrome di Sjögren (SS)

A.3.1

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

A study to look at the effectiveness and safety of test product VIB4920 in subjects with Sjögren's Syndrome (SS)

Uno studio per esaminare l’efficacia e la sicurezza del prodotto di prova VIB4920 in soggetti affetti da sindrome di Sjögren (SS)

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

VIB4920.P2.S2

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04129164

A.5.4

Other Identifiers

Name:

Numero IND

Number:

128905

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	VIELABIO 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	Viela Bio, 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	Viela Bio, Inc.
B.5.2	Functional name of contact point	Clinical Development
B.5.3	Address:
B.5.3.1	Street Address	One MedImmune Way
B.5.3.2	Town/ city	Gaithersburg
B.5.3.3	Post code	MD 20878
B.5.3.4	Country	United States
B.5.4	Telephone number	0012405580038
B.5.5	Fax number	0013018418424
B.5.6	E-mail	clinicaltrials@vielabio.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	VIB4920
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	2245953-10-8
D.3.9.2	Current sponsor code	VIB4920
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	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	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	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Sjögren's syndrome

Sindrome di Sjögren

E.1.1.1

Medical condition in easily understood language

Sjögren's syndrome

Sindrome di Sjögren

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10059142
E.1.2	Term	Sjoegren's syndrome
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Population #1:
To evaluate the clinical efficacy of multiple doses of VIB4920 in glandular and extraglandular manifestations of SS patients with moderate to high systemic disease activity.

Population #2:
To evaluate the clinical efficacy of multiple doses of VIB4920 in the key subjective complaints of SS (dryness, fatigue and pain).

Popolazione n. 1:
Valutare l’efficacia clinica di dosi multiple di VIB4920 in manifestazioni extraghiandolari su pazienti SS con malattia sistemica da moderata ad alta.

Popolazione n. 2:
Valutare l’efficacia clinica di dosi multiple di VIB4920 nella cura dei sintomi principali di SS riportati (secchezza, stanchezza e dolore).

E.2.2

Secondary objectives of the trial

Population #1:
1. To evaluate the effect of VIB4920 on systemic activity and patientreported outcomes in subjects with SS.
2. To evaluate the safety and tolerability of multiple doses of VIB4920 in subjects with SS.
3. To characterize the PK of VIB4920 in subjects with SS.
4. To assess the immunogenicity of VIB4920 in subjects with SS.

Population #2:
1. To evaluate the effect of VIB4920 on patient-reported outcomes in subjects with SS.
2. To evaluate the safety and tolerability of multiple doses of VIB4920 in subjects with SS.
3. To characterize the PK of VIB4920 in subjects with SS.
4. To assess the immunogenicity of VIB4920 in subjects with SS.

Popolazione n. 1:
1. Valutare l’effetto di VIB4920 sull’attività patologica sistemica e sugli esiti riportati dal paziente nei soggetti affetti da SS.
2. Valutare la sicurezza e la tollerabilità di dosi multiple di VIB4920 in soggetti affetti da SS.
3. Definire la farmacocinetica di VIB4920 nei soggetti affetti da SS.
4. Valutare l’immunogenicità di VIB4920 nei soggetti affetti da SS.

Popolazione n. 2:
1. Valutare l’effetto di VIB4920 sugli esiti riportati dal paziente nei soggetti affetti da SS.
2. Valutare la sicurezza e la tollerabilità di dosi multiple di VIB4920 in soggetti affetti da SS.
3. Definire la farmacocinetica di VIB4920 nei soggetti affetti da SS.
4. Valutare l’immunogenicità di VIB4920 nei soggetti affetti da SS.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Pop #1:
1. Adults, 18yy or older at time of Inf.Consent.(the min age for adult particip can be >18yy in countries with different regul).
2. Diagnosed with SS by meeting the 2016 ACR/EULAR Classif Criteria
3. ESSDAI score of = 5 at screening; the following domains will be scored but will not contribute to the min ESSDAI score of 5 required for incl: Periph nerv system, Centr nerv system, and Pulmonary
4. Pos for either anti-Ro autoantibodies or RF, or both at screening
5. Written inf consent and any locally required authoriz. obtained from the subject/legal rep prior to performing any protocol-related proced, including screening evaluations
6. FCBP who are sexually active with a nonsterilized male partner must use a highly effective method of contrac from signing the ICF and must agree to continue using such precautions through the end of the study F-U; cessation of contrac. after this point should be discussed with a resp physician. A recommend that the female partners (of CB potential) of male study particip should use a highly effective method of contrac. other than a barrier method is made
7. Nonsterilized male subjects who are sexually active with a female partner of CB potential must use a condom with spermicide from D1 through the end of the study
8. Meets all of the following TB criteria:
a. No history of latent or active TB prior to screening, with the exception of latent TB with documented completion of appropriate treatment
b. No signs or symptoms suggestive of active TB from medical history or physical examin
c. No recent (= 12w of screening) close contact with a person with active TB
d. Neg IGRA test result for TB obtained within 12 weeks prior to randomiz. Subjects with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded
e. Chest radiograph (obtained during the screening period or any time within 12w prior to signing of the ICF) with no evidence of current active TB or other infection, or old active TB, malignancy, or clinically signif abnormalities suggesting an active process (unless due to SS)
Pop #2:
1. Male or female adults, 18yy old or older at time of inf consent
2. Diagnosed with SS by meeting the 2016 ACR/EULAR Classif Criteria
3. ESSPRI score of = 5 at screening
4. ESSDAI score of < 5 at screening
5. Pos for either anti-Ro autoantibodies or RF, or both at screening
6. Residual salivary gland function as defined by whole stimulated salivary flow >0.1 mL/min
7. Written inf consent and any locally required obtained from the subject/legal rep prior to performing any protocol-related proced, including screening evaluations
8. FCBP who are sexually active with a nonsterilized male partner must use a highly effective method of contrac from signing the ICF, and must agree to continue using such precautions through the end of the F-U; cessation of contrac after this point should be discussed with a resp physician. A recommend that the female partners (of CB potential) of male study particip should use a highly effective method of contrac other than a barrier method will be made
9. Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from D1 through to the end of the study
10. Meets all of the following TB criteria:
a. No history of latent or active TB prior to screening, with the exception of latent TB with documented completion of appropriate treatment
b. No signs or symptoms suggestive of active TB from medical history or physical examination
c. No recent (= 12w of screening) close contact with a person with active TB.
d. Neg IGRA test result for TB obtained within 12 weeks prior to randomiz.
e. Chest radiograph (obtained during the screening period or anytime within 12w prior to signing of the ICF) with no evidence of current active TB or other infection, or old active TB, malignancy, or clinically signif abnormalities suggesting an active process (unless due to SS)

Pop#1.
1. Adulti =18 anni al momento del cons inform (l'età min per i paz adulti può essere > a 18aa in paesi con normative diverse)
2. Diagn di SS conformem ai criteri ACR/EULAR 2016
3. Punt ESSDAI=5 allo screening; i seguenti ambiti saranno contati ma non contribuiranno al punt min ESSDAI di 5 richiesto per l'inclus: Sist nerv perif, sist nerv centr e polmon
4. Pos ad autoanticorpi anti-Ro o RF o entrambi allo screening
5. ICF e qualsiasi autorizz richiesta a livello locale, ottenuta dal sogg/rappr legale prima dello svolgim di qualsiasi proced relativa al prot, inclusi gli esami di screening
6. Le donne in età fertile e sess attive con partner di sesso masch non sterilizz devono usare un metodo contracc altam efficace dal momento della firma dell’ICF e devono accett di continuare a usare tali precauzioni fino alla fine del F-U; la cessaz della contracc success a qs momento potrà essere discussa con un medico resp. Si raccom alle partner di sesso femm (in età fertile) dei partecip di sesso masch di utilizzare un metodo contracc altam efficace che non sia un metodo di barriera
7. I sogg di sesso masch non sterilizz e sessualm attivi che hanno una partner in età fertile, devono utilizz un preserv con spermicida dal G1 fino a fine studio
8. Rispettano tt i seguenti criteri relativi alla TB:
a. Ness anamnesi di TB latente o attiva prima dello screening, ad escl di TB latente conclusa a seguito di adeguata cura documentata
b. Nes sintomo che suggerisca una TB attiva dall’anamn clinica o da un esame obiett
c. Nes stretto contatto recente (=12 settim di screening) con una persona con TB attiva
d. Test IGRA (test rilascio interferone gamma) neg per la TB ottenuto 12 sett prima della randomizz. I sogg con un esito del test incerto possono ripetere il test, ma se il test ripetuto è nuovam incerto, saranno esclusi.
e. Radiogr torace (ottenuta durante lo screening o in quals momento entro le 12 sett prima di firmare l’ICF) con ness evidenza di TB o altra infez attiva corrente, o preced TB attiva, neopl o anomalie clinicam significat che suggeriscano un processo in corso (se non dovuto alla SS).
Pop#2:
1. Paz di sesso masch o femm =18 anni al momento del cons inform
2. Diagn di SS conformem ai criteri ACR/EULAR 2016
3. Punt ESSPRI=5 allo screening
4. Punt ESSDAI<5 allo screening
5. Pos ad autoanticorpi anti-Ro o RF o entrambi allo screening
6. Funz della ghiand saliv residua come definita dal flusso saliv stimolato >0,1 ml/min
7. ICF e qualsiasi autorizz richiesta a livello locale, ottenuta dal sogg/rappr legale prima dello svolgim di qualsiasi proced relativa al prot, inclusi gli esami di screening
8. Le donne in età fertile e sess attive con partner di sesso masch non sterilizz devono usare un metodo contracc altam efficace dal momento della firma dell’ICF e devono accett di continuare a usare tali precauzioni fino alla fine del F-U; la cessaz della contracc success a qs momento potrà essere discussa con un medico resp. Si raccom alle partner di sesso femm (in età fertile) dei partecip di sesso masch di utilizz un metodo contracc altam efficace che non sia un metodo di barriera
9. I sogg di sesso masch non sterilizz e sess attivi che hanno una partner in età fertile devono utilizz un preserv con spermicida dal G1 fino a fine studio
10. Rispettano tt i seguenti criteri relativi alla TB:
a. Ness anamnesi di TB latente o attiva prima dello screening, ad escl di TB latente conclusa a seguito di adeguata cura documentata
b. Ness sintomo che suggerisca una TB attiva dall’anamn clinica o da un esame obiett
c. Ness stretto contatto recente (=12 sett di screening) con una persona con TB attiva
d. Test IGRA neg per la TB ottenuto 12 sett prima della randomizz.
e. Radiogr torace (ottenuta durante lo screening o in qualsiasi momento nelle 12 sett precedenti la firma dell’ICF) con ness evidenza di TB o altra infez attiva corrente, o preced TB attiva, neopl o anomalie clinicam signifi che suggeriscano un processo in corso (se non dovuto alla SS).

E.4

Principal exclusion criteria

Please refer to the study Protocol

Si prega di fare riferimento al Protocollo

E.5 End points

E.5.1

Primary end point(s)

Population #1:
Change from baseline in ESSDAI at Day 169.
Population #2:
Change from baseline in ESSPRI at Day 169.

Popolazione n. 1:
Cambiamenti rispetto al basale nell’ESSDAI al Giorno 169.

Popolazione n. 2:
Cambiamenti rispetto al basale nell’ESSPRI al Giorno 169.

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline and Day 169

Basale e Giorno 169

E.5.2

Secondary end point(s)

Population #1:
1. Change from baseline in ESSPRI at Day 169.
2. Proportion of subjects achieving ESSDAI[3] and ESSDAI[4] response, defined as a decrease of at least 3[4] points from baseline in the ESSDAI at Day 169 without premature discontinuation from the study and without receiving rescue therapy.
3. Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Day 169.
4. Change from baseline in Ocular Surface Disease Index (OSDI©) at Day 169.
5. Patient's Global Impression of Severity (PGIS) at Day 169.
6. Safety and tolerability of multiple IV doses of VIB4920 as measured by the incidence of TEAEs, treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and laboratory, vital sign, and electrocardiogram (ECG) abnormalities.
7. PK during the study.
8. Proportion of subjects with positive immunogenic response measured by anti-VIB4920 antibodies until the completion of the study.
Population #2:
1. Proportion of subjects achieving ESSPRI response, defined as = 1 point or 15% reduction from baseline in ESSPRI score at Day 169 without premature discontinuation from the study and without receiving rescue therapy.
2. Change from baseline in FACIT-Fatigue score at Day 169.
3. Change from baseline in OSDI at Day 169.
4. Patient's Global Impression of Severity at Day 169
5. Safety and tolerability of multiple IV doses of VIB4920 as measured by the incidence of TEAEs, TESAEs, AESIs, and laboratory, vital sign, and ECG abnormalities.
6. PK during the study.
7. Proportion of subjects with positive immunogenic response measured by anti-VIB4920 antibodies until the completion of the study.

Popolazione n. 1:
1. Cambiamenti rispetto al basale nell’ESSPRI al Giorno 169.
2. Percentuale di soggetti che hanno raggiunto un punteggio ESSDAI[3] e ESSDAI[4], definito come un calo di almeno 3[4] punti dal basale dell’ESSDAI al Giorno 169 senza interruzione anticipata dallo studio e senza aver ricevuto una terapia di salvataggio.
3. Cambiamenti rispetto al basale nella valutazione funzionale relativa al trattamento della patologia cronica (FACIT)-Punteggio stanchezza al Giorno 169.
4. Cambiamenti rispetto al basale nell’indice della patologia della superficie oculare (OSDI©) al Giorno 169.
5. Impressione globale di Gravità per il paziente (PGIS) al Giorno 169.
6. Sicurezza e tollerabilità di dosi multiple EV di VIB4920, misurate mediante incidenza di TEAE (evento avverso emergente dal trattamento), TESAE (grave evento avverso emergente dal trattamento), AESI (eventi avversi di particolare interesse) e anomalie di analisi di laboratorio, parametri vitali ed elettrocardiogramma (ECG).
7. PK durante lo studio.
8. Percentuale di soggetti con risposta immunogenica positiva misurata da anticorpi anti-VIB4920 fino al completamento dello studio.

Popolazione n. 2:
1. Percentuale di soggetti che hanno raggiunto un punteggio ESSPRI, definito come = 1 punto o un calo del 15% dal basale del punteggio ESSPRI al Giorno 169 senza interruzione anticipata dallo studio e senza aver ricevuto una terapia di salvataggio.
2. Cambiamenti rispetto al basale nel FACIT-Punteggio stanchezza al Giorno 169.
3. Cambiamenti rispetto al basale nell’OSDI al Giorno 169.
4. Impressione globale di Gravità per il paziente al Giorno 169
5. Sicurezza e tollerabilità di dosi multiple EV di VIB4920, misurate mediante incidenza di TEAE, TESAE, AESI e anomalie di analisi di laboratorio, parametri vitali ed ECG.
6. PK durante lo studio.
7. Percentuale di soggetti con risposta immunogenica positiva misurata da anticorpi anti-VIB4920 fino al completamento dello studio.

E.5.2.1

Timepoint(s) of evaluation of this end point

ESSPRI, ESSDAI, FACIT-Fatigue, OSDI - Baseline and Day 169
PGIS - Day 169
Safety - all study visits from throughout study
PK - all study visits from Day 1 throughout study
Immunogenic response - Days 1, 29, 85, 169, 197, 253, 309 and 365

ESSPRI, ESSDAI, FACIT-Stanchezza, OSDI - Basale e Giorno 169
PGIS - Giorno 169
Sicurezza - tutte le visite dello studio nel corso di tutto lo studio
PK - tutte le visite dello studio dal Giorno 1 e per tutto lo studio
Risposta immunogenica - Giorni 1, 29, 85, 169, 197, 253, 309 e 365

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

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability, immunogenicity, biomarker analysis

Tollerabilità, immunogenicità, analisi dei biomarcatori

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

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

China

India

Korea, Republic of

Mexico

Peru

Turkey

United States

France

Greece

Italy

Poland

Spain

United Kingdom

Argentina

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 will be completed once the last subject out has completed all Visit 15 or early discontinuation assessments.

Lo studio sarà completato quando l’ultimo soggetto avrà completato tutte le 15 visite o le valutazioni in caso di interruzione anticipata

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:

120

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

174

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

2020-04-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-02-27

P. End of Trial
P.	End of Trial Status	Ongoing

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