Clinical Trials Register

Summary
EudraCT Number:	2018-001271-20
Sponsor's Protocol Code Number:	B7981019
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-01-14
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

2018-001271-20

A.3

Full title of the trial

A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study To Evaluate The Efficacy And Safety Profile Of Pf-06651600 With A Partially Blinded Extension Period To Evaluate The Efficacy And Safety Of Pf06651600 And Pf-06700841 In Subjects With Active Non-Segmental Vitiligo

Studio di Fase 2b a dosaggi variabili, randomizzato, in doppio cieco, controllato con placebo, multicentrico per valutare il profilo di efficacia e sicurezza di PF06654600, con un periodo di estensione parzialmente in cieco per valutare l'efficacia e la sicurezza di PF06651600 e PF06700841 in soggetti con vitiligine non segmentale in fase attiva

A.3.1

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

A medical research study to evaluate the safety and effectiveness of two investigational medications for vitiligo

Studio di ricerca medica atto a valutare la sicurezza e l'efficacia di due medicinali sperimentali per la vitiligine

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

B7981019

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03715829

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	PFIZER 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	Pfizer, 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	Pfizer Inc.
B.5.2	Functional name of contact point	Clinical Trials.gov Call Center
B.5.3	Address:
B.5.3.1	Street Address	235 E 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	0018007181021
B.5.5	Fax number	000000
B.5.6	E-mail	ClinicalTrials.gov_Inquiries@pfizer.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	-
D.3.2	Product code	[PF-06651600]
D.3.4	Pharmaceutical form	Tablet
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	PF-06651600
D.3.9.2	Current sponsor code	PF-06651600
D.3.9.3	Other descriptive name	PF-06651600-15
D.3.9.4	EV Substance Code	SUB174316
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: 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	-
D.3.2	Product code	[PF-06651600]
D.3.4	Pharmaceutical form	Tablet
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	PF-06651600
D.3.9.2	Current sponsor code	PF-06651600
D.3.9.3	Other descriptive name	PF-06651600-15
D.3.9.4	EV Substance Code	SUB174316
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	50
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	-
D.3.2	Product code	[PF-06700841]
D.3.4	Pharmaceutical form	Tablet
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	PF-06700841
D.3.9.2	Current sponsor code	PF-06700841
D.3.9.3	Other descriptive name	PF-06700841-15
D.3.9.4	EV Substance Code	SUB184971
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: 4
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	-
D.3.2	Product code	[PF-06700841]
D.3.4	Pharmaceutical form	Tablet
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	PF-06700841
D.3.9.2	Current sponsor code	PF-06700841
D.3.9.3	Other descriptive name	PF-06700841-15
D.3.9.4	EV Substance Code	SUB184971
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	25
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
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Vitiligo

Vitiligine

E.1.1.1

Medical condition in easily understood language

Vitiligo is a chronic skin disorder characterized by a patchy loss of skin color

La vitiligine è una malattina cronica della pelle caratterizzata dalla perdita a chiazze del colore della pelle

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10047642
E.1.2	Term	Vitiligo
E.1.2	System Organ Class	10040785 - Skin and subcutaneous 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

Dose Ranging Period:
• To evaluate the efficacy of PF-06651600 dose/dosing regimens at Week 24 in adult subjects with active non segmental vitiligo
• To evaluate the safety and tolerability of PF-06651600 over time in adult subjects with active non segmental vitiligo
Extension Period:
• To evaluate the safety and tolerability of PF-06651600 and PF-06700841 in adult subjects with active non segmental vitiligo

Periodo di dose ranging:
- Valutare l’efficacia della dose/dei regimi di dosaggio di PF-06651600 alla Settimana 24 in soggetti adulti con vitiligine non segmentale in fase attiva
- Valutare la sicurezza e la tollerabilità di PF-06651600 nel tempo in soggetti adulti con vitiligine non segmentale in fase attiva.
Periodo di estensione:
- Valutare la sicurezza e la tollerabilità di PF-06651600 e PF-06700841 in soggetti adulti con vitiligine non segmentale in fase attiva.

E.2.2

Secondary objectives of the trial

Dose Ranging Period:
• To evaluate the efficacy of PF-06651600 compared to placebo as measured by other clinical assessments over time in adult subjects with active non segmental vitiligo

Periodo di dose ranging:
- Valutare l’efficacia di PF-06651600 rispetto a placebo, come misurata in base ad altre valutazioni cliniche nel tempo in soggetti adulti con vitiligine non segmentale in fase attiva.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male or female subjects between 18-65 years of age, inclusive, at time of informed consent.
• Must have moderate to severe active non-segmental vitiligo.

- I soggetti di sesso maschile o femminile di età compresa tra 18 e 65 anni (inclusi) alla firma del consenso informato.
- I soggetti devono avere una vitiligine non segmentale in fase attiva da moderata a grave.

E.4

Principal exclusion criteria

• History of human immunodeficiency virus (HIV) or positive HIV serology at screening.
• Infected with hepatitis B or hepatitis C viruses.
• Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).

- Essere risultati sieropositivi o immunodepressi da HIV in screening precedenti.
- Essere infetti dal virus dell'epatite B o C.
- Avere una comprovata infezione da Mycobacterium Tuberculosis (TB) attiva, latente o inadeguatamente trattata.

E.5 End points

E.5.1

Primary end point(s)

• Percent change from baseline of vitiligo area scoring index (VASI) at Week 24
• Number of treatment emergent adverse events(TEAEs)
• Number of subjects with change from baseline in laboratory tests results
• Number of subjects reporting TEAEs
• Number of specific clinical laboratory abnormalities
• Number of treatment emergent serious adverse events (TESAEs)
• Number of subjects who experienced TESAEs

- Variazione percentuale rispetto al basale nel punteggio del Vitiligo Area Scoring Index (VASI) alla Settimana 24
- Numero di eventi avversi emergenti dal trattamento (Treatment Emergent Adverse Events, TEAEs)
- Numero di soggetti che mostrano un cambiamento nei risultati dei test di laboratorio rispetto al basale
- Numero di soggetti che riportano TEAEs
- Numero di speficiche anomalie cliniche di laboratorio
- Numero di eventi avversi seri emergenti dal trattamento (Treatment Emergent Serious Adverse Events, TESAEs)
- Numero di soggetti che affrontano TESAEs

E.5.1.1

Timepoint(s) of evaluation of this end point

baseline, 24 weeks; baseline up to end of study (56 weeks)

basale, settimana 24; dal basale fino alla fine dello studio (56 settimane)

E.5.2

Secondary end point(s)

• Percentage of subjects achieving at least 50% improvement in VASI from baseline (VASI50) (at Week 24)
• Percent change from baseline in VASI (baseline to week 20)
• Percent change from baseline in facial VASI (baseline to week 24)
• Percent change from baseline in vitiligo extent score (VES) (baseline to week 24)
• Percent change from baseline in self- assessment vitiligo extent score (SA-VES) (baseline to week 24)
• Absolute change from baseline in VASI (baseline to week 24)
• Percentage of subjects achieving VASI50 (baseline to week 20)
• Percentage of subjects achieving at least 75% improvement in VASI from baseline (VASI75) (baseline to week 24)
• Percentage of subjects achieving at least 90% improvement in VASI from baseline (VASI90) (baseline to week 24)
• Percentage of subjects achieving at least 100% improvement in VASI from baseline (VASI100) (baseline to week 24)
• Percentage of subjects achieving facial VASI50 (baseline to week 24)
• Percentage of subjects achieving facial VASI75 (baseline to week 24)
• Percentage of subjects achieving facial VASI90 (baseline to week 24)
• Percentage of subjects achieving facial VASI100 (baseline to week 24)
• Percentage of subjects achieving at least 50% improvement in VES (VES50) (baseline to week 24)
• Percentage of subjects achieving at least 75% improvement in VES (VES75) (baseline to week 24)
• Percentage of subjects achieving at least 90% improvement in VES (VES90) (baseline to week 24)
• Percentage of subjects achieving at least 100% improvement in VES (VES100) (baseline to week 24)
• Change from baseline in vitiligo specific quality of life (VitiQoL) (baseline to week 24)
• Percentage of subjects achieving a static investigator global assessment (sIGA) 0 or 1, and at least 2-point improvement (week 24)

- Percentuale di soggetti che raggiungono il VASI50 (definito come miglioramento almeno del 50% nel VASI rispetto al basale) alla Settimana 24
- Variazione percentuale rispetto al basale nel VASI (dal basale alla settimana 20)
- Variazione percentuale rispetto al basale nel VASI facciale (dal basale alla settimana 24)
- Variazione percentuale rispetto al basale nel punteggio di estensione della vitiligine (VES) (dal basale alla settimana 24)
- Variazione percentuale rispetto al basale nel punteggio VES autovalutato (SA_VES) (dal basale alla settimana 24)
- Variazione assoluta rispetto al basale nel VASI (dal basale alla settimana 24)
- Percentuale di soggetti che raggiungono il VASI50 (dal basale alla settimana 20)
- Percentuale di soggetti che raggiungono almeno il 75% di miglioramento nel VASI dal baseline (VASI75) (dal basale alla settimana 24)
- Percentuale di soggetti che raggiungono almeno il 90% di miglioramento nel VASI dal baseline (VASI90) (dal basale alla settimana 24)
- Percentuale di soggetti che raggiungono almeno il 100% di miglioramento nel VASI dal baseline (VASI100) (dal basale alla settimana 24)
- Percentuale dei soggetti che raggiungono il VASI50 facciale (dal basale alla settimana 24)
- Percentuale dei soggetti che raggiungono il VASI75 facciale (dal basale alla settimana 24)
- Percentuale dei soggetti che raggiungono il VASI90 facciale (dal basale alla settimana 24)
- Percentuale dei soggetti che raggiungono il VASI100 facciale (dal basale alla settimana 24)
- Percentuale di soggetti che raggiungono almeno il 50% di miglioramento nel VES (il VES50) (dal basale alla settimana 24)
- Percentuale di soggetti che raggiungono almeno il 75% di miglioramento nel VES (il VES75) (dal basale alla settimana 24)
- Percentuale di soggetti che raggiungono almeno il 90% di miglioramento nel VES (il VES90) (dal basale alla settimana 24)
- Percentuale di soggetti che raggiungono almeno il 100% di miglioramento nel VES (il VES100) (dal basale alla settimana 24)
- Variazione rispetto al basale nella qualità della vita specifica per la vitiligine (VitiQoL) (dal basale alla settimana 24)
- Percentuale di soggetti che ottengono una valutazione globale statica dello sperimentatore (sIGA) di 0 o 1 e un miglioramento di almeno 2 punti alla Settimana 24.

E.5.2.1

Timepoint(s) of evaluation of this end point

at week 24; baseline to week 20; baseline to week 24

alla settimana 24; dal basale fino alla settimana 20; dal basale fino alla settimana 24

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

Yes

E.6.13.1

Other scope of the trial description

Tolerability

Tollerabilità

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

Yes

E.8.1.7.1

Other trial design description

periodo di estensione parzialmente in cieco

partially blinded extension period

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

Australia

Canada

Japan

Korea, Republic of

Taiwan

United States

Belgium

Germany

Italy

Spain

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS (Last Visit Last Subject)

LVLS (ultima visita dell'ultimo soggetto)

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:

660

F.1.3

Elderly (>=65 years)

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

185

F.4.2.2

In the whole clinical trial

660

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

2019-07-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-11-05

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

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