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    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:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-14
    Trial 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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-001271-20
    A.3Full 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.3.1Title 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.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberB7981019
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03715829
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPFIZER INC
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number000000
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name-
    D.3.2Product code [PF-06651600]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06651600
    D.3.9.2Current sponsor codePF-06651600
    D.3.9.3Other descriptive namePF-06651600-15
    D.3.9.4EV Substance CodeSUB174316
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name-
    D.3.2Product code [PF-06651600]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06651600
    D.3.9.2Current sponsor codePF-06651600
    D.3.9.3Other descriptive namePF-06651600-15
    D.3.9.4EV Substance CodeSUB174316
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name-
    D.3.2Product code [PF-06700841]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06700841
    D.3.9.2Current sponsor codePF-06700841
    D.3.9.3Other descriptive namePF-06700841-15
    D.3.9.4EV Substance CodeSUB184971
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name-
    D.3.2Product code [PF-06700841]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06700841
    D.3.9.2Current sponsor codePF-06700841
    D.3.9.3Other descriptive namePF-06700841-15
    D.3.9.4EV Substance CodeSUB184971
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vitiligo
    Vitiligine
    E.1.1.1Medical 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.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10047642
    E.1.2Term Vitiligo
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.2.2Secondary 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.2.3Trial contains a sub-study No
    E.3Principal 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.4Principal 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.5.1Primary 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.5.1.1Timepoint(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.5.2Secondary 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.5.2.1Timepoint(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.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    periodo di estensione parzialmente in cieco
    partially blinded extension period
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial12
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Canada
    Germany
    Italy
    Japan
    Korea, Republic of
    Spain
    Taiwan
    United States
    E.8.7Trial 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.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days20
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 660
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 185
    F.4.2.2In 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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-05
    P. End of Trial
    P.End of Trial StatusOngoing
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