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    Summary
    EudraCT Number:2019-000328-16
    Sponsor's Protocol Code Number:20170588
    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:2021-06-15
    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 number2019-000328-16
    A.3Full title of the trial
    Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy
    Studio di fase 2b di dose-ranging volto a valutare l'efficacia e la sicurezza di Rozibafusp Alfa (AMG 570) in soggetti con lupus eritematoso sistemico (LES) attivo con risposta inadeguata alla terapia standard (SOC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy
    Studio di fase 2 di dose-ranging volto a valutare l'efficacia e la sicurezza di Rozibafusp Alfa (AMG 570) in soggetti con lupus eritematoso sistemico (LES) attivo con risposta inadeguata alla terapia standard (SOC)
    A.3.2Name or abbreviated title of the trial where available
    Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
    Sicurezza ed efficacia di AMG 570 in soggetti con lupus eritematoso sistemico (LES) attivo
    A.4.1Sponsor's protocol code number20170588
    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 SponsorAMGEN 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen S.r.l.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressVia Tazzoli 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number0039026241121
    B.5.5Fax number003902624112370
    B.5.6E-mailmedicalinformationitaly@amgen.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 nameAMG 570
    D.3.2Product code [AMG 570]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAMG 570
    D.3.9.3Other descriptive nameAMG 570
    D.3.9.4EV Substance CodeSUB186902
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 nameAMG 570
    D.3.2Product code [AMG 570]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAMG 570
    D.3.9.3Other descriptive nameAMG 570
    D.3.9.4EV Substance CodeSUB186902
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number280
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 nameAMG 570
    D.3.2Product code [AMG 570]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAMG 570
    D.3.9.3Other descriptive nameAMG 570
    D.3.9.4EV Substance CodeSUB186902
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number420
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Systemic Lupus Erythematosus (SLE)
    Lupus eritematoso sistemico attivo (LES)
    E.1.1.1Medical condition in easily understood language
    Active Systemic Lupus Erythematosus (SLE)
    Lupus eritematoso sistemico attivo (LES)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective 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
    Evaluate the efficacy of AMG 570 at week 52 as measured by the Systemic Lupus Erythematosus Responder Index (SRI-4)
    Valutare l'efficacia di AMG 570 alla settimana 52 misurata secondo il Systemic Lupus Erythematosus Responder Index (SRI-4)
    E.2.2Secondary objectives of the trial
    - Evaluate the efficacy of AMG 570 at week 24
    - Evaluate the efficacy of AMG 570 at week 52
    - Evaluate the efficacy of AMG 570 as measured by SRI-4 response with oral corticosteroid (OCS) tapering
    - Evaluate the efficacy of AMG 570 on disease flares
    - Evaluate the efficacy of AMG 570 on joints and skin.
    - Describe the efficacy of AMG 570 using patient reported outcomes.
    - Characterize the safety of AMG 570.
    - To characterize the pharmacokinetics (PK) of AMG 570.
    - Valutare l'efficacia di AMG 570 alla settimana 24
    - Valutare l'efficacia di AMG 570 alla settimana 52
    - Valutare l'efficacia di AMG 570 come rilevato dal SRI-4 response con riduzione della dose di corticosteroidi orali (OCS)
    - Valutare l'efficacia di AMG 570 sulle riacutizzazioni della malattia
    - Valutare l'efficacia di AMG 570 su articolazioni e pelle
    - Descrivere l'efficacia di AMG 570 mediante gli esiti riferiti dai pazienti
    - Caratterizzare la sicurezza di AMG 570
    - Caratterizzare la farmacocinetica (PK) di AMG 570
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenetics
    Version: EU supplement version 1
    Date: 31/05/2019
    Title: A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects with Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy
    Objectives: To investigate inherited genetic variations to evaluate their possible correlation to the disease and/or responsiveness to the therapies used in this study.

    Farmacogenetica
    Versione: EU supplement version 1
    Data: 31/05/2019
    Titolo: Studio di fase 2 di dose-ranging per valutare l’efficacia e la sicurezza di AMG 570 in soggetti con lupus eritematoso sistemico (LES) attivo con risposta inadeguata alla terapia standard (SOC)
    Obiettivi: Esaminare eventuali variazioni genetiche ereditarie per stabilire se esista una correlazione tra tali variazioni e la malattia e/o la risposta alle terapie utilizzate in questo studio.
    E.3Principal inclusion criteria
    - Subject has provided informed consent prior to initiation of any study specific activities/procedures.
    - Age > = 18 years to < = 75 years at screening visit.
    - Fulfills classification criteria for SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE (Aringer et al, 2019), with antinuclear antibody > = 1:80 by immunofluorescence on Hep-2 cells being present at screening. Anti-dsDNA results based on the Farr assay will be used to SLE classification criteria, while test results from the Phadia method will be used for the purposes of hSLEDAI scoring during screening and throughout the study
    - Hybrid SLEDAI-2K score > = 6 points with "Clinical" hSLEDAI-2K score > = 4 points.
    The "Clinical" hSLEDAI-2K is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results including urine or immunologic parameters.
    Additional protocol specific rules:
    o Arthritis: Arthritis (at least 3 tender and swollen joints) must involve joints in the hands or wrists for the hSLEDAI scoring
    - Alopecia: Subjects should have hair loss without scarring; should neither have alopecia areata nor androgenic alopecia; and should have a CLASI activity score for alopecia > = 2
    - Oral ulcers: Ulcers location and appearance must be documented by the investigator

    *Please, refer to protocol for the full list
    - Soggetti che hanno fornito il consenso informato prima dell'inizio di eventuali attività / procedure specifiche dello studio
    - Età compresa tra > = 18 e < = 75 anni alla visita di screening.
    Soddisfa i criteri di classificazione per il LES secondo la European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification (Aringer et al, 2019) con anticorpo antinucleare > = 1:80 per immunofluorescenza su cellule Hep-2 presenti allo screening. I risultati antidsDNA basati sul saggio Farr saranno utilizzati per i criteri di classificazione del LES, mentre i risultati del test con il metodo Phadia saranno utilizzati ai fini del punteggio di hSLEDAI durante lo screening e per tutto lo studio
    - Punteggio ibrido SLEDAI-2K > = 6 punti con punteggio "Clinico" hSLEDAI-2K > = 4 punti.
    Il punteggio "Clinico" hSLEDAI-2K è il punteggio di valutazione hSLEDAI senza l'inclusione di punti attribuibili ai risultati di laboratorio, compresi i parametri urinari o immunologici.
    Regole specifiche del protocollo aggiuntivo:
    o Artrite: L'artrite (almeno 3 articolazioni dolenti e gonfie) deve coinvolgere le articolazioni delle mani o dei polsi per il punteggio hSLEDAI
    - Alopecia: I soggetti dovrebbero avere la perdita di capelli senza cicatrici; non dovrebbero avere né alopecia areata né alopecia androgenetica; e dovrebbero avere un punteggio di attività CLASI per l'alopecia > = 2
    - Ulcere orali: La posizione e l'aspetto delle ulcere devono essere documentati dall'investigatore

    *Fare riferimento al protocollo per la lista completa
    E.4Principal exclusion criteria
    - Urine protein creatinine ratio >= 3000mg/g (or equivalent) at screening or induction therapy for lupus nephritis within 1 year prior to screening visit
    - Active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.
    - Diagnosis of any inflammatory joint or skin disease other than SLE (confirmed accurate by the PI) which would interfere with SLE disease assessment based on investigator judgement.
    - Any disease other than SLE that has required treatment with oral or parenteral corticosteroids for > 2 weeks within 6 weeks prior to screening.

    *Please, refer to protocol for the full list
    -Rapporto di creatinina proteine urinarie >= 3000 mg/g (o equivalente) allo screening o terapia di induzione per la nefrite lupica entro 1 anno prima della visita di screening
    - Lupus attivo del SNC entro 1 anno prima dello screening inclusa, ma non limitata a, meningite asettica, atassia, vasculite del sistema nervoso centrale, neuropatia cranica, sindrome demielinizzante, neurite ottica, psicosi, convulsioni o mielite trasversa
    - Diagnosi di qualsiasi infiammazione articolare o malattia della pelle diversa dal LES (confermata dal PI) che interferirebbe con la valutazione della malattia SLE sulla base del giudizio dello sperimentatore
    - Qualsiasi malattia diversa dal LES che ha richiesto il trattamento con corticosteroidi orali o parenterali per > 2 settimane entro 6 settimane prima dello screening.

    *Fare riferimento al protocollo per la lista completa
    E.5 End points
    E.5.1Primary end point(s)
    SRI-4 response at week 52
    risposta SRI-4 alla settimana 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Settimana 52
    E.5.2Secondary end point(s)
    - SRI-4 response at week 24
    - BILAG based Combined Lupus Assessment (BICLA) response at week 24
    - Lupus Low Disease Activity State (LLDAS) response at week 52
    - BICLA response at week 52
    - SRI-4 response at week 52 with reduction of OCS to < = 7.5 mg/day by week 44 and sustained through week 52 in subjects with a baseline OCS dose > = 10 mg/day
    - Annualized moderate and severe flare rate (as measured by SELENA SLEDAI Flare Index) over 52 weeks
    - Annualized severe flare rate (as measured by SELENA-SLEDAI Flare Index) over 52 weeks
    - Annualized flare rate (as measured by BILAG score designation of "worse" or "new" resulting in a B score in >= 2 organs or an A score in >= 1 organ) over 52 weeks
    - Total tender and swollen joint count (not limited to hands and wrists) > = 50% improvement from baseline at week 12, 24, 36, and 52 in subjects with > = 6 tender and > = 6 swollen joints involving the hands and wrists at baseline
    - Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) activity score > = 50% improvement from baseline at week 12, 24, 36, and 52 in subjects with a CLASI activity score > = 8 at baseline.
    - Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS Fatigue SF7A) score and change from baseline at week 12, 24, 36, 44, and 52
    - Medical Outcomes Short Form 36 version 2 Questionnaire (SF36v2) score and change from baseline at week 12, 24, 36, 44, and 52.
    - Lupus QoL score and change from baseline at week 12, 24, 36, 44, and 52.
    - Patient Global Assessment (PtGA) score and change from baseline at week 12, 24, 36, 44, and 52.
    - Treatment-emergent adverse events
    - Serious adverse events
    - Clinically significant changes in laboratory values and vital signs
    - Trough serum concentrations and terminal elimination half-life of AMG 570
    - SRI-4 risposta alla settimana 24
    - Risposta BILAG basata sul Combined Lupus Assessment (BICLA) alla settimana 24
    - Risposta Lupus Low Disease Activity State (LLDAS) alla settimana 52
    - Risposta di BICLA alla settimana 52
    - Risposta SRI-4 alla settimana 52 con riduzione dell'OCS a < = 7,5 mg/giorno di settimana 44 e sostenuta fino alla settimana 52 in soggetti con un OCS di base dose > = 10 mg/giorno
    - Tasso annualizzato di riacutizzazione moderata e grave (misurato da SELENA-SLEDAI Flare Index) per 52 settimane
    - Tasso annualizzato di riacutizzazione grave (misurato da SELENA-SLEDAI Flare Index) in 52 settimane
    - Tasso annualizzato di riacutizzazione (misurato dalla designazione del punteggio BILAG di "peggio" o "nuovo" che danno come risultato un punteggio B in >= 2 organi o un punteggio A in >= 1 organo) per 52 settimane
    - Miglioramento totale > = 50% nella conta delle articolazioni (non limitato a mani e polsi) dolenti e tumefatte rispetto al basale alle settimane 12, 24, 36 e 52 in soggetti con > = 6 articolazioni dolenti e > = 6 tumefatte che coinvolge le mani e i polsi al basale
    - Miglioramento > = 50%nell'indice di attività Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) dal basale alle settimane 12, 24, 36 e 52 in soggetti con punteggio di attività CLASI > = 8 al basale.
    - Punteggio Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS Fatigue SF7A) e variazione rispetto al basale alla settimana 12, 24, 36, 44 e 52.
    - Punteggio del questionario Medical Outcomes Short Form 36 versione 2 (SF36v2) e variazione rispetto al basale alla settimana 12, 24, 36, 44 e 52.
    - Punteggio Lupus QoL e variazione rispetto al basale alla settimana 12, 24, 36, 44 e 52.
    - Punteggio PtGA (Patient Global Assessment) e variazione rispetto al basale alla settimana 12, 24, 36, 44 e 52 sulla valutazione globale del paziente.
    - Trattamento degli eventi avversi emergenti
    - Eventi avversi gravi
    - Cambiamenti clinicamente significativi nei valori di laboratorio e nei segni vitali
    - Concentrazioni sieriche grezze e emivita di eliminazione terminale di AMG 570
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Week 24
    - Week 24
    - Week 52
    - Week 52
    - Weeks 52, 44
    - Week 52
    - Week 52
    - Week 52
    - Weeks 12, 24, 36 and 52
    - Weeks 12, 24, 36 and 52
    - Weeks 12, 24, 36, 44 and 52
    - Weeks 12, 24, 36, 44 and 52
    - Weeks 12, 24, 36, 44 and 52
    - Weeks 12, 24, 36, 44 and 52
    - Duration of the study
    - settimana 24
    - settimana 24
    - settimana 52
    - settimana 52
    - settimana 52, 44
    - settimana 52
    - settimana 52
    - settimana 52
    - settimana 12, 24, 36 e 52
    - settimana 12, 24, 36 e 52
    - settimana 12, 24, 36, 44 e 52
    - settimana 12, 24, 36, 44 e 52
    - settimana 12, 24, 36, 44 e 52
    - settimana 12, 24, 36, 44 e 52
    - durata dello studio
    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 No
    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
    Adaptive design
    Adaptive design
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Canada
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    United States
    Austria
    Bulgaria
    France
    Germany
    Hungary
    Italy
    Poland
    Portugal
    Switzerland
    United Kingdom
    Czechia
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 295
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 320
    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 Decision2019-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-12
    P. End of Trial
    P.End of Trial StatusOngoing
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