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    Summary
    EudraCT Number:2022-000880-40
    Sponsor's Protocol Code Number:R2477-FOP-2175
    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:2022-09-14
    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 number2022-000880-40
    A.3Full title of the trial
    PHASE 3 RANDOMIZED, PLACEBO-CONTROLLED STUDY TO ASSESS SAFETY, TOLERABILITY AND EFFICACY OF GARETOSMAB IN PATIENTS WITH FIBRODYSPLASIA OSSIFICANS PROGRESSIVA
    STUDIO DI FASE III RANDOMIZZATO, CONTROLLATO CON PLACEBO PER VALUTARE LA SICUREZZA, LA TOLLERABILITÀ E L’EFFICACIA DI GARETOSMAB IN PAZIENTI CON FIBRODISPLASIA OSSIFICANTE PROGRESSIVA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Examination of Safety and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants with Fibrodysplasia Ossificans Progressiva (FOP)
    Valutazione della sicurezza e dell’efficacia di garetosmab rispetto al placebo somministrato per via endovenosa (EV) in partecipanti adulti con fibrodisplasia ossificante progressiva (FOP)
    A.3.2Name or abbreviated title of the trial where available
    Optima
    Optima
    A.4.1Sponsor's protocol code numberR2477-FOP-2175
    A.5.4Other Identifiers
    Name:INDNumber:130595
    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 SponsorREGENERON PHARMACEUTICALS, 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 supportRegeneron Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number00000000
    B.5.5Fax number00000000
    B.5.6E-mailclinicaltrials@regeneron.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1779
    D.3 Description of the IMP
    D.3.1Product nameGaretosmab
    D.3.2Product code [REGN2477]
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGaretosmab
    D.3.9.2Current sponsor codeREGN2477
    D.3.9.4EV Substance CodeSUB182187
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1779
    D.3 Description of the IMP
    D.3.1Product nameGaretosmab
    D.3.2Product code [REGN2477]
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGaretosmab
    D.3.9.2Current sponsor codeREGN2477
    D.3.9.4EV Substance CodeSUB182187
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 placeboConcentrate for solution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fibrodysplasia Ossificans Progressiva
    Fibrodisplasia Ossificante Progressiva
    E.1.1.1Medical condition in easily understood language
    Rare genetic disease which causes abnormal formation of bone at abnormal locations such as in the muscles, tendons and ligaments.
    Malattia genetica rara che provoca la formazione anormale di osso in posizioni inusuali come nei muscoli, nei tendini e nei legamenti.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10068715
    E.1.2Term Fibrodysplasia ossificans progressiva
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary efficacy objective of the study is to assess the effect of high-dose garetosmab versus placebo on the formation of new HO lesions from baseline to week 56, as determined by low-dose
    computerized tomography (CT).
    The primary safety objective of the study is to assess the safety and tolerability of garetosmab versus placebo from baseline to week 56.
    L’obiettivo primario di efficacia dello studio è di valutare l'effetto di garetosmab ad alto dosaggio rispetto al placebo sulla formazione di nuove lesioni di OE dal basale alla settimana 56, determinata da tomografia computerizzata (TC) a basso dosaggio.
    L’obiettivo primario di sicurezza dello studio è di valutare la sicurezza e la tollerabilità di garetosmab rispetto al placebo dal basale alla settimana 56.
    E.2.2Secondary objectives of the trial
    • To assess the effect of high-dose garetosmab versus placebo on the number per patient of clinician-assessed flare-up episodes to week 56
    • To assess the effect of low-dose garetosmab versus placebo on the formation of new HO lesions from baseline to week 56 as determined by CT
    • To assess the effect of low-dose garetosmab versus placebo on the number per patient of clinician-assessed flare-up episodes to week 56
    • valutare l’effetto di garetosmab ad alto dosaggio rispetto al placebo sul numero di episodi di riacutizzazione valutati dal medico per paziente fino alla settimana 56;
    • valutare l’effetto di garetosmab a basso dosaggio rispetto al placebo sulla formazione di nuove lesioni di OE dal basale alla settimana 56, determinata da TC;
    • valutare l’effetto di garetosmab a basso dosaggio rispetto al placebo sul numero di episodi di riacutizzazione valutati dal medico per paziente fino alla settimana 56.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female 18 years or older at screening
    2. Clinical diagnosis of Fibrodysplasia Ossificans Progressiva (FOP) [(based on findings of congenital malformation of the great toes, episodic soft tissue swelling, and/or progressive
    Heterotopic Ossification (HO)]
    3. Confirmation of FOP diagnosis with documentation of Type I activin A receptor (ACVR1) FOP causing mutation
    4. FOP disease activity within 1 year of screening visit. FOP disease activity is defined as pain, swelling, stiffness, or other signs and symptoms associated with FOP flare-ups; or worsening of joint function, or radiographic progression of HO lesions (increase in size or number of HO lesions) with/without being associated with flare-up episodes
    5. Willing and able to undergo CT imaging procedures and other procedures as defined in the protocol
    Other Protocol Defined Inclusion Criteria Apply
    1. Paziente di sesso maschile o femminile di età pari o superiore a 18 anni allo screening.
    2. Diagnosi clinica di fibrodisplasia ossificante progressiva (FOP) (in base ai riscontri di malformazione congenita dell’alluce, rigonfiamento episodico del tessuto morbido e/o ossificazione eterotopica (OE) progressiva).
    3. Conferma della diagnosi di FOP con documentazione della mutazione del recettore dell’attivina A di tipo I (ACVR1) che causa la FOP.
    4. Attività da malattia FOP entro 1 anno dalla visita di screening. L’attività da malattia FOP viene definita come dolore, gonfiore, rigidità o altri segni e sintomi associati a riacutizzazione di FOP; o peggioramento della funzione articolare, o progressione radiografica delle lesioni di OE (aumento della dimensione o del numero di lesioni di OE) associate o meno a episodi di riacutizzazione.
    5. Paziente disposto/a e in grado di sottoporsi a procedure TC e altre procedure definite nel protocollo.
    Si applicano altri criteri di inclusione definiti nel protocollo.
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    1. Cumulative Analog Joint Involvement Scale (CAJIS) score at screening >19
    2. Participant has significant concomitant illness or history of significant illness such as but not limited to cardiac, renal, rheumatologic, neurologic, psychiatric, endocrine, metabolic, or lymphatic disease, that in the opinion of the study investigator might confound the results of the study or pose additional risk to the patient by their participation in the study
    3. Previous history or diagnosis of cancer
    4. Severely impaired renal function defined as estimated glomerular filtration rate <30 milliliter per minute (mL/min) (/1.73 m^2 calculated by the Modification of Diet in Renal Disease equation)
    5. Uncontrolled diabetes defined as hemoglobin A1C (HbA1c) >9% at screening
    6. History of poorly controlled hypertension as defined by:
    a. Systolic blood pressure =180 mm Hg or diastolic blood pressure = 110 mm Hg at the screening visit
    b. Systolic blood pressure of 160 mm Hg to 179 mm Hg or diastolic blood pressure of 100 mm Hg to 109 mm Hg at the screening visit, AND a history of end-organ damage (including history of left-ventricular hypertrophy, heart failure, angina, myocardial infarction, stroke, transient ischemic attack, peripheral arterial disease, end-stage renal disease, and moderate-to-advanced retinopathy)
    7. Known history of cerebral vascular malformation
    8. Cardiovascular conditions such as New York Heart Association class III or IV heart failure, cardiomyopathy, intermittent claudication, myocardial infarction, or acute coronary syndrome within 6 months prior to screening; symptomatic ventricular cardiac arrhythmia
    9. History of severe respiratory compromise requiring oxygen, respiratory support (eg, bilevel positive airway pressure [biPAP] or continuous positive airway pressure [CPAP]), or a history of aspiration pneumonia requiring hospitalization
    10. Prior use in the past year and concomitant use of bisphosphonates
    11. Concurrent participation in another interventional clinical study or a non-interventional study with radiographic measures or invasive procedures (eg, collection of blood or tissue samples).
    12. Treatment with another investigational drug, denosumab, imatinib or isotretinoin in the last 30 days or within 5 half-lives of the investigational drug, whichever is longer
    13. Pregnant or breastfeeding women
    14. Women of childbearing potential (WOCBP)* who are unwilling to practice highly effective contraception
    15. Male patients with WOCBP partners* who are not willing to use condoms with WOCBP partners to prevent potential fetal exposure
    Note: Other Protocol Defined Exclusion Criteria Apply
    Principali criteri di esclusione:
    1. punteggio della Scala analogica cumulativa di coinvolgimento articolare (CAJIS) allo screening >19;
    2. il/la partecipante presenta malattia concomitante significativa o anamnesi di malattia significativa come, a titolo esemplificativo ma non esaustivo, malattia cardiaca, renale, reumatologica, neurologica, psichiatrica, endocrina, metabolica o linfatica che, a parere dello sperimentatore dello studio, potrebbe confondere i risultati dello studio o porre ulteriori rischi per il/la paziente in caso di partecipazione allo studio;
    3. pregressa anamnesi o diagnosi di tumore;
    4. grave deterioramento della funzione renale definito come tasso di filtrazione glomerulare stimato <30 millilitri al minuto (ml/min) (/1,73 m^2 calcolato mediante l’equazione Modifica della dieta nelle malattie renali);
    5. diabete non controllato definito come emoglobina A1C (HbA1c) >9% allo screening;
    6. anamnesi di ipertensione scarsamente controllata definita da:
    a. pressione arteriosa sistolica =180 mm Hg o diastolica = 110 mm Hg alla visita di screening;
    b. pressione arteriosa sistolica da 160 mm Hg a 179 mm Hg o diastolica da 100 mm Hg a 109 mm Hg alla visita di screening E anamnesi di danno d’organo terminale (inclusa anamnesi di ipertrofia ventricolare sinistra, insufficienza cardiaca, angina, infarto miocardico, ictus, attacco ischemico transitorio, arteriopatia periferica, malattia renale allo stadio terminale e retinopatia da moderata ad avanzata);
    7. anamnesi nota di malformazione vascolare cerebrale;
    8. condizioni cardiovascolari come insufficienza cardiaca di classe III o IV secondo la classificazione della New York Heart Association (NYHA), cardiomiopatia, claudicazione intermittente, infarto miocardico o sindrome coronarica acuta entro 6 mesi prima dello screening; aritmia cardiaca ventricolare sintomatica;
    9. anamnesi di grave compromissione respiratoria che richiede somministrazione di ossigeno, supporto respiratorio (per es., pressione positiva su 2 livelli delle vie aeree (BiPAP) o pressione positiva continua delle vie aeree (CPAP)) o anamnesi di polmonite da aspirazione che richiede ricovero;
    10. uso pregresso nell’anno precedente e uso concomitante di bifosfonati;
    11. partecipazione simultanea a un altro studio clinico interventistico o a uno studio non interventistico con misurazioni radiografiche o procedure invasive (per es., prelievo di campioni di sangue o di tessuto);
    12. trattamento con un altro farmaco sperimentale, denosumab, imatinib o isotretinoina, entro 30 giorni o 5 emivite del farmaco sperimentale, a seconda di quale evento sia di maggiore durata;
    13. donne in stato di gravidanza o allattamento;
    14. donne in età fertile che non sono disposte a utilizzare metodi contraccettivi altamente efficaci;
    15. pazienti di sesso maschile con partner in età fertile che non sono disposti a utilizzare preservativi con le partner in età fertile per prevenire la potenziale esposizione del feto;
    Nota: si applicano altri criteri di esclusione definiti nel protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    1. Primary Efficacy Endpoint: The number of new HO lesions adjudicated
    as positive based on CT
    2. Primary Safety Endpoint: The incidence and severity of treatmentemergent adverse events of special interest (AESIs)
    1. Endpoint primario di efficacia: numero di nuove lesioni di OE ritenute positive in base alla TC.
    2. Endpoint primario di sicurezza: incidenza e gravità degli eventi avversi emergenti dal trattamento di speciale interesse (AESI).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Efficacy Endpoint: Week 56
    Primary Safety Endpoint: Baseline to 56 weeks
    Primary Efficacy Endpoint: Settimana 56.
    Endpoint primario di sicurezza: dal Basale alla Settimana 56
    E.5.2Secondary end point(s)
    1. Number of clinician-assessed flare-ups
    2. Occurrence of clinician-assessed flare-ups (Yes/No)
    3. Number of patient-reported flare-ups
    4. Occurrence of patient-reported flare-ups (Yes/No)
    5. Occurrence of new HO lesions adjudicated as positive based on CT (Yes/No)
    6. Total volume of new HO lesions adjudicated as positive based on CT
    7. Number of new HO lesions adjudicated as positive based on CT
    8. Change in joint function assessment by physician using cumulative
    analog joint involvement scale (CAJIS)
    9. Change in pulmonary function as assessed by spirometry
    10. Change in disease severity as assessed by the Patient's Global
    Impression of Severity (PGIS)
    11. Change in disease severity as assessed by the Patient's Global
    Impression of Change (PGIC)
    12. Change in disease severity as assessed by the Clinician's Global
    Impression of Change (CGIC)
    13. Concentration of total activin A in serum over time
    14. Concentrations of garetosmab in serum
    15. Immunogenicity of as measured by the presence of anti-drug
    antibodies (ADA) to garetosmab
    1. Numero di riacutizzazioni valutate dal medico
    2. Comparsa di riacutizzazioni valutate dal medico (Sì/No)
    3. Numero di riacutizzazioni segnalate dal paziente
    4. Comparsa di riacutizzazioni segnalate dal paziente (Sì/No)
    5. Comparsa di nuove lesioni di OE ritenute positive in base alla TC (Sì/No)
    6. Volume totale delle nuove lesioni di OE ritenute positive in base alla TC
    7. Numero di nuove lesioni di OE ritenute positive in base alla TC
    8. Variazione nella valutazione della funzione articolare eseguita dal medico utilizzando la Scala analogica cumulativa di coinvolgimento articolare (CAJIS)
    9. Variazione nella funzione polmonare valutata tramite spirometria
    10. Variazione nella gravità della malattia valutata in base al questionario Impressione globale di gravità riferita dal paziente (Scala PGI-S)
    11. Variazione nella gravità della malattia valutata in base al questionario Impressione globale di cambiamento riferita dal paziente (Scala PGI-C)
    12. Variazione nella gravità della malattia valutata in base al questionario Impressione globale di cambiamento riferita dal medico (Scala CGI-C)
    13. Concentrazione di attivina A totale nel siero nel corso del tempo
    14. Concentrazioni di garetosmab nel siero
    15. Immunogenicità misurata dalla presenza di anticorpi antifarmaco (ADA) verso garetosmab
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoint timeframes:
    1-6: Week 28 and 56
    7: Week 28
    8-12: Baseline to Week 28 and 56
    13-15 Baseline to Week 56
    Finestre temporali dell’endpoint secondario:
    1-6: Settimana 28 e 56
    7: Settimana 28
    8-12: dal Basale alla Settimana 28 e 56
    13-15: dal Basale alla Settimana 56
    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 No
    E.6.10Pharmacogenetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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 trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Brazil
    Canada
    Chile
    China
    Colombia
    Hong Kong
    Japan
    Korea, Democratic People's Republic of
    Korea, Republic of
    Malaysia
    Mexico
    South Africa
    United States
    Finland
    France
    Poland
    Netherlands
    Spain
    United Kingdom
    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
    The end of study is defined as the date the last patient completes the last study visit (follow-up phone call or remote visit at week 108), withdraws from the study, or is lost to follow-up (i.e., the study patient
    can no longer be contacted by the investigator).
    La fine dello studio è definita come la data il cui l’ultimo paziente completa l’ultima visita dello studio (telefonata di follow-up o visita da remoto alla settimana 108), si ritira dallo studio o viene perso al follow-up (ovvero lo sperimentatore non riesce più a contattare il paziente dello studio).
    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 months8
    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 months8
    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: 66
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 66
    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)
    Standard Treatment
    trattamento standard
    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 Decision2022-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-26
    P. End of Trial
    P.End of Trial StatusOngoing
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