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    Summary
    EudraCT Number:2022-000880-40
    Sponsor's Protocol Code Number:R2477-FOP-2175
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-13
    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 ConcernedSpain - AEMPS
    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
    Estudio en fase III, aleatorizado y controlado con placebo para evaluar la seguridad, la tolerabilidad y la eficacia de garetosmab en pacientes con fibrodisplasia osificante progresiva
    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)
    Estudio de la seguridad y eficacia de garetosmab en comparación con un placebo por vía intravenosa (i.v.) en participantes adultos con fibrodisplasia osificante progresiva (FOP)
    A.3.2Name or abbreviated title of the trial where available
    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.5.6E-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 Solution for 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 Solution for 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 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 osificante progresiva
    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.
    Enfermedad genética rara que provoca la formación anómala de hueso en ubicaciones inusuales, como los músculos, tendones y ligamentos.
    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.
    El objetivo de eficacia principal de este estudio es evaluar el efecto del garetosmab en dosis alta y compararla con la del placebo en cuanto a la formación de nuevas lesiones por osificación heterotópica (OH) entre el inicio y la semana 56, que se determinará mediante tomografía computarizada (TC) de dosis baja.

    El objetivo de seguridad principal de este estudio es evaluar la seguridad y la tolerabilidad del garetosmab y compararlas con las del placebo entre el inicio y la semana 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
    • Evaluar el efecto del garetosmab en dosis alta en comparación con el del placebo en cuanto al número de episodios de reagudización evaluada por el profesional sanitario por cada paciente hasta la semana 56.

    • Evaluar el efecto del garetosmab en dosis baja en comparación con el del placebo en cuanto a la formación de nuevas lesiones por OH entre el inicio y la semana 56, según la determinación mediante TC.

    • Evaluar el efecto del garetosmab en dosis baja en comparación con el del placebo en cuanto al número de episodios de reagudización evaluada por el profesional sanitario por cada paciente hasta la semana 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. Hombre o mujer de al menos 18 años en el momento de la selección
    2. Diagnóstico clínico de fibrodisplasia osificante progresiva (FOP) (basado en la detección de malformaciones congénitas en los dedos gordos de los pies, hinchazón episódica del tejido blando u osificación heterotópica [OH] progresiva)
    3. Confirmación del diagnóstico de FOP con detección documentada de mutación del gen del receptor de la activina A de tipo I (ACVR1) que causa FOP
    4. FOP activa en el último año antes de la visita de selección. Se considera que la FOP está activa cuando se produce dolor, hinchazón, rigidez u otros signos y síntomas asociados con los brotes de la FOP; o bien empeoramiento del funcionamiento articular o progresión en radiografías de las lesiones de la OH (aumento de las mismas en tamaño o número), con o sin vinculación con los brotes
    5. Disposición y capacidad para someterse a pruebas de diagnóstico por la imagen de tipo TAC y otros procedimientos definidos en el protocolo

    Se aplican otros criterios de inclusión definidos en el protocolo
    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
    Criterios de exclusión fundamentales:
    1. Puntuación >19 en la escala analógica acumulativa de afectación articular (CAJIS) en la selección
    2. El participante padece o ha padecido en el pasado otra enfermedad significativa (por ejemplo, entre otras, enfermedades cardíacas, renales, reumatológicas, neurológicas, psiquiátricas, endocrinas, metabólicas o linfáticas) que, en opinión del investigador del estudio, puede confundir los resultados del estudio o incrementar el riesgo que implica participar en el estudio
    3. Antecedentes o diagnóstico de cáncer
    4. Importante afectación del funcionamiento renal, que se define como una tasa de filtración glomerular estimada de <30 mililitros por minuto (ml/min) (/1,73 m2 calculada mediante la ecuación de modificación de la dieta en la enfermedad renal)
    5. Diabetes sin controlar, que se define como un valor de hemoglobina A1C (HbA1c) de >9 % en la selección
    6. Antecedentes de hipertensión mal controlada, que se define como:
    a. Presión arterial sistólica de ≥180 mm Hg o presión arterial diastólica de ≥110 mm Hg en la visita de selección
    b. Presión arterial sistólica de entre 160 y 179 mm Hg o presión arterial diastólica de entre 100 y 109 mm Hg en la visita de selección Y antecedentes de daño orgánico específico (incluidos los antecedentes de hipertrofia del ventrículo izquierdo, fallo cardíaco, angina, infarto de miocardio, accidente cerebrovascular, ataque isquémico transitorio, enfermedad arterial periférica, insuficiencia renal terminal y retinopatía entre moderada y avanzada)
    7. Antecedentes conocidos de malformación vascular cerebral
    8. Patologías cardiovasculares, como fallo cardíaco de clase III o IV conforme a la New York Heart Association, miocardiopatía, claudicación intermitente, infarto de miocardio o síndrome coronario agudo en los 6 meses previos a la selección, y arritmia cardíaca ventricular sintomática
    9. Antecedentes de problemas respiratorios graves que hayan requerido oxígeno o respiración asistida (p. ej., presión positiva binivel en las vías respiratorias [biPAP] o presión positiva continua en las vías respiratorias [CPAP]), o antecedentes de neumonía por aspiración que haya requerido hospitalización
    10. Uso previo en el último año y uso concomitante de bifosfonatos
    11. Participación concomitante en otro estudio clínico intervencionista o un estudio no intervencionista con mediciones radiográficas o procedimientos invasivos (p. ej., toma de muestras de sangre o tejido)
    12. Tratamiento con otro fármaco en investigación, denosumab, imatinib o isotretinoína en los últimos 30 días o en el plazo de 5 semividas del fármaco de investigación, lo que suponga más tiempo
    13. Embarazo o lactación en la mujer
    14. Capacidad de concebir de la mujer* si no existe disposición por su parte para utilizar un método anticonceptivo muy eficaz
    15. Capacidad de concebir de la pareja del paciente de sexo masculino* si no existe disposición por parte de este para utilizar preservativos en las relaciones con su pareja a fin de evitar la posible exposición del feto

    Nota: Se aplican otros criterios de exclusión definidos en el protocolo
    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 treatment-emergent adverse events of special interest (AESIs)
    1. Criterio principal de valoración de la eficacia: el número de lesiones nuevas por OH confirmadas como positivas mediante TC en la semana 56.

    2. Criterio principal de valoración de la seguridad: incidencia y la intensidad de acontecimientos adversos de interés especial (AAIE) surgidos durante el tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Efficacy Endpoint: Week 56
    Primary Safety Endpoint: Baseline to 56 weeks
    Criterio principal de valoración de la eficacia: semana 56.
    Criterio principal de valoración de la seguridad: desde el inicio a la semana 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. Número de brotes valorados por un facultativo
    2. Aparición de brotes valorados por un facultativo (Sí/No)
    3. Número de brotes notificados por el paciente
    4. Aparición de brotes notificados por el paciente (Sí/No)
    5. Aparición de nuevas lesiones de OH calificadas como positivas conforme a un TAC (Sí/No)
    6. Volumen total de nuevas lesiones de OH calificadas como positivas conforme a un TAC
    7. Número de nuevas lesiones de OH calificadas como positivas conforme a un TAC
    8. Cambio en la valoración del funcionamiento articular por parte del facultativo utilizando la escala analógica acumulativa de implicación articular (CAJIS)
    9. Cambio en el funcionamiento pulmonar valorado mediante espirometría
    10. Cambio en la gravedad de la enfermedad valorado mediante el cuestionario Impresión global del paciente sobre la gravedad (PGIS)
    11. Cambio en la gravedad de la enfermedad valorado mediante el cuestionario Impresión global del paciente sobre el cambio (PGIC)
    12. Cambio en la gravedad de la enfermedad valorado mediante el cuestionario Impresión global del facultativo sobre el cambio (CGIC)
    13. Concentración de activina A total en suero a lo largo del tiempo
    14. Concentraciones de garetosmab en suero
    15. Inmunogenicidad determinada por la presencia de anticuerpos antifármaco (AAF) contra 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
    Calendario de los criterios secundarios de valoración:
    1-6: Semanas 28 y 56
    7: Semana 28
    8-12: Del inicio a las semanas 28 y 56
    13-15 Del inicio a la semana 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenicidad
    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.8.5The 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 No
    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
    Malaysia
    Mexico
    South Africa
    United States
    Finland
    France
    Poland
    Netherlands
    Spain
    Italy
    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).
    El final del estudio se define como la fecha en que el último paciente realice la última visita del estudio (llamada telefónica de seguimiento o visita remota en la semana 108), se retire del estudio o deje de estar disponible para el seguimiento (es decir, el investigador ya no puede contactar con él).
    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
    Tratamiento de referencia
    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 Decision2022-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-26
    P. End of Trial
    P.End of Trial StatusOngoing
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