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    Summary
    EudraCT Number:2021-003756-16
    Sponsor's Protocol Code Number:BP43445
    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:2021-12-28
    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 number2021-003756-16
    A.3Full title of the trial
    A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE MASKED, ACTIVE COMPARATORCONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 ADMINISTERED INTRAVITREALLY IN PATIENTS WITH DIABETIC MACULAR EDEMA
    ESTUDIO DE FASE II, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO CONTROLADO CON TRATAMIENTO ACTIVO PARA INVESTIGAR LA EFICACIA, SEGURIDAD,
    TOLERABILIDAD, FARMACOCINÉTICA Y FARMACODINÁMICA DE RO7200220 ADMINISTRADO POR VÍA INTRAVÍTREA EN PACIENTES CON EDEMA MACULAR DIABÉTICO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients with Diabetic Macular Edema
    Estudio para investigar la eficacia, seguridad, tolerabilidad, farmacocinética y farmacodinamia de RO7200220 administrado por vía intravítrea en pacientes con edema macular diabético
    A.4.1Sponsor's protocol code numberBP43445
    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 SponsorRoche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    B.5.5Fax number+34913248196
    B.5.6E-mailspain.start_up_unit@roche.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 nameAnti IL-6
    D.3.2Product code RO7200220
    D.3.4Pharmaceutical form Solution for injection in vial
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnti-IL6
    D.3.9.3Other descriptive nameRO7200220, EBI-031
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Lucentis
    D.2.1.1.2Name of the Marketing Authorisation holderGenentech Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLucentis
    D.3.2Product code RO4893594
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLucentis
    D.3.9.1CAS number 347396-82-1
    D.3.9.3Other descriptive nameRanibizumab
    D.3.9.4EV Substance CodeSUB22314
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic Macular Edema (DME)
    Edema Macular Diabético (EMD)
    E.1.1.1Medical condition in easily understood language
    DME is an accumulation of fluid in the macula, the part of the retina that controls our most detailed vision abilities-due to leaking blood vessels
    El EMD es una acumulación de fluido en la mácula, la parte de la retina que controla nuestra capacidad de visión más detallada debido a la filtración de los vasos sanguíneos
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10057934
    E.1.2Term Diabetic macular edema
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To investigate the effect of RO7200220 on best corrected visual acuity (BCVA)
    • Investigar el efecto de RO7200220 sobre la mejor agudeza visual corregida (MAVC)
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of RO7200220
    • To investigate the effect of RO7200220 on additional BCVA outcomes
    • To investigate the effect of RO7200220 on anatomical outcome measures using spectral domain optical coherence tomography (SD-OCT)
    • Evaluar la seguridad y la tolerabilidad de RO7200220
    • Investigar el efecto de RO7200220 sobre otros criterios de valoración relacionados con la MAVC
    • Investigar el efecto de RO7200220 de acuerdo con los criterios de valoración anatómicos mediante tomografía de coherencia óptica en el dominio espectral (SDOCT)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >= 18 years
    • Diagnosis of diabetes mellitus (DM; Type 1 or Type 2)
    • Agrees to use protocol defined methods of contraception
    • Macular edema associated with diabetic retinopathy (DR) with CST of ≥ 325 µm with Spectralis®
    • Decreased visual acuity (VA) attributable primarily to DME, with BCVA letter score of 73 to 19 letters on ETDRS-like charts at screening.
    • Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis
    • Edad >= 18 años
    • Diagnóstico de diabetes mellitus (DM tipo 1 o 2)
    • Acuerdo para usar los métodos anticonceptivos definidos en el protocolo
    • Edema macular asociado a retinopatia diabética (RD)con CST≥ 325 µm con Spectralis®
    • Disminución de la agudeza visual (AV) atribuible principalmente al EMD, con una puntuación de letras de la MAVC de 73 a 19 letras en los optotipos de tipo ETDRS durante la selección
    • Medios oculares transparentes y dilatación pupilar adecuada para permitir la obtención de imágenes retinianas de buena calidad con el fin de confirmar el diagnóstico.
    E.4Principal exclusion criteria
    • Any major illness or major surgical procedure within 4 weeks prior to Day 1
    • Any febrile illness within 1 week prior to screening or Day 1
    • Any stroke or myocardial infarction within 24 weeks prior to Day 1
    • Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis within 24 weeks prior to Day 1 or anticipated to require hemodialysis or peritoneal dialysis at any time during the study
    • Active malignancy within 1 year of screening except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of < 6 and a stable prostate-specific antigen (PSA) for > 1 year
    • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of either of the Investigational Medicinal Products (IMPs) or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the Investigator
    • Any known hypersensitivity to any of the following compounds: fluorescein, biologic IVT agents such as Lucentis® (ranibizumab), Eylea® (aflibercept), Avastin®(bevacizumab), any ingredient of the formulation used, dilating eye drops, or any anesthetics and microbial drops used
    • Evidence of HIV infection and/or positive human HIV antibodies; evidence of syphilis or tuberculosis and/or positive assay
    •Prior or concomitant periocular or IVT corticosteroids in the study eye (Triamcinolone, Ozurdex®: 16 weeks prior Day 1, Iluvien® or Retisert®: 3 years prior Day1)
    • Prior or concomitant IVT anti-VEGF in the study eye (Lucentis®, Eylea®, Avastin®: 8 weeks prior Day 1)
    • Any previous or concomitant systemic corticosteroids within 4 weeks prior to Day 1
    • Any previous or concomitant systemic anti-VEGF treatment within 24 weeks prior to Day 1
    • Any previous or concomitant use of systemic anti-IL-6 or anti-IL-6-receptor treatment
    • Any concurrent use of biologics for immune-related diseases
    • Participants who are currently enrolled or have participated in any other clinical study 12 weeks prior Day 1 (faricimab: last IVT injection within 1 year prior Day1; brolucizumab: ever)
    • Uncontrolled blood pressure (BP), defined as systolic >180 mmHG and/or diastolic >100 mmHg.
    • Participants with HbA1c > 12% at screening
    • Any proliferative DR
    • Any panretinal photocoagulation prior to Day 1
    • Macular (focal, grid, or micropulse) laser treatment prior to Day 1
    • History of vitreoretinal surgery/pars plana vitrectomy, including PDS with ranibizumab implant/explant surgery
    • Any cataract surgery within 12 weeks prior to Day 1 or any planned surgery during the study
    • History of any glaucoma surgery
    • Uncontrolled glaucoma
    • History of rubeosis iridis
    • Any concurrent ocular conditions that, in the opinion of the Investigator require medical or surgical intervention during the study, likely contribute to worsening of BCVA or preclude any visual improvement.
    • Rhegmatogenous or tractional retinal detachment, pre-retinal and/or sub-macular fibrosis, vitreomacular traction, foveal hard exudates, or epiretinal membrane involving the fovea or disrupting the macular architecture, as evaluated by the Central Reading Center (CRC)
    • Actual or history of myopia > -8 diopters
    • Any active ocular or periocular infection on Day 1
    • Any presence of active intraocular inflammation on Day 1 or any history of intraocular inflammation
    • Non-functioning non-study eye
    • Enfermedad o intervención quirúrgica importante en las 4 semanas previas al día 1
    • Una enfermedad febril en la semana previa a la selección o el día 1
    • Accidente cerebrovascular o infarto de miocardio en las 24 semanas previas al día 1
    • Insuficiencia renal que requiera trasplante renal, hemodiálisis o diálisis peritoneal en las 24 semanas previas al día 1 o posible necesidad de hemodiálisis o diálisis peritoneal en cualquier momento del estudio
    • Neoplasia maligna activa en el último año antes de la selección, excepto carcinoma in situ del cuello uterino debidamente tratado, carcinoma de piel distinto del melanoma y cáncer de próstata con una puntuación de Gleason < 6 y un antígeno prostático específico que se mantenga estable durante > 1 año
    • Antecedentes de otra enfermedad, disfunción metabólica, hallazgo en la exploración física o resultado analítico que suscite sospechas razonables de un trastorno que contraindique el uso de alguno de los medicamentos en investigación o que pueda afectar a la interpretación de los resultados del estudio o que suponga un riesgo elevado de complicaciones del tratamiento para el participante, según el criterio del investigador.
    • Hipersensibilidad conocida a alguno de los siguientes compuestos: fluoresceína, biofármacos IVT como Lucentis® (ranibizumab), Eylea® (aflibercept), Avastin® (bevacizumab), algún componente de la formulación utilizada, colirio dilatador o algún anestésico y colirio microbiano utilizado
    • Signos de infección por VIH o anticuerpos positivos contra el VIH; signos de sífilis o tuberculosis o análisis positivo
    •Corticosteroides perioculares o IVT previos o concomitantes en el ojo evaluado: (Triamcinolona, Ozurdex®: 16 semanas previas al día 1, Iluvien® o Retisert®: en los 3 años previos al dia 1)
    • Tratamiento anti-VEGF IVT anterior o concomitante en el ojo evaluado (Lucentis®, Eylea®, Avastin®: en las 8 semanas anteriores al día 1)
    • Cualquier corticoesteroide sistémico anterior o concomitante en las 4 semanas anteriores al día 1
    • Cualquier tratamiento anti-VEGF sistémico previo o concomitante durante las 24 semanas anteriores al día 1
    • Uso previo o concomitante de tratamiento sistémico anti-IL-6 o antirreceptor de la IL-6
    • Uso concomitante de biofármacos para enfermedades inmunomediadas
    • Participantes que estén participando o hayan participado en otro estudio clínico 12 semanas antes del día 1 (faricimab: con la última inyección IVT ≤ 1 año antes del día 1; brolucizumab: nunca)
    • Presión arterial (PA) no controlada, definida como sistólica > 180 mm Hg o diastólica > 100 mm Hg
    • Participantes con HbA1c > 12% en la selección
    • Cualquier RD proliferativa
    • Cualquier fotocoagulación panretiniana antes del día 1
    • Tratamiento con láser macular (focal, en rejilla o micropulso) antes del día 1
    • Antecedentes de cirugía vitreorretiniana/vitrectomía pars plana, incluida cirugía de implante/explante de PDS con ranibizumab.
    • Intervención de cataratas en las 12 semanas previas al día 1 o intervención quirúrgica programada durante el estudio
    • Antecedentes de intervención quirúrgica de glaucoma
    • Glaucoma no controlado
    • Antecedentes de rubeosis del iris
    • Cualquier enfermedad ocular concomitante que en opinión del investigador pudiera requerir intervención médica o quirúrgica durante el período del estudio, contribuir al empeoramiento de la MAVC o impedir cualquier mejora visual
    • Desprendimiento de retina regmatógeno o por tracción, fibrosis prerretiniana o submacular, tracción vitreomacular, exudados duros de la fóvea o membrana epirretiniana con afectación de la fóvea o alteración de la arquitectura macular, según la evaluación del Centro de Interpretación Central (CRC)
    • Presencia o antecedentes de miopía superior a -8 dioptrías
    • Infección ocular o periocular activa el día 1
    • Presencia de inflamación intraocular activa el día o antecedentes de inflamación intraocular
    • Ojo no evaluado no funcional
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from baseline in BCVA averaged over Week 20 and Week 24 in treatment-naïve participants
    1. Variación con respecto al momento basal de la MAVC promediada durante las semanas 20 y 24 en participantes no tratados previamente
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline to Week 20 and Week 24
    1. En el momento basal hasta las semanas 20 y 24
    E.5.2Secondary end point(s)
    1. Incidence, severity, and nature of adverse events (ocular and systemic)
    2. Incidence of abnormal laboratory findings, abnormal vital signs and electrocardiogram (ECG) parameters
    3. Incidence of abnormalities recorded in standard ophthalmological assessments (local safety and tolerability)
    4. Change from baseline in BCVA averaged over Week 20 and Week 24 in previously treated participants and the overall enrolled population
    5. Change from baseline in BCVA over time
    6. Proportion of participants gaining ≥ 15, ≥ 10, ≥ 5, or ≥ 0 letters in BCVA from baseline over time
    7. Proportion of patients avoiding a loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 letters in BCVA from baseline over time
    8. Proportion of participants with BCVA ≥ 69 letters (20/40 Snellen equivalent), or ≥ 84 letters (20/20 Snellen equivalent) over time
    9. Proportion of participants with BCVA of ≤38 letters (Snellen equivalent 20/200) over time
    10. Change from baseline in Central Subfield Thickness (CST) at Week 24
    11. Change from baseline in CST over time
    12. Proportion of participants with absence of DME (CST <325 μm for Spectralis SD-OCT, or <315 μm for Cirrus SD-OCT or Topcon SDOCT) over time
    13. Proportion of participants with absence of intraretinal fluid and/or subretinal fluid over time
    1. Incidencia, intensidad y naturaleza de los acontecimientos adversos (oculares y sistémicos).
    2. Incidencia de anomalías analíticas, constantes vitales anómalas y parámetros electrocardiográficos (ECG).
    3. Incidencia de anomalías registradas en evaluaciones oftalmológicas habituales (seguridad y tolerabilidad locales).
    4. Variación con respecto al momento basal de la MAVC promediada durante las semanas 20 y 24 en los participantes tratados previamente y en la población total incluida
    5. Variación con respecto al inicio de la MAVC a lo largo del tiempo
    6. Proporción de participantes con mejora ≥ 15, ≥ 10, ≥ 5 o ≥ 0 letras en la MAVC con respecto al valor basal a lo largo del tiempo
    7. Proporción de pacientes en los que se evita una pérdida ≥ 15, ≥ 10, ≥ 5 o ≥ 0 letras en la MAVC con respecto al valor basal a lo largo del tiempo
    8. Proporción de participantes con una MAVC ≥ 69 letras (20/40 equivalente de Snellen) o ≥ 84 letras (20/20 equivalente de Snellen) a lo largo del tiempo
    9. Proporción de participantes con una MAVC ≤ 38 letras (equivalente de Snellen 20/200) a lo largo del tiempo
    10. Variación del grosor del subcampo central (CST) macular entre el momento basal y la semana 24
    11. Variación del CSTcon respecto al momento basal a lo largo del tiempo
    12. Proporción de participantes con ausencia de EMD (CST < 325 μm para SD-OCT Spectralis o < 315 μm para SD-OCT Cirrus o SD-OCT Topcon) a lo largo del tiempo
    13. Proporción de participantes con ausencia de líquido intrarretiniano o subretiniano a lo largo del tiempo
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. Up to Week 48
    4. Baseline to Week 20 and Week 24
    5-9. Baseline to Week 48
    10. Baseline to Week 24
    11-13. Baseline to Week 48
    1-3. Hasta la semana 48
    4. Momento basal hasta la semana 20 y 24
    5-9. Momento basal hasta la semana 48
    10. Momento basal hasta la semana 24
    11-13. Momento basal hasta la semana 48
    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 No
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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 No
    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) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Argentina
    Canada
    Czechia
    Hungary
    Israel
    Korea, Republic of
    Poland
    Spain
    United Kingdom
    United States
    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
    The end of the study is defined as the date when the last participant, last observation (LPLO) occurs.
    El final del estudio se define como la fecha en que se produce el último participante, última observación (LPLO).
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days15
    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: 192
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 128
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 89
    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)
    The Sponsor does not intend to provide RO7200220 or other study interventions to participants after conclusion of the study or any earlier participant withdrawal.
    El Promotor no tiene la intención de proporcionar RO7200220 u otras intervenciones del estudio a los participantes después de la finalización del estudio o de cualquier retirada anticipada del participante.
    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 Decision2022-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-01
    P. End of Trial
    P.End of Trial StatusOngoing
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