Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.

    The EU Clinical Trials Register currently displays   41207   clinical trials with a EudraCT protocol, of which   6750   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2017-000087-15
    Sponsor's Protocol Code Number:BP39529
    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:2017-06-08
    Trial results View results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-000087-15
    A.3Full title of the trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants with Early Parkinson’s Disease with A 52-Week Blinded Extension (Pasadena)
    Un estudio para evaluar la eficacia de RO7046015 intravenosa (PRX002) en participantes con enfermedad de Parkinson temprana con una extensión ciega de 52 semanas (Pasadena)
    A.4.1Sponsor's protocol code numberBP39529
    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 SponsorF. Hoffmann-La Roche Ltd
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. 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.5.5Fax number34913257300
    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 nameaSyn Mab
    D.3.2Product code RO7046015
    D.3.4Pharmaceutical form Concentrate for 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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeRO7046015
    D.3.9.3Other descriptive namePRX002, ELT2, anti-alpha-synuclein monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate and solvent for solution 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
    Parkinson’s disease
    Enfermedad de Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease is a progressive disorder of the nervous system that affects movement
    La enfermedad de Parkinson es un trastorno progresivo del sistema nervioso que afecta al movimiento
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of RO7046015 versus placebo, in participants with early Parkinson’s disease (PD) (H&Y Stages I-II) who are untreated or treated with monoamine oxidase-B (MAO-B) inhibitors since baseline, as measured by change from baseline over 52 weeks on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Total Score (sum of Parts I, II and III)
    • Evaluar la eficacia del RO7046015 frente a placebo en participantes con enfermedad de Parkinson (EP) incipiente (estadios I-II de H-Y) que no han recibido tratamiento o tratados con inhibidores de la monoaminooxidasa B (MAO-B) desde el período inicial, determinada dicha eficacia mediante el cambio con respecto al período inicial durante 52 semanas de la puntuación total de la Escala Unificada de la enfermedad de Parkinson de la Sociedad de Trastornos del Movimiento (Movement Disorder Society-Unified Parkinson's Disease Rating Scale, MDS UPDRS) (suma de las partes I, II y III).
    E.2.2Secondary objectives of the trial
    •To evaluate the effects of RO7046015 versus placebo over 52 weeks, in participants with early PD (H&Y Stages I - II) who are untreated or treated with MAO-B inhibitors since baseline on the following:
    –Change from baseline in dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) signal in the ipsilateral putamen (ipsilateral to the clinically-dominant side).
    –Change from baseline in motor function assessed by the MDS-UPDRS motor subscale (Part III).
    –Change in overall PD-related symptoms using the following:
    o Clinical Global Impression of Improvement (CGI-I).
    o Patient Global Impression of Change (PGIC).
    –Time to start of dopaminergic symptomatic treatment
    •To evaluate the safety and tolerability of treatment with RO7046015 for up to 104 weeks, with or without concomitant dopaminergic treatment
    •To evaluate the immunogenicity of RO7046015
    •To describe the pharmacokinetics (PK) of RO7046015 using population PK modelling
    • Evaluar los efectos del RO7046015 en com con el placebo dur 52 sem en los participantes con EP incipiente (estadios I II de H-Y) q no han recibido tto o no tratados con inhi de la MAO-B dsd el período inicial:
    Cambio resp al valor inicial en el estudio de imágenes del transportador de dopamina en la señal de la tomografía computarizada de emisión monofotónica DaT-SPECT en el putamen homolateral resp al lado clínicamente dominante
    Cambio respecto al valor inicial de la función motora evaluada p la subescala motora de la MDS-UPDRS parte III.
    Cambio de los sínt totales relacionados con la EP:
    Impr clínica glob Esc de mejoría de la enfermedad, (CGI-I)
    oImpr global de cambio comunicada p el paciente (Patient Global Impression of Change, PGIC).
    oTpo hasta el inicio del tto sint. dopaminérgico.
    •Seg.y tolerabilidad del tto con RO7046015 durante un máximo de 104 s, con o sin tto dop conc.
    -Inmunogenia del RO7046015.
    (FC) del RO7046015 con un modelo de FC poblacional.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Idiopathic PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD untreated or treated with MAO-B inhibitor
    - Male or female, 40 to 80 years of age, body weight range of >=45 kg/99 lbs to =< 110 kg/242 lbs and a body mass index (BMI) of 18 to 34 kg/m2
    - A diagnosis of PD for 2 years or less at screening
    - H&Y Stage I or II.
    - A screening brain Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) consistent with PD (central reading)
    - Clinical status does not require dopaminergic PD medication and is not expected to require dopaminergic treatment within 52 weeks from baseline
    - If presently being treated for PD, a stable dose of MAO-B inhibitor (rasagiline
    or selegiline) for at least 90 days prior to baseline and not expected to change within 52 weeks
    - For women of childbearing potential: use of highly effective contraceptive methods (that result in a failure rate of <1% per year) during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug
    - For men: use of contraceptive measures as defined below:
    With female partners of childbearing potential or pregnant female partners, men must use a condom during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The female partners should use a contraception method with a failure rate of <1% per year during the treatment period and for at least 30 days (or longer if required by local regulations) after the last dose of study drug.
    -EP idiopática con bradicinesia más uno de los otros signos fundamentales de la EP (temblores en reposo o rigidez), sin ninguna otra causa comprobada o posible de la EP, no tratados o tratados con un inhibidor de la MAO-B.
    -Varones o mujeres de 40-80 años de edad, intervalo de peso corporal de  45 kg/99 lb a  110 kg/242 lbs y un índice de masa corporal (IMC) de 18 a 34 kg/m2.
    -Diagnóstico de enfermedad de Parkinson durante 2 años o menos en la selección.
    -Estadio I o II de H-Y.
    -DaT-SPECT cerebral en la selección en consonancia con la EP (lectura central).
    -Estado clínico que no requiere medicación dopaminérgica para la EP y no se espera que requiera tratamiento dopaminérgico en las 52 semanas posteriores al período inicial.
    -Si actualmente está en tratamiento para la EP, recibe una dosis estable de un inhibidor de la MAO-B (rasagilina o selegilina) durante al menos 90 días antes del período inicial y no se esperan cambios en 52 semanas.
    -Para las mujeres en edad fértil: uso de métodos anticonceptivos de gran eficacia (que dan lugar a una tasa de fracasos de 1 % al año) durante el período de tratamiento y durante al menos 30 días (o más, si así lo exige la normativa local) después de la última dosis del fármaco del estudio.
    -Para los varones: uso de medidas anticonceptivas, tal como se define a continuación:
    Con parejas femeninas en edad fértil o pareja embarazada, los varones deben utilizar un preservativo durante el período de tratamiento y durante al menos 30 días (o más, si así lo exige la normativa local) después de la última dosis del fármaco del estudio para evitar exponer el embrión. Los varones deben abstenerse de donar semen durante ese mismo período. Las parejas femeninas deben utilizar un método anticonceptivo con una tasa de fracaso 1 % al año durante el período de tratamiento y durante al menos 30 días (o más, si así lo exige la normativa local) después de la última dosis del fármaco del estudio
    E.4Principal exclusion criteria
    Current or Past Medical History:
    - Clinical signs or past medical history indicating a Parkinson syndrome other than idiopathic PD, including but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia.
    - Known carriers of certain familial PD genes (Parkin, PINK1, DJ1) (GBA, synuclein, LRRK2 mutation carriers are allowed).
    - History of PD related freezing episodes or falls.
    - A diagnosis of a significant CNS disease other than Parkinson’s disease; history of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child.
    - Mini Mental State Examination (MMSE) =< 25
    - Reside in a nursing home or assisted care facility.
    - History of or screening brain MRI scan indicative of clinically significant abnormality
    - Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study or interfere with the participant’s ability to comply with study procedures or abide by study restrictions, or with the ability to interpret safety data:
    - Autoimmune disease
    - A history of cancer
    - Any active infectious disease.
    - Current, or history of, alcohol or drug abuse or dependence
    - Any major illness
    - Any current psychiatric diagnosis
    - The following cardiovascular conditions:
    - Myocardial infarction
    - Confirmed hypotension
    - Uncontrolled hypertension:
    - Resting pulse rate (PR) greater than 100 or less than 45 bpm.
    - Clinically significant cardiovascular disease
    - Clinically significant abnormalities in lab tests results
    - Lactating women
    Medications and treatments:
    - Prior treatment with dopaminergic medication (e.g., levodopa or a dopaminergic agonist) with no clinical treatment response or a clinical treatment response inconsistent with PD.
    - Use of any of the following: catechol-O-methyl transferase (COMT) inhibitors (entacapone, tolcapone), amantadine or anticholinergics, or dopaminergic medication (levodopa and both ergot and non-ergot [pramipexole, ropinirole, rotigotine] dopamine agonists) for more than a total of 60 days or within 60 days of baseline.
    - Anti-epileptic medication for non seizure related treatment which has not remained stable for at least 60 days prior to baseline
    - Anti-depressant or anxiolytic use that has not remained stable for at least 90 days prior to baseline
    - Use of any of the following within 90 days prior to baseline; neuroleptics, metoclopramide, alpha methyldopa, clozapine, olanzapine, flunarizine, amoxapine, amphetamine derivatives, reserpine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, and modafinil.
    - Participated in an investigational drug or device study including prior treatment of PD involving intracranial surgery or implantation of a device
    - Any prior treatment with an investigational PD-related vaccine
    - Prior participation in any RO7046015 or PRX002 study.
    - Receipt of an investigational product or device, or participation in a drug research study within a period of 30 days (or 5 half-lives of the drug, whichever is longer) before baseline
    - Receipt of a monoclonal antibody or an investigational immunomodulator within 180 days (or 5 half-lives, whichever is longer) before baseline
    - Systemic corticosteroids or other immunomodulating drugs within 30 days prior to baseline
    - Allergy to any of the components of RO7046015 or a known hypersensitivity or an IRR to the administration of any other monoclonal antibody

    - Any contraindications to obtaining a brain MRI
    - For participants consenting to provide optional CSF samples by lumbar puncture (LP): LP will only be performed if the participant does not have any contraindication to undergoing an LP
    - Donation of blood over 500 mL within three months prior to screening
    Historial médico actual o pasado:
    -Signos clínicos o antecedentes médicos pasados que indiquen un síndrome de -Parkinson que no sea una EP idiopática, incluidos, entre otros, la parálisis supranuclear progresiva de la mirada, la atrofia multisistémica, el parkinsonismo inducido por medicamentos, el temblor esencial y la distonía primaria
    -Portadores conocidos de determinados genes de EP familiar (Parkin, PINK1, DJ1) (se permiten los portadores de mutaciones GBA, sinucleína o LRRK2).
    -Antecedentes de episodios de congelación o caídas relacionados con la EP
    -Diagnóstico de una importante afectación del SNC distinta de la enfermedad de Parkinson,antecedentes de traumatismos craneales repetidos; antecedentes de epilepsia o trastornos convulsivos distintos de las convulsiones febriles en la infancia.
    -Miniexamen del estado mental (MMSE) =< 25.
    -Residen en una residencia o centro de asistidos.
    -Antecedentes de o RM cerebral de selección indicativos de anomalía clínicamente significativa
    -Enfermedad o afección concomitante en los 6 meses previos a la selección, o tal y como se especifica a continuación, que pudiera interferir con la realización del estudio o un tratamiento que pudiera interferir con la realización del estudio, o que, en opinión del investigador, suponga un riesgo inaceptable para el participante en este estudio o que interfiera con la capacidad del participante para cumplir con los procedimientos del estudio o acatar las restricciones del estudio,o con la capacidad de interpretar los datos de seguridad, incluidos, entre otros
    Una enfermedad autoinmunitaria
    Antecedentes de cáncer
    Cualquier enfermedad infecciosa activa
    Consumo actual o antecedentes de consumo de alcohol o abuso o dependencia de sustancias
    Cualquier enfermedad grave
    Cualquier diagnóstico psiquiátrico
    Presencia de alguna de las siguientes enfermedades cardiovasculares:
    -Infarto de miocardio
    -Hipotensión confirmada
    -Hipertensión no controlada
    -Frecuencia del pulso en reposo (FP) mayor de 100 o menor de 45 lpm.
    -Enfermedad cardiovascular clínicamente significativa
    -Anomalías clínicamente significativas en los resultados de las pruebas analíticas
    -Mujeres en período de lactancia
    Medicacion y tratamiento:
    -Tratamiento previo con medicación dopaminérgica (p. ej., levodopa o un agonista dopaminérgico) sin respuesta clínica o respuesta clínica al tratamiento que no concuerda con la EP.
    -Uso de cualquiera de los siguientes: inhibidores de la catecol-o-metil transferasa (COMT) (entacapona o tolcapona), amantadina o anticolinérgicos o medicamentos dopaminérgicos (levodopa y agonistas dopaminérgicos tanto alcaloides del cornezuelo de centeno como otros no derivados del cornezuelo de centeno [pramipexol, ropinirol o rotigotina]) durante más de un total de 60 días o en los 60 días previos al período inicial
    -Medicación antiepiléptica para un tratamiento no relacionado con convulsiones, que no se ha mantenido estable durante al menos 60 días antes del período inicial.
    -Uso de antidepresivos o ansiolíticos que no se han mantenido estables durante al menos 90 días antes del período inicial
    -Uso de cualquiera de los siguientes fármacos en los 90 días anteriores al período inicial: neurolépticos, metoclopramida, alfa metildopa, clozapina, olanzapina, flunarizina, amoxapina, derivados de anfetaminas, reserpina, bupropión, buspirona, cocaína, mazindol, metanfetamina, metilfenidato, norefedrina, fentermina, fenilpropanolamina y modafinilo.
    -Participación en un estudio con un fármaco o un dispositivo en fase de investigación, incluido el tratamiento previo de la EP con cirugía intracraneal o la implantación de un dispositivo
    -Cualquier tratamiento previo con una vacuna relacionada con la EP en fase de investigación.
    -Participación previa en cualquier estudio de RO7046015 o PRX002.
    -Recepción de un producto o dispositivo en investigación, o participación en un estudio de investigación de un fármaco en un plazo de 30 días (o 5 semividas del fármaco, el período más largo entre ambos) anteriores al período inicial.
    -Recepción de un anticuerpo monoclonal o un inmunomodulador en fase de investigación clínica en un plazo de 180 días (o 5 semividas, el período más largo entre ambos) anteriores al período inicial
    -Corticoesteroides sistémicos u otros fármacos inmunomoduladores en los 30 días anteriores al período inicial.
    -Alergia a alguno de los componentes del RO7046015 o hipersensibilidad conocida o una reacción relacionada con la infusión (RRI)a la administración de cualquier otro anticuerpo monoclonal.
    -Cualquier contraindicación para la obtención de la RM cerebral
    -Para los participantes que den su consentimiento para proporcionar muestras opcionales de LCR mediante punción lumbar (PL): la PL se realizará únicamente si el participante no presenta ninguna contraindicación para someterse a una PL
    -Donación de sangre mayor de 500 ml en los tres meses anteriores a la selección
    E.5 End points
    E.5.1Primary end point(s)
    1. Change in total MDS-UPDRS score (sum of Parts I, II and III) from baseline over 52 weeks of treatment with RO7046015 or placebo.
    1 Cambio en la puntuación total de la MDS-UPDRS (suma de partes I, II y III) respecto al período inicial durante 52 semanas de tratamiento con RO7046015 o placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline and Week 52
    1. Baseline y semana 52
    E.5.2Secondary end point(s)
    1. DaT-SPECT change from baseline in ipsilateral (to the clinically dominant side) putamen binding ratio values
    2. Change from baseline in MDS-UPDRS Parts III
    3. Clinical Global Impression of Improvement (CGI-I) by visit
    4. Patient Global Impression of Change (PGIC) by visit
    5. Time to start of dopaminergic symptomatic treatment
    6. Incidence and severity of adverse events (AEs) and serious AEs (SAEs)
    7. Incidence of Anti-drug antibodies (ADAs)
    8. Population and individual primary PK parameter estimations
    .1.Cambio en los valores de la relación de unión en el putamen homolateral (respecto al lado clínicamente dominante) en la DaT-SPECT respecto al período inicial
    2.Cambio respecto al período inicial en la parte III de la MDS-UPDRS3.
    3. Impresión Clínica Global de Mejora (CGI-I) por visita
    4. Impresión global del cambio por el paciente (PGIC) por visita.
    5.Tiempo hasta el inicio del tratamiento sintomático dopaminérgico
    6. Incidencia y gravedad de los eventos adversos (EA) y AE graves (EAE)
    7. Incidencia de anticuerpos anti-fármacos (ADA)
    8. Estimaciones de parámetros poblacionales y PK primarios individuales
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline and Week 52
    2. Baseline and Week 52
    3. Baseline, Week 24 and Week 52
    4. Baseline, Week 24 and Week 52
    5. From Baseline to Week 52
    6. From Baseline to Week 52 and to Week 104
    7. Baseline, Week 4, 20, 36, 52, 56, 68, 80 and Week 104
    8. Day 7, Day 14, Weeks 4, 20, 36, 52, 56, 68, 80 and 104
    .1.Baseline y Semana 52
    2. Baseline y Semana 52
    3. Baseline, Semana 24 y Semana 52
    4. Baseline, Semana 24 y Semana 52
    5. Baseline a la semana 52
    6. Desde Baseline hasta la semana 52 y hasta la semana 104
    7 Baseline, Semana 4, 20, 36, 52, 56, 68, 80 y Semana 104
    8. Día 7, Día 14, Semanas 4, 20, 36, 52, 56, 68, 80 y 104
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    -Evaluate the immunogenicity of RO7046015
    - To evaluate clinical and biomarker outcomes
    -Evaluar la inmunogenicidad de RO7046015
    - Evaluar los resultados clínicos y biomarcadores
    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. 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) 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    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 at the follow-up visit. LPLO is expected to occur up to 116 weeks after the last participant is enrolled, or after the 52-week primary analysis or earlier in the case that the study is discontinued following any of the planned interim analyses.
    El final del estudio se define como la fecha en la cual se obtiene la última observación del último participante (UOUP) en la visita de seguimiento. Se prevé que la UOUP se produzca hasta un máximo de 116 semanas después de la inclusión del último participante o después del análisis principal de la semana 52 o antes, si el estudio se suspende después de cualquiera de los análisis intermedios previstos.
    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 months5
    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 months5
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    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 post-trial access to the study drug, RO7046015 (after completion of either the 52-week placebo-controlled period or the 52-week allparticipants- on-treatment extension).
    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 Decision2017-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-07
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice