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    Summary
    EudraCT Number:2022-003107-15
    Sponsor's Protocol Code Number:D9185C00001
    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:2022-10-28
    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 number2022-003107-15
    A.3Full title of the trial
    A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA).
    Ensayo multicéntrico Fase III, aleatorizado, doble-ciego, de grupos paralelos y controlado frente a placebo, para evaluar la eficacia y seguridad de tozorakimab (MEDI3506) en pacientes hospitalizados por infección pulmonar vírica que requieren oxigenoterapia (TILIA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA).
    Eficacia y seguridad de tozorakimab en pacientes hospitalizados por infección pulmonar vírica que requieren oxigenoterapia (TILIA)
    A.4.1Sponsor's protocol code numberD9185C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressSerrano Galvache, 56; Parque Norte, Edificio Álamo
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900200444
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.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 nametozorakimab
    D.3.2Product code MEDI3506
    D.3.4Pharmaceutical form Solution for injection
    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 INNtozorakimab
    D.3.9.1CAS number 2376858-66-9
    D.3.9.2Current sponsor codeMEDI3506
    D.3.9.3Other descriptive namehuman immunoglobulin (Ig) G1 monoclonal antibody (mAb)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 injection
    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
    Severe viral lung infections
    Infecciones pulmonares víricas graves
    E.1.1.1Medical condition in easily understood language
    Severe viral lung infections
    Infecciones pulmonares víricas graves
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10001053
    E.1.2Term Acute respiratory failure
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 effect of tozorakimab versus placebo as add on to SoC in participants with viral lung infection requiring supplemental oxygen on the prevention of death or progression to IMV/ECMO by Day 60
    Evaluar la eficacia de tozorakimab frente a placebo como complemento al tratamiento estándar en pacientes con infección pulmonar vírica que requieren suplemento de oxígeno en la prevención de la muerte o progresión a ventilación mecánica invasiva (IMV/ECMO) el día 60
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of tozorakimab versus placebo as add-on to standard of care on:

    a) all-cause mortality by Day 60

    b) ICU stay

    c) duration of oxygen supplementation

    d) prolonging time to death or IMV/ECMO

    e) prolonging time to death

    f) ventilator use

    g) ICU admissions

    h) duration of hospitalisation

    i) clinical status as assessed by the Investigator using WHO 10-category ordinal Clinical Progression Scale by Day 60.

    2. To evaluate the pharmacokinetics and immunogenicity of tozorakimab.

    3. To evaluate the use of baseline serum biomarker levels to predict treatment response with tozorakimab versus placebo as add on to standard of care.

    4. To assess the safety and tolerability of tozorakimab versus placebo as add-on to standard of care.
    1. Evaluar la eficacia de tozorakimab frente a placebo como complemento al tratamiento estándar sobre:

    a) la mortalidad por cualquier causa el día 60

    b) la estancia en la en la unidad de cuidados intensivos (UCI)

    c) la duración del suplemento de oxígeno

    d) la prolongación del tiempo hasta la muerte o IMV/ECMO

    e) la prolongación del tiempo hasta la muerte

    f) el uso de ventilación asistida

    g) el ingreso en la UCI

    h) la duración de la hospitalización

    i) el estado clínico evaluado por el investigador utilizando la escala de progresión clínica ordinal de 10 categorías de la OMS el día 60.

    2. Evaluar la farmacocinéticay la inmunogenicidad de tozorakimab.

    3. Evaluar el uso de los niveles basales de biomarcadores séricos para predecir la respuesta al tratamiento con tozorakimab frente a placebo como complemento al tratamiento estándar.

    4. Evaluar la seguridad y tolerabilidad de tozorakimab frente a placebo como complemento al tratamiento estándar.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult participants ≥ 18 years old at the time of signing the informed consent form.

    2. Patients hospitalised with viral lung infection.

    3. Hypoxaemia requiring treatment with supplemental O2
    1. Pacientes adultos ≥ 18 años en el momento de firma del consentimiento informado.

    2. Pacientes hospitalizados con infección pulmonar vírica.

    3. Hipoxemia que requiere tratamiento con suplemento de oxígeno.
    E.4Principal exclusion criteria
    1. Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or pulmonary sepsis. Bacterial co-infection is allowed, unless, in the opinion of the investigator, bacterial infection defines the severity of the participant’s condition.

    2. Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non-infective aetiology.

    3. Ongoing or impending IMV/ECMO at randomisation.
    1. Infección pulmonar fúngica o parasitaria conocida, infección pulmonar por aspiración, absceso pulmonar o sepsis pulmonar. Se permite la coinfección bacteriana, a menos que, a juicio del investigador, la infección bacteriana defina la gravedad del estado del paciente.

    2. Hipoxemia causada principalmente por lesión extrapulmonar o por lesión pulmonar de etiología no infecciosa.

    3. IMV/ECMO en curso o inminente en la aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants who die or progress to IMV/ECMO
    Proporción de pacientes que mueren o progresan a IMV/ECMO
    E.5.1.1Timepoint(s) of evaluation of this end point
    By Day 60
    En el día 60
    E.5.2Secondary end point(s)
    1. Proportion of participants who die

    2. Number of days alive and outside of ICU

    3. Number of days alive and free of supplemental oxygen

    4. Time to death or progression to IMV/ECMO

    5. Proportion of participants who die or progress to IMV/ECMO

    6. Time to death (all cause)

    7. Proportion of participants who die

    8. Number of days alive and free of IMV/ECMO

    9. Number of days alive and ventilator free

    10. Proportion of participants with ICU admission or death

    11. Proportion of participants alive and discharged

    12. Time to discharge

    13. Time to being off supplemental oxygen

    14. WHO CPS score rank-based comparison

    15. Incidence of anti-drug antibodies

    16. Baseline serum biomarker levels relative to primary endpoint
    1. Proporción de participantes que mueren

    2. Número de días de superviencia y fuera de la UCI

    3. Número de días de supervivencia y sin oxígeno suplementario

    4. Tiempo hasta la muerte o progresión a IMV/ECMO

    5. Proporción de pacientes que mueren o progresan a IMV/ECMO

    6. Tiempo hasta la muerte (todas las causas)

    7. Proporción de pacientes que mueren

    8. Número de días de supervivencia y libre de IMV/ECMO

    9. Número de días de supervivencia y sin respiración asistida

    10. Proporción de pacientes con ingreso en UCI o muerte

    11. Proporción de pacientes vivos y dados de alta de hospitalización

    12. Hora del alta de hospitalización

    13.Hora de retirada del suplemento de oxígeno

    14. Comparación basada en el rango de puntuación de la CPS de la OMS

    15. Incidencia de anticuerpos antifármacos

    16.Niveles basales de biomarcadores séricos en relación con el criterio principal de evaluación
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. By Day 60

    2. Over 60 day period

    3. Over 60 day period

    4. NA

    5. By Day 28

    6. NA

    7. By Day 28

    8. Over 60 day period

    9. Over 60 day period

    10. By Day 28 and Day 60

    11. By Day 28 and Day 60

    12. NA

    13. NA

    14. NA

    15. NA

    16. NA
    1. En el día 60

    2. Durante un periodo de 60 días

    3. Durante un periodo de 60 días

    4. NA

    5. En el día 28

    6.NA

    7. En el día 28

    8. Durante un periodo de 60 días

    9. Durante un periodo de 60 días

    10. En el día 28 y en el día 60

    11. En el día 28 y en el día 60

    12. NA

    13. NA

    14. NA

    15. NA

    16. NA
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 trial2
    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 EEA91
    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
    Australia
    Brazil
    Canada
    Chile
    China
    Colombia
    Hong Kong
    India
    Israel
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Peru
    Philippines
    Saudi Arabia
    South Africa
    Taiwan
    Thailand
    United States
    Viet Nam
    Austria
    France
    Poland
    Sweden
    Bulgaria
    Netherlands
    Romania
    Spain
    Czechia
    Germany
    Italy
    Belgium
    Denmark
    Hungary
    Slovakia
    Turkey
    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
    LSLV
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days6
    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: 1176
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1176
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    as these are acutely ill patients there may be some patients incapable of giving consent personally, so legal representatives or guardian consent will be taken
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 843
    F.4.2.2In the whole clinical trial 2352
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    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 Decision2022-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
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