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    Summary
    EudraCT Number:2017-003158-18
    Sponsor's Protocol Code Number:203PF203
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-06-05
    Trial results View 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 number2017-003158-18
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis
    Estudio aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de BG00011 en pacientes con fibrosis pulmonar idiopática
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis
    Evaluación de la eficacia y la seguridad de BG00011 en participantes con fibrosis pulmonar idiopática
    A.4.1Sponsor's protocol code number203PF203
    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 SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointBiogen España
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 41
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number34913107110
    B.5.5Fax number34913107181
    B.5.6E-mailclinicaltrials@biogenidec.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 namehumanized anti-alpha v beta 6 mAb
    D.3.2Product code BG00011
    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 IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.2Current sponsor codeBG00011
    D.3.9.3Other descriptive nameBG00011
    D.3.9.4EV Substance CodeSUB191995
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number56
    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 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 Yes
    D.3.11.13.1Other medicinal product typehumanized monoclonal antibody
    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 placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    mild to moderate Idiopathic Pulmonary Fibrosis
    Fibrosis Pulmonar Idiopática (FPI) de leve a moderada
    E.1.1.1Medical condition in easily understood language
    Mild to moderate scarring of lung tissue
    Cicatrización de leve a moderada del tejido pulmonar
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of BG00011 compared with placebo in subjects with Idiopathic pulmonary fibrosis (IPF).
    Evaluar la eficacia de BG00011 en comparación con placebo en sujetos con Fibrosis Pulmonar Idiopática (FPI).
    E.2.2Secondary objectives of the trial
    To evaluate
    -The efficacy of BG00011 compared with placebo in subjects with IPF as determined by change in percent predicted FVC
    -The safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011
    To assess in subjects who receive BG00011 compared with placebo:
    -Progression-free survival.
    -The occurrence of IPF exacerbation.
    -The incidence of absolute decline in FVC ≥10% .
    -The time to death or lung transplantation, and the transplant-free survival rate at Week 26 and Week 52.
    -The time to nonselective hospitalizations.
    -Additional PFT findings.
    - Performance on the 6MWT.
    Please refer to protocol for further secondary objectives
    Evaluar:
    -Eficacia de BG00011 en comparación con placebo en sujetos con FPI, determinada mediante el cambio en el % del valor previsto de la CVF.
    -Seguridad y tolerabilidad de BG00011;y evaluar concentración sérica de BG00011.
    Valorar en sujetos que reciben BG00011 en comparación con placebo:
    -Supervivencia sin progresión.
    -Aparición de una exacerbación de la FPI.
    -Incidencia de disminución absoluta en la CVF ≥10 %.
    -Tiempo transcurrido hasta muerte o el trasplante pulmonar, y tasa de supervivencia sin trasplante en semana 26 y semana 52.
    -Tiempo transcurrido hasta hospitalizaciones no programadas.
    -Hallazgos adicionales en pruebas de función pulmonar (PFP).
    -Resultado en PM6M.
    Consulte el protocolo para ver más objetivos secundarios.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Female subjects must be surgically sterile,
    postmenopausal (minimum 1 year without menses), or
    agree to use 1 or more forms of highly effective
    contraception from the time of signing of the informed
    consent form (ICF) until 3 months after the last injection
    of study medication. Male subjects must also agree to
    use 1 or more forms of highly effective contraception for
    either themselves or their partners from signing of ICF
    until 4 months after last injection of study medication.
    - Diagnosed with Idiopathic pulmonary fibrosis (IPF).
    - Combination of high-resolution computed tomography
    (HRCT) pattern and, if one has been obtained, surgical
    lung biopsy pattern, consistent with diagnosis of IPF.
    - Carbon monoxide diffusion capacity (DLco) (corrected
    for hemoglobin): 30% to 79% predicted of normal at
    Screening, with no clinically significant deterioration
    between the Screening Visit and randomization, as
    determined by the Investigator.
    - Forced (expiratory) vital capacity (FVC) ≥50%
    predicted of normal at Screening, with no clinically
    significant deterioration between the Screening Visit and
    randomization, as determined by the Investigator.
    - If a subject is taking nintedanib or pirfenidone, they
    must be on a stable dose for at least 8 weeks prior to
    randomization.
    NOTE: Other protocol defined inclusion criteria may apply.
    - Las mujeres deben ser quirúrgicamente estériles, posmenopáusicas (mínimo de 1 año sin menstruación) o aceptar el uso de 1 o más métodos anticonceptivos altamente eficaces desde el momento de la firma del formulario de consentimiento informado (FCI) hasta 3 meses después de la última inyección del medicamento del estudio. Los varones también deben aceptar el uso de 1 o más métodos anticonceptivos altamente eficaces para ellos mismos o sus parejas, desde la firma del FCI hasta 4 meses después de la última inyección del medicamento del estudio.
    - Diagnóstico de fibrosis pulmonar idiopática (FPI).
    - Combinación del patrón en la tomografía axial computarizada de alta resolución (TACAR) y, si se ha obtenido, patrón en la biopsia pulmonar quirúrgica, que concuerda con el diagnóstico de FPI.
    - Capacidad de difusión del monóxido de carbono (DLco) (corregida para la hemoglobina): del 30 % al 79 % del valor previsto de la normalidad en la selección, con ausencia de deterioro clínicamente significativo entre la visita de selección y la aleatorización, según lo determinado por el investigador.
    - Capacidad vital (espiratoria) forzada (CVF) ≥50 % del valor previsto de la normalidad en la selección, con ausencia de deterioro clínicamente significativo entre la visita de selección y la aleatorización, según lo determinado por el investigador.
    - Si un sujeto está tomando nintedanib o pirfenidona, debe estar recibiendo una dosis estable durante al menos 8 semanas antes de la aleatorización.
    NOTA: Podrán aplicarse otros criterios de inclusión definidos en el protocolo.
    E.4Principal exclusion criteria
    - Unable to perform pulmonary functional tests (PFTs) or
    undergo HRCT procedure.
    - Peripheral capillary oxygen saturation (SpO2) <90% at
    rest (if on oxygen supplementation, must be ≤2 L/min at
    rest).
    - Airway obstruction (i.e., prebronchodilator FEV1/FVC
    <0.7) or evidence of a bronchodilator response as
    defined by an absolute increase of ≥12% and an
    increase of ≥200 milliliters (mL) in FEV1 or FVC, or both,
    after bronchodilator use, compared with the values
    before bronchodilator use at Screening.
    - End-stage fibrotic disease likely requiring organ
    transplantation within 12 months, or if the subject has
    initiated active evaluation for organ transplantation.
    - The extent of emphysema in the lungs exceeds
    fibrosis, based on central review of HRCT
    scans.
    - Body weight <60 kg at Screening.
    - History of or ongoing malignant disease, including solid
    tumors and hematologic malignancies, with the
    exception of basal cell carcinomas, squamous cell
    carcinomas, and carcinoma in situ of the cervix that
    have been completely excised and considered cured >2
    years prior to Screening.
    - Significant cardiac disease (e.g., New York Heart
    Association Class 3 or 4; myocardial
    infarction within the past 6 months; unstable angina;
    coronary angioplasty or coronary artery bypass graft
    within the past 6 months; uncontrolled atrial or
    ventricular cardiac arrhythmias; or pulmonary
    hypertension requiring pharmacologic treatment).
    - Clinical diagnosis of any connective tissue disease
    (including but not limited to scleroderma,
    polymyositis/dermatomyositis, systemic lupus
    erythematosus, and rheumatoid arthritis) or a diagnosis
    of interstitial pneumonia with autoimmune features as
    determined by the Investigator.
    - Other disease that may interfere with testing
    procedures or, in the judgment of the Investigator, may
    interfere with study participation or may put the patient
    at risk when participating in this study.
    - Other unspecified reasons that, in the opinion of the
    Investigator or Biogen, make the subject unsuitable for
    enrollment.
    NOTE: Other protocol defined exclusion criteria may apply.
    - Incapaz de realizar pruebas de función pulmonar (PFP) o de someterse a un procedimiento de TACAR.
    - Saturación de oxígeno capilar periférico (SpO2) <90 % en reposo (si recibe aporte suplementario de oxígeno, debe ser ≤2 l/min en reposo).
    - Obstrucción de las vías respiratorias (es decir, VEF1/CVF antes del broncodilatador <0,7) o indicios de una respuesta broncodilatadora, definida por un aumento absoluto de ≥12 % y un aumento de ≥200 mililitros (ml) en el VEF1 o la CVF, o en ambos, tras el uso del broncodilatador, en comparación con los valores antes del uso del broncodilatador en la selección.
    - Enfermedad fibrótica en fase terminal que probablemente requiera un trasplante de órgano en el plazo de 12 meses, o si el sujeto ha iniciado la evaluación activa para un trasplante de órgano.
    - El grado de enfisema en los pulmones supera la fibrosis, según la revisión central de las exploraciones por TACAR.
    - Peso <60 kg en la selección.
    - Antecedentes o presencia de neoplasia maligna, incluidos tumores sólidos y neoplasias malignas hematológicas, a excepción de carcinomas basocelulares y epidermoides de la piel y carcinoma in situ de cuello uterino que se han extirpado por completo y se consideran curados >2 años antes de la selección.
    - Cardiopatía significativa (p. ej., Clase 3 o 4 según la New York Heart Association; infarto de miocardio en los últimos 6 meses; angina de pecho inestable; angioplastia coronaria o injerto de derivación aortocoronaria en los últimos 6 meses; arritmias cardíacas auriculares o ventriculares no controladas; o hipertensión pulmonar que requiere tratamiento farmacológico).
    - Diagnóstico clínico de cualquier enfermedad del tejido conjuntivo (entre otras, esclerodermia, dermatomiositis/polimiositis, lupus eritematoso sistémico y artritis reumatoide) o un diagnóstico de neumonía intersticial con características autoinmunes, según lo determinado por el investigador.
    - Otra enfermedad que pueda interferir en los procedimientos analíticos o, en opinión del investigador, pueda afectar a la participación en el estudio o poner en riesgo al paciente por participar en este estudio.
    - Otra razón no especificada que, en opinión del investigador o de Biogen, haga que el sujeto no sea apto para la inscripción.
    NOTA: Podrán aplicarse otros criterios de exclusión definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Yearly Rate of Change in Forced (Expiratory) Vital Capacity (FVC)
    Tasa anual de cambio en la capacidad vital (espiratoria) forzada (CVF)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various time point assessments throughout the study
    Evaluaciones en diversos puntos temporales durante todo el estudio
    E.5.2Secondary end point(s)
    - Percent Predicted Yearly Rate of Change in FVC
    - Time to Progression
    - Time to First Acute Exacerbation
    - Percentage of Participants with at least 1 Acute Exacerbation
    - Number of Exacerbations
    - Number of Participants with Absolute Decline of 10% Predicted in FVC
    - Time to Death or Lung Transplantation
    - Time to All Non-Elective Hospitalizations
    - Time to All Non-Elective Respiratory Hospitalizations
    - Change from Baseline in Absolute Predicted FVC
    - Change from Baseline in Percent Predicted FVC
    - Change from Baseline in Absolute Predicted Carbon Monoxide Diffusion Capacity (DLco)
    - Change from Baseline in Percent Predicted Carbon Monoxide Diffusion Capacity (DLco)
    - Change from Baseline in Absolute Predicted Total Lung Capacity
    - Change from Baseline in Percent Predicted Total Lung Capacity
    - Change from Baseline in 6 Minute Walk Test (6MWT) Parameters
    - Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
    - Percentage of Participants With Anti-BG00011 Antibodies in the Serum
    - Concentration of BG00011 in the Serum
    - Porcentaje del valor previsto de la tasa anual de cambio en la CVF
    - Tiempo hasta la progresión
    - Tiempo hasta la primera exacerbación aguda
    - Porcentaje de participantes con al menos 1 exacerbación aguda
    - Número de exacerbaciones
    - Número de participantes con una disminución absoluta del 10 % del valor previsto en la CVF
    - Tiempo hasta la muerte o el trasplante pulmonar
    - Tiempo hasta todas las hospitalizaciones no programadas
    - Tiempo hasta todas las hospitalizaciones por causas respiratorias no programadas
    - Cambio respecto al inicio en el valor absoluto previsto de CVF
    - Cambio respecto al inicio en el porcentaje previsto de CVF
    - Cambio respecto al inicio en el valor absoluto previsto de la capacidad de difusión del monóxido de carbono (DLco)
    - Cambio respecto al inicio en el porcentaje previsto de la capacidad de difusión del monóxido de carbono (DLco)
    - Cambio respecto al inicio en el valor absoluto previsto de la capacidad pulmonar total
    - Cambio respecto al inicio en el porcentaje previsto de la capacidad pulmonar total
    - Cambio respecto el inicio en los parámetros de la prueba de marcha de 6 minutos (PM6M)
    - Porcentaje de participantes con acontecimientos adversos (AA) y acontecimientos adversos graves (AAG)
    - Porcentaje de participantes con anticuerpos anti-BG00011 en el suero
    - Concentración de BG00011 en el suero
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change to baseline, weeks 26 and 52
    Cambio al inicio, semanas 26 y 52
    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 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) 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Belgium
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Israel
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Russian Federation
    Spain
    Turkey
    United Kingdom
    United States
    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 last subject, last visit.
    El final del estudio es la última visita del último sujeto.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months37
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months37
    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: 87
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 203
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 93
    F.4.2.2In the whole clinical trial 290
    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)
    Normal treatment
    Tratamiento normal
    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 Decision2018-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-10-31
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