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    Summary
    EudraCT Number:2019-001363-67
    Sponsor's Protocol Code Number:D5241C00001
    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:2019-08-09
    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 number2019-001363-67
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)
    Estudio en fase 2a, multicéntrico, con grupos paralelos, controlado con placebo, doble ciego y aleatorizado para investigar la eficacia y la seguridad de tezepelumab en pacientes con enfermedad pulmonar obstructiva crónica (EPOC) de moderada a muy grave (COURSE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2a study to assess the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe COPD.
    Ensayo en fase 2a para evaluar la eficacia y seguridad de tezepelumab en adultos con EPOC moderada a muy grave
    A.3.2Name or abbreviated title of the trial where available
    COURSE
    COURSE
    A.4.1Sponsor's protocol code numberD5241C00001
    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.4.1Name of organisation providing supportAmgen
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressNot Applicable
    B.5.3.2Town/ cityNot Applicable
    B.5.3.3Post codeNot Applicable
    B.5.3.4CountryUnited States
    B.5.4Telephone number18772409479
    B.5.6E-mailinformation.center@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 nameTezepelumab via APFS
    D.3.2Product code MEDI9929 anti-TSLP mAb (AMG157)
    D.3.4Pharmaceutical form Solution for injection
    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 INNTezepelumab
    D.3.9.1CAS number 1572943-04-4
    D.3.9.2Current sponsor codeMEDI9929
    D.3.9.3Other descriptive nameAMG157
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number99 to 121
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal 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 placeboSolution for injection
    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
    Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
    Enfermedad Pulmonar Obstructiva Crónica (EPOC) entre moderada y muy grave
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease (COPD)
    Enfermedad Pulmonar Obstructiva Crónica (EPOC)
    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 LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    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 tezepelumab SC Q4W as compared with placebo on COPD exacerbations in adults with moderate to very severe COPD
    Evaluar el efecto de tezepelumab en comparación con placebo sobre las exacerbaciones de la EPOC en pacientes adultos con EPOC entre moderada y muy grave
    E.2.2Secondary objectives of the trial
    To assess the effect of tezepelumab SC Q4W compared with placebo on:
    1. Time to first moderate or severe exacerbations.
    2. Rate of severe COPD exacerbations.
    3. Lung function.
    4. Respiratory health status/health-related quality of life.
    5. Pharmacokinetics and immunogenicity.
    Evaluar el efecto de tezepelumab en comparación con placebo sobre:
    1. Tiempo hasta la primera exacerbación moderada/grave.
    2. Tasa de exacerbaciones graves de la EPOC.
    3. Función pulmonar.
    4. Estado de salud respiratoria y la calidad de vida relacionada con la salud.
    5. Farmacocinética e inmunogenicidad.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Evaluate the effect of tezepelumab compared with placebo on:
    1. Sputum biomarkers, cell counts and microbiome
    2. Pharmacodynamic (PD) markers in nasal lining and sputum cell samples.
    3. Nasal lining fluid biomarkers.
    Evaluar el efecto de tezepelumab en comparación con placebo sobre:
    1. Biomarcadores, recuentos de células y microbioma del esputo.
    2. Marcadores farmacodinámicos en las células epiteliales nasales y de las células del esputo.
    3. Biomarcadores del líquido de la mucosa nasal.
    E.3Principal inclusion criteria
    1) Subjects must be between 40-80 years of age.
    2) Weight ≥40 kg at screening visit.
    3) History of moderate to very severe physician-diagnosed COPD for at least 12 months prior to enrolment with a post-bronchodilator FEV1 ≥20% and ≤80% of predicted normal value.
    4) History of at least 2 documented moderate to severe COPD exacerbations within 2 to 52 weeks prior to enrollment.
    5) CAT score of ≥15 at Visit 1.
    6) Subjects should have evidence of having been treated with triple (medium or high dose ICS/LABA/LAMA) therapy for COPD throughout the year prior to enrollment, the dose should be stable for 3 months prior to screening visit.
    7) Current smoker or ex-smoker with a tobacco history of ≥10 pack-years.
    8) If on allergen-specific immunotherapy, subjects must be on a maintenance dose and schedule for at least 2 months prior to screening visit.
    9) If on theophylline or roflumilast, subjects must be on maintenance treatment for at least 12 months prior to screening visit and on stable dose 3 months prior to screening visit.
    10) Chest x-ray or computed tomography (CT) scan of the chest/lungs must not show unsuspected lung pathology that would prevent the subject's ability to complete the study.
    1) Los pacientes deberán tener entre 40 y 80 años.
    2) Peso ≥ 40 kg en la visita de selección.
    3) Antecedentes de EPOC de moderada a muy grave diagnosticada por un médico durante al menos 12 meses antes de la inclusión con un FEV1 posbroncodilatador ≥ 20% y ≤ 80% del valor normal teórico.
    4) Antecedentes de al menos dos exacerbaciones moderadas o graves de la EPOC documentadas en las 2 a 52 semanas previas a la inclusión.
    5) Puntuación CAT ≥ 15 en la visita 1.
    6) Los pacientes deberán presentar pruebas de haber recibido tratamiento triple (dosis media o alta de CI/LABA/LAMA) para la EPOC durante el año previo a la inclusión; la dosis deberá haberse mantenido estable durante los 3 meses anteriores a la visita de selección.
    7) Fumador activo o exfumador con antecedentes de tabaquismo ≥ 10 paquetes-año.
    8) En caso de recibir inmunoterapia específica con alérgenos, los pacientes deberán haber recibido una dosis y pauta de mantenimiento durante al menos 2 meses antes de la visita de selección.
    9) Si están recibiendo teofilina o roflumilast, los pacientes deberán haber recibido tratamiento de mantenimiento durante al menos 12 meses antes de la visita de selección y estar recibiendo una dosis estable desde 3 meses antes de la visita de selección.
    10) La radiografía de tórax o la tomografía computarizada (TC) de tórax/pulmones no debe mostrar una enfermedad pulmonar insospechada que impida que el paciente pueda completar el ensayo.
    E.4Principal exclusion criteria
    1) Clinically important pulmonary disease other than COPD.
    2) Current or previous asthma diagnosis.
    3) Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious (including risk factors for pneumonia), endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable.
    4) Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 14 days prior to enrolment (Visit 1) or during screening period.
    5) History of clinically significant infection (excluding pneumonia), acute upper or lower respiratory infection, requiring antibiotics or antiviral medication within 14 days prior to enrolment (Visit 1) or during the screening period.
    6) History of pneumonia requiring antibiotics or antiviral medication within 28 days prior to enrolment (Visit 1) or during the screening period.
    7) History of allergy or reaction to any component of tezepelumab.
    8 History of anaphylaxis to any other biologic therapy.
    9) History of alcohol or drug abuse within the past year.
    10) History of cancer.
    11) Subjects with tuberculosis (TB)
    12) Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures requiring general anaesthesia.
    13) Pregnant or breastfeeding.
    14) Subjects randomized in the current or previous Tezepelumab studies.
    1) Enfermedad pulmonar clínicamente importante distinta de la EPOC.
    2) Diagnóstico actual o previo de asma.
    3) Cualquier trastorno, entre otros, alteración cardiovascular, gastrointestinal, hepática, renal, neurológica, musculoesquelética, infecciosa (incluidos factores de riesgo de neumonía), endocrina, metabólica, hematológica, psiquiátrica o física importante que no se encuentre estable.
    4) Tratamiento con corticosteroides o antibióticos sistémicos u hospitalización por una exacerbación de la EPOC en los 14 días previos a la inclusión (visita 1) o durante el período de selección.
    5) Antecedentes de infección clínicamente significativa (excepto neumonía), infección respiratoria aguda de vías altas o bajas con necesidad de antibióticos o medicación antiviral en los 14 días previos a la inclusión (visita 1) o durante el período de selección.
    6) Antecedentes de neumonía con necesidad de antibióticos o medicación antiviral en los 28 días previos a la inclusión (visita 1) o durante el período de selección.
    7) Antecedentes de alergia o reacción a cualquiera de los componentes del tezepelumab.
    8) Antecedentes de anafilaxia a cualquier otro tratamiento biológico.
    9) Antecedentes de alcoholismo o drogadicción en el último año.
    10) Antecedentes de cáncer.
    11) Pacientes con tuberculosis (TB).
    12) Cirugía mayor en las 8 semanas previas a la visita 1 o intervenciones quirúrgicas programadas que requieran anestesia general.
    13) Embarazo o lactancia.
    14) Pacientes aleatorizados en otro estudio actual o previo de tezepelumab.
    E.5 End points
    E.5.1Primary end point(s)
    1) Rate of moderate or severe COPD exacerbations.
    1) Tasa de exacerbaciones moderadas o graves de la EPOC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Rate ratio of moderate or severe COPD exacerbation vs placebo over 52 weeks.
    Relación entre las tasas de exacerbaciones moderadas o graves de la EPOC en comparación con el placebo durante 52 semanas
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    1) Time to first moderate or severe COPD exacerbation.
    2) Rate of severe COPD exacerbations
    3) Change from baseline in pre-brohchodilator (BD) forced expiratory volume in 1 second (FEV1)
    4) Change from baseline in SGRQ score and CAT. Proportion of subjects achieving an MCID of 4 units or more in SGRQ total score.
    5) Evaluate pharmacokinetics (serum trough concentration) and immunogenicity (incidence of anti-drug antibodies(ADA)) of tezepelumab.
    Criterios de valoración secundarios:
    1) Tiempo transcurrido hasta la primera exacerbación moderada o grave de la EPOC.
    2) Tasa de exacerbaciones graves de la EPOC.
    3) Variación con respecto al valor basal del volumen espiratorio máximo en el primer segundo (FEV1) antes del broncodilatador (BD).
    4) Variación de la puntuación del SGRQ y la CAT con respecto al momento basal. Porcentaje de pacientes que logren una MCID de 4 unidades o más en la puntuación total del SGRQ.
    5) Evaluar la farmacocinética (concentración sérica mínima) y la inmunogenicidad (incidencia de anticuerpos contra el fármaco (ACF)) de tezepelumab.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Key Secondary Endpoints:
    1) over 52 weeks
    2) over 52 weeks
    3) at week 52
    4) at week 52
    5) over 52 weeks
    Criterios de valoración secundarios fundamentales:
    1) Durante 52 semanas.
    2) Durante 52 semanas.
    3) En la semana 52.
    4) En la semana 52.
    5) Durante 52 semanas.
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Canada
    Denmark
    France
    Germany
    Israel
    Korea, Republic of
    Netherlands
    Spain
    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
    Last Subject Last Visit (LSLV)
    Última Visita del Último Paciente
    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 months7
    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 months9
    E.8.9.2In all countries concerned by the trial days21
    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: 141
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 141
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 167
    F.4.2.2In the whole clinical trial 282
    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 Decision2019-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-30
    P. End of Trial
    P.End of Trial StatusOngoing
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