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    Summary
    EudraCT Number:2021-003797-30
    Sponsor's Protocol Code Number:D9180C00003
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-11-01
    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 ConcernedFinland - Fimea
    A.2EudraCT number2021-003797-30
    A.3Full title of the trial
    A Phase III, Multicentre, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (Oberon)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess efficacy, safety, and tolerability of Tozorakimab in patients with symptomatic chronic obstructive pulmonary disease (COPD) with a history of exacerbations.
    A.3.2Name or abbreviated title of the trial where available
    OBERON
    A.4.1Sponsor's protocol code numberD9180C00003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05166889
    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
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    B.5.4Telephone number1-877-240-9479
    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 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 IMPSubcutaneous 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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Obstructive Pulmonary Disease (COPD)
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease (COPD)
    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 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    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 2 dose regimens of tozorakimab as add on to standard of care compared with standard of care plus placebo on the rate of moderate to severe exacerbations in former smokers.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of 2 dose regimens of tozorakimab as add on to
    standard of care compared with standard of care plus placebo on:

    a) the rate of moderate to severe COPD exacerbations in former and
    current smokers

    b) change in pre-bronchodilator lung function

    c) respiratory symptoms

    d) respiratory health status/health related quality of life

    e) time to first moderate to severe COPD exacerbations

    f) severe COPD exacerbations

    g) COPD health status/health-related quality of life

    h) COPD-related healthcare resource utilization

    i) daily rescue medication use

    2.To evaluate the pharmacokinetics and immunogenicity of 2 dose
    regimens of tozorakimab.

    3. To assess the safety and tolerability of two dose regimen of
    tozorakimab as add on to standard of care compared with standard of
    care plus placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be ≥ 40 years of age and capable of giving signed informed consent.

    2. Documented diagnosis of COPD for at least one year prior to enrolment.

    3. Post BD FEV1/FVC < 0.70 and post-BD FEV1 >20% of predicted normal value.

    4. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.

    5. Documented optimized inhaled dual or triple therapy with COPD and at a stable dose for at least 3 months prior to enrolment.

    6. Smoking history of ≥ 10 pack-years.

    7. CAT total score ≥10, with each of the phlegm (sputum) and cough items ≥ 2.
    E.4Principal exclusion criteria
    1. Clinically important pulmonary disease other than COPD.

    2. Radiological findings suggestive of a respiratory disease other than
    COPD that is significantly contributing to the participant's respiratory
    symptoms. Radiological findings of pulmonary nodules suspicious for
    lung cancer, as per applicable guidances,without appropriate follow up
    prior to randomisation. Radiological findings suggestive of acute
    infection.

    3. Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18.

    4. Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study.

    5. COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.

    6. Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection.

    7. Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.

    8. Significant COVID-19 illness within the 6 months prior to enrolment.

    9. Unstable cardiovascular disorder.

    10. Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.

    11. History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2.

    12. History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C)

    13. Evidence of active liver disease, including jaundice during screening.

    14. Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrolment. Suspected malignancy or undefined neoplasms.

    15. Participants who have evidence of active TB.

    16. Participants that have previously received tozorakimab.

    17. Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant’s ability to complete the entire duration of the study.

    18. Active vaping of any products or using smoked marijuana within the 6 months prior to randomization and during the study.
    E.5 End points
    E.5.1Primary end point(s)
    Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52.
    E.5.2Secondary end point(s)
    1. Annualized rate of moderate to severe COPD exacerbations in former
    or current smokers

    2. Change from baseline in SGRQ total score in former smokers

    3. Change from baseline in SGRQ total score in former or current
    smokers

    4. Change from baseline in pre-bronchodilator, pre dose trough FEV1
    (mL) in former smokers

    5. Change from baseline in pre-bronchodilator, pre dose trough FEV1
    (mL) in former or current smokers

    6. Change from baseline in E-RS:COPD total score in former smokers

    7. Change from baseline in E-RS:COPD total score in former or current
    smokers

    8. Time to first moderate to severe COPD exacerbation in former smokers

    9. Time to first severe COPD exacerbation in former smokers

    10. Annualized rate of severe COPD exacerbations in former smokers

    11. Proportion of patients achieving MCID in SGRQ total score in former
    smokers

    12. Proportion of patients achieving MCID in E-RS:COPD total score in
    former smokers

    13. Change from baseline in CAT total score in former smokers

    14. Proportion of participants achieving MCID in CAT score in former
    smokers

    15. Proportion of participants having ≥ 1 healthcare resource utilization
    type in former smokers

    16. Annualized rate of healthcare resource utilization in former smokers

    17. Change from baseline in rescue medication in former smokers

    18. Trough serum concentrations of tozorakimab

    19. Presence of anti-drug antibodies

    20. Safety and tolerability
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over 52 weeks./At week 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 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 Yes
    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) 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA86
    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
    Korea, Democratic People's Republic of
    Canada
    India
    Japan
    Mexico
    Turkey
    United States
    Viet Nam
    Belgium
    Bulgaria
    Czechia
    Denmark
    Finland
    Hungary
    Netherlands
    Norway
    Portugal
    Spain
    Sweden
    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)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    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: 519
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 541
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 534
    F.4.2.2In the whole clinical trial 1060
    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)
    Participants who complete a 52-week study treatment period, and have not been prematurely discontinued from IP, may be offered an opportunity to enter a controlled long term extension study.
    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 Decision2021-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-29
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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