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    Summary
    EudraCT Number:2018-001953-28
    Sponsor's Protocol Code Number:EFC15804
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-13
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2018-001953-28
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 inflammation
    Randomizované, dvojito zaslepené, placebom kontrolované, 52týždňové pivotné klinické skúšanie s paralelnými skupinami, hodnotiace účinnosť, bezpečnosť a znášanlivosť dupilumabu u pacientov so stredne ťažkou až ťažkou chronickou obštrukčnou chorobou pľúc (CHOCHP) so zápalom 2. typu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pivotal study to assess the efficacy, safety and tolerability of dupilumab in patients with moderate-tosevere COPD with Type 2 inflammation (BOREAS)
    A.3.2Name or abbreviated title of the trial where available
    BOREAS
    A.4.1Sponsor's protocol code numberEFC15804
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1211-8804
    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 SponsorSanofi-aventis Recherche & Développement
    B.1.3.4CountryFrance
    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 supportSanofi-aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.r.o.
    B.5.2Functional name of contact pointwww.sanofi.cz
    B.5.3 Address:
    B.5.3.1Street AddressEvropská 846/176a
    B.5.3.2Town/ cityPraha 6
    B.5.3.3Post code160 00
    B.5.3.4CountryCzechia
    B.5.4Telephone number+420233 086 111
    B.5.5Fax number+420233 086 224
    B.5.6E-mailcz-info@sanofi.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 nameDupilumab
    D.3.2Product code SAR231893
    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 INNDupilumab
    D.3.9.2Current sponsor codeSAR231893
    D.3.9.3Other descriptive nameREGN668
    D.3.9.4EV Substance CodeSUB88511
    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 in pre-filled syringe
    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
    E.1.1.1Medical condition in easily understood language
    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 26.1
    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 efficacy of dupilumab 300 mg q2w in patients with moderate or severe COPD as measured by
    - Annualized rate of acute moderate and severe COPD exacerbation (AECOPD)
    E.2.2Secondary objectives of the trial
    To evaluate the effect of dupilumab 300 mg q2w on
    - Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo
    - Health related quality of life, assessed by the change from baseline to Week 52 in the St. George’s
    Respiratory Questionnaire (SGRQ)
    - Pre-bronchodilator FEV1 over 52 weeks compared to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participants with a physician diagnosis of COPD who meet the following criteria at screening:
    -Current or former smokers with a smoking history of ≥10 pack-years.
    -Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity [FVC] ratio
    <0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%).
    -Medical Research Council (MRC) Dyspnea Scale grade ≥2.
    -Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough.
    -Documented history of high exacerbation risk defined as exacerbation history of ≥2 moderate or ≥1 severe within the year prior to inclusion. At least one exacerbation should have occurred while the patient was taking inhaled corticosteroid (ICS)/long acting beta agonist (LABA)/long acting muscarinic agonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate exacerbations are recorded by the investigator and defined as acute exacerbation of COPD (AECOPD) that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations has to require the use of systemic corticosteriods. Severe exacerbations are recorded by the investigator and defined as AECOPD requiring hospitalization/emergency room visit or treatment for >24 hours in emergency department/urgent care facility or result in death.
    -Background triple therapy (inhaled corticosteroid [ICS] + long acting beta agonist [LABA] + long acting muscarinic agonist [LAMA]) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to Visit 1; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.
    -Evidence of Type 2 inflammation: Patients with blood eosinophils ≥300 cells/microliter at Visit 1.
    E.4Principal exclusion criteria
    - COPD diagnosis for less than 12 months prior to randomization.
    - A current diagnosis of asthma or history of asthma according to the 2018 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines; or a history of asthma with age of onset ≥ 40 years of age.
    - Significant pulmonary disease other than COPD (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
    - Cor pulmonale, evidence of right cardiac failure.
    - Treatment with oxygen of more than 12 hours per day.
    - Hypercapnia requiring Bi-level ventilation.
    - AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during the screening period.
    - Respiratory tract infection within 4 weeks prior to screening, or during the screening period.
    - History of, or planned pneumonectomy or lung volume reduction surgery. Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation <4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program can be included).
    - Diagnosis of α-1 anti-trypsin deficiency.
    E.5 End points
    E.5.1Primary end point(s)
    1. Annual rate of acute COPD exacerbation (AECOPD) : Annualized rate of moderate or severe COPD exacerbations over the 52-week treatment period compared to placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline to week 52
    E.5.2Secondary end point(s)
    1. Change in pre-bronchodilator FEV1 : Change in pre-bronchodilator FEV1 from baseline to Week 12 compared to placebo
    2. Change in SGRQ : Change from baseline to Week 52 in SGRQ total score compared to placebo
    3. Improvement in SGRQ : Proportion of patients with SGRQ improvement ≥4 points at Week 52
    4. Change in pre-bronchodilator FEV1 from baseline to Week 52 : Change in pre-bronchodilator FEV1 from baseline to Week 52 compared to placebo
    5. Change in pre-bronchodilator FEV1 from baseline to time points up to Week 44 : Change in pre-bronchodilator FEV1 from baseline to weeks other than 12 and 52 (i.e. Weeks 2, 4, 8, 24, 36 and 44) compared to placebo
    6. Change in post-bronchodilator FEV1 lung function : Change in post-bronchodilator FEV1 from baseline at Weeks 2, 4, 8, 12, 24, 36 and 52 compared to placebo
    7. Change in forced expiratory flow (FEF) 25-75% : Change in FEF 25-75% from baseline to Weeks 2, 4, 8, 12, 24, 36, 44 and 52
    8. Annualized rate of severe AECOPD : Annualized rate of severe COPD exacerbations compared to placebo over the 52-week treatment period
    9. Time to first AECOPD : Time to first moderate or severe COPD exacerbation compared with placebo during the 52-week treatment period
    10. Adverse events : Number of adverse events (AEs)/treatment-emergent adverse events (TEAEs)
    11. Potentially clinically significant abnormality (PCSA) in laboratory tests : Percentage of patients with at least one incidence of PCSA
    12. Anti-drug antibodies : Incidence of anti-drug antibodies against dupilumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline to week 12
    2. 3. 4. 8. 9. Baseline to week 52
    5. Baseline to weeks 2, 4, 8, 24, 36, 44
    6. Baseline to weeks 2, 4, 8, 12, 24, 36, 52
    7. Baseline to weeks 2, 4, 8, 12, 24, 36, 44, 52
    10. 11. 12. Baseline through week 64
    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 Yes
    E.6.11Pharmacogenomic No
    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 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 EEA78
    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
    Chile
    Ukraine
    Canada
    China
    Israel
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    United States
    Bulgaria
    Czechia
    Denmark
    Finland
    Germany
    Hungary
    Italy
    Poland
    Romania
    Slovakia
    Spain
    Sweden
    Türkiye
    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 visit of the last participant (LVLS).
    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 months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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: 1588
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 466
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 658
    F.4.2.2In the whole clinical trial 2054
    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
    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 Decision2019-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-05-02
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