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    Summary
    EudraCT Number:2019-002619-24
    Sponsor's Protocol Code Number:R668-ABPA-1923
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-06-18
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-002619-24
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients with Allergic Bronchopulmonary Aspergillosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Dupilumab in Patients with Allergic Bronchopulmonary Aspergillosis
    A.3.2Name or abbreviated title of the trial where available
    LIBERTY-ABPA AIRED
    A.4.1Sponsor's protocol code numberR668-ABPA-1923
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown, NY
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 Yes
    D.2.1.1.1Trade name Dupixent
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Research & Development
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNdupilumab
    D.3.9.2Current sponsor codeREGN668
    D.3.9.3Other descriptive nameDUPILUMAB
    D.3.9.4EV Substance CodeSUB130625
    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 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 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
    Allergic bronchopulmonary aspergillosis (ABPA)
    E.1.1.1Medical condition in easily understood language
    ABPA is a progressive, immunologic lung disease caused by hypersensitivity to the fungus Aspergillus fumigatus (A fumigatus).
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10001707
    E.1.2Term Allergic bronchopulmonary aspergillosis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of dupilumab on the annualized rate of exacerbations in patients with ABPA.
    E.2.2Secondary objectives of the trial
    -To evaluate the effects of dupilumab on lung function in patients with ABPA
    -To evaluate the effects of dupilumab on ABPA-related exacerbations
    -To evaluate the effects of dupilumab on hospitalization/emergency department
    (ED)/urgent care visits in patients with ABPA
    -To evaluate the effects of dupilumab on asthma control in patients with ABPA
    -To evaluate the effects of dupilumab on health-related quality of life (HRQoL) in
    patients with ABPA
    -To evaluate the effects of dupilumab on radiological changes in the lungs in patients
    with ABPA
    -To evaluate the effects of dupilumab on serum total IgE and Aspergillus-specific IgE
    concentrations
    -To evaluate the effects of dupilumab on fractional exhaled nitric oxide (FeNO) levels
    -To evaluate safety and tolerability of dupilumab in patients with ABPA
    -To evaluate dupilumab concentrations in serum and the incidence of anti-dupilumab
    antibodies in patients with ABPA
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sputum/Blood Immunophenotyping Substudy
    E.3Principal inclusion criteria
    1. Diagnoses of both ABPA and asthma.
    2. On a maintenance therapy for their asthma with controller medication which must include ICS and may include 1 or more additional controller medications including a LABA, LTRA, and/or LAMA, etc for at least 12 weeks, with a stable dose and regimen with no change in the dose or frequency of administration for at least 4 weeks prior to the screening visit, and between the screening and baseline/randomization visits
    3. For patients on OCS: must be on a chronic stable dose (no change in the dose) of up to 10 mg/day or 30 mg every alternate day of OCS (prednisone/prednisolone or the equivalent) for at least 4 weeks prior to the screening visit and between the screening and the baseline/randomization visit.
    4. Must have experienced >=1 severe respiratory exacerbation requiring treatment with systemic corticosteroids or hospitalization or treatment in ED/urgent care within 12 months prior to the screening visit, or must have received systemic corticosteroids during 5 of the 6 months prior to the screening visit and between the screening and baseline visits.

    NOTE: Other protocol defined inclusion criteria apply
    E.4Principal exclusion criteria
    1. Weight less than 30.0 kilograms
    2. Current smoker or e-cigarette user, cessation of smoking or e-cigarette use within 6 months prior to randomization, or >10 pack-years smoking history
    3. Post-bronchodilator FEV1 <30% predicted normal at screening
    4. Respiratory exacerbation requiring systemic corticosteroids within 4 weeks prior to screening and between screening and baseline visit (for patients on daily OCS, exacerbation requiring at least doubling of the daily maintenance dose of corticosteroids)
    5. Upper or lower respiratory tract infection within the 4 weeks prior to screening (visit 1) or between the screening and randomization visits
    6. Significant chronic pulmonary disease other than asthma complicated with ABPA (eg, physician-diagnosed bronchiectasis due to a condition other than ABPA or with a history of a positive lower respiratory culture for P aeruginosa or other multi-drug-resistant, gram-negative bacilli; cystic fibrosis; sarcoidosis; interstitial lung disease not due to ABPA; chronic obstructive pulmonary disease [COPD] not due to ABPA; hypereosinophilic syndrome; etc) or a diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts
    7. Diagnosis or suspected diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA; also called Churg-Strauss Syndrome)

    NOTE: Other protocol defined exclusion criteria apply
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in the study is the annualized rate of severe respiratory exacerbations defined as new onset of symptoms or clinical worsening requiring systemic corticosteroid treatment for ≥3 days; for patients who are on maintenance systemic corticosteroids, at least doubling of the dose of daily systemic corticosteroids for ≥3 days (with or without antibiotic therapy if indicated) compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to week 52
    E.5.2Secondary end point(s)
    1. Change from baseline in pre-bronchodilator FEV1 compared to placebo at week 24
    2. Change from baseline in pre-bronchodilator FEV1 compared to placebo at week 52
    3. Annualized rate of ABPA-related exacerbations, defined as severe respiratory exacerbations (as defined above) that are associated with a doubling of serum total IgE from the prior pre-exacerbation value compared to placebo
    4. Annualized rate of severe respiratory exacerbations requiring either hospitalization or observation for >24 hours in an ED/urgent care facility compared to placebo
    5. Change from baseline in ACQ-5 compared to placebo
    6. Change from baseline in SGRQ total score compared to placebo
    7. Percentage of participants achieving a reduction in the SGRQ score of 4 points or greater compared to placebo
    8. Change in mucus plugging score on chest CT compared to placebo
    9. Percent change from baseline in total IgE in serum compared to placebo
    10. Percent change from baseline in A fumigatus-specific IgE in serum compared to placebo
    11. Percent and absolute change from baseline in FeNO compared to placebo
    12. Incidence of treatment-emergent adverse events (TEAEs)
    13. Immunogenicity of dupilumab, as determined by the incidence, titer, and clinical impact of treatment-emergent ADA to dupilumab
    14. Concentrations of functional dupilumab in serum by treatment regimen
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 24
    2. Week 52
    3- 12. Up to week 52
    13 - 14. Up to 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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Bulgaria
    Canada
    France
    Germany
    Hungary
    Japan
    Netherlands
    Poland
    Romania
    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 date the last patient completes the last study visit, withdraws from the study, or is lost to follow-up (ie, the study patient can no longer be contacted by the investigator).
    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 days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 18
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 18
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 170
    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 Decision2020-06-25
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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