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    Summary
    EudraCT Number:2019-004889-18
    Sponsor's Protocol Code Number:1.3
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-10
    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 ConcernedAustria - BASG
    A.2EudraCT number2019-004889-18
    A.3Full title of the trial
    Effect of Dupilumab in patients with aspirin-exacerbated respiratory
    disease (AERD)
    -A single-center prospective pilot study
    Wirksamkeit von Dupilumab auf den Krankheitsverlauf bei Patienten mit AERD (Aspirin-exacerbated resoiratory disease)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Dupilumab in patients with allergic asthma, nasal polyps and
    aspirin intolerance
    A.4.1Sponsor's protocol code number1.3
    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 SponsorMedical University of Vienna
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical University of Vienna
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Vienna
    B.5.2Functional name of contact pointClinical trial information lead
    B.5.3 Address:
    B.5.3.1Street AddressWaehringer Guertel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.6E-mailjulia.eckl-dorna@meduniwien.ac.at
    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 (Dupilumab)
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Genzyme
    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 nameDupixent
    D.3.4Pharmaceutical form 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.3.9.1CAS number 1190264-60-8
    D.3.9.2Current sponsor codeSanofi
    D.3.9.3Other descriptive nameDupixent
    D.3.9.4EV Substance CodeSUB179171
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Aspirin-exacerbated respiratory disease (AERD), also known as Samter's
    Triad or Widal's triad, comprises the triad of allergic asthma, chronic
    rhinosinusitis with nasal polyps (CRswNP) and nonsteroidal antiinflammatory
    drug (NSAID) intolerance. The prevalence of AERD remains
    unclear. It is estimated that among patients with CRSwNP approximately
    30% have allergic asthma and 15% have aspirin intolerance.
    E.1.1.1Medical condition in easily understood language
    Triad of allergic asthma, nasal polyps and intolerance to pain killers
    (aspirin)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the efficacy of dupilumab in 30 patients with AERD regarding the
    intolerance to salicylic acid after 6 months. This will be evaluated by oral
    drug provocation testing with low dose salicylic acid after 6 months of
    dupilumab treatment. As control groups 10 patients with polyps without aspirin intolerance and 10 healthy controls will undergo apirin provocation testing.
    E.2.2Secondary objectives of the trial
    Serum ECP, total IgE, allergen-specific IgE, tryptase, peripheral blood eosinophils
    Skin prick test
    Smell identification test (UPSIT) for assessment of olfaction
    Cytokine pattern in nasal secretions at indicated timepoints and also before and after provocation
    Nasal mucosa as assessed by nasal biopsies before and after one month of therapy
    Inflammatory cytokine patterns at mRNA levels in samples obtained by nasal curettes
    Nasal microbiome
    Total nasal endoscopic polyps scores (TPS),
    Sino-Nasal Outcome Test-22 (SNOT-22), which measures the quality of life of patients with chronic rhinosinusitis 3-5
    Sinus computed tomographic scans (Lund-McKay)
    Asthma control test (ACT), Asthma control questionnaire (ACQ)
    Lung function
    Baseline, concomitant medication (CM) at all time points
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18 – 70
    • Female and male patients
    • Diagnosed with AERD (nasal polyps, asthma, aspirin intolerance)
    o CRwNP (according to the European Position Paper on Rhinosinusitis
    and Nasal Polyps Guidelines)8
    o Documented aspirin intolerance
    o Allergic asthma bronchiales diagnosed by a respiratory physician
    (based on Global Initiative for Asthma guidelines)
    Signed and dated informed consent form
    E.4Principal exclusion criteria
    • Pregnancy
    • Clinically significant abnormal laboratory values and active infection
    (Tbc, HIV, hepatitis A/B/C)
    • History of malignancy or immunodeficiency
    • Chronic obstructive lung disorders (COPD), other obstructive lung
    disorders (bronchiolitis)
    • Need for systemic corticosteroid therapy 1 month prior to screening
    visit
    E.5 End points
    E.5.1Primary end point(s)
    Effect regarding the tolerance to salicylic acid of patients with AERD
    following dupilumab therapy for 6 months. After 6 months of therapy,
    patients will not tolerate aspirin dose levels as tested with different
    dosages (125mg, 250mg and 500 mg)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    Changes in blood- or nasal–derived biomarkers, total nasal endoscopic
    polyps scores, patients' quality of life or allergic asthma
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 50
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state50
    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)
    Patients with significant improvement of nasal polyps and allergic
    asthma as evaluated by lung function testing/ ENT examination after 6
    months will continue to receive dupilumab in an outpatient clinical
    setting. Patients w/o clinical improvement will stop dupilumab
    treatment.
    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 Decision2022-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-09
    P. End of Trial
    P.End of Trial StatusOngoing
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