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    Summary
    EudraCT Number:2022-003303-14
    Sponsor's Protocol Code Number:DETACT
    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:2022-12-20
    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 number2022-003303-14
    A.3Full title of the trial
    Effect of Dupilumab on mucus plugs and inflammatory patterns in sEvere asThmatiC paTients (DETACT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influence of Dupilumab, a monoclonal antibody blocking interlekin 4 and interleukin 13, on the mucus buildup as well as inflammation parameters in patients with severe asthma
    A.3.2Name or abbreviated title of the trial where available
    DETACT
    A.4.1Sponsor's protocol code numberDETACT
    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, Clinic of Internal Medicine II, Department of Pulmonology
    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, Clinic for Internal Medicine II, Department of Pulmonology
    B.5.2Functional name of contact pointUniv. Prof. Dr. Marco Idzko
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number0043140 400 47740
    B.5.5Fax number0043140 400 47840
    B.5.6E-mailmarco.idzko@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
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    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.3.4Pharmaceutical 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 codeDETACT
    D.3.9.4EV Substance CodeSUB179171
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe asthma is a chronic inflammatory condition of the airways, characterized with wheezing, breathlessness, chest tightness and coughing. T2-high asthma is promoted by differentiated T helper cells driving eosinophil recruitment and the secretion of type 2 cytokines including IL-4, IL-5 and IL-13. Recent reports suggest that persistent T2 inflammation and eosinophilia in the lung are associated with mucus plugging, but its correlation with airway obstruction is poorly understood.
    -
    E.1.1.1Medical condition in easily understood language
    Severe asthma is a chronic inflammatory condition of the airways, associated with wheezing, breathlessness, chest tightness and coughing. It can reduce the quality of life and activities performance.
    -
    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
    The objective of this study is to investigate the effect of dupilumab treatment on mucus plugging in severe asthma patients with blood eosinophilia. Therefore, we plan to apply computer tomography to investigate mucus plugging and thoroughly examine different airway samples from T2-high severe asthmatic patients at a cellular, molecular, microbiological and metabolomic level. This study will help to unravel underlying treatment mechanisms of dupilumab therapy in severe asthmatics.
    -
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are to evaluate the effect of dupilumab:
    • on cellular composition and activation pattern of bronchoalveolar lavage (BAL) immune cells
    • on cellular activation profile in lung tissue
    • on inflammatory mediator expression in the BAL and lung tissue
    • on composition of the lung microbiome (BAL)
    • blood eosinophils
    • daily measured Fractional exhaled Nitric Oxide levels (FeNO)
    • daily measured lung function
    -
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients who:
    • are ≥18 years of age
    • have a recorded clinical diagnosis of asthma (ICD-10 Code: J45)
    • meet the requirements for treatment of severe T2-high asthma for Dupilumab defined as:
    o FeNO > 25 ppB
    o two measurements of 250 eosinophils /µl in the blood OR one measurement of blood eosinophils 250 cells/µl during reduction of OCS dosing if treated with oral corticosteroids and/or one measurement of sputum ≥ 2% or BAL eosinophils ≥ 1%
    • have a history of treatment with monoclonal antibodies for asthma if a wash out period of 2 half-lives or 1 month (whatever is longer) has passed
    -
    E.4Principal exclusion criteria
    Patients who:
    • are pregnant as determined by a ß-HCG test
    • have severe anatomic variations or deviations that do not allow bronchoscopy
    • suffer from additional others confounding underlying lung disorder including but not limited to:
    o Bronchiectasis, chronic obstructive pulmonary disorder (COPD), pulmonary fibrosis, emphysema,
    o Cystic fibrosis, any known parasitic infections and lung cancer.
    • show pulmonary conditions with symptoms of asthma and blood eosinophilia, including but not limited to:
    o Churg-Strauss syndrome,
    o allergic bronchopulmonary aspergillosis
    o hypereosinophilic syndrome
    • suffer from a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
    • have clinically meaningful comorbidity as determined by the evaluating committee
    • experience of an asthma exacerbation within 4 weeks prior to the first main visit
    • immune disorder and/or immunosuppressive treatment (e.g. cyclosporine), ongoing biological treatment of asthma (e.g., mepolizumab, omalizumab, benralizumab) or last biological treatment 2 half-lives or 1 month before the first main visit
    • have a history of drug and alcohol abuses
    • are currently smoking or are former smokers for less than 6 months with >10 pack years should be excluded from this study.
    -
    E.5 End points
    E.5.1Primary end point(s)
    Characteristics of Mucus plugging evaluated with CT-scan after a Treatment with Dupilumab for 20 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    CT scans will be performed two times as no-contrast CTs. The score of the extent of air-trapping, bronchial wall thickening and mucus plugging per pulmonary segment based will be evaluated. The bronchoscopy may either be clinically indicated (not study-related) to evaluate the status of severe asthma and define treatment options, or study-specific if not clinically indicated. In the most cases is the CT Scan on baseline clinically indicated and the CT after 20 weeks of therapy with Dupilumab will be study-specific.
    E.5.2Secondary end point(s)
    baseline demographics, clinical characteristics, biomarker level,
    inflammatory pattern (e.g. cellular distribution/cytokine levels), lung
    microbiome with the severity of mucus plugs
    • baseline demographics, clinical characteristics, biomarker level,
    inflammatory pattern (e.g. cellular distribution/cytokine levels), lung
    microbiome with treatment response determined by lung function,
    patients related outcomes, UHCR, number of asthma exacerbations and
    uOCS
    mucus plugging with treatment response determined by lung function,
    patients related outcomes, UHCR, number of asthma exacerbations and
    uOCS to evaluate mucus plugs as a viable parameter for treatment
    response
    And we want to evluate:
    • if changes in daily measured FeNO interferes with daily measured lung
    function parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    In this prospective exploratory pilot study, we plan to include 10 patients with severe asthma indicated for Dupixent treatment. The individual study duration will be no longer than 26 weeks (4-week run in + 20 weeks of routine visits + 2-week follow-up) including 14 scheduled site visits.
    -
    -
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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
    After 20 weeks of Therapy with Dupixent, clinical and laboratory investigations as named in Protocol would be performed, and with the last investigations the study will be ended. This ist planned for Week 22 from beginning of the study.
    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 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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-12-20. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    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 state10
    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
    Nein
    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 Decision2023-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-16
    P. End of Trial
    P.End of Trial StatusOngoing
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