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    Summary
    EudraCT Number:2022-002891-35
    Sponsor's Protocol Code Number:RECHMPL22_0123
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-04-09
    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 ConcernedFrance - ANSM
    A.2EudraCT number2022-002891-35
    A.3Full title of the trial
    REVErsing airway Remodelling with Tezepelumab (REVERT): a protocol for a double-blind randomized controlled trial for patients with asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    REVErsing airway Remodelling with Tezepelumab (REVERT)
    A.3.2Name or abbreviated title of the trial where available
    REVERT
    A.4.1Sponsor's protocol code numberRECHMPL22_0123
    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 SponsorUniversity Hospital of Montpellier
    B.1.3.4CountryFrance
    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 supportAstraZeneca
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Montpellier
    B.5.2Functional name of contact pointFanny CARDON
    B.5.3 Address:
    B.5.3.1Street AddressHôpital La Colombière - Pavillon 32 - 39, Avenue Charles Flahault
    B.5.3.2Town/ cityMontpellier Cedex 5
    B.5.3.3Post code34295
    B.5.3.4CountryFrance
    B.5.4Telephone number+33467330824
    B.5.5Fax number+33467339172
    B.5.6E-mailfanny-cardon@chu-montpellier.fr
    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 nameTezepelumab
    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 INNTezepelumab
    D.3.9.1CAS number 1572943-04-4
    D.3.9.2Current sponsor codeMEDI9929
    D.3.9.3Other descriptive nameAMG 157
    D.3.9.4EV Substance CodeSUB179650
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    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
    exacerbating asthma
    E.1.1.1Medical condition in easily understood language
    Severe asthma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    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
    Compare the change-from-baseline in the average percentage bronchial wall area (%WA = (wall area (mm2)/ (wall area (mm2) + lumen area (mm2)))×100) for patients with asthma and undergoing 6 months of tezepelumab treatment with a similar population treated via placebo
    E.2.2Secondary objectives of the trial
    Continued treatment effects associated with longer treatment (12 months) or remanence after treatment stopping at 6 months will also be quantified.
    Study arms will additionally be compared in terms of:
    • Changes in radiomics (CT-scan data);
    • Changes in exacerbation rates and lung function;
    • Changes in serum club cell secretory protein (CCSP);
    • Changes in nasal single-cell transcriptomic signatures.
    This study also has an exploratory component designed to characterize the physiological repair environment. In depth radiomic and transcriptomic (including single-cell analyses) profiling will be performed. Finally, the capacity of baseline data to predict the response to tezepelumab will also be explored.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Admitted to screening visit:
    • Minimum age: 18
    • Maximum age: 85
    • Able to perform an inspiratory and expiratory thoracic computed tomography (CT) scan, plus a nasal CT
    • Physician-diagnosed asthma according to GINA criteria
    • Disease with clinical impact: at least 1 severe or 2 moderate exacerbations† in the previous 12 months despite treatment according to the best standards of care
    • Maximal inhaled therapy comprising high dose ICS and at least a second controller according to GINA

    Based on results of screening visit and run-in:
    • Post-bronchodilator forced expiratory volume in 1 second (FEV1) predicted values must be at 25-90%
    • Asthma Control Questionnaire 6 (ACQ6) > 1.5
    • Oral corticosteroid maintenance therapy (if used) is 7.5 mg/day
    • In stable condition for the 4-week run-in period
    • On CT scan, the average percentage wall area index at the B1 and B8 bronchi (generation 3) is >65%
    E.4Principal exclusion criteria
    • CT abnormalities evocative of any respiratory condition other than asthma‡
    • Treatment regimen discordant with best practices
    • Pulmonary disease other than asthma‡ requiring treatment during the previous 12 months
    • A smoking history of >20 pack years
    • Biological therapy§ during the past 3 months
    • Absence of signed consent
    • Non-beneficiary of the French social security, single-payer health insurance system
    • Presence of any condition (physical, psychological or other) that might, in the investigator’s opinion, hinder study performance††
    • The patient is unavailable or unwilling to participate in future visits
    • Potential interference from other studies‡‡
    • Protected populations according to the French public health code§§
    • Male or female patients seeking to conceive a child
    E.5 End points
    E.5.1Primary end point(s)
    the %WA at the B1 and B8 bronchi, generations 3, 4 and 5
    E.5.1.1Timepoint(s) of evaluation of this end point
    between baseline and 6 months
    E.5.2Secondary end point(s)
    Clinical outcomes
    • Presence/absence of nasal polyposis
    • Annualized exacerbation rates
    • Days alive and not exacerbating
    • Days alive and not hospitalized
    • Pre- and post-bronchodilator spirometry [forced expiratory volume in 1 second (FEV1; litres and percent predicted), forced vital capacity (FVC; litres and percent predicted) and the FEV1/FVC ratio (litres/litres))
    • Pre- and post-bronchodilator plethysmography [total lung capacity (TLC; litres and percent predicted), residual volume (RV; litres and percent predicted) and the TLC/RV ratio (litres/litres)] (only at baseline, 6 months and 12 months)
    • Inspiratory and expiratory oscillometry parameters: (i) the machine used; (ii) resistance at 5 Hz (R5), (iii) resistance at 20 Hz (R20), (iv) R20-R5, (v) reactance at 5 Hz (X5).

    Validated questionnaires
    • Asthma Control Questionnaire 6 (ACQ6)
    • Breathlessness, Cough and Sputum Scale (BCSS)
    • Sino Nasal Outcome Test 22 (SNOT-22)
    • St George Respiratory Questionnaire (SGRQ)
    • The European Community Respiratory Health Survey (ECRHS) III Main questionnaire, items 21-23

    Bloodwork
    Club cell secretory protein (CCSP), an emerging blood marker associated with pulmonary function and cellular cross-talk (Berg et al. 2002; Gamez et al. 2015; Knabe et al. 2019; Knabe et al. 2016; Londhe et al. 2011), will be assayed. In addition, a serum collection will be created for the study to enable ancillary studies.

    Nasal brushing analyses
    Nasal brushings will be used for transcriptomic analyses at baseline and single-cell analyses longitudinally.

    Single cell analyses
    Single cell analyses will be performed on a subset of patients from volunteer centres (properly equipped and willing to prepare cell fixation from nasal brushings)

    Safety
    In addition to standard adverse event reporting performed throughout the study, injection site reactions will also be specifically recorded.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 6 and 12 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 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) 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 concerned12
    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 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
    LVLS
    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 months3
    E.8.9.1In the Member State concerned days
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state90
    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 Decision2023-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-04
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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