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    Summary
    EudraCT Number:2020-001217-20
    Sponsor's Protocol Code Number:LPS16677
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-07-17
    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 ConcernedGermany - PEI
    A.2EudraCT number2020-001217-20
    A.3Full title of the trial
    A phase 4, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of the effect of dupilumab on sleep disturbance in patients with uncontrolled persistent asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dupilumab asthma sleep study
    A.3.2Name or abbreviated title of the trial where available
    MORPHEO
    A.4.1Sponsor's protocol code numberLPS16677
    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 & Developpement
    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 Deutschland GmbH
    B.5.2Functional name of contact point
    B.5.3.4CountryGermany
    B.5.6E-mailmedinfo.de@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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    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
    Asthma
    E.1.1.1Medical condition in easily understood language
    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
    To assess the effect of dupilumab on sleep
    E.2.2Secondary objectives of the trial
    -To evaluate the effect of dupilumab on additional patient reported sleep outcomes
    -To evaluate the effect of dupilumab on objective sleep assessment
    -To evaluate the effect of dupilumab on asthma symptoms
    -To evaluate the effect of dupilumab on lung function
    -To evaluate the safety of dupilumab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PSG sub-study in the US:To evaluate the effect of dupilumab on
    additional objective sleep assessments using polysomnography (PSG)-
    tertiary/exploratory objective
    E.3Principal inclusion criteria
    - Physician diagnosis of asthma based on the Global Initiative for
    Asthma (GINA) 2020 Guidelines for ≥12 months treated with medium to
    high dose inhaled corticosteroid (ICS) and a second controller (ie, longacting beta agonist, leukotriene receptor antagonist). A third controller
    is allowed but not mandatory. The dose regimen should be stable for at
    least 1 month before the study and during the screening period
    - History of at least one severe asthma exacerbation within 1 year prior
    to screening. Severe exacerbation is defined as deterioration of asthma
    that results in emergency treatment, hospitalization due to asthma, or
    treatment with systemic steroids (oral or injectable)
    - Eosinophils ≥150 cells/μL and fractional exhaled nitric oxide (FeNO) ≥
    25 ppb during screening, prior to randomization
    NOTES:
    * Historical values of blood eosinophil count meeting the eligibility
    criterion measured within 6 months prior to screening Visit 1 in the
    absence of oral corticosteroid (OCS) treatment are allowed.
    * FeNO value to be checked for eligibility at Visit 2 as well.
    - Asthma control questionnaire (ACQ)-5 ≥2.5 at screening Visit 1 and Visit 2, prior to randomization
    - Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) ≤
    80% of predicted normal during screening, prior to randomization
    - Exhibit bronchodilator reversibility (≥12% and 200 mL improvement in
    FEV1 post short-acting beta agonist administration) during screening
    period, prior to randomization, unless reversibility test meeting the
    inclusion criteria was done within 6 months prior to screening Visit 1
    - Weekly average nocturnal awakenings due to asthma symptoms in the
    week prior to screening Visit 1 is ≥1
    E.4Principal exclusion criteria
    - Current smoker
    - Former smoker for 10 years with a smoking history of >10 pack-years
    - Severe Asthma exacerbation during screening, prior to randomization
    - History or clinical evidence of chronic obstructive pulmonary disease
    (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other
    significant lung disease (eg, lung fibrosis, sarcoidosis, interstitial lung
    disease, pulmonary hypertension, bronchiectasis, Churg-Strauss
    Syndrome)
    - History of or current evidence of clinically significant non-respiratory
    diseases that in the opinion of the investigator may interfere with the
    aims of the study or put the participant at undue risk
    - Active tuberculosis (TB) or non-tuberculous mycobacterial infection, or
    a history of incompletely treated TB will be excluded unless it is well
    documented by a specialist that the participant has been adequately
    treated and can now start treatment with a biologic agent, in the medical
    judgment of the Investigator and/or infectious disease specialist.
    Tuberculosis testing would be performed on a country by country basis,
    according to local guidelines if required by Regulatory Authorities or
    ethics boards
    - Diagnosed active endoparasitic infection; suspected or high risk of
    endoparasitic infection, unless clinical and (if necessary) laboratory
    assessment have ruled out active infection before randomization
    - History of human immunodeficiency (HIV) infection or positive HIV test
    at screening Visit 1
    - Active chronic or acute infection requiring treatment with systemic
    antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks
    before screening
    - Known or suspected immunodeficiency including history of invasive
    opportunistic infections, despite infection resolution
    - Current evidence of clinically significant oncological disease
    - History of systemic hypersensitivity or anaphylaxis to any biologic
    therapy
    - Severe uncontrolled depression
    - Sleep disturbances not related to asthma, including sleep apnea,
    hypersomnia, or insomnia secondary to chronic pain, atopic dermatitis
    (AD), COPD or other conditions
    - Participant who works night shift (ie, any work between 8 pm and 6
    am)
    - Erratic sleep habits, as determined by the Investigator
    - Restless leg syndrome or periodic limb movement disorder
    - Chronic treatment with OCS for more than 2 weeks before screening
    Visit 1
    - Participant taking sedative, anxiolytic, or hypnotic treatments,
    including melatonin, within 3 months before randomization
    - Participant taking systemic sedative antihistamines (excluding newer
    generations of antihistamines) or theophylline
    - Current treatment with antidepressants, lipophilic beta blockers,
    clonidine, opioids, or other medications known to interfere with sleep and may confound the study assessments, as determined by the
    Investigator
    - Participant who has taken biologic therapy (including
    dupilumab)/systemic immunosuppressant to treat inflammatory disease
    or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel
    disease, primary biliary cirrhosis, systemic lupus erythematosus,
    multiple sclerosis, etc) within 2 months or 5 half-lives before screening
    Visit 1, whichever is longer.
    - Treatment with live (attenuated) vaccine within 4 weeks before
    screening Visit 1
    NOTE: For participants who have vaccination with live, attenuated
    vaccines planned during the course of the study (based on national
    vaccination schedule/local guidelines), it will be determined, after
    consultation with a physician, whether the administration of vaccine can
    be postponed until after the end of the study, (i.e. after the 12 week
    follow-up period off-treatment or until the participant switches to
    commercialized dupilumab or other biologic product, whichever comes
    first), or preponed to before the start of the study without compromising
    the health of the participant:
    * Participant for whom administration of live (attenuated) vaccine can
    be safely postponed would be eligible to enroll into the study.
    * Participant who have their vaccination preponed can enroll in the study
    only after a gap of 4 weeks following administration of the vaccine.
    E.5 End points
    E.5.1Primary end point(s)
    Change in sleep disturbance score in Asthma Sleep Disturbance Questionnaire ; Change from baseline to Week 12 in sleep disturbance score using the Asthma Sleep Disturbance Questionnaire
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 12
    E.5.2Secondary end point(s)
    1 - Change in the number of nocturnal awakenings in Sleep Diary ; Change from baseline to Week 12 in the number of nocturnal awakenings as recorded in Sleep Diary
    2 - Change in PROMIS sleep-related impairment assessment ; Change from baseline to Week 12 in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep-related impairment 8a scale.
    3 - Change in sleep quality in Sleep Diary ; Change from baseline to Week 12 in sleep quality (Sleep Diary)
    4 - Change in restorative sleep in Sleep Diary ; Change from baseline to Week 12 in restorative sleep (Sleep Diary)
    5 - Change in WASO in Sleep Diary ; Change from baseline to Week 12 in wake after sleep onset (WASO) (Sleep Diary)
    6 - Change in WASO (actigraphy data) ; Change from baseline to Week 12 in WASO based on actigraphy data
    7 - Change in daytime and nighttime asthma symptoms in Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) ; Change from baseline to Week 12 in Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD)
    8 - Change in pre-bronchodilator (BD) FEV1 ; Change from baseline to Week 12 in prebronchodilator forced expiratory volume in 1 second (pre-BD FEV1)
    9 - Incidence of Adverse events ; Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESI), including clinically significant changes in vital signs considered to be adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3, 4, 5, 6, 7, 8 : Baseline to Week 12
    9 : Baseline to Week 24
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Exploratory
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    United States
    Netherlands
    Spain
    Germany
    Italy
    Portugal
    Russian Federation
    Ukraine
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days17
    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: 578
    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 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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 91
    F.4.2.2In the whole clinical trial 578
    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 Decision2020-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-10
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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