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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of dupilumab on exercise capacity in patients with moderate-to-severe asthma

    Summary
    EudraCT number
    		 2019-002742-20
    Trial protocol
    		 DE   GB  
    Global end of trial date
    15 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Apr 2024
    First version publication date
    06 Apr 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    R668-AS-1903
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc
    Sponsor organisation address
    777 Old Saw Mill River Road, Tarrytown, United States, 10591
    Public contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc, 001 844-734-6643, clinicaltrials@regeneron.com
    Scientific contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc, 001 844-734-6643, clinicaltrials@regeneron.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Determine whether dupilumab treatment improves exercise capacity and physical activities.
    Protection of trial subjects
    It is the responsibility of both the sponsor and the investigator(s) to ensure that this clinical study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with the ICH guidelines for GCP and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jul 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    40
    EEA total number of subjects
    34
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    40
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 127 participants screened, 87 screen-fail, 40 participants randomized

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Matching dupilumab placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for Dupilumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo - 600 mg loading dose on study day 1 followed by 300 mg Q2W from weeks 2 to 10

    Arm title
    		 dupilumab
    Arm description
    		 A loading dose at the start of the treatment followed by once every two weeks (Q2W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dupilumab
    Investigational medicinal product code
    REGN668
    Other name
    DUPIXENT
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    600 mg loading dose on study day 1 followed by 300 mg Q2W from weeks 2 to 10

    Number of subjects in period 1
    		Placebo dupilumab
    Started
    20
    20
    Completed
    18
    20
    Not completed
    2
    0
         Adverse event, non-fatal
    1
    -
         Did not complete End of Study follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching dupilumab placebo

    Reporting group title
    dupilumab
    Reporting group description
    		 A loading dose at the start of the treatment followed by once every two weeks (Q2W).

    Reporting group values
    		 Placebo dupilumab Total
    Number of subjects
    		 20 20 40
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 20 20 40
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 46.5 ± 7.7 45.3 ± 7.8 -
    Sex: Female, Male
    Units: Participants
        Female
    		 11 8 19
        Male
    		 9 12 21
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 2 1 3
        White
    		 18 19 37
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 2 3
        Not Hispanic or Latino
    		 19 18 37
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching dupilumab placebo

    Reporting group title
    dupilumab
    Reporting group description
    		 A loading dose at the start of the treatment followed by once every two weeks (Q2W).

    Primary: Change from baseline to week 12 in constant work rate exercise endurance time

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    End point title
    		 Change from baseline to week 12 in constant work rate exercise endurance time [1]
    End point description
    CWRET (Constant Work Rate Exercise Test) will be performed on an electromagnetically-braked cycle ergometer in an exercise physiology laboratory overseen by a trained pulmonologist or medical doctor designee.
    End point type
    Primary
    End point timeframe
    Up to week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point
    End point values
    		 Placebo dupilumab
    Number of subjects analysed
    17
    20
    Units: Minutes
        arithmetic mean (confidence interval 95%)
    0.923 (-0.614 to 2.460)
    1.742 (-0.054 to 3.538)
    No statistical analyses for this end point

    Secondary: Change from baseline to week 12 in pre- and post-exercise Forced Expiratory Volume in One Second (FEV1)

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    End point title
    		 Change from baseline to week 12 in pre- and post-exercise Forced Expiratory Volume in One Second (FEV1)
    End point description
    Based on spirometry data
    End point type
    Secondary
    End point timeframe
    Up to week 12
    End point values
    		 Placebo dupilumab
    Number of subjects analysed
    20
    20
    Units: Liters
    arithmetic mean (confidence interval 95%)
        Pre-exercise
    0.2123 (0.0072 to 0.4174)
    0.4205 (0.1409 to 0.7000)
        2-min Post-Exercise
    0.2550 (-0.2390 to 0.7490)
    0.2902 (0.0886 to 0.4919)
        5-min Post-Exercise
    0.2416 (0.0238 to 0.4593)
    0.4156 (0.1505 to 0.6808)
        10-min Post-Exercise
    0.2211 (0.0180 to 0.4243)
    0.4613 (0.2167 to 0.7060)
        20-min Post-Exercise
    0.2496 (0.0608 to 0.4384)
    0.4738 (0.2230 to 0.7245)
    No statistical analyses for this end point

    Secondary: Change from baseline to week 12 in the mean duration of moderate-to-vigorous physical activity

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    End point title
    		 Change from baseline to week 12 in the mean duration of moderate-to-vigorous physical activity
    End point description
    Defined as ≥3 METs. Based on accelerometry data
    End point type
    Secondary
    End point timeframe
    Up to week 12
    End point values
    		 Placebo dupilumab
    Number of subjects analysed
    15
    16
    Units: Minutes
        arithmetic mean (confidence interval 95%)
    -11.01 (-30.52 to 8.50)
    9.38 (-13.41 to 32.18)
    No statistical analyses for this end point

    Secondary: Change from baseline to week 12 in average number of steps walked per day

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    End point title
    		 Change from baseline to week 12 in average number of steps walked per day
    End point description
    Based on accelerometry data
    End point type
    Secondary
    End point timeframe
    Up to week 12
    End point values
    		 Placebo dupilumab
    Number of subjects analysed
    15
    16
    Units: Steps
        arithmetic mean (confidence interval 95%)
    -1066.11 (-2921.32 to 789.10)
    925.92 (-691.46 to 2543.30)
    No statistical analyses for this end point

    Secondary: Change from baseline to week 12 in total energy expenditure

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    End point title
    		 Change from baseline to week 12 in total energy expenditure
    End point description
    Metabolic equivalents of tasks [METs]. Based on accelerometry data
    End point type
    Secondary
    End point timeframe
    Up to week 12
    End point values
    		 Placebo dupilumab
    Number of subjects analysed
    15
    16
    Units: METs (metabolic equivalent of task)
        arithmetic mean (confidence interval 95%)
    23.40 (-87.37 to 134.17)
    59.36 (-15.83 to 134.55)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 22 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching dupilumab placebo

    Reporting group title
    Dupilumab 300 mg Q2W
    Reporting group description
    		 A loading dose at the start of the treatment followed by once every two weeks (Q2W).

    Serious adverse events
    		 Placebo Dupilumab 300 mg Q2W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Dupilumab 300 mg Q2W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 20 (45.00%)
    3 / 20 (15.00%)
    Injury, poisoning and procedural complications
    Immunisation reaction
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Syncope
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Eye disorders
    Eye discharge
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Food poisoning
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Cough
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Sinus pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Tendonitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Sacroiliitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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