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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients with Allergic Bronchopulmonary Aspergillosis

    Summary
    EudraCT number
    		 2019-002619-24
    Trial protocol
    		 DE   HU   GB   NL   BG   FR   PL   RO  
    Global end of trial date
    09 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Feb 2025
    First version publication date
    21 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    R668-ABPA-1923
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04442269
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc.
    Sponsor organisation address
    777 Old Saw Mill River Road, Tarrytown, NY, 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
    09 Feb 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of dupilumab on lung function in participants with Allergic Bronchopulmonary Aspergillosis (ABPA).
    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
    15 Sep 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    France: 15
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Japan: 5
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Romania: 6
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 13
    Worldwide total number of subjects
    62
    EEA total number of subjects
    38
    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)
    43
    From 65 to 84 years
    18
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 62 participants were randomized in a 1:1 randomization ratio (35 participants were assigned to the dupilumab group and 27 participants to the placebo group).

    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 without active substance
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching dupilumab without active substance

    Arm title
    		 Dupilumab 300 mg Q2W
    Arm description
    		 Subcutaneous (SC) dose every two weeks (Q2W)
    Arm type
    		 Experimental

    Investigational medicinal product name
    dupilumab
    Investigational medicinal product code
    REGN668
    Other name
    Dupixent
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 milligrams (mg) every 2 weeks (Q2W)

    Number of subjects in period 1
    		Placebo Dupilumab 300 mg Q2W
    Started
    27
    35
    Completed
    20
    29
    Not completed
    7
    6
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    3
    2
         Adverse event, non-fatal
    1
    -
         Decision by the Investigator/Sponsor
    1
    1
         Protocol Deviation
    -
    1
         Travel Limitations
    1
    1
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching dupilumab without active substance

    Reporting group title
    Dupilumab 300 mg Q2W
    Reporting group description
    		 Subcutaneous (SC) dose every two weeks (Q2W)

    Reporting group values
    		 Placebo Dupilumab 300 mg Q2W Total
    Number of subjects
    		 27 35 62
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.1 ( 14.38 ) 61.2 ( 8.62 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 17 22 39
        Male
    		 10 13 23
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 4 6
        Not Hispanic or Latino
    		 24 29 53
        Unknown or Not Reported
    		 1 2 3
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 25 28 53
        Asian
    		 1 4 5
        Other
    		 0 1 1
        Not Reported
    		 1 2 3

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching dupilumab without active substance

    Reporting group title
    Dupilumab 300 mg Q2W
    Reporting group description
    		 Subcutaneous (SC) dose every two weeks (Q2W)

    Primary: Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) compared to placebo

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    End point title
    		 Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) compared to placebo
    End point description
    Randomized participants with available data for analysis in the statistical model
    End point type
    Primary
    End point timeframe
    At Week 24
    End point values
    		 Placebo Dupilumab 300 mg Q2W
    Number of subjects analysed
    26
    34
    Units: Liters
        least squares mean (standard error)
    0.002 ( 0.0558 )
    0.203 ( 0.0482 )
    Statistical analysis title
    		 Placebo, Dupilumab 300 mg Q2W
    Comparison groups
    Placebo v Dupilumab 300 mg Q2W
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0022
    Method
    		 Repeated Measures Mixed Models Analysis
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.201
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.0768
         upper limit
    		 0.3256

    Secondary: Annualized rate of Allergic Bronchopulmonary Aspergillosis (ABPA)-related exacerbations

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    End point title
    		 Annualized rate of Allergic Bronchopulmonary Aspergillosis (ABPA)-related exacerbations
    End point description
    Defined as severe respiratory exacerbations that are associated with a doubling of serum total Immunoglobulin E (IgE) from the prior pre-exacerbation value. The full analysis set (FAS) includes all randomized participants. It is based on the treatment allocated as randomized. Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years)
    End point type
    Secondary
    End point timeframe
    Over the 24 to 52 Week Treatment Period
    End point values
    		 Placebo Dupilumab 300 mg Q2W
    Number of subjects analysed
    27
    35
    Units: Events per person-year
    number (not applicable)
        Adjusted Rate
    99999
    99999
        Unadjusted Rate
    0
    0
    No statistical analyses for this end point

    Secondary: Annualized rate of severe respiratory exacerbations

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    End point title
    		 Annualized rate of severe respiratory exacerbations
    End point description
    Defined as new onset of symptoms or clinical worsening of respiratory symptoms requiring systemic corticosteroid treatment for ≥3 consecutive days; for participants who are on maintenance systemic corticosteroids, at least double the dose of maintenance systemic corticosteroids for ≥3 consecutive days (with or without antibiotic therapy if indicated) The full analysis set (FAS) includes all randomized participants. It is based on the treatment allocated as randomized. Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years)
    End point type
    Secondary
    End point timeframe
    Over the 24 to 52 Week Treatment Period
    End point values
    		 Placebo Dupilumab 300 mg Q2W
    Number of subjects analysed
    27
    35
    Units: Events per person year
    number (not applicable)
        Adjusted Rate
    1.551
    0.695
        Unadjusted Rate
    0.943
    0.545
    No statistical analyses for this end point

    Secondary: Annualized rate of severe respiratory exacerbations requiring either hospitalization or observation for >24 hours in an ED/urgent care facility

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    End point title
    		 Annualized rate of severe respiratory exacerbations requiring either hospitalization or observation for >24 hours in an ED/urgent care facility
    End point description
    Annualized rate of severe respiratory exacerbations requiring either hospitalization or observation for >24 hours in an emergency department/urgent care facility (events per person-year) The full analysis set (FAS) includes all randomized participants. It is based on the treatment allocated as randomized. Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years)
    End point type
    Secondary
    End point timeframe
    Over the 24 to 52 Week Treatment Period
    End point values
    		 Placebo Dupilumab 300 mg Q2W
    Number of subjects analysed
    27
    35
    Units: Events per person year
    number (not applicable)
        Adjusted Rate
    99999
    99999
        Unadjusted Rate
    0.041
    0.128
    No statistical analyses for this end point

    Secondary: Change from baseline in Asthma Control Questionnaire (ACQ)-5 Score

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    End point title
    		 Change from baseline in Asthma Control Questionnaire (ACQ)-5 Score
    End point description
    ACQ is completed by participant to measure both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. The ACQ-5 score is the mean of the first 5 questions, between 0 (totally controlled) and 6 (severely uncontrolled). A higher score indicates lower asthma control. Participants with a score below 1.0 reflect adequately controlled asthma and participants with scores above 1.0 reflect inadequately controlled asthma. The optimal cut-point score of 1.50 should be used to be confident that a participant has inadequately controlled asthma. Randomized participants with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest
    End point type
    Secondary
    End point timeframe
    Over the 24 to 52 Week Treatment Period
    End point values
    		 Placebo Dupilumab 300 mg Q2W
    Number of subjects analysed
    27
    35
    Units: ACQ-5 Score
    arithmetic mean (standard deviation)
        Week 24 (n=23,32)
    -1.10 ( 1.102 )
    -1.24 ( 1.081 )
        Week 36 (n=22,29)
    -0.81 ( 0.878 )
    -1.15 ( 1.208 )
        Week 44 (n=20,26)
    -0.87 ( 1.233 )
    -1.01 ( 1.359 )
        Week 52 (n=16,27)
    -0.84 ( 1.183 )
    -1.29 ( 1.241 )
    No statistical analyses for this end point

    Secondary: Change from baseline in St. George’s Respiratory Questionnaire (SGRQ) total score

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    End point title
    		 Change from baseline in St. George’s Respiratory Questionnaire (SGRQ) total score
    End point description
    SGRQ will be completed by the participant to measure and quantify health status in adult participants with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL). Randomized participants with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest
    End point type
    Secondary
    End point timeframe
    Over the 24 to 52 Week Treatment Period
    End point values
    		 Placebo Dupilumab 300 mg Q2W
    Number of subjects analysed
    27
    35
    Units: SGRQ Total Score
    arithmetic mean (standard deviation)
        Week 12 (n=22,34)
    -9.463 ( 16.3993 )
    -17.956 ( 14.6184 )
        Week 24 (n=22,31)
    -7.626 ( 14.5412 )
    -23.079 ( 15.9104 )
        Week 36 (n=21,29)
    -8.796 ( 16.4257 )
    -20.178 ( 15.5266 )
        Week 52 (n=19,28)
    -8.938 ( 15.3127 )
    -25.309 ( 20.1035 )
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving a reduction in the SGRQ total score of 4 points or greater from baseline

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    End point title
    		 Percentage of participants achieving a reduction in the SGRQ total score of 4 points or greater from baseline
    End point description
    SGRQ will be completed by the participants to measure and quantify health status in adult participants with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL). Participants must have both the baseline and at least one post-baseline measurement at the given post-baseline time point to be included in the calculation of the proportion at the given post-baseline time point.
    End point type
    Secondary
    End point timeframe
    Up to 52 Weeks
    End point values
    		 Placebo Dupilumab 300 mg Q2W
    Number of subjects analysed
    27
    35
    Units: Percent
    number (confidence interval 95%)
        Week 12 (n=22,34)
    50.0 (30.72 to 69.28)
    85.3 (69.87 to 93.55)
        Week 24 (n=22,31)
    63.6 (42.95 to 80.27)
    87.1 (71.15 to 94.87)
        Week 36 (n=21,29)
    57.1 (36.55 to 75.53)
    86.2 (69.44 to 94.50)
        Week 52 (n=19,28)
    68.4 (46.01 to 84.64)
    89.3 (72.80 to 96.29)
    No statistical analyses for this end point

    Secondary: Percent change from baseline in total IgE in serum

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    End point title
    		 Percent change from baseline in total IgE in serum
    End point description
    Randomized participants with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest
    End point type
    Secondary
    End point timeframe
    Over the 24 to 52 Week Treatment Period
    End point values
    		 Placebo Dupilumab 300 mg Q2W
    Number of subjects analysed
    27
    35
    Units: Percentage of change
    arithmetic mean (standard deviation)
        Week 24 (n=24,32)
    -0.665 ( 40.2236 )
    -47.245 ( 19.4110 )
        Week 36 (n=22,29)
    -5.945 ( 27.6767 )
    -57.752 ( 18.0812 )
        Week 52 (n=21,28)
    -2.767 ( 42.8914 )
    -62.175 ( 17.0285 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline in A fumigatus-specific IgE in serum

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    End point title
    		 Percent change from baseline in A fumigatus-specific IgE in serum
    End point description
    Randomized participants with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest
    End point type
    Secondary
    End point timeframe
    Over the 24 to 52 Week Treatment Period
    End point values
    		 Placebo Dupilumab 300 mg Q2W
    Number of subjects analysed
    27
    35
    Units: Percentage of change
    arithmetic mean (standard deviation)
        Week 24 (n=23,32)
    0.099 ( 39.7612 )
    -39.859 ( 25.3095 )
        Week 36 (n=21,30)
    6.766 ( 39.9041 )
    -45.654 ( 26.7915 )
        Week 52 (n=21,27)
    12.618 ( 94.6306 )
    -49.126 ( 30.6790 )
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in fractional exhaled nitric oxide (FeNO)

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    End point title
    		 Absolute change from baseline in fractional exhaled nitric oxide (FeNO)
    End point description
    Randomized participants with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest
    End point type
    Secondary
    End point timeframe
    Over the 24 to 52 Week Treatment Period
    End point values
    		 Placebo Dupilumab 300 mg Q2W
    Number of subjects analysed
    27
    35
    Units: ppb
    arithmetic mean (standard deviation)
        Week 24 (n=20,26)
    -4.80 ( 23.521 )
    -22.04 ( 38.410 )
        Week 36 (n=18,29)
    3.11 ( 20.571 )
    -21.48 ( 40.538 )
        Week 44 (n=21,28)
    1.38 ( 21.896 )
    -19.18 ( 37.122 )
        Week 52 (n=19,26)
    -4.79 ( 27.634 )
    -19.04 ( 35.471 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline in fractional exhaled nitric oxide (FeNO)

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    End point title
    		 Percent change from baseline in fractional exhaled nitric oxide (FeNO)
    End point description
    Randomized participants with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest
    End point type
    Secondary
    End point timeframe
    Over the 24 to 52 Week Treatment Period
    End point values
    		 Placebo Dupilumab 300 mg Q2W
    Number of subjects analysed
    27
    35
    Units: Percentage of change
    arithmetic mean (standard deviation)
        Week 24 (n=20,26)
    1.67 ( 44.069 )
    -29.91 ( 32.527 )
        Week 36 (n=18,29)
    19.80 ( 44.053 )
    -24.56 ( 43.975 )
        Week 44 (n=21,28)
    15.43 ( 54.887 )
    -19.83 ( 48.308 )
        Week 52 (n=19,26)
    2.55 ( 56.506 )
    -20.35 ( 48.100 )
    No statistical analyses for this end point

    Secondary: Number of Participants with treatment-emergent adverse events (TEAEs) from baseline

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    End point title
    		 Number of Participants with treatment-emergent adverse events (TEAEs) from baseline
    End point description
    The safety analysis set (SAF) includes all randomized participants who received any study drug; it is based on the treatment received
    End point type
    Secondary
    End point timeframe
    Through the end of the 52 Week Treatment Period
    End point values
    		 Placebo Dupilumab 300 mg Q2W
    Number of subjects analysed
    27
    35
    Units: Participants with TEAEs
    22
    30
    No statistical analyses for this end point

    Secondary: Number of Participants with treatment-emergent anti-drug antibody (ADA) responses and titer over time

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    End point title
    		 Number of Participants with treatment-emergent anti-drug antibody (ADA) responses and titer over time
    End point description
    TE = Treatment-Emergent TB = Treatment-Boosted The Pharmacokinetic Analysis Set (PKAS) includes all randomized participants who received any study drug and who had at least one non-missing drug concentration result following the first dose of study drug. The PKAS is based on the treatment received rather than as randomized.
    End point type
    Secondary
    End point timeframe
    Up to 64 Weeks
    End point values
    		 Placebo Dupilumab 300 mg Q2W
    Number of subjects analysed
    25
    34
    Units: Participants
        TE & TB Max Titer Category Low (<1,000)
    0
    1
        TE & TB Max Category Moderate (1,000-10,000)
    0
    0
        TE & TB Max Category High (>10,000)
    0
    0
    No statistical analyses for this end point

    Secondary: Concentrations of functional dupilumab in serum by treatment regimen

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    End point title
    		 Concentrations of functional dupilumab in serum by treatment regimen [1]
    End point description
    Includes all randomized participants who received dupilumab and who had at least one non-missing dupilumab result following the first dose. The PKAS is based on the treatment received rather than as randomized.
    End point type
    Secondary
    End point timeframe
    Up to 64 Weeks
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Information not reported for placebo arm.
    End point values
    		 Dupilumab 300 mg Q2W
    Number of subjects analysed
    34
    Units: mg/L
    arithmetic mean (standard deviation)
        Week 0 (n=33)
    0 ( 0 )
        Week 12 (n=31)
    63.8 ( 35.4 )
        Week 24 (n=33)
    86.5 ( 53.6 )
        Week 52 (n=32)
    82.2 ( 55.4 )
        Week 64 (n=29)
    1.67 ( 4.38 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Dupilumab 300 mg Q2W
    Reporting group description
    		 Subcutaneous (SC) dose every two weeks (Q2W)

    Reporting group title
    Placebo
    Reporting group description
    		 Matching dupilumab without active substance

    Serious adverse events
    		 Dupilumab 300 mg Q2W Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 35 (8.57%)
    5 / 27 (18.52%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Pelvic fracture
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Trisomy 16
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory disorder
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal and urinary disorders
    Nephrotic syndrome
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    Influenza
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis allergic
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dupilumab 300 mg Q2W Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 35 (82.86%)
    19 / 27 (70.37%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 35 (17.14%)
    2 / 27 (7.41%)
         occurrences all number
    15
    3
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 27 (0.00%)
         occurrences all number
    35
    0
    Injection site pain
         subjects affected / exposed
    3 / 35 (8.57%)
    1 / 27 (3.70%)
         occurrences all number
    3
    1
    Pyrexia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    Malaise
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Influenza like illness
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Asthenia
         subjects affected / exposed
    2 / 35 (5.71%)
    3 / 27 (11.11%)
         occurrences all number
    2
    9
    Injection site swelling
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 27 (0.00%)
         occurrences all number
    6
    0
    Eye disorders
    Blepharitis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 27 (7.41%)
         occurrences all number
    1
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 27 (3.70%)
         occurrences all number
    2
    1
    Constipation
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Respiratory disorder
         subjects affected / exposed
    4 / 35 (11.43%)
    9 / 27 (33.33%)
         occurrences all number
    4
    22
    Cough
         subjects affected / exposed
    4 / 35 (11.43%)
    1 / 27 (3.70%)
         occurrences all number
    6
    1
    Asthma
         subjects affected / exposed
    4 / 35 (11.43%)
    3 / 27 (11.11%)
         occurrences all number
    5
    4
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    Back pain
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    Arthralgia
         subjects affected / exposed
    8 / 35 (22.86%)
    0 / 27 (0.00%)
         occurrences all number
    15
    0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 27 (7.41%)
         occurrences all number
    2
    2
    Urinary tract infection
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 27 (0.00%)
         occurrences all number
    6
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 35 (11.43%)
    1 / 27 (3.70%)
         occurrences all number
    6
    1
    COVID-19
         subjects affected / exposed
    6 / 35 (17.14%)
    3 / 27 (11.11%)
         occurrences all number
    6
    3
    Pneumonia
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 27 (3.70%)
         occurrences all number
    3
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Rhinitis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Sinusitis
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 27 (3.70%)
         occurrences all number
    2
    1
    Tooth infection
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 27 (3.70%)
         occurrences all number
    2
    2
    Respiratory tract infection bacterial
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 27 (11.11%)
         occurrences all number
    0
    3
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 27 (7.41%)
         occurrences all number
    2
    3
    Cystitis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    Conjunctivitis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    Bronchopulmonary aspergillosis allergic
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 27 (0.00%)
         occurrences all number
    5
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jan 2020
    Language updates
    11 Feb 2021
    The purpose of this protocol amendment was to: update inclusion and exclusion criteria; add provisions to protect patient safety and data integrity during the COVID-19 pandemic; and for minor clarifications, editorial corrections and consistency.
    02 Feb 2023
    The purpose of this protocol amendment was to modify study phase, number of participants to be enrolled, study schedule, treatment period, and endpoints. This was due to difficulty in reaching study enrollment goal during the COVID-19 pandemic and low prevalence of ABPA.
    24 Mar 2023
    The purpose of this amendment was to modify the study phase.

    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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    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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