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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Study in Cat-Allergic Patients with Allergic Rhinitis Who Live with a Cat to Assess the Efficacy and Safety of Anti-Fel d 1 Antibodies during Natural Cat Exposure in the Home

    Summary
    EudraCT number
    		 2021-002089-42
    Trial protocol
    		 DE   BE   FR   PL  
    Global end of trial date
    24 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Nov 2023
    First version publication date
    08 Nov 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    R1908-1909-ALG-2102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04981717
    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 8447346643, clinicaltrials@regeneron.com
    Scientific contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 8447346643, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Apr 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine that REGN1908-1909 reduces the symptoms associated with cat allergy
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the International Council for Harmonisation (ICH) guidelines for Good Clinical Practice (GCP) and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jul 2021
    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
    Belgium: 8
    Country: Number of subjects enrolled
    Canada: 83
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Germany: 57
    Country: Number of subjects enrolled
    Poland: 187
    Country: Number of subjects enrolled
    United States: 100
    Worldwide total number of subjects
    446
    EEA total number of subjects
    263
    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)
    14
    Adults (18-64 years)
    426
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 1,227 participants were screened, 453 enrolled, 7 participants not randomized, 446 participants were 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, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
    Arm type
    		 Placebo

    Investigational medicinal product name
    REGN1909 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for cutaneous solution
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Q12W for a total of 5 doses

    Investigational medicinal product name
    REGN1908 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for cutaneous solution
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Q12W for a total of 5 doses

    Arm title
    		 REGN1908-1909
    Arm description
    		 Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations
    Arm type
    		 Experimental

    Investigational medicinal product name
    REGN1909
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for cutaneous solution
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Q12W for a total of 5 doses

    Investigational medicinal product name
    REGN1908
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for cutaneous solution
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Q12W for a total of 5 doses

    Number of subjects in period 1
    		Placebo REGN1908-1909
    Started
    222
    224
    Completed
    8
    4
    Not completed
    214
    220
         Physician decision
    1
    -
         Consent withdrawn by subject
    50
    37
         Adverse event, non-fatal
    1
    3
         Pregnancy
    1
    -
         Lost to follow-up
    4
    5
         Sponsor Request
    157
    172
         Protocol deviation
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations

    Reporting group title
    REGN1908-1909
    Reporting group description
    		 Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations

    Reporting group values
    		 Placebo REGN1908-1909 Total
    Number of subjects
    		 222 224 446
    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)
    		 8 6 14
        Adults (18-64 years)
    		 211 215 426
        From 65-84 years
    		 3 3 6
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.0 ± 12.68 37.4 ± 12.58 -
    Gender categorical
    Units: Participants
        Female
    		 136 147 283
        Male
    		 86 77 163
    Ethnicity
    Units: Subjects
        NOT HISPANIC OR LATINO
    		 216 217 433
        HISPANIC OR LATINO
    		 5 5 10
        NOT REPORTED
    		 1 2 3
    Race
    Units: Subjects
        WHITE
    		 210 206 416
        BLACK OR AFRICAN AMERICAN
    		 1 3 4
        ASIAN
    		 7 11 18
        AMERICAN INDIAN OR ALASKA NATIVE
    		 1 0 1
        NOT REPORTED
    		 2 1 3
        OTHER
    		 1 3 4

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Randomized 1:1 ratio of matching placebo for REGN1908-1909 600 mg administered Q12W for a total of 5 administrations

    Reporting group title
    REGN1908-1909
    Reporting group description
    		 Randomized 1:1 ratio of REGN1908-1909 600 mg administered Q12W for a total of 5 administrations

    Primary: Daily combined symptom and medication score (CSMS) averaged over last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo

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    End point title
    		 Daily combined symptom and medication score (CSMS) averaged over last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo [1]
    End point description
    CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe).
    End point type
    Primary
    End point timeframe
    Weeks 48 to 60
    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 have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Score on a Scale
        number (not applicable)
    Notes
    [2] - Study terminated, period timeline not assessed
    [3] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Daily total nasal symptom score (TNSS) averaged over the last 12 weeks of treatment period in patients who receive REGN1908-1909 versus placebo

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    End point title
    		 Daily total nasal symptom score (TNSS) averaged over the last 12 weeks of treatment period in patients who receive REGN1908-1909 versus placebo
    End point description
    Total nasal symptom score (TNSS) is from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a Likert scale ranging from 0 (none) to 3 (severe) for congestion, itching, and rhinorrhea, and from 0 (none) to 3 (5 or more sneezes) for sneezing.
    End point type
    Secondary
    End point timeframe
    Weeks 48 to 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: Score on a scale
        number (not applicable)
    Notes
    [4] - Study terminated, period timeline not assessed
    [5] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Percent change from pre-treatment baseline in average CSMS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo

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    End point title
    		 Percent change from pre-treatment baseline in average CSMS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 48 to 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: Percentage
        number (not applicable)
    Notes
    [6] - Study terminated, period timeline not assessed
    [7] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Percent change from baseline to the end of treatment in cat skin prick test (SPT) mean wheal diameter in patients who receive REGN1908-1909 versus placebo

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    End point title
    		 Percent change from baseline to the end of treatment in cat skin prick test (SPT) mean wheal diameter in patients who receive REGN1908-1909 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Week 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: Percent
        number (not applicable)
    Notes
    [8] - Study terminated, period timeline not assessed
    [9] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Percent change from pre-treatment baseline in average TSS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo

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    End point title
    		 Percent change from pre-treatment baseline in average TSS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 48 to 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: Percent
        number (not applicable)
    Notes
    [10] - Study terminated, period timeline not assessed
    [11] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Daily total symptom score (TSS) averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo

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    End point title
    		 Daily total symptom score (TSS) averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
    End point description
    TSS is a combined score of TOSS and TNSS. TNSS and TOSS are scored as in part 1 each for a combined TSS of 0 (none) to 18 (severe)
    End point type
    Secondary
    End point timeframe
    Weeks 48 to 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: Score on a scale
        number (not applicable)
    Notes
    [12] - Study terminated, period timeline not assessed
    [13] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Percent change from pre-treatment baseline in average TNSS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo

    		 Close Top of page
    End point title
    		 Percent change from pre-treatment baseline in average TNSS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 48 to 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: Percentage
        number (not applicable)
    Notes
    [14] - Study terminated, period timeline not assessed
    [15] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Daily CSMS averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo

    		 Close Top of page
    End point title
    		 Daily CSMS averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
    End point description
    The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 12
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    222
    224
    Units: Average Score
        least squares mean (standard error)
    15.290 ± 0.9173
    16.184 ± 0.9370
    No statistical analyses for this end point

    Secondary: Percent change from pre-treatment baseline in average CSMS over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo

    		 Close Top of page
    End point title
    		 Percent change from pre-treatment baseline in average CSMS over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
    End point description
    The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 12
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    222
    224
    Units: Percent
        number (standard deviation)
    -33.16
    -29.25
    No statistical analyses for this end point

    Secondary: Percent change from pre-treatment baseline in average TSS over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo

    		 Close Top of page
    End point title
    		 Percent change from pre-treatment baseline in average TSS over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
    End point description
    The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 12
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    222
    224
    Units: Percent
        arithmetic mean (standard deviation)
    -31.16 ± 28.390
    -27.25 ± 30.185
    No statistical analyses for this end point

    Secondary: Daily TNSS averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo

    		 Close Top of page
    End point title
    		 Daily TNSS averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
    End point description
    The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 12
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    222
    224
    Units: Average Score
        least squares mean (standard error)
    5.88 ± 0.314
    6.18 ± 0.320
    No statistical analyses for this end point

    Secondary: Percent change from pre-treatment baseline in average TNSS over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo

    		 Close Top of page
    End point title
    		 Percent change from pre-treatment baseline in average TNSS over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
    End point description
    The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 12
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    222
    224
    Units: Percent
        arithmetic mean (standard deviation)
    -30.33 ± 27.976
    -26.77 ± 29.471
    No statistical analyses for this end point

    Secondary: Daily TSS score averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo

    		 Close Top of page
    End point title
    		 Daily TSS score averaged over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
    End point description
    The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 12
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    222
    224
    Units: Average Score
        arithmetic mean (standard deviation)
    7.80 ± 3.507
    8.11 ± 3.743
    No statistical analyses for this end point

    Secondary: Percent change from pre-treatment baseline in average TOSS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo

    		 Close Top of page
    End point title
    		 Percent change from pre-treatment baseline in average TOSS over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 48 to 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [16]
    0 [17]
    Units: Percent
        number (not applicable)
    Notes
    [16] - Study terminated, period timeline not assessed
    [17] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Daily TOSS averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo

    		 Close Top of page
    End point title
    		 Daily TOSS averaged over the last 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 48 to 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [18]
    0 [19]
    Units: Score on a scale
        number (not applicable)
    Notes
    [18] - Study terminated, period timeline not assessed
    [19] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Percent change from pre-treatment baseline in average TOSS, over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo

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    End point title
    		 Percent change from pre-treatment baseline in average TOSS, over the initial 12 weeks of the treatment period in patients who receive REGN1908-1909 versus placebo
    End point description
    Total ocular symptom score is 0 to 6 and is based on itching/redness/gritty feeling and tearing/watering; each of the 2 symptoms is graded 0 (absent), 1 (mild), 2 (moderate), and 3 (severe)
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 12
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    222
    224
    Units: Percent
        arithmetic mean (standard deviation)
    -32.92 ± 35.708
    -27.90 ± 38.216
    No statistical analyses for this end point

    Secondary: Percent change in forced expiratory volume (FEV)1 in patients with asthma who receive REGN1908-1909 versus placebo

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    End point title
    		 Percent change in forced expiratory volume (FEV)1 in patients with asthma who receive REGN1908-1909 versus placebo
    End point description
    The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
    End point type
    Secondary
    End point timeframe
    Baseline to week 12
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    112
    117
    Units: Percent
        arithmetic mean (standard deviation)
    -0.05 ± 5.334
    1.35 ± 7.314
    No statistical analyses for this end point

    Secondary: Percent change in FEV1 in patients with asthma who receive REGN1908-1909 versus placebo

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    End point title
    		 Percent change in FEV1 in patients with asthma who receive REGN1908-1909 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [20]
    0 [21]
    Units: Percent
        number (not applicable)
    Notes
    [20] - Study terminated, period timeline not assessed
    [21] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Percent change in cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo (up to week 12)

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    End point title
    		 Percent change in cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo (up to week 12)
    End point description
    The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
    End point type
    Secondary
    End point timeframe
    Baseline to week 12
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    222
    224
    Units: Percent
        arithmetic mean (standard deviation)
    -26.76 ± 33.787
    -35.27 ± 31.438
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 60 in Rhinoconjunctivitis Quality of Life Questionnaire for Ages 12+ (RQLQ(S)+12) in participants who received REGN1908-1909 versus placebo

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    End point title
    		 Change from Baseline to Week 60 in Rhinoconjunctivitis Quality of Life Questionnaire for Ages 12+ (RQLQ(S)+12) in participants who received REGN1908-1909 versus placebo
    End point description
    The RQLQ had 25 questions in 6 domains (nose symptoms, eye symptoms, practical problems, activity limitation, non-hay fever symptoms and emotional function). Participants recalled how they have been during the previous week and responded to each question on a 7-point scale. The overall RQLQ score was the mean of all 25 responses and the individual domain scores were the means of the items in those domains.
    End point type
    Secondary
    End point timeframe
    Baseline to week 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [22]
    0 [23]
    Units: Score on a scale
        number (not applicable)
    Notes
    [22] - Study terminated, period timeline not assessed
    [23] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Change in FEV1 in participants with asthma who receive REGN1908-1909 versus placebo (up to week 60)

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    End point title
    		 Change in FEV1 in participants with asthma who receive REGN1908-1909 versus placebo (up to week 60)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [24]
    0 [25]
    Units: Participants
        number (not applicable)
    Notes
    [24] - Study terminated, period timeline not assessed
    [25] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Daily medication score (DMS) averaged over the initial 12 weeks of the treatment period in participants who receive REGN1908-1909 versus placebo

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    End point title
    		 Daily medication score (DMS) averaged over the initial 12 weeks of the treatment period in participants who receive REGN1908-1909 versus placebo
    End point description
    The Daily Medication Score (DMS) was calculated by adding points for each pre-specified medication. The scale is 0 (minimum) to 20 (maximum)
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 12
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    222
    224
    Units: Score on a scale
        arithmetic mean (standard deviation)
    6.467 ± 4.5117
    6.582 ± 4.9101
    No statistical analyses for this end point

    Secondary: Change in FEV1 in participants with asthma who receive REGN1908-1909 versus placebo (up to week 12)

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    End point title
    		 Change in FEV1 in participants with asthma who receive REGN1908-1909 versus placebo (up to week 12)
    End point description
    The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
    End point type
    Secondary
    End point timeframe
    Baseline to week 12
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    222
    224
    Units: Participants
        arithmetic mean (standard deviation)
    -0.0086 ± 0.17005
    0.0321 ± 0.21546
    No statistical analyses for this end point

    Secondary: Percent change in cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo

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    End point title
    		 Percent change in cat SPT mean wheal diameter in patients who receive REGN1908-1909 versus placebo
    End point description
    The full analysis set (FAS) includes all randomized participants; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
    End point type
    Secondary
    End point timeframe
    Baseline to week 72
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [26]
    0 [27]
    Units: Percent
        number (not applicable)
    Notes
    [26] - Study terminated, period timeline not assessed
    [27] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Percent change from pre-treatment baseline in average DMS averaged over the last 12 weeks of the treatment period in participants who receive REGN1908-1909 versus placebo

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    End point title
    		 Percent change from pre-treatment baseline in average DMS averaged over the last 12 weeks of the treatment period in participants who receive REGN1908-1909 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 48 to 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [28]
    0 [29]
    Units: Percent
        number (not applicable)
    Notes
    [28] - Study terminated, period timeline not assessed
    [29] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: DMS averaged over the last 12 weeks of the treatment period in participants who receive REGN1908-1909 versus placebo

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    End point title
    		 DMS averaged over the last 12 weeks of the treatment period in participants who receive REGN1908-1909 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 48 to 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [30]
    0 [31]
    Units: Score on a scale
        number (not applicable)
    Notes
    [30] - Study terminated, period timeline not assessed
    [31] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Asthma daily symptom (ADS) score, averaged over the initial 12 weeks of the treatment period using Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) in participants with asthma who receive REGN1908-1909 versus placebo

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    End point title
    		 Asthma daily symptom (ADS) score, averaged over the initial 12 weeks of the treatment period using Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) in participants with asthma who receive REGN1908-1909 versus placebo
    End point description
    The total daily asthma symptom score is a participant-reported outcome concerning the occurrence of asthma symptoms and their effect on a patient's daily activities and sleep. It is composed of two parts: daytime (five items) and nighttime (four items), both scored ordinally. Higher scores indicate more severe symptoms.
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 12
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    112
    117
    Units: Score on a scale
        arithmetic mean (standard deviation)
    2.52 ± 2.141
    2.17 ± 2.005
    No statistical analyses for this end point

    Secondary: Change from baseline to week 60 in Asthma Control Questionnaire 5 Question Version (ACQ-5) in participant with asthma who receive REGN1908-1909 versus placebo

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    End point title
    		 Change from baseline to week 60 in Asthma Control Questionnaire 5 Question Version (ACQ-5) in participant with asthma who receive REGN1908-1909 versus placebo
    End point description
    The ACQ-5 had 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total mean score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), higher scores indicated lower asthma control.
    End point type
    Secondary
    End point timeframe
    Baseline to week 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [32]
    0 [33]
    Units: Score
        number (not applicable)
    Notes
    [32] - Study terminated, period timeline not assessed
    [33] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: ADS score averaged over the last 12 weeks of the treatment period using ADSD and the ANSD in participants with asthma who receive REGN1908-1909 versus placebo (weeks 48 to 60)

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    End point title
    		 ADS score averaged over the last 12 weeks of the treatment period using ADSD and the ANSD in participants with asthma who receive REGN1908-1909 versus placebo (weeks 48 to 60)
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 48 to 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [34]
    0 [35]
    Units: Score on a scale
        number (not applicable)
    Notes
    [34] - Study terminated, period timeline not assessed
    [35] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Daily TOSS averaged over the initial 12 weeks of the treatment period in participants who receive REGN1908-1909 versus placebo

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    End point title
    		 Daily TOSS averaged over the initial 12 weeks of the treatment period in participants who receive REGN1908-1909 versus placebo
    End point description
    The full analysis set (FAS) includes all randomized patrticipants; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 12
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    222
    224
    Units: Score on a scale
        arithmetic mean (standard deviation)
    2.33 ± 1.346
    2.42 ± 1.414
    No statistical analyses for this end point

    Secondary: Daily number of nighttime awakenings averaged over the initial 12 weeks of the treatment period in patients with asthma who receive REGN1908-1909 versus placebo

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    End point title
    		 Daily number of nighttime awakenings averaged over the initial 12 weeks of the treatment period in patients with asthma who receive REGN1908-1909 versus placebo
    End point description
    The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 12
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    112
    117
    Units: Number
        arithmetic mean (standard deviation)
    0.72 ± 1.166
    0.54 ± 0.846
    No statistical analyses for this end point

    Secondary: Incidence of serious TEAEs throughout the study

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    End point title
    		 Incidence of serious TEAEs throughout the study
    End point description
    The safety analysis set (SAF) includes all randomized participants who received any study drug; it is based on the treatment received (as treated).
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 72
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [36]
    0 [37]
    Units: Number
        number (not applicable)
    Notes
    [36] - Study terminated, period timeline not assessed
    [37] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Number of treatment-emergent adverse events (TEAEs) throughout the study

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    End point title
    		 Number of treatment-emergent adverse events (TEAEs) throughout the study
    End point description
    The full analysis set (FAS) includes all randomized participants; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS.
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 72
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [38]
    0 [39]
    Units: Participants
        number (not applicable)
    Notes
    [38] - Study terminated, period timeline not assessed
    [39] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Daily number of nighttime awakenings averaged over the last 12 weeks of the treatment period in patients with asthma who receive REGN1908-1909 versus placebo (weeks 48 to 60)

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    End point title
    		 Daily number of nighttime awakenings averaged over the last 12 weeks of the treatment period in patients with asthma who receive REGN1908-1909 versus placebo (weeks 48 to 60)
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 48 to 60
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [40]
    0 [41]
    Units: Number
        number (not applicable)
    Notes
    [40] - Study terminated, period timeline not assessed
    [41] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Incidence of adverse event of special interests (AESIs) throughout the study

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    End point title
    		 Incidence of adverse event of special interests (AESIs) throughout the study
    End point description
    The safety analysis set (SAF) includes all randomized patients who received any study drug; it is based on the treatment received (as treated).
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 72
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    0 [42]
    0 [43]
    Units: Participants
        number (not applicable)
    Notes
    [42] - Study terminated, period timeline not assessed
    [43] - Study terminated, period timeline not assessed
    No statistical analyses for this end point

    Secondary: Total REGN1908 concentration in serum over the study duration

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    End point title
    		 Total REGN1908 concentration in serum over the study duration [44]
    End point description
    Each PK analysis includes all treated participants who received any amount of study drug (active, [SAF]) and had at least 1 non-missing result of each respective analyte following the first dose of study drug. The PKAS is based on the actual treatment received (as treated) rather than as randomized. Placebo participants were not analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 72
    Notes
    [44] - 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: 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.
    End point values
    		 REGN1908-1909
    Number of subjects analysed
    224
    Units: mg/L
    arithmetic mean (standard deviation)
        Baseline [12 years old < 18 years old] (n = 6)
    0.0753 ± 0.123
        Week 12 [12 years old < 18 years old] (n = 5)
    7.19 ± 2.54
        Week 24 [12 years old < 18 years old] (n = 4)
    10.5 ± 2.04
        Week 36 [12 years old < 18 years old] (n = 4)
    9.56 ± 4.98
        Baseline ( >= 18 years old) n = 205
    0.0179 ± 0.116
        Week 12 ( >= 18 years old) n = 193
    5.26 ± 2.60
        Week 24 ( >= 18 years old) n = 169
    5.99 ± 3.58
        Week 36 ( >= 18 years old) n = 126
    4.47 ± 3.63
        Week 48 ( >= 18 years old) n = 67
    2.14 ± 2.76
        Week 60 ( >= 18 years old) n = 11
    0.526 ± 0.377
    No statistical analyses for this end point

    Secondary: Total REGN1909 concentration in serum over the study duration

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    End point title
    		 Total REGN1909 concentration in serum over the study duration [45]
    End point description
    Each PK analysis includes all treated participants who received any amount of study drug (active, [SAF]) and had at least 1 non-missing result of each respective analyte following the first dose of study drug. The PKAS is based on the actual treatment received (as treated) rather than as randomized. Placebo participants were not analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 72
    Notes
    [45] - 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: 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.
    End point values
    		 REGN1908-1909
    Number of subjects analysed
    224
    Units: mg/L
    arithmetic mean (standard deviation)
        Baseline [12 years old < 18 years old] (n = 6)
    0 ± 0
        Week 12 [12 years old < 18 years old] (n = 5)
    3.49 ± 1.99
        Week 24 [12 years old < 18 years old] (n = 4)
    4.59 ± 0.957
        Week 36 [12 years old < 18 years old] (n = 4)
    4.02 ± 2.39
        Baseline [>= 18 years old] (n = 205)
    0.0160 ± 0.118
        Week 12 [>= 18 years old] (n = 193)
    2.32 ± 1.50
        Week 24 [>= 18 years old] (n = 169)
    2.46 ± 1.79
        Week 36 [>= 18 years old] (n = 126)
    1.91 ± 2.03
        Week 48 [>= 18 years old] (n = 67)
    0.903 ± 1.47
        Week 60 [>= 18 years old] (n = 11)
    0.161 ± 0.175
    No statistical analyses for this end point

    Secondary: Incidence of treatment-emergent ADAs to REGN1909 throughout the study

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    End point title
    		 Incidence of treatment-emergent ADAs to REGN1909 throughout the study
    End point description
    The AAS is defined for each study drug separately and includes all treated participants who received any amount of study drug (active or placebo, [SAF]) and had at least 1 non-missing ADA result following the first dose of study drug or placebo. The AAS is based on the actual treatment received (as treated) rather than as randomized.
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 72
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    213
    210
    Units: Participants
        Treatment-Emergent Response
    5
    5
    No statistical analyses for this end point

    Secondary: Incidence of treatment-emergent anti-drug antibodies (ADAs) to REGN1908 throughout the study

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    End point title
    		 Incidence of treatment-emergent anti-drug antibodies (ADAs) to REGN1908 throughout the study
    End point description
    The AAS is defined for each study drug separately and includes all treated participants who received any amount of study drug (active or placebo, [SAF]) and had at least 1 non-missing ADA result following the first dose of study drug or placebo. The AAS is based on the actual treatment received (as treated) rather than as randomized.
    End point type
    Secondary
    End point timeframe
    Weeks 0 to 72
    End point values
    		 Placebo REGN1908-1909
    Number of subjects analysed
    213
    210
    Units: Participants
        Treatment-Emergent Response
    4
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose to study termination (~60 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    R1908-1909 600 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 R1908-1909 600 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 218 (0.92%)
    2 / 222 (0.90%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Gastrointestinal procedural complication
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 222 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Meniere's disease
         subjects affected / exposed
    0 / 218 (0.00%)
    1 / 222 (0.45%)
         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 / 218 (0.46%)
    0 / 222 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 218 (0.46%)
    0 / 222 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 R1908-1909 600 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 218 (24.77%)
    58 / 222 (26.13%)
    Infections and infestations
    COVID-19
         subjects affected / exposed
    22 / 218 (10.09%)
    28 / 222 (12.61%)
         occurrences all number
    22
    29
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 218 (6.42%)
    9 / 222 (4.05%)
         occurrences all number
    16
    11
    Nasopharyngitis
         subjects affected / exposed
    21 / 218 (9.63%)
    25 / 222 (11.26%)
         occurrences all number
    28
    30

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Apr 2021
    To correct a typo and provide a clarification within the inclusion criteria
    19 May 2021
    To add safety assessments and change the timing of the primary endpoint assessment

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Sep 2022
    Study Terminated
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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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