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    Clinical Trial Results:
    A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY ASSESSING THE EFFICACY OF ANTI-BET V 1 MONOCLONAL ANTIBODIES TO REDUCE SYMPTOMS OF SEASONAL ALLERGIC RHINITIS

    Summary
    EudraCT number
    		 2020-004094-52
    Trial protocol
    		 DE   DK   BE  
    Global end of trial date
    24 Aug 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Sep 2022
    First version publication date
    08 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    R5713-5714-5715-ALG-2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04709575
    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 Trial Management, Regeneron Pharmaceuticals, Inc, 001 1-844-734-6643, 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
    24 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Aug 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo
    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
    14 Jan 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: 31
    Country: Number of subjects enrolled
    Canada: 118
    Country: Number of subjects enrolled
    Denmark: 37
    Country: Number of subjects enrolled
    Germany: 130
    Country: Number of subjects enrolled
    United States: 37
    Worldwide total number of subjects
    353
    EEA total number of subjects
    198
    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)
    336
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 589 participants screened, 353 randomized and from these 349 treated. 4 participants were randomized but not treated. Reasons not randomized: 235 did not meet I/E criteria, 1 withdrew consent.

    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
    		 REGN5713-5714-5715
    Arm description
    		 REGN5713-5714-5715 administered subcutaneously
    Arm type
    		 Experimental

    Investigational medicinal product name
    REGN5713-5714-5715
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous powder
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single SC dose, 900 mg

    Investigational medicinal product name
    REGN5713-5714-5715 placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous powder
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single SC dose, 600 mg

    Arm title
    		 Placebo Only
    Arm description
    		 Placebo matching REGN5713-5714-5715 administered subcutaneously
    Arm type
    		 Placebo

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		REGN5713-5714-5715 Placebo Only
    Started
    176
    177
    Completed
    166
    172
    Not completed
    10
    5
         Consent withdrawn by subject
    6
    2
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    2
    2
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    REGN5713-5714-5715
    Reporting group description
    		 REGN5713-5714-5715 administered subcutaneously

    Reporting group title
    Placebo Only
    Reporting group description
    		 Placebo matching REGN5713-5714-5715 administered subcutaneously

    Reporting group values
    		 REGN5713-5714-5715 Placebo Only Total
    Number of subjects
    		 176 177 353
    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)
    		 167 169 336
        From 65-84 years
    		 9 8 17
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.6 ( 14.15 ) 42.1 ( 14.36 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 102 102 204
        Male
    		 74 75 149
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 2 4
        Not Hispanic or Latino
    		 172 174 346
        Unknown or Not Reported
    		 2 1 3
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1
        Asian
    		 3 10 13
        Native Hawaiian or Other Pacific Islander
    		 1 0 1
        Black or African American
    		 1 2 3
        White
    		 165 161 326
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 6 3 9

    End points

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    End points reporting groups
    Reporting group title
    REGN5713-5714-5715
    Reporting group description
    		 REGN5713-5714-5715 administered subcutaneously

    Reporting group title
    Placebo Only
    Reporting group description
    		 Placebo matching REGN5713-5714-5715 administered subcutaneously

    Primary: Combined symptom and medication score (CSMS) in participants who receive a single dose of REGN5713-5714-5715 versus placebo

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    End point title
    		 Combined symptom and medication score (CSMS) in participants who receive a single dose of REGN5713-5714-5715 versus placebo
    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
    Until the end of Birch Pollen Season, up to Week 16
    End point values
    		 REGN5713-5714-5715 Placebo Only
    Number of subjects analysed
    171
    172
    Units: Scores on a Scale
        least squares mean (standard error)
    7.503 ( 0.6545 )
    8.498 ( 0.6534 )
    Statistical analysis title
    		 Linear-Mixed Effect Model
    Comparison groups
    REGN5713-5714-5715 v Placebo Only
    Number of subjects included in analysis
    343
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0497
    Method
    		 LS Mean Difference
    Parameter type
    		 linear mixed-effect model
    Point estimate
    -0.995
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9886
         upper limit
    		 -0.0011

    Secondary: Total symptom score (TSS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 versus placebo

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    End point title
    		 Total symptom score (TSS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 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
    Until the end of Birch Pollen Season, up to Week 16
    End point values
    		 REGN5713-5714-5715 Placebo Only
    Number of subjects analysed
    171
    172
    Units: Percentage of Participants
        least squares mean (standard error)
    5.19 ( 0.397 )
    5.62 ( 0.396 )
    No statistical analyses for this end point

    Secondary: Total nasal symptom score (TNSS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 versus placebo

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    End point title
    		 Total nasal symptom score (TNSS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 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
    Until the end of Birch Pollen Season, up to Week 16
    End point values
    		 REGN5713-5714-5715 Placebo Only
    Number of subjects analysed
    171
    172
    Units: Percentage of Participants
        least squares mean (standard error)
    3.76 ( 0.278 )
    4.00 ( 0.277 )
    No statistical analyses for this end point

    Secondary: Total ocular symptom score (TOSS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 versus placebo

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    End point title
    		 Total ocular symptom score (TOSS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 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
    Until the end of Birch Pollen Season, up to Week 16
    End point values
    		 REGN5713-5714-5715 Placebo Only
    Number of subjects analysed
    171
    172
    Units: Percentage of Participants
        least squares mean (standard error)
    1.43 ( 0.150 )
    1.62 ( 0.150 )
    No statistical analyses for this end point

    Secondary: Daily medication score (DMS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 versus placebo

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    End point title
    		 Daily medication score (DMS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 versus placebo
    End point description
    The Daily Medication Score (DMS) is calculated by adding points for each pre-specified medication taken as follows: desloratadine 5 mg 6 points/dose; maximum daily score 6 points, olopatadine 1 mg/mL each drop 1.5 points/drop; maximum daily score 6 points, mometasone furoate 50 ug/dose 2.0 points/spray; maximum daily score 8 points). The scale is 0 (minimum) to 20 (maximum)
    End point type
    Secondary
    End point timeframe
    Until the end of Birch Pollen Season, up to Week 16
    End point values
    		 REGN5713-5714-5715 Placebo Only
    Number of subjects analysed
    171
    172
    Units: Percentage of Participants
        least squares mean (standard error)
    2.316 ( 0.3993 )
    2.882 ( 0.3986 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) throughout the study

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    End point title
    		 Number of Participants with Treatment-Emergent Adverse Events (TEAEs) throughout the study
    End point description
    Number of participants with any Treatment Emergent Adverse Events (TEAEs)
    End point type
    Secondary
    End point timeframe
    Up to Day 127
    End point values
    		 REGN5713-5714-5715 Placebo Only
    Number of subjects analysed
    173
    176
    Units: Count of Participants
    92
    85
    No statistical analyses for this end point

    Secondary: Number of Participants with Serious TEAEs throughout the study

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    End point title
    		 Number of Participants with Serious TEAEs throughout the study
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Day 127
    End point values
    		 REGN5713-5714-5715 Placebo Only
    Number of subjects analysed
    173
    176
    Units: Count of Participants
    3
    0
    No statistical analyses for this end point

    Secondary: Change from baseline to the end of study in birch SPT mean wheal diameter in participants who receive a single dose of REGN5713-5714-5715 versus placebo

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    End point title
    		 Change from baseline to the end of study in birch SPT mean wheal diameter in participants who receive a single dose of REGN5713-5714-5715 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline through Day 127
    End point values
    		 REGN5713-5714-5715 Placebo Only
    Number of subjects analysed
    171
    172
    Units: millimeters
        least squares mean (standard error)
    -3.139 ( 0.5086 )
    0.553 ( 0.5067 )
    No statistical analyses for this end point

    Secondary: Percent change from baseline to the end of study in birch SPT mean wheal diameter in participants who receive a single dose of REGN5713-5714-5715 versus placebo

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    End point title
    		 Percent change from baseline to the end of study in birch SPT mean wheal diameter in participants who receive a single dose of REGN5713-5714-5715 versus placebo
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline through Day 127
    End point values
    		 REGN5713-5714-5715 Placebo Only
    Number of subjects analysed
    171
    172
    Units: Percentage
        least squares mean (standard error)
    -26.38 ( 5.179 )
    8.17 ( 5.160 )
    No statistical analyses for this end point

    Secondary: Serum concentration of REGN5713 over the study duration

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    End point title
    		 Serum concentration of REGN5713 over the study duration [1]
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Day 127
    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: No statistical analysis was presented for this endpoint
    End point values
    		 REGN5713-5714-5715
    Number of subjects analysed
    172
    Units: mg/L
    arithmetic mean (standard deviation)
        Day 0
    0 ( 0 )
        Day 56
    10.0 ( 3.97 )
        Day 112
    2.53 ( 1.57 )
    No statistical analyses for this end point

    Secondary: Serum concentration of REGN5714 over the study duration

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    End point title
    		 Serum concentration of REGN5714 over the study duration [2]
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Day 127
    Notes
    [2] - 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 analysis was presented for this endpoint
    End point values
    		 REGN5713-5714-5715
    Number of subjects analysed
    172
    Units: mg/L
    arithmetic mean (standard deviation)
        Day 0
    0 ( 0 )
        Day 56
    14.7 ( 4.68 )
        Day 112
    4.82 ( 2.16 )
    No statistical analyses for this end point

    Secondary: Serum concentration of REGN5715 over the study duration

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    End point title
    		 Serum concentration of REGN5715 over the study duration [3]
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Day 127
    Notes
    [3] - 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 analysis was presented for this endpoint
    End point values
    		 REGN5713-5714-5715
    Number of subjects analysed
    172
    Units: mg/L
    arithmetic mean (standard deviation)
        Day 0
    0 ( 0 )
        Day 56
    16.6 ( 5.34 )
        Day 112
    5.34 ( 2.35 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with treatment emergent anti-drug antibodies to REGN5713 throughout the study

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    End point title
    		 Percentage of Participants with treatment emergent anti-drug antibodies to REGN5713 throughout the study
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Day 127
    End point values
    		 REGN5713-5714-5715 Placebo Only
    Number of subjects analysed
    168
    171
    Units: Percentage of Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with treatment emergent anti-drug antibodies to REGN5714 throughout the study

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    End point title
    		 Percentage of Participants with treatment emergent anti-drug antibodies to REGN5714 throughout the study
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Day 127
    End point values
    		 REGN5713-5714-5715 Placebo Only
    Number of subjects analysed
    168
    171
    Units: Percentage of Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with treatment emergent anti-drug antibodies to REGN5715 throughout the study

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    End point title
    		 Percentage of Participants with treatment emergent anti-drug antibodies to REGN5715 throughout the study
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Day 127
    End point values
    		 REGN5713-5714-5715 Placebo Only
    Number of subjects analysed
    168
    171
    Units: Percentage of Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Number of "Well Days"

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    End point title
    		 Number of "Well Days"
    End point description
    “Well Days” are defined as days when rescue medication is not utilized and the Total symptom score (TSS) is ≤2/18
    End point type
    Secondary
    End point timeframe
    Until the end of Birch Pollen Season, up to Week 16
    End point values
    		 REGN5713-5714-5715 Placebo Only
    Number of subjects analysed
    171
    172
    Units: Days
        least squares mean (standard error)
    8.3 ( 1.42 )
    8.6 ( 1.42 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    28 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    R5713-5714-5715 900 mg
    Reporting group description
    		 REGN5713-5714-5715 administered subcutaneously

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching REGN5713-5714-5715 administered subcutaneously

    Serious adverse events
    		 R5713-5714-5715 900 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 173 (1.73%)
    0 / 176 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 176 (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
    		 R5713-5714-5715 900 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 173 (18.50%)
    43 / 176 (24.43%)
    Injury, poisoning and procedural complications
    Vaccination complication
         subjects affected / exposed
    17 / 173 (9.83%)
    22 / 176 (12.50%)
         occurrences all number
    26
    29
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 173 (8.67%)
    19 / 176 (10.80%)
         occurrences all number
    19
    22
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 173 (2.89%)
    9 / 176 (5.11%)
         occurrences all number
    5
    9

    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
    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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