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    Clinical Trial Results:
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, Administered as Monotherapy for the Treatment of Acute Uncomplicated Seasonal Influenza A Infection in Otherwise Healthy Adults

    Summary
    EudraCT number
    		 2016-000425-40
    Trial protocol
    		 ES  
    Global end of trial date
    13 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Nov 2018
    First version publication date
    16 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GV29893
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02623322
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.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
    13 Nov 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the safety and tolerability of a single intravenous (IV) dose of MHAA4549A as compared to placebo when administered in otherwise healthy subjects with acute uncomplicated seasonal influenza A.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Oct 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 4 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    New Zealand: 12
    Country: Number of subjects enrolled
    South Africa: 52
    Country: Number of subjects enrolled
    United States: 49
    Worldwide total number of subjects
    124
    EEA total number of subjects
    6
    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)
    123
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 34 investigational sites in 6 countries including the United States (15 centers), South Africa (12 centers), Canada, Spain, New Zealand (2 centers in each country), and Great Britain (1 center).

    Pre-assignment
    Screening details
    		 Randomisation stratified by onset of influenza-like illness (≤36 hours and >36 hours) and type of influenza test used for enrollment (rapid polymerase chain reaction (PCR) or rapid antigen test). Permuted block randomisation method used to obtain an approximate 1:1:1 ratio of subjects in the 3600 mg MHAA4549A, 8400 mg MHAA4549A, and placebo strata.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received single-dose placebo by intravenous (IV) administration.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received single-dose placebo by IV administration.

    Arm title
    		 MHAA4549A 3600 mg
    Arm description
    		 Subjects received single-dose MHAA4549A, 3600 milligrams (mg), by IV administration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MHAA4549A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received single-dose MHAA4549A, 3600 mg, by IV administration.

    Arm title
    		 MHAA4549A 8400 mg
    Arm description
    		 Subjects received single-dose MHAA4549A, 8400 mg, by IV administration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MHAA4549A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received single-dose MHAA4549A, 8400 mg, by IV administration.

    Number of subjects in period 1
    		Placebo MHAA4549A 3600 mg MHAA4549A 8400 mg
    Started
    43
    41
    40
    Completed
    41
    40
    40
    Not completed
    2
    1
    0
         Lost to follow-up
    2
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received single-dose placebo by intravenous (IV) administration.

    Reporting group title
    MHAA4549A 3600 mg
    Reporting group description
    		 Subjects received single-dose MHAA4549A, 3600 milligrams (mg), by IV administration.

    Reporting group title
    MHAA4549A 8400 mg
    Reporting group description
    		 Subjects received single-dose MHAA4549A, 8400 mg, by IV administration.

    Reporting group values
    		 Placebo MHAA4549A 3600 mg MHAA4549A 8400 mg Total
    Number of subjects
    		 43 41 40 124
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.3 ( 10.8 ) 36.5 ( 12.5 ) 35.0 ( 13.6 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 27 22 22 71
        Male
    		 16 19 18 53

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received single-dose placebo by intravenous (IV) administration.

    Reporting group title
    MHAA4549A 3600 mg
    Reporting group description
    		 Subjects received single-dose MHAA4549A, 3600 milligrams (mg), by IV administration.

    Reporting group title
    MHAA4549A 8400 mg
    Reporting group description
    		 Subjects received single-dose MHAA4549A, 8400 mg, by IV administration.

    Primary: Percentage of Subjects with Adverse Events (AEs)

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    End point title
    		 Percentage of Subjects with Adverse Events (AEs) [1]
    End point description
    An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. The safety population included all subjects randomised to treatment.
    End point type
    Primary
    End point timeframe
    Baseline to Day 100
    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: Data was not collected for this end point.
    End point values
    		 Placebo MHAA4549A 3600 mg MHAA4549A 8400 mg
    Number of subjects analysed
    43
    41
    40
    Units: percentage of subjects
        number (not applicable)
    30.2
    39.0
    30.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Requiring Hospitalisation for Influenza-Related Complications

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    End point title
    		 Percentage of Subjects Requiring Hospitalisation for Influenza-Related Complications
    End point description
    Data was not collected for this outcome measure, since no subject was hospitalised for influenza-related complications.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 100
    End point values
    		 Placebo MHAA4549A 3600 mg MHAA4549A 8400 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [2] - No subject was hospitalised due to infection events.
    [3] - No subject was hospitalised due to infection events.
    [4] - No subject was hospitalised due to infection events.
    No statistical analyses for this end point

    Secondary: Duration of Hospitalisation for Influenza-Related Complications

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    End point title
    		 Duration of Hospitalisation for Influenza-Related Complications
    End point description
    Data was not collected for this outcome measure, since no subject was hospitalised for influenza-related complications.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 100
    End point values
    		 Placebo MHAA4549A 3600 mg MHAA4549A 8400 mg
    Number of subjects analysed
    0 [5]
    0 [6]
    0 [7]
    Units: days
        number (not applicable)
    Notes
    [5] - No subject was hospitalised due to infection events.
    [6] - No subject was hospitalised due to infection events.
    [7] - No subject was hospitalised due to infection events.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Requiring Antibiotics for Secondary Bacterial Respiratory Infections

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    End point title
    		 Percentage of Subjects Requiring Antibiotics for Secondary Bacterial Respiratory Infections
    End point description
    Subjects with antibiotic usage for secondary bacterial respiratory infections were identified by counting subjects with AEs containing the terms, “pneumonia, lung, myocarditis, ARDS (acute respiratory distress syndrome), otitis media, or respiratory.” The intent-to-treat infected (ITTI) population included all randomised subjects who had an influenza A infection confirmed by central polymerase chain reaction (PCR).
    End point type
    Secondary
    End point timeframe
    Baseline to Day 100
    End point values
    		 Placebo MHAA4549A 3600 mg MHAA4549A 8400 mg
    Number of subjects analysed
    33
    35
    31
    Units: percentage of subjects
        number (confidence interval 80%)
    3.0 (0.32 to 11.28)
    0 (0.00 to 6.37)
    0 (0.00 to 7.16)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v MHAA4549A 3600 mg
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3031
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in event rates (Wald)
    Point estimate
    -3.03
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -12.25
         upper limit
    		 6.19
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v MHAA4549A 8400 mg
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3324
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in event rates (Wald)
    Point estimate
    -3.03
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -12.82
         upper limit
    		 6.76

    Secondary: Percentage of Subjects with Complications of Influenza

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    End point title
    		 Percentage of Subjects with Complications of Influenza
    End point description
    Subjects with complications of influenza were identified by counting subjects with AEs containing the terms, “pneumonia, lung, myocarditis, ARDS (acute respiratory distress syndrome), otitis media, or respiratory.” ITTI population included all randomised subjects who had an influenza A infection confirmed by central PCR.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 100
    End point values
    		 Placebo MHAA4549A 3600 mg MHAA4549A 8400 mg
    Number of subjects analysed
    33
    35
    31
    Units: percentage of subjects
        number (confidence interval 80%)
    3.0 (0.32 to 11.28)
    0 (0.00 to 6.37)
    0 (0.00 to 7.16)
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v MHAA4549A 3600 mg
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3031
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in event rates (Wald)
    Point estimate
    -3.03
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -12.25
         upper limit
    		 6.19
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Placebo v MHAA4549A 8400 mg
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3324
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in event rates (Wald)
    Point estimate
    -3.03
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -12.82
         upper limit
    		 6.76

    Secondary: Percentage of Subjects with Influenza A Relapse/Reinfection

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    End point title
    		 Percentage of Subjects with Influenza A Relapse/Reinfection
    End point description
    ITTI population included all randomised subjects who had an influenza A infection confirmed by central PCR.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 100
    End point values
    		 Placebo MHAA4549A 3600 mg MHAA4549A 8400 mg
    Number of subjects analysed
    33
    35
    31
    Units: percentage of subjects
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Area Under the Concentration-Time Curve (AUC) of MHAA4549A

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    End point title
    		 Area Under the Concentration-Time Curve (AUC) of MHAA4549A [8]
    End point description
    The AUC is a measure of the plasma concentration of the drug over time. It is used to characterise drug absorption. AUC was measured in micrograms times hours per milliliter (mcg*h/mL). Data was not collected for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours)
    Notes
    [8] - 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: Data was not collected for this end point.
    End point values
    		 MHAA4549A 3600 mg MHAA4549A 8400 mg
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: mcg*h/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [9] - Data was not collected for this outcome measure.
    [10] - Data was not collected for this outcome measure.
    No statistical analyses for this end point

    Secondary: Maximum Serum Concentration (Cmax) of MHAA4549A

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    End point title
    		 Maximum Serum Concentration (Cmax) of MHAA4549A [11]
    End point description
    The pharmacokinetic (PK)−evaluable population included all subjects who received MHA4549A.
    End point type
    Secondary
    End point timeframe
    Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours)
    Notes
    [11] - 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: Data was not collected for this end point.
    End point values
    		 MHAA4549A 3600 mg MHAA4549A 8400 mg
    Number of subjects analysed
    40
    37
    Units: mcg/mL
        arithmetic mean (standard deviation)
    1050 ( 299 )
    2190 ( 581 )
    No statistical analyses for this end point

    Secondary: Time to Alleviation of Symptoms of Influenza A Infection

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    End point title
    		 Time to Alleviation of Symptoms of Influenza A Infection
    End point description
    Time to alleviation of all 7 symptoms (i.e., nasal congestion, sore throat, cough, aches, fatigue, headaches, chills/sweats) was assessed using a rating scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe) for each symptom. The outcome was defined in two ways: time to a total symptom score of <=1 and time to a total symptom score of <=7. Resolution had to be maintained for 24 hours without use of symptom relief medications. For subjects who were enrolled with mild symptoms, the symptom score had to be reduced by one point during the study duration. ITTI population included all randomised subjects who had an influenza A infection confirmed by central PCR.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 14
    End point values
    		 Placebo MHAA4549A 3600 mg MHAA4549A 8400 mg
    Number of subjects analysed
    33
    35
    31
    Units: hours
    median (confidence interval 80%)
        Total Symptom Score of <=1
    117.30 (108.62 to 157.15)
    153.80 (125.52 to 175.23)
    145.82 (132.98 to 156.68)
        Total Symptom Score of <=7
    44.50 (27.23 to 58.65)
    74.18 (64.32 to 87.98)
    65.59 (44.12 to 87.23)
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    Total Symptom Score of <=1
    Comparison groups
    Placebo v MHAA4549A 3600 mg
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7858
    Method
    		 Wilcoxon
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.37
    Statistical analysis title
    		 Statistical Analysis 6
    Statistical analysis description
    Total Symptom Score of <=1
    Comparison groups
    Placebo v MHAA4549A 8400 mg
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.517
    Method
    		 Wilcoxon
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.36
    Statistical analysis title
    		 Statistical Analysis 7
    Statistical analysis description
    Total Symptom Score of <=7
    Comparison groups
    Placebo v MHAA4549A 3600 mg
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0312
    Method
    		 Wilcoxon
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.63
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 0.89
    Statistical analysis title
    		 Statistical Analysis 8
    Statistical analysis description
    Total Symptom Score of <=7
    Comparison groups
    Placebo v MHAA4549A 8400 mg
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2044
    Method
    		 Wilcoxon
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.74
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.04

    Secondary: Percentage of Subjects with Influenza-Related Deaths

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    End point title
    		 Percentage of Subjects with Influenza-Related Deaths
    End point description
    The safety population included all subjects randomised to treatment.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 100
    End point values
    		 Placebo MHAA4549A 3600 mg MHAA4549A 8400 mg
    Number of subjects analysed
    43
    41
    40
    Units: percentage of subjects
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to Day 100
    Adverse event reporting additional description
    The safety population included all subjects randomised to treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received single-dose placebo by intravenous (IV) administration.

    Reporting group title
    MHAA4549A 3600 mg
    Reporting group description
    		 Subjects received single-dose MHAA4549A, 3600 milligrams (mg), by IV administration.

    Reporting group title
    MHAA4549A 8400 mg
    Reporting group description
    		 Subjects received single-dose MHAA4549A, 8400 mg, by IV administration.

    Serious adverse events
    		 Placebo MHAA4549A 3600 mg MHAA4549A 8400 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo MHAA4549A 3600 mg MHAA4549A 8400 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 43 (9.30%)
    7 / 41 (17.07%)
    6 / 40 (15.00%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 43 (4.65%)
    3 / 41 (7.32%)
    3 / 40 (7.50%)
         occurrences all number
    2
    3
    3
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 41 (2.44%)
    2 / 40 (5.00%)
         occurrences all number
    1
    1
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 41 (7.32%)
    1 / 40 (2.50%)
         occurrences all number
    1
    3
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Apr 2016
    Revised the study design to address operational constraints associated with subject enrollment and follow-up. Updated sections to be consistent with current company standards.
    13 May 2016
    Reduced the inclusion criteria enrollment window (from ≤ 120 hours) to “≤ 72 hours (3 days) between onset of influenza-like illness (as determined by the investigator) and start of study treatment.”

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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