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    Clinical Trial Results:
    A Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of MSTT1041A in Patients with Uncontrolled Severe Asthma

    Summary
    EudraCT number
    		 2016-001549-13
    Trial protocol
    		 BE   DE   CZ   PL  
    Global end of trial date
    26 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Aug 2020
    First version publication date
    02 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GB39242
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02918019
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hoffmann-La Roche
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, 4070
    Public contact
    F. Hoffmann-La Roche AG, Hoffmann-La Roche, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, Hoffmann-La Roche, +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
    26 Jul 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was a study to evaluate the efficacy, safety, and pharmacokinetics of astegolimab (MSTT1041A) compared to placebo as add-on therapy in participants with severe, uncontrolled asthma receiving medium- or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier (LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation.
    Protection of trial subjects
    All participants were required to sign an informed consent form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Sep 2016
    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
    Argentina: 33
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Bulgaria: 52
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    Czech Republic: 40
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    New Zealand: 2
    Country: Number of subjects enrolled
    Peru: 26
    Country: Number of subjects enrolled
    Poland: 68
    Country: Number of subjects enrolled
    Romania: 13
    Country: Number of subjects enrolled
    Russian Federation: 38
    Country: Number of subjects enrolled
    Ukraine: 72
    Country: Number of subjects enrolled
    United States: 111
    Country: Number of subjects enrolled
    South Africa: 17
    Worldwide total number of subjects
    502
    EEA total number of subjects
    191
    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)
    427
    From 65 to 84 years
    75
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adult participants with severe, uncontrolled asthma receiving medium- or high-dose inhaled corticosteroid (ICS) therapy and at least one additional controller medication

    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
    		 Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received SC placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Arm title
    		 Astegolimab (MSTT1041A) 70mg
    Arm description
    		 Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Astegolimab
    Investigational medicinal product code
    Other name
    MSTT1041A
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 70mg SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Arm title
    		 Astegolimab (MSTT1041A) 210mg
    Arm description
    		 Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Astegolimab
    Investigational medicinal product code
    Other name
    MSTT1041A
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 210mg SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Arm title
    		 Astegolimab (MSTT1041A) 490mg
    Arm description
    		 Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Astegolimab
    Investigational medicinal product code
    Other name
    MSTT1041A
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 490mg SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Number of subjects in period 1
    		Placebo Astegolimab (MSTT1041A) 70mg Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg
    Started
    127
    127
    126
    122
    Completed
    121
    117
    117
    113
    Not completed
    6
    10
    9
    9
         Physician decision
    1
    3
    2
    -
         Consent withdrawn by subject
    3
    4
    6
    4
         Adverse event, non-fatal
    -
    1
    -
    1
         Death
    -
    -
    1
    -
         Protocol deviation
    1
    1
    -
    2
         Lost to follow-up
    1
    1
    -
    1
         Principal investigator request
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Reporting group title
    Astegolimab (MSTT1041A) 70mg
    Reporting group description
    		 Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Reporting group title
    Astegolimab (MSTT1041A) 210mg
    Reporting group description
    		 Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Reporting group title
    Astegolimab (MSTT1041A) 490mg
    Reporting group description
    		 Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Reporting group values
    		 Placebo Astegolimab (MSTT1041A) 70mg Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg Total
    Number of subjects
    		 127 127 126 122 502
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 111 106 107 103 427
        From 65-84 years
    		 16 21 19 19 75
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.4 ( 12.2 ) 52.4 ( 11.9 ) 52.5 ( 12.0 ) 51.4 ( 12.0 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 82 81 90 79 332
        Male
    		 45 46 36 43 170
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 5 5 8 4 22
        Asian
    		 6 4 4 9 23
        Black
    		 8 9 6 6 29
        White
    		 107 105 108 102 422
        Multiple
    		 1 4 0 1 6
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 18 19 15 14 66
        Not Hispanic or Latino
    		 109 108 110 108 435
        Not Stated
    		 0 0 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Reporting group title
    Astegolimab (MSTT1041A) 70mg
    Reporting group description
    		 Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Reporting group title
    Astegolimab (MSTT1041A) 210mg
    Reporting group description
    		 Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Reporting group title
    Astegolimab (MSTT1041A) 490mg
    Reporting group description
    		 Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Primary: Reduction in Rate of Asthma Exacerbations

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    End point title
    		 Reduction in Rate of Asthma Exacerbations
    End point description
    Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that result in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days.
    End point type
    Primary
    End point timeframe
    Baseline to Week 54
    End point values
    		 Placebo Astegolimab (MSTT1041A) 70mg Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg
    Number of subjects analysed
    127 [1]
    127 [2]
    126 [3]
    122 [4]
    Units: Percentage
        number (not applicable)
    9999
    36.9
    21.9
    43
    Notes
    [1] - 9999= value not reported
    [2] - adjusted rate reported
    [3] - adjusted rate reported
    [4] - adjusted rate reported
    Statistical analysis title
    		 MSTT1041A 490mg/Placebo
    Comparison groups
    Placebo v Astegolimab (MSTT1041A) 490mg
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0049
    Method
    		 Poisson regression
    Parameter type
    		 Rate Ratio
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 0.84

    Secondary: Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

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    End point title
    		 Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
    End point description
    FEV1 measures how much air a person can exhale during the first second of a forced breath.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 54
    End point values
    		 Placebo Astegolimab (MSTT1041A) 70mg Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg
    Number of subjects analysed
    120 [5]
    117 [6]
    115 [7]
    113 [8]
    Units: Milliliters (mL)
        arithmetic mean (confidence interval 95%)
    107 (47 to 167)
    130 (70 to 191)
    154 (93 to 215)
    172 (110 to 234)
    Notes
    [5] - adjusted mean reported
    [6] - adjusted mean reported
    [7] - adjusted mean reported
    [8] - adjusted mean reported
    No statistical analyses for this end point

    Secondary: Time to First Asthma Exacerbation

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    End point title
    		 Time to First Asthma Exacerbation
    End point description
    Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that result in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days.
    End point type
    Secondary
    End point timeframe
    52 Weeks
    End point values
    		 Placebo Astegolimab (MSTT1041A) 70mg Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg
    Number of subjects analysed
    127 [9]
    127 [10]
    126 [11]
    122 [12]
    Units: Weeks
        median (confidence interval 95%)
    9999 (46.6 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    Notes
    [9] - 9999 = Value not estimable due to insufficient no. of participants with event
    [10] - 9999 = Value not estimable due to insufficient no. of participants with event
    [11] - 9999 = Value not estimable due to insufficient no. of participants with event
    [12] - 9999 = Value not estimable due to insufficient no. of participants with event
    No statistical analyses for this end point

    Secondary: Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score

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    End point title
    		 Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score
    End point description
    The AQLQ measures the functional problems (physical, emotional, social, and occupational) most troublesome to adults (17-70 years) with asthma. There are 32 questions in 4 domains - symptoms, activity limitation, emotional function, and environmental stimuli - scored on a 7 point scale, with 7= no impairment and 1= severely impaired. For this study, improvement achievement was defined as an increase of at least 0.5 points from baseline to week 54.
    End point type
    Secondary
    End point timeframe
    Week 54
    End point values
    		 Placebo Astegolimab (MSTT1041A) 70mg Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg
    Number of subjects analysed
    116 [13]
    116 [14]
    115 [15]
    112 [16]
    Units: Percentage
    number (not applicable)
        Week 54 - Responder
    55.3
    64.8
    61.3
    68.9
        Week 54 - Non-responder
    44.7
    35.2
    38.7
    31.1
    Notes
    [13] - adjusted rate reported
    [14] - adjusted rate reported
    [15] - adjusted rate reported
    [16] - adjusted rate reported
    No statistical analyses for this end point

    Secondary: Absolute Change in Patient-Reported Use of Short-Acting Rescue Therapy

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    End point title
    		 Absolute Change in Patient-Reported Use of Short-Acting Rescue Therapy
    End point description
    9999 = adjusted mean value is equal to zero. 9999 is reported due to limitations in the EudraCT results reporting system.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 54
    End point values
    		 Placebo Astegolimab (MSTT1041A) 70mg Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg
    Number of subjects analysed
    107
    106
    102
    99
    Units: Usage
        number (not applicable)
    9999
    9999
    9999
    9999
    No statistical analyses for this end point

    Secondary: Proportion of Weeks Without Patient-Reported Asthma-Related Nighttime Awakenings

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    End point title
    		 Proportion of Weeks Without Patient-Reported Asthma-Related Nighttime Awakenings
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline through Week 54
    End point values
    		 Placebo Astegolimab (MSTT1041A) 70mg Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg
    Number of subjects analysed
    127 [17]
    126 [18]
    126 [19]
    122 [20]
    Units: Percentage
        number (not applicable)
    0.4
    0.4
    0.3
    0.3
    Notes
    [17] - adjusted mean reported
    [18] - adjusted mean reported
    [19] - adjusted mean reported
    [20] - adjusted mean reported
    No statistical analyses for this end point

    Secondary: Absolute Change in Patient-Reported Daytime Asthma Symptom Severity as Measured by the Asthma Daily Symptom Diary (ADSD)

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    End point title
    		 Absolute Change in Patient-Reported Daytime Asthma Symptom Severity as Measured by the Asthma Daily Symptom Diary (ADSD)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 54
    End point values
    		 Placebo Astegolimab (MSTT1041A) 70mg Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg
    Number of subjects analysed
    126 [21]
    124 [22]
    125 [23]
    122 [24]
    Units: Units on a scale
        number (not applicable)
    -1
    -2
    -1
    -1
    Notes
    [21] - adjusted mean reported
    [22] - adjusted mean reported
    [23] - adjusted mean reported
    [24] - adjusted mean reported
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Adverse Events

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    End point title
    		 Percentage of Participants with Adverse Events
    End point description
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 54
    End point values
    		 Placebo Astegolimab (MSTT1041A) 70mg Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg
    Number of subjects analysed
    127
    127
    126
    122
    Units: Percentage
        number (not applicable)
    77.2
    70.9
    72.2
    72.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Anti-Drug Antibodies (ADAs)

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    End point title
    		 Percentage of Participants with Anti-Drug Antibodies (ADAs)
    End point description
    The prevalence of ADAs at baseline was defined as the proportion of the evaluable participant population in a study that is ADA positive at baseline.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Placebo Astegolimab (MSTT1041A) 70mg Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg
    Number of subjects analysed
    124
    126
    126
    121
    Units: Percentage
        number (not applicable)
    5.6
    0.8
    1.6
    1.7
    No statistical analyses for this end point

    Secondary: Serum Concentration of Astegolimab (MSTT1041A)

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    End point title
    		 Serum Concentration of Astegolimab (MSTT1041A) [25]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 54
    Notes
    [25] - 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: Values were only collected for arms receiving active treatment, which did not include the placebo arm.
    End point values
    		 Astegolimab (MSTT1041A) 70mg Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg
    Number of subjects analysed
    125
    126
    117
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        Week 26 pre-dose
    4.75 ( 123.3 )
    16.9 ( 167.3 )
    40.5 ( 161.2 )
        Week 54
    4.47 ( 144.1 )
    17.4 ( 155.4 )
    38.7 ( 226.4 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Treatment-Emergent ADAs

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    End point title
    		 Percentage of Participants with Treatment-Emergent ADAs
    End point description
    The incidence of ADAs at post-baseline timepoints was defined as the proportion of the study population found to have developed treatment-emergent ADAs.
    End point type
    Secondary
    End point timeframe
    Post-baseline
    End point values
    		 Placebo Astegolimab (MSTT1041A) 70mg Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg
    Number of subjects analysed
    126
    125
    123
    120
    Units: Percentage
        number (not applicable)
    7.1
    9.6
    8.9
    3.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to Week 54
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received subcutaneous (SC) placebo matched to astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Reporting group title
    Astegolimab (MSTT1041A) 210mg
    Reporting group description
    		 Participants received 210mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Reporting group title
    Astegolimab (MSTT1041A) 490mg
    Reporting group description
    		 Participants received 490mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Reporting group title
    Astegolimab (MSTT1041A) 70mg
    Reporting group description
    		 Participants received 70mg of SC astegolimab (MSTT1041A) at randomization (Week 2), Week 6, and every 4 weeks (Q4W) thereafter through Week 50.

    Serious adverse events
    		 Placebo Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg Astegolimab (MSTT1041A) 70mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 127 (6.30%)
    9 / 126 (7.14%)
    6 / 122 (4.92%)
    14 / 127 (11.02%)
         number of deaths (all causes)
    0
    1
    1
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 127 (0.79%)
    1 / 126 (0.79%)
    0 / 122 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    1 / 122 (0.82%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 126 (0.79%)
    1 / 122 (0.82%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal prolapse
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 127 (1.57%)
    4 / 126 (3.17%)
    1 / 122 (0.82%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Chronic rhinosinusitis with nasal polyps
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vocal cord disorder
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    1 / 122 (0.82%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 126 (0.79%)
    0 / 122 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 126 (0.79%)
    0 / 122 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 126 (1.59%)
    0 / 122 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 126 (0.79%)
    0 / 122 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    1 / 122 (0.82%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Rectal haemorrhage
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 126 (0.79%)
    0 / 122 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatotoxicity
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Livedo reticularis
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 126 (0.00%)
    1 / 122 (0.82%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 126 (0.00%)
    1 / 122 (0.82%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 126 (0.00%)
    0 / 122 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Astegolimab (MSTT1041A) 210mg Astegolimab (MSTT1041A) 490mg Astegolimab (MSTT1041A) 70mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    76 / 127 (59.84%)
    75 / 126 (59.52%)
    68 / 122 (55.74%)
    65 / 127 (51.18%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 127 (4.72%)
    6 / 126 (4.76%)
    14 / 122 (11.48%)
    8 / 127 (6.30%)
         occurrences all number
    6
    7
    20
    10
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    1 / 127 (0.79%)
    8 / 126 (6.35%)
    6 / 122 (4.92%)
    10 / 127 (7.87%)
         occurrences all number
    3
    23
    107
    38
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    58 / 127 (45.67%)
    53 / 126 (42.06%)
    39 / 122 (31.97%)
    42 / 127 (33.07%)
         occurrences all number
    108
    83
    61
    68
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 127 (1.57%)
    4 / 126 (3.17%)
    4 / 122 (3.28%)
    7 / 127 (5.51%)
         occurrences all number
    3
    5
    4
    7
    Back pain
         subjects affected / exposed
    7 / 127 (5.51%)
    5 / 126 (3.97%)
    4 / 122 (3.28%)
    5 / 127 (3.94%)
         occurrences all number
    8
    5
    4
    5
    Infections and infestations
    Influenza
         subjects affected / exposed
    5 / 127 (3.94%)
    2 / 126 (1.59%)
    7 / 122 (5.74%)
    2 / 127 (1.57%)
         occurrences all number
    5
    2
    7
    2
    Nasopharyngitis
         subjects affected / exposed
    13 / 127 (10.24%)
    21 / 126 (16.67%)
    16 / 122 (13.11%)
    12 / 127 (9.45%)
         occurrences all number
    18
    30
    23
    21
    Rhinitis
         subjects affected / exposed
    7 / 127 (5.51%)
    3 / 126 (2.38%)
    2 / 122 (1.64%)
    7 / 127 (5.51%)
         occurrences all number
    8
    3
    3
    11
    Sinusitis
         subjects affected / exposed
    3 / 127 (2.36%)
    3 / 126 (2.38%)
    5 / 122 (4.10%)
    7 / 127 (5.51%)
         occurrences all number
    3
    3
    7
    9
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 127 (9.45%)
    8 / 126 (6.35%)
    6 / 122 (4.92%)
    9 / 127 (7.09%)
         occurrences all number
    19
    9
    6
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Oct 2017
    Addition/clarification of primary and secondary endpoints; eligibility criteria updates
    23 Jan 2019
    Updated timepoints for efficacy objectives

    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.
    Further development of the investigational medical product (IMP) has been discontinued.
    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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