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    Clinical Trial Results:
    A Phase II, Randomized, Double-blind, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of MSTT1041A in Patients with Moderate to Severe Atopic Dermatitis

    Summary
    EudraCT number
    		 2018-003429-27
    Trial protocol
    		 DE  
    Global end of trial date
    11 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2021
    First version publication date
    14 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS40965
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03747575
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hoffmann-La Roche
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, 4070
    Public contact
    F. Hoffmann-LaRoche AG, Hoffmann-La Roche, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-LaRoche 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
    11 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective was to assess the efficacy and safety of MSTT1041A (astegolimab) in participants with moderate to severe atopic dermatitis (AD).
    Protection of trial subjects
    All participants are required to sign an Informed Consent Form (ICF).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Feb 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    United States: 43
    Worldwide total number of subjects
    65
    EEA total number of subjects
    22
    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)
    61
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adults with moderate or severe atopic dermatitis

    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
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.
    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
    Administered as a loading dose Week 1, then as four subcutaneous (SC) injections every 4 weeks (Q4W)

    Arm title
    		 Treatment
    Arm description
    		 Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).
    Arm type
    		 Experimental

    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
    Administered as a 245 mg loading dose Week 1, then as four 490 mg subcutaneous (SC) injections every 4 weeks (Q4W)

    Number of subjects in period 1
    		Placebo Treatment
    Started
    32
    33
    Completed
    23
    26
    Not completed
    9
    7
         Consent withdrawn by subject
    6
    3
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.

    Reporting group title
    Treatment
    Reporting group description
    		 Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).

    Reporting group values
    		 Placebo Treatment Total
    Number of subjects
    		 32 33 65
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 30 31 61
        >=65 years
    		 2 2 4
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 39.3 ( 14.4 ) 39.7 ( 15.2 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 20 20 40
        Male
    		 12 13 25
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 4 0 4
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 8 8 16
        White
    		 20 25 45
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 2 4
        Not Hispanic or Latino
    		 30 30 60
        Unknown or Not Reported
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.

    Reporting group title
    Treatment
    Reporting group description
    		 Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).

    Primary: Percent Change of Total Eczema Area and Severity Index (EASI) Score

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    End point title
    		 Percent Change of Total Eczema Area and Severity Index (EASI) Score [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical analyses were performed
    End point values
    		 Placebo Treatment
    Number of subjects analysed
    32
    33
    Units: Percentage
        arithmetic mean (standard error)
    -58.24 ( 9.092 )
    -51.47 ( 8.639 )
    No statistical analyses for this end point

    Secondary: Proportion of Participants who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1

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    End point title
    		 Proportion of Participants who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Treatment
    Number of subjects analysed
    32
    33
    Units: Percentage
        number (not applicable)
    6.3
    15.2
    No statistical analyses for this end point

    Secondary: Proportion of Participants who Achieve >/=75% Reduction from Baseline in Eczema Area and Severity Index (EASI-75) Score

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    End point title
    		 Proportion of Participants who Achieve >/=75% Reduction from Baseline in Eczema Area and Severity Index (EASI-75) Score
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Treatment
    Number of subjects analysed
    32
    33
    Units: Percentage
        number (not applicable)
    18.8
    27.3
    No statistical analyses for this end point

    Secondary: Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS)

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    End point title
    		 Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Treatment
    Number of subjects analysed
    32
    33
    Units: Percentage
        arithmetic mean (standard error)
    -39.43 ( 7.839 )
    -31.22 ( 7.376 )
    No statistical analyses for this end point

    Secondary: Percent Change in Body Surface Area (BSA) with Atopic Dermatitis (AD) Involvement

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    End point title
    		 Percent Change in Body Surface Area (BSA) with Atopic Dermatitis (AD) Involvement
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Treatment
    Number of subjects analysed
    32
    33
    Units: Percentage
        arithmetic mean (standard error)
    -38.87 ( 9.134 )
    -42.23 ( 8.637 )
    No statistical analyses for this end point

    Secondary: Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD)

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    End point title
    		 Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Treatment
    Number of subjects analysed
    32
    33
    Units: Percentage
        arithmetic mean (standard error)
    -39.50 ( 7.202 )
    -35.45 ( 6.837 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Adverse Events (AE)

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    End point title
    		 Percentage of Participants with Adverse Events (AE)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Week 24
    End point values
    		 Placebo Treatment
    Number of subjects analysed
    32
    33
    Units: Percentage
        number (not applicable)
    58.1
    41.2
    No statistical analyses for this end point

    Secondary: Serum Concentrations of MSTT1041A

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    End point title
    		 Serum Concentrations of MSTT1041A [2]
    End point description
    End point type
    Secondary
    End point timeframe
    At pre-defined intervals from baseline up to Week 24
    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: Results are specific to the arm that received MSTT1041A
    End point values
    		 Treatment
    Number of subjects analysed
    33 [3]
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        Day 1 Visit 2/prior to infusion
    9999 ( 9999 )
        Week 1 Visit 3/prior to infusion
    42.6 ( 34.4 )
        Week 4 Visit 5/prior to infusion
    37.6 ( 52.5 )
        Week 8 Visit 7/prior to infusion
    36.6 ( 54.5 )
        Week 12 Visit 9/prior to infusion
    40.1 ( 60.5 )
        Week 16 Visit 11
    38.2 ( 76.0 )
        Period completion/early discontinuation
    7.83 ( 151.2 )
    Notes
    [3] - Summary statistics not reportable for time points where > one-third of samples were not reportable.
    No statistical analyses for this end point

    Secondary: Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs)

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    End point title
    		 Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Week 24
    End point values
    		 Placebo Treatment
    Number of subjects analysed
    32
    33
    Units: Participants
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 16
    Adverse event reporting additional description
    The safety population contained all randomized participants who received at least one dose of study drug. Participants are grouped according to actual treatment received.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a loading dose of SC placebo matched to MSTT1041A followed by SC placebo Q4W.

    Reporting group title
    Treatment
    Reporting group description
    		 Participants received a loading dose of 245 mg of subcutaneous (SC) MSTT1041A, followed by 490 mg of SC MSTT1041A every 4 weeks (Q4W).

    Serious adverse events
    		 Placebo Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 31 (25.81%)
    3 / 34 (8.82%)
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    5 / 31 (16.13%)
    3 / 34 (8.82%)
         occurrences all number
    6
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 34 (0.00%)
         occurrences all number
    5
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? 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
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