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    Clinical Trial Results:
    A randomized, placebo-controlled, double-blind, parallel-group, multicenter Phase 2a study to investigate efficacy and safety of zabedosertib (BAY 1834845) for the treatment of adult patients with moderate-to-severe atopic dermatitis

    Summary
    EudraCT number
    		 2022-000520-38
    Trial protocol
    		 CZ   FR   IT   PL  
    Global end of trial date
    28 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Mar 2025
    First version publication date
    05 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY1834845/22158
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05656911
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.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
    28 Feb 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of zabedosertib vs. placebo in adult patients with moderate-to-severe atopic dermatitis (AD) with inadequate response to topical corticosteroids or if topical treatments are medically not advisable.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects (or their legally authorized representative according to local legislation). Participating subjects (or their legally authorized representative according to local legislation) signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 All subjects had to use a stable amount of emollient as background therapy during the course of the study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 2022
    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
    United Kingdom: 5
    Country: Number of subjects enrolled
    United States: 5
    Country: Number of subjects enrolled
    Poland: 14
    Country: Number of subjects enrolled
    Czechia: 30
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Italy: 8
    Worldwide total number of subjects
    77
    EEA total number of subjects
    67
    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)
    77
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at 22 centers in Europe and US between 21-DEC-2022 (first subject first visit) and 31-JAN-2024 (last subject last visit).

    Pre-assignment
    Screening details
    		 A total of 129 subjects were screened in this study. Of those, 52 did not pass screening (44 were screened failures, 1 was physician decision, 6 were subject decision, 1 was other reasons). A total of 77 subjects were randomized.

    Period 1
    Period 1 title
    Treatment phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Zabedosertib (BAY1834845)
    Arm description
    		 Subjects received zabedosertib for up to 12 weeks (84 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zabedosertib
    Investigational medicinal product code
    BAY1834845
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg, oral administration, two times a day

    Arm title
    		 Placebo
    Arm description
    		 Subjects received matching placebo to zabedosertib for up to 12 weeks (84 days).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    oral administration, two times a day

    Number of subjects in period 1
    		Zabedosertib (BAY1834845) Placebo
    Started
    52
    25
    Completed
    36
    19
    Not completed
    16
    6
         Physician decision
    2
    -
         Subject Decision
    4
    2
         Adverse event, non-fatal
    3
    1
         Other Reasons
    1
    -
         Lack of efficacy
    6
    3
    Period 2
    Period 2 title
    Follow-up phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Zabedosertib (BAY1834845)
    Arm description
    		 Subjects received zabedosertib for up to 12 weeks (84 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zabedosertib
    Investigational medicinal product code
    BAY1834845
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg, oral administration, two times a day

    Arm title
    		 Placebo
    Arm description
    		 Subjects received matching placebo to zabedosertib for up to 12 weeks (84 days).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    oral administration, two times a day

    Number of subjects in period 2
    		Zabedosertib (BAY1834845) Placebo
    Started
    36
    19
    Completed
    35
    18
    Not completed
    1
    1
         Subject Decision
    -
    1
         Missing
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Zabedosertib (BAY1834845)
    Reporting group description
    		 Subjects received zabedosertib for up to 12 weeks (84 days).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo to zabedosertib for up to 12 weeks (84 days).

    Reporting group values
    		 Zabedosertib (BAY1834845) Placebo Total
    Number of subjects
    		 52 25 77
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.2 ( 11.3 ) 32.9 ( 10.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 26 7 33
        Male
    		 26 18 44
    Race
    Units: Subjects
        White
    		 47 22 69
        Black or African American
    		 1 2 3
        Asian
    		 4 1 5
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 50 24 74
        Hispanic or Latino
    		 2 1 3

    End points

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    End points reporting groups
    Reporting group title
    Zabedosertib (BAY1834845)
    Reporting group description
    		 Subjects received zabedosertib for up to 12 weeks (84 days).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo to zabedosertib for up to 12 weeks (84 days).
    Reporting group title
    Zabedosertib (BAY1834845)
    Reporting group description
    		 Subjects received zabedosertib for up to 12 weeks (84 days).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo to zabedosertib for up to 12 weeks (84 days).

    Subject analysis set title
    Per protocol set (PPS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized subjects who: had an EASI score at baseline; had an EASI score at Day 56 (Visit 6) or later or took rescue medication between Day 56 (Visit 6) and Day 84 (Visit 7) or took standard of care or discontinued study intervention due to lack of efficacy (at any time); showed compliance of at least 80% with study intervention between start of treatment and end of treatment or start of rescue medication at or after Day 56 (Visit 6), whatever comes first; showed compliance of at least 80% with study intervention during the last 4 weeks before end of treatment or start of rescue medication at or after Day 56 (Visit 6), whatever comes first; without validity findings with respect to the efficacy related entry criteria.

    Subject analysis set title
    Safety analysis set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who took at least 1 dose of study intervention.

    Primary: Achievement of 75% reduction from baseline in the Eczema Area and Severity Index (EASI 75 response) at Week 12 (Day 84)

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    End point title
    		 Achievement of 75% reduction from baseline in the Eczema Area and Severity Index (EASI 75 response) at Week 12 (Day 84)
    End point description
    The endpoint was the composite variable defined as follows: - an EASI 75 response at Week 12 (Day 84), - no stop of study intervention for reasons related to lack of efficacy, - no rescue medication use during the 4 weeks before Day 84 and - no use of systemic atopic dermatitis (AD) treatment. The main estimand was the difference in the proportion of responders between treatment groups in adults with moderate-to-severe atopic dermatitis where use of topical rescue medication from Day 56 (Visit 6) onwards, use of systemic standard of care for AD and discontinuation of treatment due to lack of efficacy are handled as non-response (composite strategy). The estimand was regardless of use of rescue medication before Day 56 (Visit 6), regardless of non-compliance with emollients, and had treatment not been discontinued due to other reasons not related to lack of efficacy. Bayesian analysis according to estimand is presented.
    End point type
    Primary
    End point timeframe
    Week 12 (Day 84)
    End point values
    		 Zabedosertib (BAY1834845) Placebo
    Number of subjects analysed
    47 [1]
    22 [2]
    Units: Responder rate (percentage %)
        number (not applicable)
    32.3
    37.4
    Notes
    [1] - PPS
    [2] - PPS
    Statistical analysis title
    		 Bayesian analysis according to estimand
    Statistical analysis description
    Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.
    Comparison groups
    Zabedosertib (BAY1834845) v Placebo
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    -5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29
         upper limit
    		 18
    Notes
    [3] - Posterior probability is 34.0%.

    Secondary: Percent change from baseline in EASI at Week 12 (Day 84)

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    End point title
    		 Percent change from baseline in EASI at Week 12 (Day 84)
    End point description
    The EASI is a ClinRO assessing the extent of AD at four body regions by measuring the average severity of four clinical signs at each body region, each on a scale of 0 to 3. The minimum EASI score is 0 and the maximum EASI score is 72, with a higher score indicating worse severity of AD. The main estimand was based on the same strategies to address intercurrent events as described above for the primary endpoint. The mean difference between the treatment arms was used as summary measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12 (Day 84)
    End point values
    		 Zabedosertib (BAY1834845) Placebo
    Number of subjects analysed
    47 [4]
    22 [5]
    Units: percentage (%) of change
        least squares mean (confidence interval 95%)
    -44.58 (-55.96 to -33.19)
    -55.88 (-71.91 to -39.85)
    Notes
    [4] - PPS
    [5] - PPS
    Statistical analysis title
    		 ANCOVA analysis
    Statistical analysis description
    The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.
    Comparison groups
    Zabedosertib (BAY1834845) v Placebo
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.257 [6]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    11.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.26
         upper limit
    		 30.87
    Notes
    [6] - two-sided. No adjustment for multiple comparisons.

    Secondary: Achievement of EASI 50 response at Week 12 (Day 84)

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    End point title
    		 Achievement of EASI 50 response at Week 12 (Day 84)
    End point description
    The EASI is a ClinRO assessing the extent of AD at four body regions by measuring the average severity of four clinical signs at each body region, each on a scale of 0 to 3. The minimum EASI score is 0 and the maximum EASI score is 72, with a higher score indicating worse severity of AD. EASI 50 corresponds to the achievement of 50% reduction from baseline in EASI. The main estimand was calculated similarly as for EASI 75. Bayesian analysis according to estimand is presented.
    End point type
    Secondary
    End point timeframe
    Week 12 (Day 84)
    End point values
    		 Zabedosertib (BAY1834845) Placebo
    Number of subjects analysed
    47 [7]
    22 [8]
    Units: Responder rate (percentage %)
        number (not applicable)
    52.7
    55.4
    Notes
    [7] - PPS
    [8] - PPS
    Statistical analysis title
    		 Bayesian analysis according to estimand
    Statistical analysis description
    Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.
    Comparison groups
    Zabedosertib (BAY1834845) v Placebo
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27
         upper limit
    		 22.1
    Notes
    [9] - Posterior probability is 41.7%.

    Secondary: Achievement of EASI 90 response at Week 12 (Day 84)

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    End point title
    		 Achievement of EASI 90 response at Week 12 (Day 84)
    End point description
    The EASI is a ClinRO assessing the extent of AD at four body regions by measuring the average severity of four clinical signs at each body region, each on a scale of 0 to 3. The minimum EASI score is 0 and the maximum EASI score is 72, with a higher score indicating worse severity of AD. EASI 90 corresponds to the achievement of 90% reduction from baseline in EASI. The main estimand was calculated similarly as for EASI 75. Bayesian analysis according to estimand is presented.
    End point type
    Secondary
    End point timeframe
    Week 12 (Day 84)
    End point values
    		 Zabedosertib (BAY1834845) Placebo
    Number of subjects analysed
    47 [10]
    22 [11]
    Units: Responder rate (percentage %)
        number (not applicable)
    15.6
    20.4
    Notes
    [10] - PPS
    [11] - PPS
    Statistical analysis title
    		 Bayesian analysis according to estimand
    Statistical analysis description
    Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.
    Comparison groups
    Zabedosertib (BAY1834845) v Placebo
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    -4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.6
         upper limit
    		 13.4
    Notes
    [12] - Posterior probability is 31.5%.

    Secondary: Achievement of a vIGA-AD response (score 0 or 1 and ≥ 2 points improvement) at Week 12 (Day 84)

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    End point title
    		 Achievement of a vIGA-AD response (score 0 or 1 and ≥ 2 points improvement) at Week 12 (Day 84)
    End point description
    vIGA-AD stands for validated Investigator Global Assessment for Atopic Dermatitis. The vIGA-AD is a 1-item static ClinRO using a 5-point scale from 0 (clear) to 4 (severe) based on 4 clinical features of AD lesions: erythema, induration/papulation, lichenification, and oozing/crusting, and takes extent of disease into account. The main estimand was calculated similarly as for EASI 75. Bayesian analysis according to estimand is presented.
    End point type
    Secondary
    End point timeframe
    Week 12 (Day 84)
    End point values
    		 Zabedosertib (BAY1834845) Placebo
    Number of subjects analysed
    47 [13]
    22 [14]
    Units: Responder rate (percentage %)
        number (not applicable)
    15.9
    28.5
    Notes
    [13] - PPS
    [14] - PPS
    Statistical analysis title
    		 Bayesian analysis according to estimand
    Statistical analysis description
    Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.
    Comparison groups
    Zabedosertib (BAY1834845) v Placebo
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    -12.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34.1
         upper limit
    		 7
    Notes
    [15] - Posterior probability is 10.8%.

    Secondary: Absolute change from baseline in body surface area (BSA) affected by atopic dermatitis (AD) at Week 12 (Day 84)

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    End point title
    		 Absolute change from baseline in body surface area (BSA) affected by atopic dermatitis (AD) at Week 12 (Day 84)
    End point description
    BSA affected by AD was assessed for each section of the body, e.g. using the rule of nines. The possible highest score for each region is: Head and neck - 9%; Anterior trunk - 18%; Back - 18%; Upper limbs - 18%; Lower limbs - 36%; Genitals - 1%. Affected BSA was reported as a percentage of all major body sections combined. The main estimand was based on the same strategies to address intercurrent events as described above for the primary endpoint. The mean difference between the treatment arms was used as summary measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12 (Day 84)
    End point values
    		 Zabedosertib (BAY1834845) Placebo
    Number of subjects analysed
    47 [16]
    22 [17]
    Units: BSA (%)
        least squares mean (confidence interval 95%)
    -13.28 (-18.98 to -7.58)
    -20.34 (-28.60 to -12.07)
    Notes
    [16] - PPS
    [17] - PPS
    Statistical analysis title
    		 ANCOVA analysis
    Statistical analysis description
    The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.
    Comparison groups
    Zabedosertib (BAY1834845) v Placebo
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.166 [18]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.92
         upper limit
    		 17.03
    Notes
    [18] - two-sided. No adjustment for multiple comparisons.

    Secondary: Achievement of a ≥ 4 point-improvement (reduction) in the weekly average of the Peak Pruritus 0-10 NRS score from baseline to Week 12 (Day 84) for subjects with Peak Pruritus 0-10 NRS score ≥ 4 at baseline

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    End point title
    		 Achievement of a ≥ 4 point-improvement (reduction) in the weekly average of the Peak Pruritus 0-10 NRS score from baseline to Week 12 (Day 84) for subjects with Peak Pruritus 0-10 NRS score ≥ 4 at baseline
    End point description
    NRS stands for numerical rating scale. The Peak Pruritus 0-10 NRS is a single patient-reported item designed to measure peak pruritus (itch), or ‘worst’ itch, over the previous 24 h based on the following question: ‘On a scale of 0 to 10, with 0 being “no itch” and 10 being “worst itch imaginable”, how would you rate your itch at the worst moment during the previous 24 hours?’. ≥ 4 points reduction of the Peak Pruritus 0-10 NRS is considered a clinically relevant within-person response. NRS was assessed on a daily basis and the average over the last 7 days before the visit day was used for analysis. The main estimand was calculated similarly as for EASI 75. Bayesian analysis according to estimand is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12 (Day 84)
    End point values
    		 Zabedosertib (BAY1834845) Placebo
    Number of subjects analysed
    47 [19]
    22 [20]
    Units: Responder rate (percentage %)
        number (not applicable)
    16.4
    25.0
    Notes
    [19] - PPS
    [20] - PPS
    Statistical analysis title
    		 Bayesian analysis according to estimand
    Statistical analysis description
    Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.
    Comparison groups
    Zabedosertib (BAY1834845) v Placebo
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 other [21]
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    -8.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.4
         upper limit
    		 11
    Notes
    [21] - Posterior probability is 20.5%.

    Secondary: Absolute values of weekly average of the Peak Pruritus 0-10 numerical rating scale (NRS) score at Week 12 (Day 84)

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    End point title
    		 Absolute values of weekly average of the Peak Pruritus 0-10 numerical rating scale (NRS) score at Week 12 (Day 84)
    End point description
    The Peak Pruritus 0-10 NRS is a single patient-reported item designed to measure peak pruritus (itch), or ‘worst’ itch, over the previous 24 h based on the following question: ‘On a scale of 0 to 10, with 0 being “no itch” and 10 being “worst itch imaginable”, how would you rate your itch at the worst moment during the previous 24 hours?’. ≥ 4 points reduction of the Peak Pruritus 0-10 NRS is considered a clinically relevant within-person response. NRS was assessed on a daily basis and the average over the last 7 days before the visit day was used for analysis. The main estimand was based on the same strategies to address intercurrent events as described above for the primary endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12 (Day 84)
    End point values
    		 Zabedosertib (BAY1834845) Placebo
    Number of subjects analysed
    47 [22]
    22 [23]
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    5.759 ( 2.218 )
    5.36 ( 2.311 )
    Notes
    [22] - PPS
    [23] - PPS
    No statistical analyses for this end point

    Secondary: Percent change of weekly average of the Peak Pruritus 0-10 NRS score from baseline at Week 12 (Day 84)

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    End point title
    		 Percent change of weekly average of the Peak Pruritus 0-10 NRS score from baseline at Week 12 (Day 84)
    End point description
    The Peak Pruritus 0-10 NRS is a single patient-reported item designed to measure peak pruritus (itch), or ‘worst’ itch, over the previous 24 h based on the following question: ‘On a scale of 0 to 10, with 0 being “no itch” and 10 being “worst itch imaginable”, how would you rate your itch at the worst moment during the previous 24 hours?’. ≥ 4 points reduction of the Peak Pruritus 0-10 NRS is considered a clinically relevant within-person response. NRS was assessed on a daily basis and the average over the last 7 days before the visit day was used for analysis. The main estimand was based on the same strategies to address intercurrent events as described above for the primary endpoint. ANCOVA analysis according to estimand is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12 (Day 84)
    End point values
    		 Zabedosertib (BAY1834845) Placebo
    Number of subjects analysed
    47 [24]
    22 [25]
    Units: percentage of change (%)
        least squares mean (confidence interval 95%)
    -20.65 (-29.54 to -11.77)
    -27.33 (-40.00 to -14.66)
    Notes
    [24] - PPS
    [25] - PPS
    Statistical analysis title
    		 ANCOVA analysis
    Statistical analysis description
    The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.
    Comparison groups
    Zabedosertib (BAY1834845) v Placebo
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.396 [26]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.75
         upper limit
    		 22.11
    Notes
    [26] - two-sided. No adjustment for multiple comparisons.

    Secondary: Frequency and severity of treatment-emergent adverse events (TEAEs)

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    End point title
    		 Frequency and severity of treatment-emergent adverse events (TEAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    From first treatment with the study intervention until 7 days after the last intake of study intervention (approximately up to 91 days)
    End point values
    		 Zabedosertib (BAY1834845) Placebo
    Number of subjects analysed
    52 [27]
    25 [28]
    Units: Subjects
        Any AE
    23
    7
        Maximum intensity for any AE -MILD
    13
    4
        Maximum intensity for any AE -MODERATE
    10
    3
        Any SAE
    0
    0
        AE with outcome death
    0
    0
    Notes
    [27] - SAF
    [28] - SAF
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events tables: from the start of study intervention until 7 days after the last intake (approximately up to 91 days). The deaths (all causes) considers all deaths that occurred at any time during the study before the last contact, up to 20 weeks.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Zabedosertib (BAY1834845)
    Reporting group description
    		 Subjects received zabedosertib for up to 12 weeks (84 days)

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo to zabedosertib for up to 12 weeks (84 days)

    Serious adverse events
    		 Zabedosertib (BAY1834845) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Zabedosertib (BAY1834845) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 52 (44.23%)
    7 / 25 (28.00%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Gingival graft
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Social circumstances
    Pregnancy of partner
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Sleep disorder
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Injury, poisoning and procedural complications
    Rib fracture
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Limb injury
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Cardiac disorders
    Sinus arrhythmia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Periorbital oedema
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Tongue oedema
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Palatal oedema
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Palatal swelling
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 25 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 52 (7.69%)
    1 / 25 (4.00%)
         occurrences all number
    4
    1
    Pustule
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Tonsillitis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Hordeolum
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Urethritis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Eczema impetiginous
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Oral herpes
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1

    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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