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    Clinical Trial Results:
    A randomized, double-blind, cross-over, placebo-controlled, multi-center, Phase 2a study to assess the safety and efficacy of BAY 2395840 in patients with diabetic neuropathic pain

    Summary
    EudraCT number
    		 2021-001392-17
    Trial protocol
    		 HU   CZ   ES   SK   DE  
    Global end of trial date
    21 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Nov 2023
    First version publication date
    26 Nov 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY2395840/19636
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05219812
    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, +46 30 300139003, clinical-trials-contact@bayer.com
    Scientific contact
    ​Therapeutic Area Head, ​Bayer AG, +46 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
    21 Nov 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the efficacy of BAY2395840 on pain associated with diabetic neuropathic pain (DNP) as compared with placebo.
    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. Participating subjects 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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Feb 2022
    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
    Czechia: 19
    Country: Number of subjects enrolled
    Hungary: 11
    Country: Number of subjects enrolled
    Slovakia: 20
    Country: Number of subjects enrolled
    Germany: 21
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    United Kingdom: 5
    Worldwide total number of subjects
    80
    EEA total number of subjects
    75
    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)
    33
    From 65 to 84 years
    47
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at 29 centers in 6 countries between 16 FEB 2022 (first participant first visit) and 21 NOV 2022 (last participant last visit).

    Pre-assignment
    Screening details
    		 133 subjects were screened in the study, 81 subjects were randomized (1 subject never received treatment). Of those, 52 subjects did not randomize to the study treatment (48 were screening failures, 3 decided not to participate, 1 failed screen due to other reasons).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dosage A of BAY2395840 - Placebo
    Arm description
    		 Subjects received dosage A of BAY2395840 in period 1, and received placebo in period 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BAY2395840
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage A, tablet, oral administration

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily, tablet, oral administration

    Arm title
    		 Placebo - Dosage A of BAY2395840
    Arm description
    		 Subjects received placebo in period 1, and received dosage A of BAY2395840 in period 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily, tablet, oral administration

    Investigational medicinal product name
    BAY2395840
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage A, tablet, oral administration

    Number of subjects in period 1
    		Dosage A of BAY2395840 - Placebo Placebo - Dosage A of BAY2395840
    Started
    40
    40
    Period 1
    40
    40
    Run-in phase
    39
    39
    Period 2
    39
    39
    Completed
    37
    38
    Not completed
    3
    2
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    1
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dosage A of BAY2395840 - Placebo
    Reporting group description
    		 Subjects received dosage A of BAY2395840 in period 1, and received placebo in period 2.

    Reporting group title
    Placebo - Dosage A of BAY2395840
    Reporting group description
    		 Subjects received placebo in period 1, and received dosage A of BAY2395840 in period 2.

    Reporting group values
    		 Dosage A of BAY2395840 - Placebo Placebo - Dosage A of BAY2395840 Total
    Number of subjects
    		 40 40 80
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.2 ± 10.5 64.4 ± 10.6 -
    Gender Categorical
    Units: Subjects
        Female
    		 21 19 40
        Male
    		 19 21 40

    End points

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    End points reporting groups
    Reporting group title
    Dosage A of BAY2395840 - Placebo
    Reporting group description
    		 Subjects received dosage A of BAY2395840 in period 1, and received placebo in period 2.

    Reporting group title
    Placebo - Dosage A of BAY2395840
    Reporting group description
    		 Subjects received placebo in period 1, and received dosage A of BAY2395840 in period 2.

    Subject analysis set title
    Safety analysis set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who took at least one dose of study intervention. Of 81 randomized subjects, 80 subjects (98.8%, 40 per treatment sequence) were valid for SAF since 1 subject never received study intervention.

    Subject analysis set title
    Per protocol set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in FAS without any validity finding impacting interpretation of study results were available. PPS included 78 subjects (39 per treatment sequence) which was 96.3% of all randomized subjects.

    Subject analysis set title
    Dosage A of BAY2395840 in PPS
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects treated with BAY2395840 in the PPS. in Group 1 (BAY2395840 - placebo treatment sequence) period 1 and in Group 2 (placebo - BAY2395840 treatment sequence) period 2.

    Subject analysis set title
    Placebo in PPS
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects treated with placebo in the PPS. Group 1 (BAY2395840 - placebo treatment sequence) period 2 and in Group 2 (placebo - BAY2395840 treatment sequence) period 1.

    Subject analysis set title
    Dosage A of BAY2395840 in SAF
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects treated with BAY2395840 in the SAF. Overall, 80 participants were valid for SAF. 2 participants (1 in Group 1 with BAY2395840 – placebo treatment sequence, 1 in Group 2 with placebo – BAY2395840 treatment sequence) did not enter period 2. Thus, 79 participants were treated with BAY2395840 in the SAF.

    Subject analysis set title
    Placebo in SAF
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects treated with placebo in the SAF. Overall, 80 participants were valid for SAF. 2 participants (1 in Group 1 with BAY2395840 – placebo treatment sequence, 1 in Group 2 with placebo – BAY2395840 treatment sequence) did not enter period 2. Thus, 79 participants were treated with placebo in the SAF.

    Primary: Change in weekly mean 24-hour average pain intensity score using the 11-point NRS from baseline to the end of intervention

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    End point title
    		 Change in weekly mean 24-hour average pain intensity score using the 11-point NRS from baseline to the end of intervention
    End point description
    Subjects were asked to report their average neuropathic pain severity in the past 24 hours using an 11-point NRS with 0 as “no pain” and 10 as “worst imaginable pain”. NRS=Pain Numeric Rating Scale
    End point type
    Primary
    End point timeframe
    Baseline to end of intervention (in total up to 16 weeks)
    End point values
    		 Dosage A of BAY2395840 in PPS Placebo in PPS
    Number of subjects analysed
    76 [1]
    75 [2]
    Units: scores
    arithmetic mean (standard deviation)
        Week 1
    -0.33 ± 0.82
    -0.39 ± 0.86
        Week 2
    -0.44 ± 0.98
    -0.75 ± 1.13
        Week 3
    -0.67 ± 1.24
    -1.06 ± 1.30
        Week 4
    -0.93 ± 1.45
    -1.23 ± 1.44
    Notes
    [1] - PPS
    [2] - PPS, the analyzed subjects at Week 1 and 2 were 75, at Week 3 it was 74, and at Week 4 it was 71.
    Statistical analysis title
    		 ANCOVA for change from baseline in NRS
    Statistical analysis description
    At Week 4 in period 1 and period 2, the estimated mean (SE) treatment difference for weekly mean 24-hour average NRS between BAY2395840 and placebo
    Comparison groups
    Dosage A of BAY2395840 in PPS v Placebo in PPS
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.314
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.146
    Notes
    [3] - Database auto-calculates total number of subjects erroneously, analysed number of subjects was 78.

    Secondary: Number of participants with treatment emergent adverse events

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    End point title
    		 Number of participants with treatment emergent adverse events
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any AE that, at any dose: a. Results in death, b. Was life-threatening, c. Required inpatient hospitalization or prolongation of existing hospitalization, d. Resulted in persistent or significant disability/incapacity, e. Was a congenital anomaly/birth defect, etc. AE=Adverse event SAE=Serious adverse event
    End point type
    Secondary
    End point timeframe
    From start of study intervention to 14 days after last dose (up to 13 weeks)
    End point values
    		 Dosage A of BAY2395840 in SAF Placebo in SAF
    Number of subjects analysed
    79 [4]
    79 [5]
    Units: subjects
        Any AE
    33
    26
        Any SAE
    2
    2
    Notes
    [4] - SAF
    [5] - SAF
    No statistical analyses for this end point

    Secondary: Change in Neuropathic Pain Symptom Inventory (NPSI) total score from baseline to the end of intervention

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    End point title
    		 Change in Neuropathic Pain Symptom Inventory (NPSI) total score from baseline to the end of intervention
    End point description
    The NPSI contained 12 items, of which five summary pain scores can be calculated: “superficial spontaneous”, “deep spontaneous”, “paroxysmal pain”, “evoked pain”, and “paresthesia/ dysesthesia”. The total score was sum of the summary scores divided by 100. The 10 descriptive items used to derive the domain summary scores are each rated on an 11-point numeric rating scale (0= “no (symptom)” and 10= “worst (symptom) imaginable”); each item has a recall period of the past 24 hours. The remaining two items report how consistently pain has been present and the number of pain episodes.
    End point type
    Secondary
    End point timeframe
    At visit 2, visit 4, visit 6, visit 8, visit 10 and at visit 12 end of intervention (EOI)
    End point values
    		 Dosage A of BAY2395840 in PPS Placebo in PPS
    Number of subjects analysed
    78 [6]
    78 [7]
    Units: scores
    arithmetic mean (standard deviation)
        Visit 4 / Visit 10
    -6.89 ± 10.53
    -5.43 ± 10.56
        Visit 6 / Visit 12
    -7.23 ± 15.10
    -5.30 ± 11.44
    Notes
    [6] - Per protocol set (PPS)
    [7] - Per protocol set (PPS)
    Statistical analysis title
    		 ANCOVA of change on NPSI
    Statistical analysis description
    The mean difference change from baseline in the NPSI total score between BAY2395840 and placebo at Week 4 in period 1 and period 2
    Comparison groups
    Dosage A of BAY2395840 in PPS v Placebo in PPS
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.19
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.528
         upper limit
    		 1.157
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.406
    Notes
    [8] - Database auto-calculates total number of subjects erroneously, analysed number of subjects was 78.

    Secondary: Change in Patient Global Impression of Severity (PGI-S) score from baseline to the end of intervention

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    End point title
    		 Change in Patient Global Impression of Severity (PGI-S) score from baseline to the end of intervention
    End point description
    Subjects were asked to best describe their diabetic nerve pain symptoms on a 6-point scale in the last week scored as: “none”(1), “very mild”(2), “mild”(3), “moderate”(4), “severe”(5), or “very severe”(6). PGI-S=Patient Global Impression of Severity
    End point type
    Secondary
    End point timeframe
    At visit 2, visit 4, visit 6, visit 8, visit 10 and at visit 12 end of intervention (EOI)
    End point values
    		 Dosage A of BAY2395840 in PPS Placebo in PPS
    Number of subjects analysed
    78 [9]
    78 [10]
    Units: scores
    arithmetic mean (standard deviation)
        Visit 4 / Visit 10
    -0.27 ± 0.85
    -0.37 ± 0.83
        Visit 6 / Visit 12
    -0.39 ± 0.88
    -0.43 ± 0.94
    Notes
    [9] - Per protocol set (PPS)
    [10] - Per protocol set (PPS)
    Statistical analysis title
    		 ANCOVA of change on PGI-S
    Statistical analysis description
    The estimated mean (SE) treatment difference based on PGI-S severity score between BAY2395840 and placebo at Week 4 in period 1 and period 2
    Comparison groups
    Dosage A of BAY2395840 in PPS v Placebo in PPS
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.131
         upper limit
    		 0.272
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.121
    Notes
    [11] - Database auto-calculates total number of subjects erroneously, analysed number of subjects was 78.

    Secondary: Number of subjects achieving a ≥30% and a ≥50% reduction in weekly mean 24-hour average pain intensity score (i.e. responder rates using NRS)

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    End point title
    		 Number of subjects achieving a ≥30% and a ≥50% reduction in weekly mean 24-hour average pain intensity score (i.e. responder rates using NRS)
    End point description
    Responder rates using NRS were defined as the proportion of participants with a ≥30% and a ≥50% reduction in weekly mean 24-hour average pain intensity score at Visit 4 in period 1 and Visit 10 in period 2. NRS=Pain Numeric Rating Scale
    End point type
    Secondary
    End point timeframe
    From baseline to end of intervention (in total up to 12 weeks)
    End point values
    		 Dosage A of BAY2395840 in PPS Placebo in PPS
    Number of subjects analysed
    78 [12]
    78 [13]
    Units: subjects
        Achieved >=30% reduction in NRS
    24
    33
        Achieved >=50% reduction in NRS
    10
    13
    Notes
    [12] - Per protocol set (PPS)
    [13] - Per protocol set (PPS)
    Statistical analysis title
    		 Marginal responder rates analysis
    Statistical analysis description
    Odds ratio for estimated responder rate on weekly mean 24-hour average pain NRS in week 4 between BAY2395840 and placebo among subjects achieving >=50% improvement in pain compared to baseline
    Comparison groups
    Dosage A of BAY2395840 in PPS v Placebo in PPS
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.653
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.2681
         upper limit
    		 1.5904
    Notes
    [14] - Database auto-calculates total number of subjects erroneously, analysed number of subjects was 78.
    Statistical analysis title
    		 Marginal responder rates analysis
    Statistical analysis description
    Odds ratio for estimated responder rate on weekly mean 24-hour average pain NRS in week 4 between BAY2395840 and placebo among subjects achieving >=30% improvement in pain compared to baseline
    Comparison groups
    Dosage A of BAY2395840 in PPS v Placebo in PPS
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.5143
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.2624
         upper limit
    		 1.008
    Notes
    [15] - Database auto-calculates total number of subjects erroneously, analysed number of subjects was 78.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs started or worsened after application of study intervention and up to 14 days after the last study intervention per period
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Placebo in SAF
    Reporting group description
    		 Subjects treated with matching placebo in the SAF. Overall, 80 participants were valid for SAF. 2 participants (1 in Group 1 with BAY2395840 - placebo treatment sequence, 1 in Group 2 with placebo - BAY2395840 treatment sequence) did not enter period 2. Thus, 79 participants were treated with placebo in the SAF.

    Reporting group title
    Dosage A of BAY2395840 in SAF
    Reporting group description
    		 Subjects treated with BAY2395840 in the SAF. Overall, 80 participants were valid for SAF. 2 participants (1 in Group 1 with BAY2395840 - placebo treatment sequence, 1 in Group 2 with placebo - BAY2395840 treatment sequence) did not enter period 2. Thus, 79 participants were treated with BAY2395840 in the SAF.

    Serious adverse events
    		 Placebo in SAF Dosage A of BAY2395840 in SAF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 79 (2.53%)
    2 / 79 (2.53%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    1
    0
    Psychiatric disorders
    Anxiety disorder
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
    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 in SAF Dosage A of BAY2395840 in SAF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 79 (8.86%)
    11 / 79 (13.92%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 79 (7.59%)
    5 / 79 (6.33%)
         occurrences all number
    14
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 79 (0.00%)
    4 / 79 (5.06%)
         occurrences all number
    0
    4
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 79 (1.27%)
    4 / 79 (5.06%)
         occurrences all number
    1
    4

    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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    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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