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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2a, Proof-of-Concept Study of ASP8302 in Subjects With Underactive Bladder

    Summary
    EudraCT number
    		 2017-003693-13
    Trial protocol
    		 SK   PL   NL   DE   GB  
    Global end of trial date
    28 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Apr 2021
    First version publication date
    22 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    8302-CL-0201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03702777
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Astellas Pharma Europe B.V. (APEB)
    Sponsor organisation address
    Sylviusweg 62, 2333 BE Leiden, Netherlands,
    Public contact
    Clinical Trial Disclosure, Astellas Pharma Europe B.V. (APEB), astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Astellas Pharma Europe B.V. (APEB), astellas.resultsdisclosure@astellas.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 Apr 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study objectives of this study are to evaluate the efficacy of ASP8302 compared with placebo in participants with underactive bladder (UAB), to investigate the safety and tolerability of ASP8302 compared with placebo in participants with UAB, to investigate the pharmacokinetics of ASP8302 in participants with UAB and to support the development of the UAB - Patient Reported Outcome (PRO).
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Nov 2018
    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: 12
    Country: Number of subjects enrolled
    Japan: 60
    Country: Number of subjects enrolled
    Netherlands: 12
    Country: Number of subjects enrolled
    Poland: 39
    Country: Number of subjects enrolled
    Slovakia: 11
    Country: Number of subjects enrolled
    United Kingdom: 1
    Worldwide total number of subjects
    135
    EEA total number of subjects
    74
    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)
    66
    From 65 to 84 years
    68
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult male and female participants diagnosed with underactive bladder (UAB), who were able to void spontaneously, with or without clean intermittent catheterization (CIC), without severe overactive bladder (OAB) and without significant bladder outlet obstruction (BOO) were enrolled in this study.

    Pre-assignment
    Screening details
    		 Prior to randomization, participants entered a single-blind placebo run-in period for 2 weeks and completed a 3-day micturition diary. After the placebo run-in period, participants' eligibility criteria were re-confirmed and participants were then randomized into the double-blind treatment period of the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received ASP8302 matching placebo orally once daily for up to 4 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received ASP8302 matching placebo orally once daily for up to 4 weeks.

    Arm title
    		 ASP8302 100 mg
    Arm description
    		 Participants received ASP8302 100 mg capsules orally once daily for up to 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ASP8302
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received ASP8302 100 mg capsules orally once daily for up to 4 weeks.

    Number of subjects in period 1
    		Placebo ASP8302 100 mg
    Started
    70
    65
    Completed
    65
    62
    Not completed
    5
    3
         Consent withdrawn by subject
    2
    2
         Adverse event, non-fatal
    1
    -
         Miscellaneous
    1
    -
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received ASP8302 matching placebo orally once daily for up to 4 weeks.

    Reporting group title
    ASP8302 100 mg
    Reporting group description
    		 Participants received ASP8302 100 mg capsules orally once daily for up to 4 weeks.

    Reporting group values
    		 Placebo ASP8302 100 mg Total
    Number of subjects
    		 70 65 135
    Age categorical
    Units: Participants
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 35 31 66
        From 65-84 years
    		 34 34 68
        85 years and over
    		 1 0 1
    Age
    Units: years
        arithmetic mean (standard deviation)
    		 61.4 ( 13.1 ) 62.7 ( 10.9 ) -
    Sex
    Units: Participants
        Female
    		 30 26 56
        Male
    		 40 39 79
    Race
    Units: Subjects
        ASIAN
    		 31 29 60
        WHITE
    		 39 36 75
    Post Void Residual Urine Volume (PVR) after standardized bladder filling measured by catheterization
    Volume of urine in the bladder after standardized bladder filling measured by catheterization (PVRc2).
    Units: milliliter (mL)
        arithmetic mean (standard deviation)
    		 369.3 ( 234.6 ) 374.7 ( 248.6 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received ASP8302 matching placebo orally once daily for up to 4 weeks.

    Reporting group title
    ASP8302 100 mg
    Reporting group description
    		 Participants received ASP8302 100 mg capsules orally once daily for up to 4 weeks.

    Primary: Change From Baseline in PVR After Standardized Bladder Filling Measured by catheterization (PVRc2) at Week 4

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    End point title
    		 Change From Baseline in PVR After Standardized Bladder Filling Measured by catheterization (PVRc2) at Week 4
    End point description
    Volume of urine in the bladder after standardized bladder filling measured by catheterization (PVRc2). The FAS-PVR Population (FAS-PVR) comprised of all randomized participants who took at least 1 dose of double-blind study medication and had a nonmissing PVRc2 value at baseline and end of trial (EoT).
    End point type
    Primary
    End point timeframe
    Baseline and week 4
    End point values
    		 Placebo ASP8302 100 mg
    Number of subjects analysed
    63
    61
    Units: mL
        median (inter-quartile range (Q1-Q3))
    -35 (-130 to 40)
    -40 (-125 to 25)
    Statistical analysis title
    		 Placebo versus ASP8302 100 mg
    Comparison groups
    Placebo v ASP8302 100 mg
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.96 [1]
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 Median difference (final values)
    Point estimate
    -5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -42
         upper limit
    		 34
    Notes
    [1] - The stratified rank analysis of covariance (ANCOVA) was used to compare the median change between placebo and ASP8302 treatment group. Hodges-Lehmann method was used to obtain an estimate in the median (and 90% CI).

    Secondary: Voided Volume After Standardized Bladder Filling (VV_St) at Week 4

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    End point title
    		 Voided Volume After Standardized Bladder Filling (VV_St) at Week 4
    End point description
    VVst is thought to increase as the bladder emptying is improved. Standardizing the bladder filling is thought to increase accuracy in comparison with normal spontaneous bladder filling which will differ between time points. No multiplicity correction was performed. FAS-PVR Population
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Placebo ASP8302 100 mg
    Number of subjects analysed
    63
    61
    Units: mL
        median (inter-quartile range (Q1-Q3))
    306 (185 to 409)
    368 (265 to 456)
    Statistical analysis title
    		 Placebo vs ASP8302 100 mg
    Comparison groups
    Placebo v ASP8302 100 mg
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.17 [2]
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 Median difference (final values)
    Point estimate
    62
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 8
         upper limit
    		 112
    Notes
    [2] - The stratified rank ANCOVA was used to compare the median between placebo and ASP8302 treatment group. Hodges-Lehmann method was used to obtain an estimate in the median (and 90% CI).

    Secondary: Bladder Voiding Efficiency Calculated With PVRc2 and VV-St (BVEc2) at Week 4

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    End point title
    		 Bladder Voiding Efficiency Calculated With PVRc2 and VV-St (BVEc2) at Week 4
    End point description
    Bladder voiding efficiency (BVE) is defined as the percentage of the total bladder capacity (BC) that is voided using the following formula: BVE = [volume voided (VV) / (PVR + VV)] x 100. BVEc2: BVE calculated for PVRc2 parameter i.e. BVEc2 = [VV_St / (PVRc2 + VV_St)] x 100. FAS-PVR Population
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Placebo ASP8302 100 mg
    Number of subjects analysed
    63
    61
    Units: percentage of BVE
        median (inter-quartile range (Q1-Q3))
    54.60 (28.40 to 76)
    53.10 (40.20 to 70)
    Statistical analysis title
    		 Placebo vs ASP8302 100 mg
    Comparison groups
    Placebo v ASP8302 100 mg
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.489 [3]
    Method
    		 Stratified rank ANCOVA
    Parameter type
    		 Median difference (final values)
    Point estimate
    3.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 10.6
    Notes
    [3] - The stratified rank ANCOVA was used to compare the median between placebo and ASP8302 treatment group. Hodges-Lehmann method was used to obtain an estimate in the median (and 90% CI).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to end of study (6 weeks)
    Adverse event reporting additional description
    The SAF consisted of all participants who took at least 1 dose of double-blind study medication, and was used for safety analyses.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    v21.0
    Reporting groups
    Reporting group title
    ASP8302 100mg
    Reporting group description
    		 Participants received ASP8302 100 mg capsules orally once daily for up to 4 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received ASP8302 matching placebo orally once daily for up to 4 weeks.

    Serious adverse events
    		 ASP8302 100mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 70 (2.86%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 70 (1.43%)
         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
    		 ASP8302 100mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 63 (6.35%)
    6 / 70 (8.57%)
    Infections and infestations
    Cystitis
         subjects affected / exposed
    4 / 63 (6.35%)
    0 / 70 (0.00%)
         occurrences all number
    4
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 63 (0.00%)
    6 / 70 (8.57%)
         occurrences all number
    0
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jun 2018
    The chnages included: 1) Updated informed consent process to delete the possibility of the obtaining informed consent from a legally authorized representative. 2) Revised the inclusion criterion 5 to remove the specification that females are heterosexually active.Updated the concomitant medications to include information on how to treat urinary tract infections. 3) Updated the criteria for discontinuation of treatment based on liver function test abnormalities to specify that treatment was to be discontinued for certain liver function test abnormalities. 4) Updated the definition of adverse event (AE) so that it may or may not be considered related to the underlying disease. 5) Added the definition and reporting of suspected unexpected serious adverse reactions (SUSARs). 6) Added a section containing subject confidentiality and privacy to the protocol appendix.
    22 Jul 2019
    The changes included: 1) The number of participants enrolled in the placebo run-in period was increased to 163. This increased number provided 130 randomized participants (65 in each arm) in order to achieve 98 evaluable participants.

    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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