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    Clinical Trial Results:
    A phase II, randomised, double-blind, placebo-controlled, parallel-group, multi-centre study investigating efficacy and safety of Sepranolone (UC1010) in patients with PMDD

    Summary
    EudraCT number
    		 2017-000822-37
    Trial protocol
    		 GB   DE   SE   PL  
    Global end of trial date
    25 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2021
    First version publication date
    06 Jan 2021
    Other versions
    Summary report(s)
    		 UM203 Asarina CSR Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    UM203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Asarina Pharma
    Sponsor organisation address
    c/o COBIS, Ole Maaloes Vej 3, Copenhagen, Denmark, 2200
    Public contact
    Karin Ekberg, Asarina Pharma , +45 707029 80 , karin.ekberg@asarinapharma.com
    Scientific contact
    Karin Ekberg, Asarina Pharma , +45 707029 80 , karin.ekberg@asarinapharma.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
    17 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the effect of two doses of UC1010 on premenstrual symptoms in women with PMDD in comparison to placebo. The effect of UC1010 given repeatedly to women with PMDD as subcutaneous injections during the luteal phase of three consecutive menstrual cycles will be compared with a corresponding placebo administration. Effect will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale also used for the diagnosis of PMDD.
    Protection of trial subjects
    The clinical safety of the patient was followed throughout their participation in the study with physical examinations (including vital signs and inspection of injection sites), safety blood sampling and AE and concomitant medication reporting. The reporting of AEs started when the first dose of IMP was taken and continued until visit 9, i.e. the close-out visit.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Apr 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
    Poland: 28
    Country: Number of subjects enrolled
    Sweden: 46
    Country: Number of subjects enrolled
    United Kingdom: 54
    Country: Number of subjects enrolled
    Germany: 78
    Worldwide total number of subjects
    206
    EEA total number of subjects
    206
    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)
    206
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment started on 20 April 2018 and was completed in November 2019. Subjects from Germany, Sweden, Poland, and UK were recruited into the study

    Pre-assignment
    Screening details
    		 475 patients enrolled, 206 randomised. 4 randomised patients never started treatment. Patients underwent a qualification period for PMDD diagnosis of at least 2 menstrual cycles. Screening criteria included: previous participation, height, weight, menstrual cycle details/symptoms, other medications/condition

    Pre-assignment period milestones
    Number of subjects started
    		 475 [1]
    Number of subjects completed
    		 202

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 screen failure: 269
    Reason: Number of subjects
    		 subjects never started treatment: 4
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects enrolled is counted as the number randomised and assigned to a treatment arm. A greater number signed the ICF and underwent a 2 month qualification period, but did not meet the criteria for PMDD diagnosis and therefore did not qualify for the study.
    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sepranolone 10 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sepranolone
    Investigational medicinal product code
    Other name
    UC1010
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10 mg per injection once every second day during the luteal phase of 3 consecutive menstrual cycles to women with a verified diagnosis of PMDD. Treatment will start 14 days prior to the next estimated menstruation start and continue until menstruation starts, but with a maximum of 7 doses per cycle. The treatment period is followed by one menstrual cycle of non-treatment as a follow-up cycle.

    Arm title
    		 Sepranolone 16 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sepranolone
    Investigational medicinal product code
    Other name
    UC1010
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    16 mg per injection once every second day during the luteal phase of 3 consecutive menstrual cycles to women with a verified diagnosis of PMDD. Treatment will start 14 days prior to the next estimated menstruation start and continue until menstruation starts, but with a maximum of 7 doses per cycle. The treatment period is followed by one menstrual cycle of non-treatment as a follow-up cycle.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo injection once every second day during the luteal phase of 3 consecutive menstrual cycles to women with a verified diagnosis of PMDD. Treatment will start 14 days prior to the next estimated menstruation start and continue until menstruation starts, but with a maximum of 7 doses per cycle. The treatment period is followed by one menstrual cycle of non-treatment as a follow-up cycle.

    Number of subjects in period 1 [2]
    		Sepranolone 10 mg Sepranolone 16 mg Placebo
    Started
    64
    68
    70
    Completed
    53
    54
    58
    Not completed
    11
    14
    12
         Consent withdrawn by subject
    3
    7
    2
         other reasons
    -
    2
    -
         Adverse event, non-fatal
    5
    3
    4
         Pregnancy
    -
    -
    1
         Lost to follow-up
    3
    2
    2
         other reason
    -
    -
    3
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 206 subjects enrolled in the study and were randomised into a treatment arm, but only 202 started treatment and are included in the baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sepranolone 10 mg
    Reporting group description
    		 -

    Reporting group title
    Sepranolone 16 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Sepranolone 10 mg Sepranolone 16 mg Placebo Total
    Number of subjects
    		 64 68 70 202
    Age categorical
    All subjects were aged 18 to 45 years at first visit
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
        18 to 45 years
    		 64 68 70 202
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 32.72 (23 to 44.6) 33.35 (20.3 to 44.7) 34.14 (22.4 to 44.6) -
    Gender categorical
    All patients were female
    Units: Subjects
        Female
    		 64 68 70 202
        Male
    		 0 0 0 0
    Race
    Units: Subjects
        White
    		 61 64 67 192
        Other
    		 3 3 2 8
        Black or African American
    		 0 1 1 2
    Smoker Status
    Units: Subjects
        Non-smoker
    		 34 43 40 117
        Ex-smoker
    		 11 13 17 41
        Smoker
    		 19 12 13 44
    Previous PMDD treatment
    Units: Subjects
        Yes
    		 17 20 17 54
        No
    		 47 48 53 148
    History of psychiatric disorders
    Units: Subjects
        Yes
    		 11 18 11 40
        No
    		 53 50 59 162
    History of PMDD diagnosis
    Units: Subjects
        Yes
    		 11 10 16 37
        No
    		 53 58 54 165
    BMI
    Units: mg/kg2
        arithmetic mean (full range (min-max))
    		 24.13 (18.5 to 34.7) 24.22 (16.6 to 34.6) 24.79 (18.4 to 34.4) -
    PMDD History
    Units: years
        arithmetic mean (full range (min-max))
    		 10.08 (2 to 27) 9.08 (2 to 24) 9.53 (1 to 30) -
    Baseline Total Symptoms
    LmaxSum21
    Units: points
        arithmetic mean (full range (min-max))
    		 82.25 (56.5 to 118.7) 87.3 (52.1 to 122.4) 85.46 (53.7 to 123.3) -
    Baseline symptoms in follicular phase
    FminSum21
    Units: points
        arithmetic mean (full range (min-max))
    		 23.96 (21 to 33.6) 23.53 (21 to 30.9) 23.39 (21 to 33.5) -
    Subject analysis sets

    Subject analysis set title
    Safety Analysis Set - Sepranolone 10mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set includes all subjects who obtained at least one dose of the investigational drug at a dose of 10mg

    Subject analysis set title
    Safety Analysis Set - Sepranolone 16mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set includes all subjects who obtained at least one dose of the investigational drug at a dose of 16mg

    Subject analysis set title
    Safety Analysis Set - placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set includes all subjects who obtained at least one dose of the placebo

    Subject analysis set title
    Intent to Treat Sepranolone 10mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects with at least one confirmed ovulatory treatment cycle and had evaluable DSRP data in that cycle who received Sepranolone 10mg

    Subject analysis set title
    Intent to Treat Sepranolone 16mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects with at least one confirmed ovulatory treatment cycle and had evaluable DSRP data in that cycle who received Sepranolone 16mg

    Subject analysis set title
    Intent to Treat Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects with at least one confirmed ovulatory treatment cycle and had evaluable DSRP data in that cycle who received Placebo

    Subject analysis set title
    Intent to Treat Active
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects with at least one confirmed ovulatory treatment cycle and had evaluable DSRP data in that cycle who received Sepranolone 10mg or 16mg

    Subject analysis sets values
    		 Safety Analysis Set - Sepranolone 10mg Safety Analysis Set - Sepranolone 16mg Safety Analysis Set - placebo Intent to Treat Sepranolone 10mg Intent to Treat Sepranolone 16mg Intent to Treat Placebo Intent to Treat Active
    Number of subjects
    64
    68
    70
    63
    62
    67
    125
    Age categorical
    All subjects were aged 18 to 45 years at first visit
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
    0
        Adults (18-64 years)
    0
    0
    0
    0
    0
    0
        From 65-84 years
    0
    0
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    0
    0
        18 to 45 years
    64
    68
    70
    63
    62
    67
    125
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    34.14 (22.4 to 44.6)
    32.72 (23 to 44.6)
    33.35 (20.3 to 44.7)
    32.7 (23 to 44.6)
    33.2 (20.3 to 43)
    34.35 (22.4 to 44.6)
    32.94 (20.3 to 44.6)
    Gender categorical
    All patients were female
    Units: Subjects
        Female
    64
    68
    70
    63
    62
    67
    125
        Male
    0
    0
    0
    0
    0
    0
    0
    Race
    Units: Subjects
        White
    61
    64
    67
    60
    58
    64
    118
        Other
    3
    3
    2
    3
    3
    2
    6
        Black or African American
    0
    1
    1
    0
    1
    1
    1
    Smoker Status
    Units: Subjects
        Non-smoker
    34
    43
    40
    34
    40
    38
    74
        Ex-smoker
    19
    12
    13
    11
    11
    16
    22
        Smoker
    11
    13
    17
    18
    11
    13
    29
    Previous PMDD treatment
    Units: Subjects
        Yes
    17
    17
    20
    17
    19
    16
    36
        No
    47
    48
    53
    46
    43
    51
    89
    History of psychiatric disorders
    Units: Subjects
        Yes
    11
    18
    11
    11
    18
    11
    29
        No
    53
    50
    59
    52
    44
    56
    96
    History of PMDD diagnosis
    Units: Subjects
        Yes
    11
    10
    16
    11
    9
    16
    20
        No
    53
    58
    54
    52
    53
    51
    105
    BMI
    Units: mg/kg2
        arithmetic mean (full range (min-max))
    24.13 (18.5 to 34.7)
    24.22 (16.6 to 34.6)
    24.79 (18.4 to 34.4)
    24.19 (18.5 to 34.7)
    24.24 (16.6 to 34.6)
    24.82 (18.4 to 34.4)
    24.21 (16.6 to 34.7)
    PMDD History
    Units: years
        arithmetic mean (full range (min-max))
    10.08 (2 to 27)
    9.08 (2 to 24)
    9.53 (1 to 30)
    10 (2 to 27)
    8.8 (2 to 22)
    9.66 (1 to 30)
    9.41 (2 to 27)
    Baseline Total Symptoms
    LmaxSum21
    Units: points
        arithmetic mean (full range (min-max))
    82.25 (56.5 to 118.7)
    87.3 (52.1 to 122.4)
    85.46 (53.7 to 123.3)
    82.35 (56.5 to 118.7)
    87.13 (52.1 to 122.4)
    85.05 (53.7 to 123.3)
    84.72 (52.1 to 122.4)
    Baseline symptoms in follicular phase
    FminSum21
    Units: points
        arithmetic mean (full range (min-max))
    23.96 (21 to 33.6)
    23.53 (21 to 30.9)
    23.39 (21 to 33.5)
    24.01 (21 to 33.6)
    23.42 (21 to 30.6)
    23.36 (21 to 33.5)
    23.72 (21 to 33.6)

    End points

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    End points reporting groups
    Reporting group title
    Sepranolone 10 mg
    Reporting group description
    		 -

    Reporting group title
    Sepranolone 16 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Safety Analysis Set - Sepranolone 10mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set includes all subjects who obtained at least one dose of the investigational drug at a dose of 10mg

    Subject analysis set title
    Safety Analysis Set - Sepranolone 16mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set includes all subjects who obtained at least one dose of the investigational drug at a dose of 16mg

    Subject analysis set title
    Safety Analysis Set - placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set includes all subjects who obtained at least one dose of the placebo

    Subject analysis set title
    Intent to Treat Sepranolone 10mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects with at least one confirmed ovulatory treatment cycle and had evaluable DSRP data in that cycle who received Sepranolone 10mg

    Subject analysis set title
    Intent to Treat Sepranolone 16mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects with at least one confirmed ovulatory treatment cycle and had evaluable DSRP data in that cycle who received Sepranolone 16mg

    Subject analysis set title
    Intent to Treat Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects with at least one confirmed ovulatory treatment cycle and had evaluable DSRP data in that cycle who received Placebo

    Subject analysis set title
    Intent to Treat Active
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects with at least one confirmed ovulatory treatment cycle and had evaluable DSRP data in that cycle who received Sepranolone 10mg or 16mg

    Primary: Change in LmaxSum21 score before and during treatment

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    End point title
    		 Change in LmaxSum21 score before and during treatment
    End point description
    End point type
    Primary
    End point timeframe
    Within-subject differences were calculated by taking the average LmaxSum21 from the 2nd and the 3rd treatment cycles and subtracting the average LmaxSum21 from the two menstrual cycles D1 and D2
    End point values
    		 Intent to Treat Sepranolone 10mg Intent to Treat Sepranolone 16mg Intent to Treat Placebo Intent to Treat Active
    Number of subjects analysed
    63
    62
    67
    125
    Units: LmaxSum21 (points)
        arithmetic mean (full range (min-max))
    -30.53 (-90.1 to 32.2)
    -30.02 (-77.7 to 9)
    -27.88 (-90.7 to 11)
    -30.28 (-90.1 to 32.2)
    Statistical analysis title
    		 Primary confirmatory efficacy analysis
    Statistical analysis description
    The primary confirmatory efficacy analysis proceeded in a hierarchical rejecting way. The null hypotheses were each tested at a two-sided type I error of alpha = 0.05, but subsequent hypotheses were only tested if the previous null hypothesis had been rejected. Using this closed testing procedure, no alpha adjustment had to be applied to control the family-wise error rate of 5%.
    Comparison groups
    Intent to Treat Placebo v Intent to Treat Active
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3465
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from first dose of IMP to last visit (follow-up).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Sepranolone 10 mg
    Reporting group description
    		 -

    Reporting group title
    Sepranolone 16 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Sepranolone 10 mg Sepranolone 16 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 68 (1.47%)
    1 / 70 (1.43%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 68 (1.47%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 68 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Sepranolone 10 mg Sepranolone 16 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 64 (26.56%)
    33 / 68 (48.53%)
    18 / 70 (25.71%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 64 (9.38%)
    4 / 68 (5.88%)
    8 / 70 (11.43%)
         occurrences all number
    9
    6
    11
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    3 / 64 (4.69%)
    5 / 68 (7.35%)
    1 / 70 (1.43%)
         occurrences all number
    15
    16
    3
    Injection site pain
         subjects affected / exposed
    2 / 64 (3.13%)
    8 / 68 (11.76%)
    3 / 70 (4.29%)
         occurrences all number
    3
    59
    27
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 68 (1.47%)
    6 / 70 (8.57%)
         occurrences all number
    0
    1
    7
    Nausea
         subjects affected / exposed
    0 / 64 (0.00%)
    4 / 68 (5.88%)
    0 / 70 (0.00%)
         occurrences all number
    0
    4
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 64 (9.38%)
    11 / 68 (16.18%)
    12 / 70 (17.14%)
         occurrences all number
    6
    11
    15

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Oct 2018
    Amendment in Sweden only: it became apparent that no spermicides are available, therefore inclusion criterion #4 required updating

    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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