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    Clinical Trial Results:
    An exploratory single centre, open label, pilot study investigating the efficacy and safety of OBE2109 200 mg daily for 12 weeks followed by 100 mg daily for 12 weeks in uterine adenomyosis.

    Summary
    EudraCT number
    		 2017-004042-14
    Trial protocol
    		 FR  
    Global end of trial date
    20 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jun 2022
    First version publication date
    09 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    16-OBE2109-015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ObsEva SA
    Sponsor organisation address
    12, Chemin des Aulx, Geneva, Switzerland,
    Public contact
    Clinical Trials Information, ObsEva SA, +41 (0)225523840, clinicaltrials@obseva.ch
    Scientific contact
    Clinical Trials Information, ObsEva SA, +41 (0)225523840, clinicaltrials@obseva.ch
    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 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    20 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of 200 mg linzagolix (OBE2109) daily for 12 weeks followed by 100 mg linzagolix daily for 12 weeks on reduction of the volume of the uterus with adenomyosis. In addition, the overall safety of 24 weeks of daily administration of linzagolix in patients with uterine adenomyosis was assessed.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki, the ICH Harmonized Tripartite Guideline for Good Clinical Practice (GCP), and all applicable local regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at one clinical site in France.

    Pre-assignment
    Screening details
    		 The study started with a 4-week screening period evaluating the symptoms of uterine adenomyosis and assessing the volume of the adenomyosis affected uterus with MRI. During this period, the patients received no study drug. A total of 10 patients were screened and 8 were enrolled in the study; 2 patients were not included because of screen failure.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Baseline
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    linzagolix
    Investigational medicinal product code
    OBE2109
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily oral administration of linzagolix 200 mg for 12 weeks followed by 100 mg for 12 weeks.

    Number of subjects in period 1
    		Baseline
    Started
    8
    Completed
    8
    Period 2
    Period 2 title
    Week 24
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Week 24
    Arm description
    		 Patients received linzagolix 200 mg daily for 12 weeks followed by 100 mg daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    linzagolix
    Investigational medicinal product code
    OBE2109
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily oral administration of linzagolix 200 mg for 12 weeks followed by 100 mg for 12 weeks.

    Number of subjects in period 2
    		Week 24
    Started
    8
    Completed
    8
    Period 3
    Period 3 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Follow-up
    Arm description
    		 At week 24, the patients entered a 12-week follow-up period without any active treatment.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Follow-up
    Started
    8
    Completed
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.0 ± 2.8 -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 0 0
    Uterine volume by MRI
    Volume of the uterus with adenomyosis as measured by MRI.
    Units: cm3
        arithmetic mean (standard deviation)
    		 333.0 ± 249.8 -

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -
    Reporting group title
    Week 24
    Reporting group description
    		 Patients received linzagolix 200 mg daily for 12 weeks followed by 100 mg daily for 12 weeks.
    Reporting group title
    Follow-up
    Reporting group description
    		 At week 24, the patients entered a 12-week follow-up period without any active treatment.

    Primary: Change from baseline to week 24 in volume of the uterus with adenomyosis measured by MRI

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    End point title
    		 Change from baseline to week 24 in volume of the uterus with adenomyosis measured by MRI
    End point description
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 Baseline Week 24
    Number of subjects analysed
    8
    8
    Units: cm3
        arithmetic mean (standard deviation)
    333.0 ± 249.8
    203.9 ± 125.7
    Statistical analysis title
    		 Week 24: Adjusted means for change from baseline
    Statistical analysis description
    The observed and change from baseline values were described using summary statistics (using appropriate transformations to normalise the data as necessary). A formal statistical assessment of change at each timepoint was carried out via a mixed model with repeated measures using two-sided 5% significance levels.
    Comparison groups
    Baseline v Week 24
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.0063
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -135.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -216.19
         upper limit
    		 -54.69
    Notes
    [1] - Please note that the number of subjects in this analysis is 8, comparing baseline values to Week 24 values.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening up to week 36.
    Adverse event reporting additional description
    Data on adverse events were to be obtained at scheduled or unscheduled study visits, based on information spontaneously provided by the subject and/or through questioning of the subject. Only treatment-emergent adverse events are reported here.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Full analysis set
    Reporting group description
    		 The Full Analysis Set (FAS) includes all screened patients and with at least one consumption of study drug.

    Serious adverse events
    		 Full analysis set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Full analysis set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 8 (100.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    6 / 8 (75.00%)
         occurrences all number
    7
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 8 (37.50%)
         occurrences all number
    3
    Pyrexia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Uterine polyp
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Vaginal odour
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Vulvovaginal dryness
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Loss of libido
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Libido decreased
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    2
    Anosmia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Migraine
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Sciatica
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    2
    Abdominal discomfort
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Night sweats
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Joint swelling
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Tendonitis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jun 2018
    Protocol version 2.0: 1. Addition of electrocardiogram (ECG) monitoring 2. Clarification of the fasting requirements 3. Change of urine pregnancy test to serum pregnancy test 4. Add possibility to perform Screening, Week 12, 24 and 36 visits over 2 days
    20 Jul 2018
    Protocol version 3.0: 1. Addition of electrocardiogram (ECG) monitoring at all visits apart from follow-up. 2. Addition of subject referral to a cardiologist.
    14 Dec 2020
    Protocol version 4.0: Addition of two interim analyses after last patient has reached week 12 and last patient has reached week 24.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34945090
    http://www.ncbi.nlm.nih.gov/pubmed/32507315
    http://www.ncbi.nlm.nih.gov/pubmed/34799277
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