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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 rectovaginal endometriosis.

    Summary
    EudraCT number
    		 2017-004043-21
    Trial protocol
    		 FR  
    Global end of trial date
    24 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jul 2022
    First version publication date
    14 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    16-OBE2109-016
    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
    29 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jun 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2021
    Was the trial ended prematurely?
    Yes
    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 rectovaginal endometriosis node. In addition, the overall safety of 24 weeks of daily administration of linzagolix in patients with rectovaginal endometriosis 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 and with Good Clinical Practice (GCP) rules and in line with local regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Oct 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: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    3
    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
    		 A total of 3 patients were screened and enrolled in the study. Nine subjects were planned to be included, but due to difficulties in recruitment, recruitment was stopped.

    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
    		 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 1
    		Baseline
    Started
    3
    Completed
    3
    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
    3
    Completed
    3
    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
    3
    Completed
    3

    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
    		 3 3
    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)
    		 3 3
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 38.33 (38 to 39) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 0 0
    Body mass index
    Units: kg/m2
        arithmetic mean (full range (min-max))
    		 26.0 (24.0 to 27.7) -
    Rectovaginal node volume
    The volume of rectovaginal nodes volumes as measured by MRI at baseline.
    Units: cm3
        arithmetic mean (full range (min-max))
    		 4.1 (1.9 to 5.4) -

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 Patients received linzagolix 200 mg daily for 12 weeks followed by 100 mg daily for 12 weeks.
    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: Changes from baseline to Week 24 in volume of rectovaginal nodes measured by MRI measuring central lesion and the entire invasion front, i.e. including the specula.

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    End point title
    		 Changes from baseline to Week 24 in volume of rectovaginal nodes measured by MRI measuring central lesion and the entire invasion front, i.e. including the specula. [1]
    End point description
    End point type
    Primary
    End point timeframe
    Week 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analyses described in the protocol were not performed due to the low number of participants.
    End point values
    		 Week 24
    Number of subjects analysed
    3
    Units: cm3
        arithmetic mean (full range (min-max))
    -1.1 (-2.7 to 0.3)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event (AE) data were collected continuously during the study.
    Adverse event reporting additional description
    AE data were obtained at scheduled study visits based on physical examination, vital signs and biological laboratory assessments. In addition, the patients reported AEs spontaneously and/or through questioning. Only treatment emergent AEs (TEAEs) are reported here.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Enrolled analysis set
    Reporting group description
    		 The enrolled analysis set (EAS) is defined for this study as all enrolled patients.

    Serious adverse events
    		 Enrolled analysis set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (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
    		 Enrolled analysis set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    Investigations
    Haematocrit decreased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Mean cell volume increased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Vascular disorders
    Hot flush
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    2
    Surgical and medical procedures
    Pleural decortication
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    7
    Headache
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    5
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Haemoglobinaemia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Haemorrhagic ascites
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 3 (33.33%)
         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
    20 Aug 2018
    • Addition of ECG monitoring • Clarification of the fasting requirements • Change of urine pregnancy test to serum pregnancy test • Add possibility to perform Screening, Week 12, 24 and 36 visits over 2 days • More accurate wording about IMP administration and packaging • Change in the visit window at the Week 12 and 24 visits • Added wording in case the result of the endometrium biopsy of Day 1 is not available

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Jun 2020
    Due to difficulty in recruitment and upcoming expiry of the investigational medical product the recruitment was stopped after inclusion of 3 patients.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Only 3 participants were enrolled, whereas 9 were initially planned and judged suitable for an exploratory assessment of linzagolix in patients with rectovaginal endometriosis, so that the results of this study must be interpreted with caution.
    For support, Contact us.
    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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