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    Clinical Trial Results:
    A double-blind randomized extension study to assess the long-term efficacy and safety of linzagolix in subjects with endometriosis-associated pain.

    Summary
    EudraCT number
    		 2019-002410-39
    Trial protocol
    		 FR   CZ   HU   BG   PL   AT   ES   RO  
    Global end of trial date
    15 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Dec 2023
    First version publication date
    22 Dec 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    19-OBE2109-006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Kissei Pharmaceutical Co., Ltd.
    Sponsor organisation address
    3-1-3 Koishikawa, Bunkyo-ku, Tokyo, Japan, 112-002
    Public contact
    Clinical Projects Management, Kissei Pharmaceutical Co., Ltd., rinsyousiken@pharm.kissei.co.jp
    Scientific contact
    Clinical Projects Management, Kissei Pharmaceutical Co., Ltd., rinsyousiken@pharm.kissei.co.jp
    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
    31 Mar 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Dec 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with add-back therapy , in the management of moderate to severe EAP in women with surgically confirmed endometriosis.
    Protection of trial subjects
    The study was conducted in accordance with Good Clinical Practice (GCP), local regulations, International Council for Harmonisation (ICH) notes for GCP (ICH/CPMP/135.95), internal standard operating procedures (SOPs) of ObsEva S.A. (=the former sponsor), and ethical principles that have their origin in the Declaration of Helsinki and its amendments.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Mar 2020
    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
    Poland: 145
    Country: Number of subjects enrolled
    Romania: 20
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Bulgaria: 6
    Country: Number of subjects enrolled
    Czechia: 4
    Country: Number of subjects enrolled
    Ukraine: 163
    Country: Number of subjects enrolled
    United States: 16
    Worldwide total number of subjects
    356
    EEA total number of subjects
    177
    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)
    356
    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 43 clinical sites throughout the world, including centers in Austria, Bulgaria, Czech Republic, Spain, Romania, Poland, Ukraine, and United States.

    Pre-assignment
    Screening details
    		 Number of subjects: - 356: Entered Extension Study - 353: Treatment Extension Analysis Set (TEAS) - 336: Per Protocol Extension Analysis Set (PP EAS) - 356: Extension Safety Analysis Set (ESAF) - 326: Follow-up Extension Analysis Set (FU EAS) - 329: Follow-up Extension Safety Analysis Set (FU SAF) - 354: Extension Pharmacokinetic Set

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo / LGX 75 mg group
    Arm description
    		 - Main study (6 months): Linzagolix placebo + ABT placebo once daily - Extension study (6 months): Linzagolix 75 mg + ABT Placebo once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Linzagolix
    Investigational medicinal product code
    Other name
    OBE2109
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75 mg

    Investigational medicinal product name
    ABT matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Estradiol (E2): 0 mg Norethindrone acetate (NETA): 0 mg

    Investigational medicinal product name
    Linzagolix 75 mg matching placebo
    Investigational medicinal product code
    Other name
    OBE2109
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0 mg

    Arm title
    		 Placebo / LGX 200 mg+ABT group
    Arm description
    		 - Main study (6 months): Linzagolix placebo + ABT placebo once daily - Extension study (6 months): Linzagolix 200 mg + ABT once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Linzagolix
    Investigational medicinal product code
    Other name
    OBE2109
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg

    Investigational medicinal product name
    Linzagolix 200 mg matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0 mg

    Investigational medicinal product name
    ABT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Estradiol (E2): 1.0 mg Norethindrone acetate (NETA): 0.5 mg

    Investigational medicinal product name
    ABT matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Estradiol (E2): 0 mg Norethindrone acetate (NETA): 0 mg

    Arm title
    		 LGX 75 mg group
    Arm description
    		 - Main study (6 months): Linzagolix 75 mg + Placebo ABT once daily - Extension study (6 months): Linzagolix 75 mg + Placebo ABT once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Linzagolix
    Investigational medicinal product code
    Other name
    OBE2109
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75 mg

    Investigational medicinal product name
    ABT matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Estradiol (E2): 0 mg Norethindrone acetate (NETA): 0 mg

    Arm title
    		 LGX 200 mg+ABT group
    Arm description
    		 - Main study (6 months): Linzagolix 200 mg + ABT once daily - Extension study (6 months): Linzagolix 200 mg + ABT once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Linzagolix
    Investigational medicinal product code
    Other name
    OBE2109
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg

    Investigational medicinal product name
    ABT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Estradiol (E2): 1.0 mg Norethindrone acetate (NETA): 0.5 mg

    Number of subjects in period 1
    		Placebo / LGX 75 mg group Placebo / LGX 200 mg+ABT group LGX 75 mg group LGX 200 mg+ABT group
    Started
    58
    57
    119
    122
    Completed
    49
    50
    101
    110
    Not completed
    9
    7
    18
    12
         Consent withdrawn by subject
    4
    5
    8
    4
         Ukrainian Russian war conflict
    2
    -
    4
    5
         Adverse event, non-fatal
    3
    2
    5
    2
         Subject planning pregnancy and AE-Nausea
    -
    -
    -
    1
         Protocol deviation
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo / LGX 75 mg group
    Reporting group description
    		 - Main study (6 months): Linzagolix placebo + ABT placebo once daily - Extension study (6 months): Linzagolix 75 mg + ABT Placebo once daily

    Reporting group title
    Placebo / LGX 200 mg+ABT group
    Reporting group description
    		 - Main study (6 months): Linzagolix placebo + ABT placebo once daily - Extension study (6 months): Linzagolix 200 mg + ABT once daily

    Reporting group title
    LGX 75 mg group
    Reporting group description
    		 - Main study (6 months): Linzagolix 75 mg + Placebo ABT once daily - Extension study (6 months): Linzagolix 75 mg + Placebo ABT once daily

    Reporting group title
    LGX 200 mg+ABT group
    Reporting group description
    		 - Main study (6 months): Linzagolix 200 mg + ABT once daily - Extension study (6 months): Linzagolix 200 mg + ABT once daily

    Reporting group values
    		 Placebo / LGX 75 mg group Placebo / LGX 200 mg+ABT group LGX 75 mg group LGX 200 mg+ABT group Total
    Number of subjects
    		 58 57 119 122 356
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 58 57 119 122 356
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.3 ± 6.6 35.0 ± 7.7 35.1 ± 6.3 34.8 ± 6.9 -
    Gender categorical
    Units: Subjects
        Female
    		 58 57 119 122 356
        Male
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo / LGX 75 mg group
    Reporting group description
    		 - Main study (6 months): Linzagolix placebo + ABT placebo once daily - Extension study (6 months): Linzagolix 75 mg + ABT Placebo once daily

    Reporting group title
    Placebo / LGX 200 mg+ABT group
    Reporting group description
    		 - Main study (6 months): Linzagolix placebo + ABT placebo once daily - Extension study (6 months): Linzagolix 200 mg + ABT once daily

    Reporting group title
    LGX 75 mg group
    Reporting group description
    		 - Main study (6 months): Linzagolix 75 mg + Placebo ABT once daily - Extension study (6 months): Linzagolix 75 mg + Placebo ABT once daily

    Reporting group title
    LGX 200 mg+ABT group
    Reporting group description
    		 - Main study (6 months): Linzagolix 200 mg + ABT once daily - Extension study (6 months): Linzagolix 200 mg + ABT once daily

    Primary: Proportion of subjects with reduction of DYS (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12

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    End point title
    		 Proportion of subjects with reduction of DYS (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12 [1]
    End point description
    End point type
    Primary
    End point timeframe
    6-month extension study treatment period (from Month 6 to Month 12)
    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: Since the endpoint is the number of the responder who have a clinically meaningful reduction in DYS and the subjects with stable or decreased use of analgesics, no statistical analyses were done.
    End point values
    		 Placebo / LGX 75 mg group Placebo / LGX 200 mg+ABT group LGX 75 mg group LGX 200 mg+ABT group
    Number of subjects analysed
    57
    55
    111
    111
    Units: Percentage
        number (not applicable)
    56.1
    78.2
    55.9
    91.0
    No statistical analyses for this end point

    Primary: Proportion of subjects with reduction of NMPP (Month 3 MCT) and stable or decreased use of analgesics

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    End point title
    		 Proportion of subjects with reduction of NMPP (Month 3 MCT) and stable or decreased use of analgesics [2]
    End point description
    End point type
    Primary
    End point timeframe
    6-month extension study treatment period (from Month 6 to Month 12)
    Notes
    [2] - 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: Since the endpoint is the number of the responder who have a clinically meaningful reduction in NMPP and the subjects with stable or decreased use of analgesics, no statistical analyses were done.
    End point values
    		 Placebo / LGX 75 mg group Placebo / LGX 200 mg+ABT group LGX 75 mg group LGX 200 mg+ABT group
    Number of subjects analysed
    57
    55
    111
    111
    Units: Percentage
        number (not applicable)
    59.6
    49.1
    59.5
    67.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6-month extension study treatment period (from Month 6 to Month 12)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo / LGX 75 mg group
    Reporting group description
    		 -

    Reporting group title
    Placebo / LGX 200 mg+ABT group
    Reporting group description
    		 -

    Reporting group title
    LGX 75 mg group
    Reporting group description
    		 -

    Reporting group title
    LGX 200 mg+ABT group
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo / LGX 75 mg group Placebo / LGX 200 mg+ABT group LGX 75 mg group LGX 200 mg+ABT group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
    3 / 119 (2.52%)
    0 / 122 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Reproductive system and breast disorders
    Genital haemorrhage
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
    0 / 119 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    1 / 119 (0.84%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    1 / 119 (0.84%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    1 / 119 (0.84%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo / LGX 75 mg group Placebo / LGX 200 mg+ABT group LGX 75 mg group LGX 200 mg+ABT group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 58 (25.86%)
    13 / 57 (22.81%)
    26 / 119 (21.85%)
    19 / 122 (15.57%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    4 / 58 (6.90%)
    0 / 57 (0.00%)
    4 / 119 (3.36%)
    5 / 122 (4.10%)
         occurrences all number
    4
    0
    4
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 58 (5.17%)
    3 / 57 (5.26%)
    5 / 119 (4.20%)
    3 / 122 (2.46%)
         occurrences all number
    6
    4
    5
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 58 (5.17%)
    2 / 57 (3.51%)
    7 / 119 (5.88%)
    0 / 122 (0.00%)
         occurrences all number
    4
    4
    7
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 58 (1.72%)
    3 / 57 (5.26%)
    3 / 119 (2.52%)
    3 / 122 (2.46%)
         occurrences all number
    1
    7
    4
    5
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 58 (1.72%)
    2 / 57 (3.51%)
    6 / 119 (5.04%)
    6 / 122 (4.92%)
         occurrences all number
    1
    2
    6
    6
    Vulvovaginal mycotic infection
         subjects affected / exposed
    3 / 58 (5.17%)
    3 / 57 (5.26%)
    1 / 119 (0.84%)
    2 / 122 (1.64%)
         occurrences all number
    3
    3
    1
    2

    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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