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    Clinical Trial Results:
    A Phase IIa, Multicenter, Randomized, Double-Blind, Parallel- Group, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of Orally Administered TU2670 in Subjects with Moderate to Severe Endometriosis-Associated Pain

    Summary
    EudraCT number
    		 2020-000090-25
    Trial protocol
    		 IT  
    Global end of trial date
    08 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Feb 2025
    First version publication date
    07 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TUC3PII-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05138562
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    TiumBio Co., Ltd.
    Sponsor organisation address
    6F, Pangyo IT Center, 30 Changup-ro 40 beon-gil, Sujeong-gu, Seongnam-si, Gyeonggi-do, Korea, Republic of, 13449
    Public contact
    TiumBio General Inquiry, TiumBio, tiumbio@tiumbio.com
    Scientific contact
    TiumBio General Inquiry, TiumBio, tiumbio@tiumbio.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
    23 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of orally administered TU2670 in the reduction of endometriosis-associated pain compared with placebo after 12 weeks of treatment.
    Protection of trial subjects
    The study was conducted in accordance with the protocol, the ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences, International Ethical Guidelines, applicable International Council for Harmonization Good Clinical Practice and other guidelines, and applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Aug 2021
    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
    Czechia: 14
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Poland: 53
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    Ukraine: 10
    Worldwide total number of subjects
    86
    EEA total number of subjects
    69
    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)
    86
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This Phase IIa, randomized, placebo-controlled study was conducted in subjects with moderate to severe endometriosis-associated pain at 27 study centers.

    Pre-assignment
    Screening details
    		 This study consists of a washout period (up to 12 weeks), screening period (up to 12 weeks), randomized treatment period (12 weeks) and follow-up period (12 weeks). Subjects were randomly assigned to receive either TU2670 120 milligram (mg), TU2670 240 mg, TU2670 320 mg, or matching placebo. A total of 86 subjects were enrolled in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TU2670 120 mg
    Arm description
    		 Subjects received TU2670 120 mg capsule orally once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TU2670
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Hard gelatin capsule of TU2670 was administered once daily in the morning after an overnight fast, preferably around the same time every day.

    Arm title
    		 TU2670 240 mg
    Arm description
    		 Subjects received TU2670 240 mg capsule orally once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TU2670
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Hard gelatin capsule of TU2670 was administered once daily in the morning after an overnight fast, preferably around the same time every day.

    Arm title
    		 TU2670 320 mg
    Arm description
    		 Subjects received TU2670 320 mg capsule orally once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TU2670
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Hard gelatin capsule of TU2670 was administered once daily in the morning after an overnight fast, preferably around the same time every day.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo matching with TU2670 capsule orally once daily for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Hard gelatin capsule of placebo matching with TU2670 was administered once daily in the morning after an overnight fast, preferably around the same time every day.

    Number of subjects in period 1
    		TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo
    Started
    20
    21
    22
    23
    Completed
    20
    19
    20
    20
    Not completed
    0
    2
    2
    3
         Consent withdrawn by subject
    -
    1
    -
    2
         Adverse event, non-fatal
    -
    1
    1
    -
         Lost to follow-up
    -
    -
    1
    -
         Protocol deviation
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TU2670 120 mg
    Reporting group description
    		 Subjects received TU2670 120 mg capsule orally once daily for 12 weeks.

    Reporting group title
    TU2670 240 mg
    Reporting group description
    		 Subjects received TU2670 240 mg capsule orally once daily for 12 weeks.

    Reporting group title
    TU2670 320 mg
    Reporting group description
    		 Subjects received TU2670 320 mg capsule orally once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matching with TU2670 capsule orally once daily for 12 weeks.

    Reporting group values
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo Total
    Number of subjects
    		 20 21 22 23 86
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.5 ( 6.02 ) 36.0 ( 7.25 ) 33.5 ( 5.69 ) 33.8 ( 6.29 ) -
    Gender categorical
    Units: Subjects
        Female
    		 20 21 22 23 86
        Male
    		 0 0 0 0 0
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0
        Native Hawaiian or Other Pacific Islanders
    		 0 0 0 0 0
        White
    		 20 21 22 23 86
        Other
    		 0 0 0 0 0
        Not Reported
    		 0 0 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0 0
        Not Hispanic or Latino
    		 20 20 22 22 84
        Not Reported
    		 0 1 0 1 2
        Unknown
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    TU2670 120 mg
    Reporting group description
    		 Subjects received TU2670 120 mg capsule orally once daily for 12 weeks.

    Reporting group title
    TU2670 240 mg
    Reporting group description
    		 Subjects received TU2670 240 mg capsule orally once daily for 12 weeks.

    Reporting group title
    TU2670 320 mg
    Reporting group description
    		 Subjects received TU2670 320 mg capsule orally once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matching with TU2670 capsule orally once daily for 12 weeks.

    Primary: Change From Baseline in Mean Dysmenorrhea Score at Week 12

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    End point title
    		 Change From Baseline in Mean Dysmenorrhea Score at Week 12
    End point description
    Mean Dysmenorrhea Score was defined as mean overall pelvic pain (OPP) score on menstrual bleeding days as measured by the Numeric Rating Scale (NRS) over the past month. The electronic NRS was self-completed by subjects in the electronic (e)-diary daily for the duration of the study. The total score on NRS range from 0 to 10 where 0= no pain and 10= worst pain imaginable. Higher scores indicate worse outcome. Baseline cycle was defined as cycle which started within Day -84 and ended at 1 day before next menstrual cycle. If multiple cycles were there, then last complete cycle prior to Visit 2 was considered. The full analysis set (FAS) included all subjects randomly assigned to study treatment and who took at least 1 dose of study treatment and had at least 1 post-baseline assessment available.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo
    Number of subjects analysed
    20
    18
    19
    21
    Units: score on a scale
        arithmetic mean (standard deviation)
    -4.8 ( 3.22 )
    -5.3 ( 2.39 )
    -5.9 ( 2.21 )
    -2.5 ( 2.78 )
    Statistical analysis title
    		 Treatment difference in Mean Dysmenorrhea Score
    Statistical analysis description
    Analysis was performed on the data in which the missing mean monthly NRS pain scores at Week 12 were imputed by having the previous visit value carried forward using last observation carried forward (LOCF).
    Comparison groups
    TU2670 120 mg v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.044 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Least Square (LS) Mean Difference
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.75
    Notes
    [1] - Estimates, 2-sided 95% confidence intervals and p-values were obtained using an analysis of covariance (ANCOVA) model with dose group as a fixed factor and baseline mean dysmenorrhea score as covariate at 5% significance level.
    Statistical analysis title
    		 Treatment difference in Mean Dysmenorrhea Score
    Statistical analysis description
    Analysis was performed on the data in which the missing mean monthly NRS pain scores at Week 12 were imputed by having the previous visit value carried forward using LOCF.
    Comparison groups
    TU2670 240 mg v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Least Square (LS) Mean Difference
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 -1.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.76
    Notes
    [2] - Estimates, 2-sided 95% confidence intervals and p-values were obtained using an ANCOVA model with dose group as a fixed factor and baseline mean dysmenorrhea score as covariate at 5% significance level.
    Statistical analysis title
    		 Treatment difference in Mean Dysmenorrhea Score
    Statistical analysis description
    Analysis was performed on the data in which the missing mean monthly NRS pain scores at Week 12 were imputed by having the previous visit value carried forward using LOCF.
    Comparison groups
    TU2670 320 mg v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Least Square (LS) Mean Difference
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 -1.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.75
    Notes
    [3] - Estimates, 2-sided 95% confidence intervals and p-values were obtained using an ANCOVA model with dose group as a fixed factor and baseline mean dysmenorrhea score as covariate at 5% significance level.

    Secondary: Change From Baseline in Mean Numeric Rating Scale Pain Score for Non-Menstrual Pelvic Pain (NMPP) at Week 12

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    End point title
    		 Change From Baseline in Mean Numeric Rating Scale Pain Score for Non-Menstrual Pelvic Pain (NMPP) at Week 12
    End point description
    Mean NRS pain score for NMPP was the mean NRS pain score on non-menstrual bleeding days. The mean NMPP (non-menstrual days) was calculated for each cycle as the total of daily NMPP scores reported during the cycle divided by the number of days during the cycle when a NMPP score was reported. The electronic NRS was self-completed by subjects in the e-diary daily for the duration of the study. The total score on NRS range from 0 to 10 where 0=no pain and 10=worst pain imaginable. Higher scores indicate worse outcome. Baseline Cycle was defined as cycle which started within day -84 and ended at 1 day before next menstrual cycle. If multiple cycles were there, then last complete cycle prior to Visit 2 was considered. The FAS included all subjects randomly assigned to study treatment and who took at least 1 dose of study treatment and had at least 1 post-baseline assessment available. Only subjects with data collected at Baseline and Week 12 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo
    Number of subjects analysed
    20
    19
    19
    19
    Units: score on a scale
        arithmetic mean (standard deviation)
    -2.6 ( 1.95 )
    -2.3 ( 2.13 )
    -2.8 ( 2.13 )
    -1.4 ( 1.55 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Mean Overall Pelvic Pain Numeric Rating Scale Pain Score at Week 12

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    End point title
    		 Change From Baseline in Mean Overall Pelvic Pain Numeric Rating Scale Pain Score at Week 12
    End point description
    Mean OPP NRS pain was the mean NRS pain score over all 28 days. The mean OPP (including menstrual and non-menstrual bleeding days) was calculated for each cycle as the total of daily OPP scores reported during the cycle divided by the number of days during the cycle when an OPP score was reported. The electronic NRS was self-completed by subjects in the e-diary daily for the duration of the study. The total score on NRS range from 0 to 10 where 0=no pain and 10=worst pain imaginable. Higher scores indicate worse outcome. Baseline Cycle was defined as cycle which started within day -84 and ended at 1 day before next menstrual cycle. If multiple cycles were there, then last complete cycle prior to Visit 2 was considered. The FAS included all subjects randomly assigned to study treatment and who took at least 1 dose of study treatment and had at least 1 post-baseline assessment available. Only subjects with data collected at Baseline and Week 12 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo
    Number of subjects analysed
    20
    19
    19
    19
    Units: score on a scale
        arithmetic mean (standard deviation)
    -2.8 ( 2.01 )
    -2.6 ( 2.18 )
    -3.2 ( 1.98 )
    -1.6 ( 1.55 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Mean Numeric Rating Scale Dyspareunia Score at Week 12

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    End point title
    		 Change From Baseline in Mean Numeric Rating Scale Dyspareunia Score at Week 12
    End point description
    Mean dyspareunia was based upon response information collected from diary for question 'Did you have sexual intercourse including penetration over the past 24 hours?' as 'Yes'. Electronic NRS was self-completed by subjects in e-diary daily. Total score: ranged from 0 to 10 where 0=no pain and 10=worst pain imaginable. Higher scores: worse outcome. Mean dyspareunia score was calculated for each cycle as total of dyspareunia scores divided by number of days when subjects engaged in any sexual activity that involved full vaginal penetration. Baseline Cycle was defined as cycle which started within day -84 and ended at 1 day before next menstrual cycle. If multiple cycles were there, then last complete cycle prior to Visit 2 was considered. FAS: all subjects randomly assigned to study treatment and who took at least 1 dose of study treatment and had at least 1 post-baseline assessment available. Only subjects with data collected at Baseline and Week 12 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo
    Number of subjects analysed
    13
    15
    15
    13
    Units: score on a scale
        arithmetic mean (standard deviation)
    -2.4 ( 2.24 )
    -2.7 ( 2.10 )
    -3.3 ( 2.54 )
    -1.4 ( 2.04 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the use of Protocol-Defined Rescue Medication at Week 12

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    End point title
    		 Change From Baseline in the use of Protocol-Defined Rescue Medication at Week 12
    End point description
    A responder was defined as a subject with a decrease in average daily rescue medication (ibuprofen) compared with baseline or who did not take rescue medication post-baseline. Baseline was defined as the last non-missing measurement taken prior to reference start date (-35 till Day 1), that is (i.e.), before first dose of study treatment. The FAS included all subjects randomly assigned to study treatment and who took at least 1 dose of study treatment and had at least 1 post-baseline assessment available. Only responders with data collected at Baseline and Week 12 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo
    Number of subjects analysed
    13
    10
    6
    11
    Units: Milligram (mg)
        arithmetic mean (standard deviation)
    -1.3 ( 1.85 )
    -0.3 ( 0.43 )
    -1.2 ( 0.85 )
    -0.5 ( 0.69 )
    No statistical analyses for this end point

    Secondary: Percentage of Responders who Used Protocol-Defined Rescue Medication at Week 12

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    End point title
    		 Percentage of Responders who Used Protocol-Defined Rescue Medication at Week 12
    End point description
    A responder was defined as a subject with a decrease in average daily rescue medication (ibuprofen) compared with baseline or who did not take rescue medication post-baseline. Baseline was defined as the last non-missing measurement taken prior to reference start date (-35 till day 1), i.e., before first dose of study treatment. The FAS included all subjects randomly assigned to study treatment and who took at least 1 dose of study treatment and had at least 1 post-baseline assessment available. Only subjects with data collected at Week 12 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo
    Number of subjects analysed
    20
    19
    18
    21
    Units: Percentage of responders
        number (not applicable)
    95.0
    89.5
    100.0
    90.5
    No statistical analyses for this end point

    Secondary: Change From Baseline in Modified Biberoglu and Behrman (MB&B) Sign and Symptom Scores at Week 12

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    End point title
    		 Change From Baseline in Modified Biberoglu and Behrman (MB&B) Sign and Symptom Scores at Week 12
    End point description
    MB&B scale consists of 2 parts. First part evaluates symptoms of endometriosis. There are 3 subscales: pelvic pain (A: 0=none and 3=severe), dysmenorrhea (B: 0=none and 3=severe), and deep dyspareunia (C: 0=none and 3=severe). Total pelvic pain score is sum of 3 scores (A+B+C) and ranges from 0 to 9;higher scores indicate worse outcome. Second part evaluates signs of endometriosis. There are 2 subscales pelvic tenderness (D: 0=none and 3=severe) and induration (E: 0=none and 3=severe). Total physical sign score is sum of two scores (D+E) and ranged from 0 to 6;higher scores indicate worse outcome. Total symptom and sign severity score is sum of all 5 scores (A+B+C+D+E) and ranges from 0 to 15;higher scores indicate worse outcome. Baseline: last non-missing measurement taken prior to reference start date (including unscheduled assessments), i.e., before first dose of study treatment. Analysis was performed on FAS. Only subjects with data collected at Baseline and Week 12 are reported
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo
    Number of subjects analysed
    17
    18
    18
    19
    Units: score on a scale
        arithmetic mean (standard deviation)
    -5.9 ( 3.77 )
    -6.8 ( 3.43 )
    -6.7 ( 2.35 )
    -4.1 ( 3.65 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Patient Global Impression of Change (PGIC) Score at Week 12

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    End point title
    		 Number of Subjects With Patient Global Impression of Change (PGIC) Score at Week 12
    End point description
    PGIC score is recorded 4 weeks after initial treatment completion. The PGIC asks the subject to "check the box that best describes how your urinary and/or vaginal symptoms are now, compared with how your symptoms were before you began this study." It is measured using a 7-item scale, where 1: "Very Much Better", 2: "Much Better, 3: "A Little Better", 4: "No Change", 5: "A Little Worse", 6: "Much Worse", and 7: "Very Much Worse". The score ranges from 1-7; higher scores indicate worse outcome. The FAS included all subjects randomly assigned to study treatment and who took at least 1 dose of study treatment and had at least 1 post-baseline assessment available.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo
    Number of subjects analysed
    20
    20
    21
    22
    Units: Participants
        Very much better
    4
    5
    8
    4
        Much better
    8
    8
    9
    4
        A little better
    5
    4
    1
    5
        No change
    1
    1
    1
    5
        A little worse
    0
    0
    0
    1
        Much worse
    0
    0
    0
    1
        Very much worse
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Endometriosis Health Profile (EHP)-5 Score at Week 12

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    End point title
    		 Change From Baseline in Endometriosis Health Profile (EHP)-5 Score at Week 12
    End point description
    EHP-5 is a valid short-form patient-reported outcome measure that was developed to measure health-related quality of life (QoL) in subjects with endometriosis. EHP consists of a core instrument which has 30 items divided into 5 different dimensions: pain (11 items), control and powerlessness (6 items), emotional well-being (6 items), lack of social support (4 items) and self-image (3 items). Items are answered on a 5-point Likert scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=always). Scores in each dimension generate a sum score ranging from 0 (best possible health status) to 100 (worst possible health status); higher score indicates a worse QoL. Baseline: last non-missing measurement taken prior to reference start date (including unscheduled assessments), i.e., before first dose of study treatment. Analysis was performed on FAS. Only subjects with data collected at Baseline and Week 12 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo
    Number of subjects analysed
    18
    18
    19
    20
    Units: score on a scale
    arithmetic mean (standard deviation)
        Pain
    -0.9 ( 1.45 )
    -1.4 ( 1.20 )
    -1.6 ( 1.12 )
    -0.8 ( 0.77 )
        Control and powerlessness
    -1.7 ( 0.91 )
    -1.7 ( 1.18 )
    -1.7 ( 1.19 )
    -0.9 ( 0.88 )
        Emotional well-being
    -0.5 ( 1.15 )
    -1.3 ( 1.24 )
    -1.2 ( 1.38 )
    -1.5 ( 0.83 )
        Lack of social support
    -1.0 ( 1.03 )
    -1.7 ( 1.19 )
    -1.3 ( 1.20 )
    -1.3 ( 0.92 )
        Self-image
    -0.8 ( 0.81 )
    -1.0 ( 1.19 )
    -1.4 ( 1.38 )
    -0.8 ( 1.62 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12

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    End point title
    		 Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12
    End point description
    SF-36 is a 36-item patient-reported scale which consists of 8 scaled scores: physical functioning scale (10 items), role physical scale (4 items), bodily pain scale (2 items), general health scale (5 items), vitality scale (4 items), social functioning scale (2 items), role emotional scale (4 items) and mental health scale (5 items). The score for a section is an average of the individual question scores, which are scaled 0-100; higher scores indicate better outcome. The summary score is comprised of a physical component summary (PCS) score and a mental component summary (MCS) score. The score ranges from 0 to 100; higher scores indicated better outcomes. Baseline was defined as the last non-missing measurement taken prior to reference start date (including unscheduled assessments), i.e., before first dose of study treatment. Analysis was performed on FAS. Only subjects with data collected at Baseline and Week 12 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo
    Number of subjects analysed
    18
    18
    19
    20
    Units: score on a scale
    arithmetic mean (standard deviation)
        Physical functioning scale
    20.0 ( 22.94 )
    19.7 ( 21.25 )
    20.5 ( 23.68 )
    15.8 ( 20.54 )
        Role physical scale
    17.0 ( 17.26 )
    25.3 ( 19.93 )
    28.3 ( 27.51 )
    21.3 ( 21.50 )
        Bodily pain scale
    30.0 ( 19.93 )
    34.8 ( 25.19 )
    43.7 ( 23.22 )
    17.5 ( 17.52 )
        General health scale
    8.5 ( 15.34 )
    8.4 ( 17.94 )
    15.8 ( 17.24 )
    8.2 ( 17.36 )
        Vitality scale
    16.7 ( 18.81 )
    16.0 ( 19.56 )
    17.8 ( 25.37 )
    14.4 ( 20.79 )
        Social functioning scale
    18.1 ( 19.28 )
    21.5 ( 23.41 )
    23.0 ( 32.08 )
    20.0 ( 29.08 )
        Role emotional scale
    12.5 ( 17.45 )
    15.3 ( 19.65 )
    16.7 ( 33.68 )
    19.6 ( 23.92 )
        Mental health scale
    11.4 ( 19.01 )
    14.4 ( 16.88 )
    15.8 ( 24.05 )
    15.3 ( 19.83 )
        PCS score
    8.1 ( 6.69 )
    9.1 ( 8.01 )
    11.4 ( 7.23 )
    5.2 ( 5.55 )
        MCS score
    5.2 ( 8.75 )
    6.3 ( 8.42 )
    6.6 ( 13.62 )
    8.1 ( 10.87 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) at Week 12

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    End point title
    		 Change From Baseline in Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) at Week 12
    End point description
    WPAI:GH measures the effect of health and symptom severity on work productivity and non-work activities by assessing absenteeism, presenteeism, and impairment of daily activities. It consists of 6-questions each with unique answers and yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. Baseline was defined as the last non-missing measurement taken prior to reference start date (including unscheduled assessments), i.e., before first dose of study treatment. Analysis was performed on FAS. Here, n= number of subjects with data collected at specified timepoints for each specified category.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo
    Number of subjects analysed
    15
    14
    17
    16
    Units: score on a scale
    arithmetic mean (standard deviation)
        Work time missed (n=15,13,16,15)
    2.6 ( 27.77 )
    -0.6 ( 19.42 )
    3.7 ( 33.02 )
    1.1 ( 24.13 )
        Impairment while working (n=14,13,15,14)
    -27.9 ( 30.17 )
    -19.2 ( 13.82 )
    -28.7 ( 22.64 )
    -16.4 ( 25.30 )
        Overall work impairment (n=14,13,15,14)
    -28.3 ( 29.52 )
    -19.2 ( 20.30 )
    -27.6 ( 26.04 )
    -17.4 ( 25.63 )
        Activity impairment (n=15,14,17,16)
    -21.3 ( 41.90 )
    -23.6 ( 25.90 )
    -34.7 ( 24.01 )
    -23.8 ( 30.08 )
    No statistical analyses for this end point

    Secondary: Plasma concentration of TU2670

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    End point title
    		 Plasma concentration of TU2670 [4]
    End point description
    Blood samples were collected at specified timepoints to determine plasma concentration of TU2670. Pharmacokinetic (PK) analysis set was a subset of the safety analysis set and included all subjects who received at least 1 dose of TU2670 and had at least 1 post-dose quantifiable TU2670 concentration without protocol deviations or events affecting the PK results. Only subjects with data collected at each specified timepoints are reported. Here, n=number of subjects with data collected for each specified category. 99999 denotes that mean was not computable as the values were below the lower limit of quantification (LLOQ), LLOQ value was 0.1 nanogram per milliliter (ng/mL). 55555 denotes that standard deviation was not computable as the mean was below LLOQ.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1 hour and 2 hours post-dose on Days 1, 8, 29, 57 and 85
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The PK parameters were evaluated for TU2670 arms.
    End point values
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg
    Number of subjects analysed
    16
    16
    15
    Units: nanogram per mililiter (ng/mL)
    arithmetic mean (standard deviation)
        Day 1: Pre-dose (n=10, 12, 11)
    99999 ( 55555 )
    99999 ( 55555 )
    99999 ( 55555 )
        Day 1: 1 hour post-dose (n=15,16,15)
    89.97 ( 52.65 )
    195.0 ( 150.4 )
    254.5 ( 190.4 )
        Day 1: 2 hours post-dose (n=12,12,14)
    75.90 ( 73.68 )
    206.1 ( 112.8 )
    273.5 ( 166.0 )
        Day 8: Pre-dose (n=13,15,7)
    1.173 ( 3.578 )
    0.9720 ( 0.9557 )
    1.441 ( 0.3866 )
        Day 8: 1 hour post-dose (n=16,16,12)
    83.44 ( 55.76 )
    200.5 ( 101.0 )
    278.4 ( 146.7 )
        Day 8: 2 hours post-dose (n=13,14,11)
    71.23 ( 48.37 )
    184.4 ( 64.33 )
    247.5 ( 187.0 )
        Day 29: Pre-dose (n=11,14,10)
    0.4627 ( 0.7996 )
    0.5629 ( 0.8671 )
    1.781 ( 2.574 )
        Day 29: 1 hour post-dose (n=16,15,14)
    74.54 ( 48.34 )
    204.3 ( 110.3 )
    253.3 ( 178.1 )
        Day 29: 2 hours post-dose (n=15,10,12)
    63.42 ( 54.73 )
    153.1 ( 86.88 )
    191.8 ( 82.78 )
        Day 57: Pre-dose (n=15,11,11)
    0.6889 ( 1.508 )
    1.071 ( 1.321 )
    2.994 ( 6.419 )
        Day 57: 1 hour post-dose (n=14,13,13)
    69.11 ( 54.62 )
    161.8 ( 121.1 )
    264.8 ( 180.6 )
        Day 57: 2 hours post-dose (n=12,10,11)
    54.28 ( 29.99 )
    157.4 ( 103.5 )
    205.5 ( 168.2 )
        Day 85: Pre-dose (n=12,10,10)
    1.733 ( 6.004 )
    0.5740 ( 0.6109 )
    2.225 ( 2.626 )
        Day 85: 1 hour post-dose (n=14,12,12)
    60.26 ( 35.63 )
    145.1 ( 107.8 )
    199.0 ( 190.7 )
        Day 85: 2 hours post-dose (n=13,8,10)
    43.87 ( 38.25 )
    151.9 ( 93.67 )
    163.0 ( 110.9 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events were collected from the first administration of study treatment up to 30 days after the last administration of study treatment, approximately 248 days.
    Adverse event reporting additional description
    The Safety analysis set included all subjects randomly assigned to study treatment and who took at least 1 dose of study treatment. Subjects were analyzed according to the treatment they actually received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    TU2670 120 mg
    Reporting group description
    		 Subjects received TU2670 120 mg capsule orally once daily for 12 weeks.

    Reporting group title
    TU2670 240 mg
    Reporting group description
    		 Subjects received TU2670 240 mg capsule orally once daily for 12 weeks.

    Reporting group title
    TU2670 320 mg
    Reporting group description
    		 Subjects received TU2670 320 mg capsule orally once daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matching with TU2670 capsule orally once daily for 12 weeks.

    Serious adverse events
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    0 / 22 (0.00%)
    0 / 23 (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
    Endometriosis
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    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
    		 TU2670 120 mg TU2670 240 mg TU2670 320 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 20 (60.00%)
    14 / 21 (66.67%)
    19 / 22 (86.36%)
    12 / 23 (52.17%)
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vascular disorders
    Hot flush
         subjects affected / exposed
    3 / 20 (15.00%)
    2 / 21 (9.52%)
    6 / 22 (27.27%)
    0 / 23 (0.00%)
         occurrences all number
    3
    2
    6
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 21 (9.52%)
    2 / 22 (9.09%)
    2 / 23 (8.70%)
         occurrences all number
    1
    2
    2
    2
    Migraine
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    1
    0
    0
    1
    Syncope
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 21 (9.52%)
    2 / 22 (9.09%)
    2 / 23 (8.70%)
         occurrences all number
    1
    2
    2
    2
    Diarrhoea
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    3 / 22 (13.64%)
    1 / 23 (4.35%)
         occurrences all number
    0
    0
    3
    1
    Abdominal pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    1
    0
    0
    2
    Constipation
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    1
    0
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 21 (9.52%)
    2 / 22 (9.09%)
    0 / 23 (0.00%)
         occurrences all number
    2
    2
    2
    0
    Amenorrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Intermenstrual bleeding
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    1
    0
    0
    1
    Breast pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    0
    0
    2
    Respiratory tract inflammation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    0
    0
    2
    Psychiatric disorders
    Libido decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    2 / 22 (9.09%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Depressed mood
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Spinal pain
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    2 / 22 (9.09%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    2
    1
    Cystitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    2 / 22 (9.09%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    0
    0
    2
    Bronchitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Dec 2021
    The protocol was amended to remove the sample-rich PK subset population from the study; instead, pre-dose and postdose sampling was to be done for all study subjects. In addition, changes were made throughout to clarify that the Investigator was empowered to make determinations of clinical significance of laboratory results and appropriate treatment of possible overdose without having to contact the study Medical Monitor beforehand (but that they were to contact the Medical Monitor at any time for consultation if they deemed it necessary).
    14 Mar 2024
    The protocol was amended to modify the imputation methods for missing data pertaining to primary and key secondary efficacy variables. Medical management of endometriosis included analgesics and treatments aimed at decidualization followed by atrophy of endometrial tissue with reduction or antagonism of estrogen production and induction of amenorrhea. The subjects had consistently completed the NRS pain score and experienced no menstrual bleeding days during both of Week 8 and Week 12 study period, the bias introduced by relying solely on LOCF for the imputation methods of missing data may be supplemented.

    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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