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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence

    Summary
    EudraCT number
    2019-000886-19
    Trial protocol
    FR   DE   GB   AT   NL  
    Global end of trial date
    25 Aug 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Aug 2023
    First version publication date
    27 Aug 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TAK-018-2001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03943446
    WHO universal trial number (UTN)
    U1111-1225-5064
    Sponsors
    Sponsor organisation name
    Takeda Development Center Americas, Inc.
    Sponsor organisation address
    95 Hayden Avenue, Lexington, Massachusetts, United States, 02421
    Public contact
    Study Director, Takeda, TrialDisclosures@takeda.com
    Scientific contact
    Study Director, Takeda, TrialDisclosures@takeda.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
    25 Aug 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Aug 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main aim is to evaluate the efficacy of TAK-018 in reducing endoscopic recurrence of intestinal inflammation in postoperative participants with CD after planned laparoscopic ileocecal resection with primary anastomosis.
    Protection of trial subjects
    Each subject signed an informed consent form before participating in the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Aug 2020
    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
    United States: 10
    Country: Number of subjects enrolled
    Austria: 8
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    United Kingdom: 1
    Worldwide total number of subjects
    34
    EEA total number of subjects
    23
    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)
    31
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants took part in the study at 18 investigative sites in the United States, Australia, Germany, France and United Kingdom from 4 August 2020 to 25 August 2022.

    Pre-assignment
    Screening details
    Participants with Crohn’s disease (CD) who had undergone a planned laparoscopic ileocecal resection received TAK-018 for prevention of the recurrence of postoperative CD. The participants were randomized in 1:1:1 ratio to three treatment groups i.e. TAK-018 low dose, TAK-018 high dose, or placebo for a 26-week treatment period.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    TAK-018 placebo-matching tablets, orally, twice daily (BID) for up to 27.7 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-018 placebo-matching tablets.

    Arm title
    TAK-018 0.30 g Low Dose
    Arm description
    TAK-018 0.30 g, tablets, orally, BID for up to 31.7 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    TAK-018
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-018 0.30 g tablets.

    Arm title
    TAK-018 1.5 g High Dose
    Arm description
    TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    TAK-018
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    TAK-018 1.5 g tablets.

    Number of subjects in period 1
    Placebo TAK-018 0.30 g Low Dose TAK-018 1.5 g High Dose
    Started
    12
    11
    11
    Pharmacokinetic (PK) analysis set
    12
    11
    11
    Completed
    5
    7
    4
    Not completed
    7
    4
    7
         Consent withdrawn by subject
    1
    1
    2
         Study Terminated by Sponsor
    1
    2
    1
         Lost to follow-up
    -
    -
    1
         Reason not Specified
    5
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    TAK-018 placebo-matching tablets, orally, twice daily (BID) for up to 27.7 weeks.

    Reporting group title
    TAK-018 0.30 g Low Dose
    Reporting group description
    TAK-018 0.30 g, tablets, orally, BID for up to 31.7 weeks.

    Reporting group title
    TAK-018 1.5 g High Dose
    Reporting group description
    TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.

    Reporting group values
    Placebo TAK-018 0.30 g Low Dose TAK-018 1.5 g High Dose Total
    Number of subjects
    12 11 11
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.97 ± 13.133 37.42 ± 16.179 39.25 ± 11.297 -
    Gender categorical
    Units: Subjects
        Female
    5 9 3 17
        Male
    7 2 8 17
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    1 1 0 2
        Not Hispanic or Latino
    9 7 10 26
        Unknown or Not Reported
    2 3 1 6
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0
        Asian
    0 0 0 0
        Native Hawaiian or Other Pacific Islander
    0 0 0 0
        Black or African American
    0 0 0 0
        White
    10 7 10 27
        More than one race
    0 0 0 0
        Unknown or Not Reported
    2 4 1 7
    Region of Enrollment
    Units: Subjects
        United States United States
    4 3 3 10
        Austria Austria
    4 2 2 8
        Germany Germany
    1 1 4 6
        United Kingdom
    0 0 1 1
        France France
    3 5 1 9
    Height
    Units: centimeters (cm)
        arithmetic mean (standard deviation)
    171.87 ± 7.709 167.95 ± 7.692 172.57 ± 8.594 -
    Body Mass Index (BMI)
    BMI was calculated based on the height and weight, using the formula: BMI (kg/m^2) = Weight (kg) / [Height (cm)* 0.01]^2.
    Units: kilogram per meters squared (kg/m^2)
        arithmetic mean (standard deviation)
    24.57 ± 4.617 23.92 ± 5.037 26.09 ± 6.175 -
    Weight
    Units: kilograms (kg)
        arithmetic mean (standard deviation)
    72.44 ± 13.514 67.61 ± 15.111 77.95 ± 19.971 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    TAK-018 placebo-matching tablets, orally, twice daily (BID) for up to 27.7 weeks.

    Reporting group title
    TAK-018 0.30 g Low Dose
    Reporting group description
    TAK-018 0.30 g, tablets, orally, BID for up to 31.7 weeks.

    Reporting group title
    TAK-018 1.5 g High Dose
    Reporting group description
    TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.

    Primary: Percentage of Participants With Endoscopic Recurrence of CD as Assessed by Rutgeerts Grading Scale at Week 26

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    End point title
    Percentage of Participants With Endoscopic Recurrence of CD as Assessed by Rutgeerts Grading Scale at Week 26
    End point description
    Endoscopic recurrence is defined as a Rutgeerts' score ≥ i2. The Rutgeerts scoring is a 5-point scale used to assess endoscopic recurrence at the ileocolonic anastomosis and preanastomotic ileum. The total score ranges from i0 to i4; where i0 = no lesions, i1= ≤ 5 aphthous ulcers, i2= > 5 aphthous ulcers with normal mucosa between lesions or lesions are confined to the anastomosis, i3= diffuse aphthous ileitis with diffusely inflamed mucosa and i4= diffuse inflammation with larger ulcers, nodules, and/or narrowing. Higher score indicates worsening. Percentages are rounded off to the nearest single decimal.
    End point type
    Primary
    End point timeframe
    At Week 26
    End point values
    Placebo TAK-018 0.30 g Low Dose TAK-018 1.5 g High Dose
    Number of subjects analysed
    12
    11
    11
    Units: percentage of participants
        number (not applicable)
    91.7
    81.8
    90.9
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v TAK-018 0.30 g Low Dose
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.59
    Method
    Fisher exact
    Parameter type
    Estimated Difference in ERR
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.44
         upper limit
    0.23
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v TAK-018 1.5 g High Dose
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1
    Method
    Fisher exact
    Parameter type
    Estimated difference in ERR
    Point estimate
    -0.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.34
         upper limit
    0.31

    Secondary: Ctrough: Observed Plasma Trough Concentrations of TAK-018

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    End point title
    Ctrough: Observed Plasma Trough Concentrations of TAK-018 [1]
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-dose and at multiple time points (up to 12 hours) post-dose at Week 3
    Notes
    [1] - 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: Only descriptive analysis was performed for this endpoint.
    End point values
    TAK-018 0.30 g Low Dose TAK-018 1.5 g High Dose
    Number of subjects analysed
    9
    5
    Units: milligrams per Litre (mg/L)
        arithmetic mean (standard deviation)
    13.8 ± 9.39
    36.2 ± 21.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Fecal Calprotectin (FCP) >135 Microgram per Gram (mcg/g) at Weeks 3, 6, 12, 18, 26 and 30

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    End point title
    Percentage of Participants With Fecal Calprotectin (FCP) >135 Microgram per Gram (mcg/g) at Weeks 3, 6, 12, 18, 26 and 30
    End point description
    Stool samples were collected for analysis of fecal calprotectin, a biomarker of intestinal inflammatory activity. Percentages are rounded off to the nearest single decimal.
    End point type
    Secondary
    End point timeframe
    At Weeks 3, 6, 12, 18, 26 and 30
    End point values
    Placebo TAK-018 0.30 g Low Dose TAK-018 1.5 g High Dose
    Number of subjects analysed
    11
    8
    7
    Units: percentage of participants
    number (not applicable)
        At Week 3 (n=9, 8, 7)
    55.6
    75.0
    42.9
        At Week 6 (n= 11, 8, 6)
    27.3
    50.0
    83.3
        At Week 12 (n= 9, 8, 6)
    44.4
    37.5
    33.3
        At Week 18 (n= 8, 6, 5)
    75.0
    50.0
    60.0
        At Week 26 (n= 7, 4, 4)
    71.4
    75.0
    50.0
        At Week 30 (n= 5, 6, 4)
    40.0
    66.7
    25.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study drug up to 30 days following last dose of study drug (up to 35.98 weeks)
    Adverse event reporting additional description
    At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    TAK-018 placebo-matching tablets, orally, twice daily (BID) for up to 27.7 weeks.

    Reporting group title
    TAK-018 1.5 g High Dose
    Reporting group description
    TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.

    Reporting group title
    TAK-018 0.30 g Low Dose
    Reporting group description
    TAK-018 0.30 g, tablets, orally, BID for up to 31.7 weeks.

    Serious adverse events
    Placebo TAK-018 1.5 g High Dose TAK-018 0.30 g Low Dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 11 (18.18%)
    4 / 11 (36.36%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Blood loss anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Inflammation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Mesenteric haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Portal vein thrombosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo TAK-018 1.5 g High Dose TAK-018 0.30 g Low Dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 12 (91.67%)
    9 / 11 (81.82%)
    6 / 11 (54.55%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertension
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    General disorders and administration site conditions
    Peripheral swelling
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Endometriosis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Depression
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Anxiety
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Blood phosphorus decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    3 / 12 (25.00%)
    1 / 11 (9.09%)
    2 / 11 (18.18%)
         occurrences all number
    4
    1
    3
    Faecal calprotectin increased
         subjects affected / exposed
    3 / 12 (25.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    3
    0
    0
    Haematocrit decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Platelet count increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    0
    1
    Red blood cell count decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Post procedural discomfort
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Tremor
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Neuralgia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Dysgeusia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphopenia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    3
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Bowel movement irregularity
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    3
    1
    0
    Abdominal distension
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    0
    1
    Abdominal discomfort
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal tenderness
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    5 / 12 (41.67%)
    2 / 11 (18.18%)
    0 / 11 (0.00%)
         occurrences all number
    5
    2
    0
    Nausea
         subjects affected / exposed
    3 / 12 (25.00%)
    3 / 11 (27.27%)
    1 / 11 (9.09%)
         occurrences all number
    3
    4
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 11 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    3
    0
    3
    Crohn's disease
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Alopecia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    1
    Sensitive skin
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Rash
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Muscle twitching
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Arthralgia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Back pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle tightness
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Sepsis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Tinea versicolour
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    COVID-19
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 11 (9.09%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jul 2019
    The following changes were implemented as per Amendment 1: 1. Update to include descriptive information on nonclinical findings relating to rat specific renal tubular degeneration to align with the investigator brochure (IB). 2. Update to clarify when study drug should be taken in relation to meal consumption and clarification regarding when treatment will start. 3. Update that subjects who terminate early from the study will have a final visit 30 days after their last dose of study drug. 4. Inclusion of stopping criteria for the study and for individual subjects based on Common Terminology Criteria for Adverse Events (CTCAE) grading. 5. Update to include surgeon’s documentation that laparoscopic ileocecal resection removed active disease. 6. Clarification to the use of concomitant medications: those excluded postoperatively and prior to study treatment, and those permitted for subject safety and well-being. 7. Inclusion of rescreening criteria. 8. Clarification that height will be measured during screening. 9. Clarification of patient reported outcomes (PRO) reporting requirements. 10. Clarification that local laboratory results should be entered into the electronic data capture (EDC). 11. Inclusion of urinalysis assessment as part of study procedures. 12. Clarification to accurately record dosing before PK sample collections. 13. Clarification of the purpose of RNA samples. 14. Inclusion of details on compliance measurement in case of a discrepancy. 15. Replacement of AE intensity terminology with the CTCAE Version 5 scale. 16. Clarification regarding the internal monitoring committee. 17. Clarification to the statistical analyses conducted for efficacy, pharmacodynamic analysis, PRO-2, interim analysis, and determination of sample size. 18. Updates to Appendix A, Schedule of Events, to align with clarifications within the text, including PRO-2 assessment on Day 1 and EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) assessment at screening.
    13 Jan 2020
    Amendment 3 changes: 1. Addition of results from chronic toxicity studies in dogs and rats. 2. Updated information for phase 1b Study EBFIM117. 3. Changes to primary, safety, secondary, and exploratory objectives. 4. Change of primary endpoint and clarification of safety, secondary, and exploratory endpoints. 5. Updates and clarifications to overall study design based on longer duration of treatment that include addition of a stratification factor at randomization, changes to sample size, and addition of a Week 30. 6. Updated schematic of study design. 7. Addition of composition of study treatment tablets and their storage. 8. Addition of stratification of subjects by smoking status during randomization. 9. Clarifications to patient reported outcomes and to descriptions of patient-reported outcome 2 (PRO-2) and EQ 5D 5L instruments. 10. Updated time period for collection of concomitant medications and procedures. 10. Updated pregnancy testing requirements for longer treatment duration. 11. Addition of information regarding SAE reporting. 12. Corrections to statistical analyses sections. 13. Updates to Appendix A, Schedule of Events (and footnotes), to align with changes in text.
    30 Jul 2020
    The following changes were implemented as per Amendment 4: 1. Specification that the surgical procedure is a prerequisite for enrollment to the study. 2. Specification of clinic visits on Day 1 (D1) and Week 26 (W26) and that study visits at screening and on W3, W6, W12, W18, and W30 may be conducted as clinic or HHC visits. 3. Clarification regarding study drug administration related to changes in study procedures related to the pandemic. 4. Clarification regarding physical examination (PE) during HHC visits. 5. Clarification regarding where PK sample collection times are recorded. 5. Addition of information regarding changes to study procedures due to the pandemic. 6. Clarification regarding posttreatment follow-up assessments for subjects who complete the study and for those who discontinue early. 7. Correction that the safety assessment does not include electrocardiogram changes from baseline.
    08 Oct 2021
    The following changes were implemented as per Amendment 5: 1. Updates to the study signatories. 2. Addition of the International Nonproprietary Name (INN): sibofimloc.

    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.
    This study is terminated as the sponsor decided to discontinue study due to inability to recruit the expected number of participants within the requisite time period.
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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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