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    Clinical Trial Results:
    A Randomised, Double-blind, Placebo-controlled Parallel Group Study to Assess the Efficacy and Safety of Induction Therapy with LYC-30937-EC in Subjects with Active Ulcerative Colitis

    Summary
    EudraCT number
    2016-000518-31
    Trial protocol
    NL   HU   PL   CZ  
    Global end of trial date
    26 Mar 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Apr 2020
    First version publication date
    01 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LYC-30937-2001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02762500
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Lycera Corp.
    Sponsor organisation address
    620 West Germantown Pike, Suite 400, Plymouth Meeting, United States, PA 19462
    Public contact
    Lycera Clinical Department, Lycera Corp., 001 6104575095, 30937_Clinical_Operations@Lycera.com
    Scientific contact
    Lycera Clinical Department, Lycera Corp., 001 6104575095, 30937_Clinical_Operations@Lycera.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
    29 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the efficacy of LYC-30937-EC in inducing remission compared with placebo in subjects with active ulcerative colitis over a treatment duration of 8 weeks.
    Protection of trial subjects
    The study was performed in accordance with the protocol, International Council for Harmonisation good clinical practice guidelines, and applicable local regulatory requirements and laws.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Jun 2016
    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
    United States: 28
    Country: Number of subjects enrolled
    Czech Republic: 5
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Poland: 81
    Country: Number of subjects enrolled
    Serbia: 5
    Worldwide total number of subjects
    124
    EEA total number of subjects
    91
    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)
    117
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled at 42 study centers within the United States, Poland, Hungary, Czech Republic, Serbia and Netherlands. Study centers included academic medical centers and non-academic medical clinics.

    Pre-assignment
    Screening details
    The screening visit took place up to 28 days (4 weeks) prior to randomization and the participant's first dose of study drug. Screening occurred over multiple days to complete and obtain results for all assessments. Participants who meet all eligibility requirements returned for the next phase of the study.

    Period 1
    Period 1 title
    Overall trial (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
    LYC-30937-EC 25 mg
    Arm description
    LYC-30937-EC was administered orally, once daily from Day 1 through the end of the double-blind treatment phase (Visit 6/Week 8) for a total of 57 days of treatment.
    Arm type
    Experimental

    Investigational medicinal product name
    LYC-30937-EC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    LYC-30937-EC 25 mg was administered once daily as a single delayed release, enteric coated hydroxyl-propyl-methyl-cellulose (HPMC) capsule. Administration occurred in the morning upon awaking after fasting overnight. Participants should not have eaten for approximately 1 hour (or more) after taking study drug, except for the randomisation visit where participants were dosed in the clinic at least 2 hours after their morning meal.

    Arm title
    Placebo
    Arm description
    Placebo was administered orally, once daily from Day 1 through the end of the double-blind treatment phase (Visit 6/Week 8) for a total of 57 days of treatment.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo for LYC-30937-EC was administered once daily as a single, delayed release, enteric coated HPMC capsule. Administration occurred in the morning upon awaking after fasting overnight. Participants should not have eaten for approximately 1 hour (or more) after taking study drug, except for the randomisation visit where participants were dosed in the clinic at least 2 hours after their morning meal.

    Number of subjects in period 1
    LYC-30937-EC 25 mg Placebo
    Started
    62
    62
    Completed
    60
    59
    Not completed
    2
    3
         Lack of efficacy
    1
    -
         Adverse event, non-fatal
    -
    2
         Consent withdrawn by subject
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LYC-30937-EC 25 mg
    Reporting group description
    LYC-30937-EC was administered orally, once daily from Day 1 through the end of the double-blind treatment phase (Visit 6/Week 8) for a total of 57 days of treatment.

    Reporting group title
    Placebo
    Reporting group description
    Placebo was administered orally, once daily from Day 1 through the end of the double-blind treatment phase (Visit 6/Week 8) for a total of 57 days of treatment.

    Reporting group values
    LYC-30937-EC 25 mg Placebo Total
    Number of subjects
    62 62 124
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.8 ± 11.94 39.3 ± 13.26 -
    Gender categorical
    Units: Subjects
        Female
    27 25 52
        Male
    35 37 72
    Baseline Total Mayo Score (TMS)
    TMS range: 0 (normal/no disease) to 12 (severe disease). TMS comprised 4 subscores: stool frequency subscore, rectal bleeding subscore, endoscopy findings subscore, and physician's global assessment subscore. One participant in the placebo treatment arm did not have a complete Mayo score at baseline and therefore they were not included in this analysis population.
    Units: Units on a scale
        arithmetic mean (standard deviation)
    7.9 ± 1.46 7.8 ± 1.77 -
    Baseline Modified Mayo Score (MMS)
    MMS range: 0 (normal/no disease) to 9 (severe disease). MMS comprised 3 subscores: stool frequency subscore, rectal bleeding subscore, and endoscopy findings subscore. One participant in the placebo treatment arm did not have a complete Mayo score at baseline and therefore they were not included in this analysis population.
    Units: Units on a scale
        arithmetic mean (standard deviation)
    6.0 ± 1.38 5.7 ± 1.55 -

    End points

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    End points reporting groups
    Reporting group title
    LYC-30937-EC 25 mg
    Reporting group description
    LYC-30937-EC was administered orally, once daily from Day 1 through the end of the double-blind treatment phase (Visit 6/Week 8) for a total of 57 days of treatment.

    Reporting group title
    Placebo
    Reporting group description
    Placebo was administered orally, once daily from Day 1 through the end of the double-blind treatment phase (Visit 6/Week 8) for a total of 57 days of treatment.

    Primary: Number of Participants Achieving Clinical Remission at Week 8 Using the MMS

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    End point title
    Number of Participants Achieving Clinical Remission at Week 8 Using the MMS
    End point description
    The MMS is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 subscores (stool frequency, rectal bleeding, and endoscopy findings), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy findings scoring was performed centrally. Clinical remission was defined as a Mayo stool frequency subscore of less than or equal to (≤ 1), Mayo rectal bleeding subscore of 0 and a Mayo endoscopy findings subscore of ≤ 1.
    End point type
    Primary
    End point timeframe
    8 weeks
    End point values
    LYC-30937-EC 25 mg Placebo
    Number of subjects analysed
    62
    62
    Units: Number of participants
    7
    12
    Statistical analysis title
    Response Rate Difference
    Statistical analysis description
    The difference in the proportion of participants who achieved a clinical remission at Week 8 of treatment (LYC-30937-EC minus placebo) and corresponding 90% confidence interval were estimated. Participants who were missing the Week 8 MMS assessment were assumed to have not achieved clinical remission.
    Comparison groups
    LYC-30937-EC 25 mg v Placebo
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.106
    Method
    1-sided Pearson chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -8.1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -18.6
         upper limit
    2.5
    Notes
    [1] - Statistical comparisons between the LYC-30937-EC treatment arm and placebo were done using a 1-sided Pearson chi-square test at the 5% level of significance (α = 0.05).

    Secondary: Number of Participants Achieving Clinical Remission at Week 8 Using the TMS

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    End point title
    Number of Participants Achieving Clinical Remission at Week 8 Using the TMS
    End point description
    The TMS is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy findings scoring was performed centrally. Clinical remission was defined as a TMS of ≤ 2, with no individual subscore greater than (>) 1 and rectal bleeding score of 0.
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    LYC-30937-EC 25 mg Placebo
    Number of subjects analysed
    62
    62
    Units: Number of participants
    7
    12
    Statistical analysis title
    Response Rate Difference
    Statistical analysis description
    The difference in the proportion of participants who achieved a clinical remission at Week 8 of treatment (LYC-30937-EC minus placebo) and corresponding 90% confidence interval were estimated. Participants who were missing the Week 8 TMS assessment were assumed to have not achieved clinical remission.
    Comparison groups
    LYC-30937-EC 25 mg v Placebo
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    = 0.106
    Method
    1-sided Pearson chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -8.1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -18.6
         upper limit
    2.5
    Notes
    [2] - Statistical comparisons between the LYC-30937-EC treatment arm and placebo were done using a 1-sided Pearson chi-square test at the 5% level of significance (α = 0.05).

    Secondary: Number of Participants with a Clinical Response at Week 8 Using the MMS

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    End point title
    Number of Participants with a Clinical Response at Week 8 Using the MMS
    End point description
    The MMS is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 subscores (stool frequency, rectal bleeding, and endoscopy findings), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy findings scoring was performed centrally. Clinical response was defined as a reduction from the baseline MMS of greater than or equal to (≥) 2 points and ≥ 25%, and a decrease from baseline in rectal bleeding score of ≥ 1 point or an absolute rectal bleeding score of ≤ 1 point.
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    LYC-30937-EC 25 mg Placebo
    Number of subjects analysed
    62
    62
    Units: Number of participants
    32
    36
    Statistical analysis title
    Response Rate Difference
    Statistical analysis description
    The difference in the proportion of participants who achieved a clinical response at Week 8 of treatment (LYC-30937-EC minus placebo) and corresponding 90% confidence interval were estimated. Participants who were missing the Week 8 MMS assessment were assumed to have not achieved clinical response.
    Comparison groups
    LYC-30937-EC 25 mg v Placebo
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    = 0.235
    Method
    1-sided Pearson chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -6.5
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -21.1
         upper limit
    8.2
    Notes
    [3] - Statistical comparisons between the LYC-30937-EC treatment arm and placebo were done using a 1-sided Pearson chi-square test at the 5% level of significance(α = 0.05).

    Secondary: Number of Participants with a Clinical Response at Week 8 Using the TMS

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    End point title
    Number of Participants with a Clinical Response at Week 8 Using the TMS
    End point description
    The TMS is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy findings scoring was performed centrally. Clinical response was defined as a reduction from baseline TMS of ≥ 3 points and ≥ 30%, and a decrease from baseline in rectal bleeding score of ≥ 1 point or an absolute rectal bleeding score of ≤ 1 point.
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    LYC-30937-EC 25 mg Placebo
    Number of subjects analysed
    62
    62
    Units: Number of participants
    26
    32
    Statistical analysis title
    Response Rate Difference
    Statistical analysis description
    The difference in the proportion of participants who achieved a clinical response at Week 8 of treatment (LYC-30937-EC minus placebo) and corresponding 90% confidence interval were estimated. Participants who were missing the Week 8 TMS assessment were assumed to have not achieved clinical response.
    Comparison groups
    LYC-30937-EC 25 mg v Placebo
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    superiority [4]
    P-value
    = 0.14
    Method
    1-sided Pearson chi-squared
    Parameter type
    Risk difference (RD)
    Point estimate
    -9.7
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -24.3
         upper limit
    5
    Notes
    [4] - Statistical comparisons between the LYC-30937-EC treatment arm and placebo were done using a 1-sided Pearson chi-square test at the 5% level of significance(α = 0.05).

    Secondary: Absolute Change From Baseline in TMS at Week 8

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    End point title
    Absolute Change From Baseline in TMS at Week 8
    End point description
    The TMS is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy findings scoring was performed centrally. A decrease from baseline to Week 8 in the TMS indicates a reduction in disease activity.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    End point values
    LYC-30937-EC 25 mg Placebo
    Number of subjects analysed
    59 [5]
    58 [6]
    Units: Change from baseline
        least squares mean (standard error)
    -2.49 ± 0.33
    -2.67 ± 0.33
    Notes
    [5] - Number of participants with non-missing change from baseline in TMS
    [6] - Number of participants with non-missing change from baseline in TMS
    Statistical analysis title
    Statistical Analysis of Change from Baseline TMS
    Statistical analysis description
    Participants who were missing the baseline or Week 8 TMS were excluded from the analysis.
    Comparison groups
    LYC-30937-EC 25 mg v Placebo
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    superiority [7]
    P-value
    = 0.708
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.18
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.6
         upper limit
    0.95
    Notes
    [7] - The mean change from baseline at Week 8 was evaluated using an analysis of covariance (ANCOVA) with a factor for treatment and a covariate for baseline TMS.

    Secondary: Percent Change From Baseline to Week 8 in Fecal Calprotectin in Participants with Baseline Fecal Calprotectin ≥ 250 micrograms per gram (μg/g)

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    End point title
    Percent Change From Baseline to Week 8 in Fecal Calprotectin in Participants with Baseline Fecal Calprotectin ≥ 250 micrograms per gram (μg/g)
    End point description
    Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation. A decrease from baseline to Week 8 in fecal calprotectin indicates a reduction in inflammation. Only participants with a baseline fecal calprotectin value ≥ 250 μg/g were included.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    End point values
    LYC-30937-EC 25 mg Placebo
    Number of subjects analysed
    44 [8]
    37 [9]
    Units: Percent change from baseline
        least squares mean (standard error)
    -35.22 ± 13.81
    9.37 ± 15.07
    Notes
    [8] - Participants with non-missing percent change from baseline in fecal calprotectin
    [9] - Participants with non-missing percent change from baseline in fecal calprotectin
    Statistical analysis title
    Statistical Analysis of Fecal Calprotectin
    Statistical analysis description
    Participants who were missing the baseline or Week 8 fecal calprotectin were excluded from the analysis.
    Comparison groups
    LYC-30937-EC 25 mg v Placebo
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    superiority [10]
    P-value
    = 0.032
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -44.59
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -78.66
         upper limit
    -10.53
    Notes
    [10] - The mean change from baseline at Week 8 was evaluated using an ANCOVA with a factor for treatment and a covariate for baseline fecal calprotectin.

    Other pre-specified: Number of Participants with Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Discontinuation from the Study

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    End point title
    Number of Participants with Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Discontinuation from the Study
    End point description
    Adverse events (AEs) were collected from the time a participant signed the informed consent. TEAEs were AEs occurring or worsening after the first dose of study drug (LYC-30937-EC 25 mg or placebo). Severity of AEs was assessed by the Investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03, with grading as follows: Grade 1 = mild (asymptomatic or mild symptoms), Grade 2 = moderate (minimal, local intervention, or noninvasive intervention indicated); Grade 3 = severe (or medically significant but not life-threatening); Grade 4 = life-threatening; Grade 5 = death.
    End point type
    Other pre-specified
    End point timeframe
    10 weeks
    End point values
    LYC-30937-EC 25 mg Placebo
    Number of subjects analysed
    62
    62
    Units: Number of participants
        Participants with ≥ 1 TEAE
    22
    27
        Participants with ≥ 1 serious TEAE
    1
    3
        Participants with TEAE leading to discontinuation
    0
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs and serious AEs were collected from the time the participant signed informed consent through last participant visit (up to 14 weeks in total).
    Adverse event reporting additional description
    All directly observed and spontaneously reported AEs were recorded. Participants were also questioned about AEs. Severity of AEs was graded according to NCI CTCAE v4.03. AEs not included in the NCI CTCAE lists were graded according to the NCI CTCAE general guidelines.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    LYC-30937-EC 25 mg
    Reporting group description
    LYC-30937-EC was administered orally, once daily from Day 1 through the end of the double-blind treatment phase (Visit 6/Week 8) for a total of 57 days of treatment. 'Subjects affected by non-serious adverse events' is the number of participants affected by non-serious AEs occurring at >5%.

    Reporting group title
    Placebo
    Reporting group description
    Placebo was administered orally, once daily from Day 1 through the end of the double-blind treatment phase (Visit 6/Week 8) for a total of 57 days of treatment. 'Subjects affected by non-serious adverse events' is the number of participants affected by non-serious AEs occurring at >5%.

    Serious adverse events
    LYC-30937-EC 25 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 62 (3.23%)
    3 / 62 (4.84%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    LYC-30937-EC 25 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 62 (16.13%)
    11 / 62 (17.74%)
    Nervous system disorders
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 62 (9.68%)
    5 / 62 (8.06%)
         occurrences all number
    6
    6
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 62 (6.45%)
    6 / 62 (9.68%)
         occurrences all number
    4
    8

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 May 2016
    The following changes were made: • Section 6.5.7 (Monitoring Subjects for AEs of Special Interest) and Section 7.12 (Stopping Rules) were revised, and Section 7.12.1 (Suspension of Study) was added to be consistent with the Food and Drug Administration (FDA) industry guidance on drug-induced liver injury. • The liver function test exclusion was reduced to 1.5 x the upper limit of normal. • The new Lycera facsimile number was added to the cover page. • Minor revisions/clarifications were made throughout.
    22 Jun 2016
    The following changes were made: • Exploratory efficacy endpoint referencing “mucosal healing” changed throughout to “endoscopic improvement” as histologic evaluation of mucosa to validate healing was not performed. • Secondary efficacy endpoint Week 8 TMS clinical remission definition revised to include rectal bleeding score of 0. • Section 4.4.1: Inclusion criteria 4 revised to require women of childbearing potential to use 2 highly effective forms of birth control. • Section 4.4.2: Elevated serum creatinine added to Exclusion criteria 6 to exclude patients with renal impairment. • Section 6.4.1 definition of left-sided disease added to clarify which subjects could have flexible sigmoidoscopy at week 8 based on demarcation of inflammation observed in Screening colonoscopy. • Section 6.4.1 clarified that endoscopy video recording was to be provided for central reading and central readers had study specific training, including that a Mayo endoscopic score of 0 or 1 could not include any degree of “friability” as this was inconsistent with remission. • Section 6.4.1 clarified that stool frequency and rectal bleeding data for Mayo scoring was obtained from the diary completed by the subjects. Also clarified that average stool frequency and rectal bleeding score calculated from the individual 3 consecutive days was used for the Mayo score. • Section 6.5.7 revised to state that study drug was to be withheld in subjects who exhibited any of the listed laboratory elevations in liver biochemical parameters and lactate. • Section 7.5 revised to add SAE reporting information including time frame for reporting SAEs to US FDA. • Section 6.6.1.2 clarified serial pharmacokinetic sub-study blood sample collection. • Section 7.10: sponsor medical monitor name and contact information added. • Section 7.12: individual stopping criteria added based on abnormal ECG findings of prolonged QT/QTc interval. • Section 11.1 removed statement that subjects were identified
    07 Dec 2016
    The following changes were made: • Throughout protocol: revised all references to “anti-tumour necrosis factor” therapy to state “biologic” therapy • Section 1.0 revised to add countries participating in study and the estimated last subject last visit; • Sections 1.0 - 2.5 updated and reorganized • Section 4.1 revised language related to open-label extension protocol • Section 4.4.1 Inclusion criteria #2 revised to add clarity to histological evaluation if done at Screening • Section 4.4.1 Inclusion criteria #4 revised to add clarity to effective birth control • Section 4.4.1 Inclusion criteria #5 revised to add clarity • Section 4.4.1 Inclusion criteria #6 revised to add clarity • Section 4.4.2 Exclusion criteria #3 revised for clarity regarding bleeding disorders • Section 4.4.2 Exclusion criteria #10 revised to define history of uveitis • Section 4.4.2 Exclusion criteria #12 revised to define type of colon polyp being referenced • Section 4.4.2 Exclusion criteria #19 revised to remove reference to use of “topical” 5-ASA and steroids • Section 5.5.2-5.5.3 revised to add clarity related to IWRS and compliance • Section 5.6 revised to be consistent with other sections of protocol and to specify that corticosteroid taper was not allowed during the study • Section 6.2.1 revised wording related to timing for Screening procedures when a subject was already scheduled for a colonoscopy • Section 6.5.4 revised to clarify calculation of QTcF will not be done by sites • Section 6.5.7 revised to specify that Baseline abdominal pain and vomiting was to be carefully assessed • Section 7.4 revised to include the CTCAE criteria for assessment of AE severity • Section 7.12.1 study suspension criteria revised to state that if 50% of subjects experienced clinically important drug-related AEs (instead of TESAEs) with severity of CTCAE Grade 2 • Appendix B revised: hepatitis blood sample removed.
    05 Jun 2017
    The following changes were made: • Section 4.4.1 Inclusion criteria #5 revised to allow inclusion of subjects on concomitant thiopurine UC treatment and to allow subjects on no UC treatment. • Section 4.4.1 Inclusion criteria #6 revised to include thiopurine. • Section 4.4.2 Exclusion criteria #7 revised to remove reference to thiopurines and to reduce the washout of other immunomodulatory medications to 4 weeks prior to the Screening endoscopy. • Section 4.4.2 Exclusion criteria #10 removed (history of uveitis). • Section 4.4.2 Exclusion criteria #12 revised to allow subjects with a history of cancer that was in remission for ≥ 5 years and exclude subjects with cancer diagnosed within the past 5 years unless approved by the study medical monitor. • Section 4.4.2 Exclusion criteria #17 biologic washout period determination revised and Appendix D added. • Section 4.4.2 Exclusion criteria #19 revised to allow use of rectal 5-ASA medications. • Section 5.6 revised to allow concomitant use of a stable dose of thiopurines. • Section 6.2.6 revised to specify that the Visit 6 date was the date of study completion. • Section 6.6.1.1, Table 3 footnote and Appendix B revised to specify that up to 20 subjects were planned to participate in the safety PK sub-study. • Section 6.6.1.2, Table 3 footnote and Appendix B revised to specify that up to 12 subjects were planned to participate in the serial PK sub-study. • Section 7.12 revised to specify that a repeat ECG was to be performed if QT/QTc prolongation stopping criteria were noted for confirmation.

    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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