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    Clinical Trial Results:
    Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration

    Summary
    EudraCT number
    		 2013-002857-32
    Trial protocol
    		 DE   HU   CZ   GB   BE   PL  
    Global end of trial date
    30 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2017
    First version publication date
    06 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG0634-CL-211
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02048618
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800
    Public contact
    Clinical Trial Information Desk, Galapagos NV, +32 15342 900, rd@glpg.com
    Scientific contact
    Clinical Trial Information Desk, Galapagos NV, +32 15342 900, rd@glpg.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
    30 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate efficacy in terms of the percentage of subjects achieving clinical remission (CD Activity Index [CDAI] score < 150) following 10 weeks treatment with GLPG0634 200 mg q.d. versus placebo in patients with active CD with evidence of mucosal ulceration.
    Protection of trial subjects
    Before implementing this study, the protocol, the proposed informed consent, and other information to subjects was to be reviewed by an Independent Ethics Committee (IEC). A signed and dated statement that the protocol and informed consent was approved by the IEC had to be given to the CRO before study initiation. The IEC, as required by local law, had to approve any amendments to the protocol, which needed formal approval. The IEC could be notified for all other amendments (i.e. administrative changes in accordance with local requirements).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Feb 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 32
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Belgium: 20
    Country: Number of subjects enrolled
    Czech Republic: 14
    Country: Number of subjects enrolled
    France: 27
    Country: Number of subjects enrolled
    Germany: 25
    Country: Number of subjects enrolled
    Hungary: 17
    Country: Number of subjects enrolled
    Russian Federation: 22
    Country: Number of subjects enrolled
    Romania: 11
    Worldwide total number of subjects
    174
    EEA total number of subjects
    152
    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)
    169
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Europe. The first participant was screened on 3 February 2014. The last study visit occurred on 30 December 2015.

    Pre-assignment
    Screening details
    		 311 subjects were screened.

    Period 1
    Period 1 title
    Period 1: Weeks 1 - 10
    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
    		 Placebo during Weeks 1 - 10; responders (having at least reduction in CDAI of 100 points) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD during Weeks 11 - 20.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 placebo tablets in the morning.

    Arm title
    		 GLPG0634 200 mg QD
    Arm description
    		 GLPG0634 200 mg once daily during Weeks 1 - 10; responders (having at least reduction in CDAI of 100 points) were re-randomized to GLPG0634 200 mg QD, GLPG0634 100 mg QD, or placebo during Weeks 11 - 20; nonresponders were re-randomized to GLPG0634 200 mg QD or placebo during Weeks 11 - 20.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634 200 mg QD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 GLPG0634 tablets in the morning.

    Number of subjects in period 1
    		Placebo GLPG0634 200 mg QD
    Started
    44
    130
    Completed
    37
    111
    Not completed
    7
    19
         Consent withdrawn by subject
    1
    3
         Treatment failure
    3
    10
         Adverse event, non-fatal
    3
    4
         Other
    -
    1
         Lost to follow-up
    -
    1
    Period 2
    Period 2 title
    Period 2: Weeks 11 - 20
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Responders
    Arm description
    		 Placebo during Weeks 1 -10; responders remained on placebo during Weeks 11 -20.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 placebo tablets in the morning.

    Arm title
    		 Placebo nonresponders
    Arm description
    		 Placebo during Weeks 1 - 10; nonresponders were re-randomized to received GLPG0634 100 mg QD + placebo during Weeks 11 - 20.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634 100 mg QD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 100 mg tablet + placebo once daily in the morning.

    Arm title
    		 GLPG0634 200 mg QD to GLPG0634 200 mg QD
    Arm description
    		 GLPG0634 200 mg QD during Weeks 1 - 10; some responders and some nonresponders were re-randomized to GLPG0634 200 mg QD during Weeks 11 - 20.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634 200 mg QD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 GLPG0634 tablets in the morning.

    Arm title
    		 GLPG0634 200 mg QD switch to GLPG0634 100 mg QD
    Arm description
    		 GLPG0634 200 mg QD during Weeks 1 - 10; some responders were re-randomized to GLPG0634 100 mg QD during Weeks 11 - 20.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG0634 100 mg QD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 GLPG0634 100 mg tablet + placebo once daily in the morning.

    Arm title
    		 GLPG0634 200 mg QD switch to placebo
    Arm description
    		 GLPG0634 200 mg QD during Weeks 1 - 10; some responders and some nonresponders were re-randomized to placebo during Weeks 11 - 20.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 placebo tablets in the morning.

    Number of subjects in period 2 [1]
    		Placebo Responders Placebo nonresponders GLPG0634 200 mg QD to GLPG0634 200 mg QD GLPG0634 200 mg QD switch to GLPG0634 100 mg QD GLPG0634 200 mg QD switch to placebo
    Started
    15
    22
    57
    30
    23
    Completed
    12
    20
    45
    25
    21
    Not completed
    3
    2
    12
    5
    2
         Consent withdrawn by subject
    1
    -
    3
    1
    2
         Treatment failure
    1
    2
    6
    2
    -
         Adverse event, non-fatal
    1
    -
    3
    2
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One subject in the GLPG0634 200 mg QD treatment group completed study part 1, was re-randomized into the same group, but was not exposed during study part 2, resulting in 57 subjects in the continued GLPG0634 200 mg QD treatment group.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo during Weeks 1 - 10; responders (having at least reduction in CDAI of 100 points) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD during Weeks 11 - 20.

    Reporting group title
    GLPG0634 200 mg QD
    Reporting group description
    		 GLPG0634 200 mg once daily during Weeks 1 - 10; responders (having at least reduction in CDAI of 100 points) were re-randomized to GLPG0634 200 mg QD, GLPG0634 100 mg QD, or placebo during Weeks 11 - 20; nonresponders were re-randomized to GLPG0634 200 mg QD or placebo during Weeks 11 - 20.

    Reporting group values
    		 Placebo GLPG0634 200 mg QD Total
    Number of subjects
    		 44 130 174
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 43 126 169
        From 65-84 years
    		 1 4 5
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 35.1 (18 to 71) 37.4 (18 to 68) -
    Gender categorical
    Units: Subjects
        Female
    		 26 71 97
        Male
    		 18 59 77
    Race
    Units: Subjects
        White
    		 43 117 160
        Other
    		 1 13 14
    BMI
    Units: kg/m²
        arithmetic mean (full range (min-max))
    		 23.87 (18.1 to 40.4) 23.78 (14.8 to 37) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo during Weeks 1 - 10; responders (having at least reduction in CDAI of 100 points) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD during Weeks 11 - 20.

    Reporting group title
    GLPG0634 200 mg QD
    Reporting group description
    		 GLPG0634 200 mg once daily during Weeks 1 - 10; responders (having at least reduction in CDAI of 100 points) were re-randomized to GLPG0634 200 mg QD, GLPG0634 100 mg QD, or placebo during Weeks 11 - 20; nonresponders were re-randomized to GLPG0634 200 mg QD or placebo during Weeks 11 - 20.
    Reporting group title
    Placebo Responders
    Reporting group description
    		 Placebo during Weeks 1 -10; responders remained on placebo during Weeks 11 -20.

    Reporting group title
    Placebo nonresponders
    Reporting group description
    		 Placebo during Weeks 1 - 10; nonresponders were re-randomized to received GLPG0634 100 mg QD + placebo during Weeks 11 - 20.

    Reporting group title
    GLPG0634 200 mg QD to GLPG0634 200 mg QD
    Reporting group description
    		 GLPG0634 200 mg QD during Weeks 1 - 10; some responders and some nonresponders were re-randomized to GLPG0634 200 mg QD during Weeks 11 - 20.

    Reporting group title
    GLPG0634 200 mg QD switch to GLPG0634 100 mg QD
    Reporting group description
    		 GLPG0634 200 mg QD during Weeks 1 - 10; some responders were re-randomized to GLPG0634 100 mg QD during Weeks 11 - 20.

    Reporting group title
    GLPG0634 200 mg QD switch to placebo
    Reporting group description
    		 GLPG0634 200 mg QD during Weeks 1 - 10; some responders and some nonresponders were re-randomized to placebo during Weeks 11 - 20.

    Primary: Clinical remission (CDAI) at Week 10

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    End point title
    		 Clinical remission (CDAI) at Week 10
    End point description
    The Crohn's Disease Activity Index (CDAI) is a measurement of disease activity using multiple disease assessment criteria. The CDAI is a composite scoring index based on the following categories: 1) Number of liquid or very soft stools 2) Abdominal pain 3) General well being 4) Extra-intestinal manifestations of Crohn’s Disease 5) Lomotil/ Imodium/opiates for diarrhea 6) Abdominal mass 7) Hematocrit (%) 8) Body Weight CDAI clinical remission is defined as a CDAI score of < 150. Intent-to-Treat (ITT) Population: all subjects randomized, exposed at least once, and with post-Baseline data for at least one efficacy parameter. Non-responder imputation was used (ie, to impute a missing response, the subject was assumed to be a non-responder).
    End point type
    Primary
    End point timeframe
    Week 10
    End point values
    		 Placebo GLPG0634 200 mg QD
    Number of subjects analysed
    44
    128
    Units: percentage of subjects
        number (not applicable)
    22.7
    46.9
    Statistical analysis title
    		 CDAI Clinical Remission at Week 10
    Comparison groups
    Placebo v GLPG0634 200 mg QD
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0077 [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in percentage rates
    Point estimate
    24.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9
         upper limit
    		 39.2
    Notes
    [1] - type III p-value from a logistic regression model per time point, with factors: treatment, baseline use of oral GCSs (yes/no), screening CRP (≤ 10 mg/L/> 10 mg/L), and previous use of anti-TNFs (naïve/experienced).

    Secondary: Clinical remission (CDAI) at Weeks 2, 4, and 6

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    End point title
    		 Clinical remission (CDAI) at Weeks 2, 4, and 6
    End point description
    The Crohn's Disease Activity Index (CDAI) is a measurement of disease activity using multiple disease assessment criteria. The CDAI is a composite scoring index based on the following categories: 1) Number of liquid or very soft stools 2) Abdominal pain 3) General well being 4) Extra-intestinal manifestations of Crohn’s Disease 5) Lomotil/ Imodium/opiates for diarrhea 6) Abdominal mass 7) Hematocrit (%) 8) Body Weight CDAI clinical remission is defined as a CDAI score of < 150. Intent-to-Treat (ITT) Population: all subjects randomized, exposed at least once, and with post-Baseline data for at least one efficacy parameter. Non-responder imputation was used (ie, to impute a missing response, the subject was assumed to be a non-responder).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, and 6
    End point values
    		 Placebo GLPG0634 200 mg QD
    Number of subjects analysed
    44
    128
    Units: percentage of subjects
    number (not applicable)
        Week 2
    20.5
    21.9
        Week 4
    18.2
    33.6
        Week 6
    27.3
    40.6
    No statistical analyses for this end point

    Secondary: Clinical response (CDAI) at Weeks 2, 4, 6, and 10

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    End point title
    		 Clinical response (CDAI) at Weeks 2, 4, 6, and 10
    End point description
    The Crohn's Disease Activity Index (CDAI) is a measurement of disease activity using multiple disease assessment criteria. The CDAI is a composite scoring index based on the following categories: 1) Number of liquid or very soft stools 2) Abdominal pain 3) General well being 4) Extra-intestinal manifestations of Crohn’s Disease 5) Lomotil/ Imodium/opiates for diarrhea 6) Abdominal mass 7) Hematocrit (%) 8) Body Weight CDAI clinical response is defined as a change from baseline in CDAI score of <= -100 points. Intent-to-Treat (ITT) Population: all subjects randomized, exposed at least once, and with post-Baseline data for at least one efficacy parameter. Non-responder imputation was used (ie, to impute a missing response, the subject was assumed to be a non-responder).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 10
    End point values
    		 Placebo GLPG0634 200 mg QD
    Number of subjects analysed
    44
    128
    Units: percentage of subjects
    number (not applicable)
        Week 2
    29.5
    37.5
        Week 4
    31.8
    40.6
        Week 6
    50
    58.6
        Week 10
    40.9
    59.4
    No statistical analyses for this end point

    Secondary: Endoscopic response, endoscopic remission, and mucocal healing (SES-CD) at Week 10

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    End point title
    		 Endoscopic response, endoscopic remission, and mucocal healing (SES-CD) at Week 10
    End point description
    The simplified endoscopic activity score for Crohn's disease (SES-CD) is an endoscopy-based scoring system assessing the ileum, right colon, transverse colon, left colon, and rectum bowel segments for the presence of ulcers, the percentage of ulcerated surface, the percentage of affected surface, and the presence of narrowing. Endoscopic 50% response is defined as a change from baseline in SES-CD score <= -50. Endoscopic 25% response is defined as a change from baseline in SES-CD score <= -25. Endoscopic remission is defined as a SES-CD score <= 4, with ulcerated surface subscore <= 1 in all 5 segments. Mucosal healing is defined as a SES-CD score of 0. Intent-to-Treat (ITT) Population: all subjects randomized, exposed at least once, and with post-Baseline data for at least one efficacy parameter. Non-responder imputation was used (ie, to impute a missing response, the subject was assumed to be a non-responder).
    End point type
    Secondary
    End point timeframe
    Week 10
    End point values
    		 Placebo GLPG0634 200 mg QD
    Number of subjects analysed
    44
    128
    Units: percentage of subjects
    number (not applicable)
        Endoscopic 50% response
    18.2
    25
        Endoscopic 25% response
    36.4
    37.5
        Endoscopic remission
    6.8
    13.3
        Mucosal healing
    2.3
    2.3
    No statistical analyses for this end point

    Secondary: Change from baseline in CDAI score at Weeks 2, 4, 6, and 10

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    End point title
    		 Change from baseline in CDAI score at Weeks 2, 4, 6, and 10
    End point description
    The Crohn's Disease Activity Index (CDAI) is a measurement of disease activity using multiple disease assessment criteria. The CDAI is a composite scoring index based on the following categories: 1) Number of liquid or very soft stools 2) Abdominal pain 3) General well being 4) Extra-intestinal manifestations of Crohn’s Disease 5) Lomotil/ Imodium/opiates for diarrhea 6) Abdominal mass 7) Hematocrit (%) 8) Body Weight Intent-to-Treat (ITT) Population: all subjects randomized, exposed at least once, and with post-Baseline data for at least one efficacy parameter. Last observation carried forward (LOCF) algorithm was used (ie, to impute a missing value, the last preceding nonmissing value was used).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 10
    End point values
    		 Placebo GLPG0634 200 mg QD
    Number of subjects analysed
    44
    128
    Units: change from baseline
    arithmetic mean (standard error)
        Week 2
    -70 ( 12.03 )
    -74.4 ( 6.61 )
        Week 4
    -66.1 ( 14.08 )
    -91.2 ( 6.98 )
        Week 6
    -83.7 ( 14.6 )
    -110.6 ( 7.27 )
        Week 10
    -94.1 ( 16.58 )
    -127.7 ( 8.79 )
    No statistical analyses for this end point

    Secondary: Change from baseline in SES-CD score at Week 10

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    End point title
    		 Change from baseline in SES-CD score at Week 10
    End point description
    The simplified endoscopic activity score for Crohn's disease (SES-CD) is an endoscopy-based scoring system assessing the ileum, right colon, transverse colon, left colon, and rectum bowel segments for the presence of ulcers, the percentage of ulcerated surface, the percentage of affected surface, and the presence of narrowing. Intent-to-Treat (ITT) Population: all subjects randomized, exposed at least once, and with post-Baseline data for at least one efficacy parameter. Last observation carried forward (LOCF) algorithm was used (ie, to impute a missing value, the last preceding nonmissing value was used).
    End point type
    Secondary
    End point timeframe
    Week 10
    End point values
    		 Placebo GLPG0634 200 mg QD
    Number of subjects analysed
    44
    128
    Units: change from baseline
        arithmetic mean (standard error)
    -2.7 ( 0.93 )
    -2.6 ( 0.47 )
    No statistical analyses for this end point

    Secondary: Change from baseline in D'Haens histopathology score at Week 10

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    End point title
    		 Change from baseline in D'Haens histopathology score at Week 10
    End point description
    The D'Haens score is a histpathological scoring system for Crohn's disease. The scoring system contains 8 histological variables that are scored independently, with grading from 0-3. The total score is the sum of all individual scores(min=0, max=16). Intent-to-Treat (ITT) Population: all subjects randomized, exposed at least once, and with post-Baseline data for at least one efficacy parameter. Last observation carried forward (LOCF) algorithm was used (ie, to impute a missing value, the last preceding nonmissing value was used).
    End point type
    Secondary
    End point timeframe
    Week 10
    End point values
    		 Placebo GLPG0634 200 mg QD
    Number of subjects analysed
    44
    128
    Units: change from baseline
        arithmetic mean (standard error)
    -0.6 ( 1.91 )
    -3.5 ( 0.97 )
    No statistical analyses for this end point

    Secondary: Change from baseline in IBDQ score at Week 10

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    End point title
    		 Change from baseline in IBDQ score at Week 10
    End point description
    The inflammatory bowel disease questionnaire (IBDQ) is a 32-item disease-specific quality-of-life questionnaire consisting of 4 domains (bowel symptoms, emotional function, social function, and systemic symptoms), which was designed to evaluate the effects of drug therapy in patients with IBD. Intent-to-Treat (ITT) Population: all subjects randomized, exposed at least once, and with post-Baseline data for at least one efficacy parameter. Last observation carried forward (LOCF) algorithm was used (ie, to impute a missing value, the last preceding nonmissing value was used).
    End point type
    Secondary
    End point timeframe
    Week 10
    End point values
    		 Placebo GLPG0634 200 mg QD
    Number of subjects analysed
    44
    128
    Units: change from basleline
        arithmetic mean (standard error)
    17.56 ( 5.085 )
    33.82 ( 2.978 )
    No statistical analyses for this end point

    Secondary: Change from baseline in CDAI pain subscore at Weeks 2, 4, 6, and 10

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    End point title
    		 Change from baseline in CDAI pain subscore at Weeks 2, 4, 6, and 10
    End point description
    The Crohn's Disease Activity Index (CDAI) is a measurement of disease activity using multiple disease assessment criteria. The CDAI is a composite scoring index based on the following categories: 1) Number of liquid or very soft stools 2) Abdominal pain 3) General well being 4) Extra-intestinal manifestations of Crohn’s Disease 5) Lomotil/ Imodium/opiates for diarrhea 6) Abdominal mass 7) Hematocrit (%) 8) Body Weight Intent-to-Treat (ITT) Population: all subjects randomized, exposed at least once, and with post-Baseline data for at least one efficacy parameter. Last observation carried forward (LOCF) algorithm was used (ie, to impute a missing value, the last preceding nonmissing value was used).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 10
    End point values
    		 Placebo GLPG0634 200 mg QD
    Number of subjects analysed
    44
    128
    Units: change from baseline
    arithmetic mean (standard error)
        Week 2
    -0.57 ( 0.094 )
    -0.53 ( 0.058 )
        Week 4
    -0.5 ( 0.105 )
    -0.63 ( 0.058 )
        Week 6
    -0.6 ( 0.106 )
    -0.76 ( 0.064 )
        Week 10
    -0.65 ( 0.119 )
    -0.86 ( 0.068 )
    No statistical analyses for this end point

    Secondary: Change from baseline in CDAI liquid stools subscore at Weeks 2, 4, 6, and 10

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    End point title
    		 Change from baseline in CDAI liquid stools subscore at Weeks 2, 4, 6, and 10
    End point description
    The Crohn's Disease Activity Index (CDAI) is a measurement of disease activity using multiple disease assessment criteria. The CDAI is a composite scoring index based on the following categories: 1) Number of liquid or very soft stools 2) Abdominal pain 3) General well being 4) Extra-intestinal manifestations of Crohn’s Disease 5) Lomotil/ Imodium/opiates for diarrhea 6) Abdominal mass 7) Hematocrit (%) 8) Body Weight Intent-to-Treat (ITT) Population: all subjects randomized, exposed at least once, and with post-Baseline data for at least one efficacy parameter. Last observation carried forward (LOCF) algorithm was used (ie, to impute a missing value, the last preceding nonmissing value was used).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 10
    End point values
    		 Placebo GLPG0634 200 mg QD
    Number of subjects analysed
    44
    128
    Units: change from baseline
    arithmetic mean (standard error)
        Week 2
    -1.1 ( 0.271 )
    -1.29 ( 0.148 )
        Week 4
    -1.17 ( 0.265 )
    -1.54 ( 0.175 )
        Week 6
    -1.42 ( 0.303 )
    -2.03 ( 0.192 )
        Week 10
    -1.57 ( 0.367 )
    -2.26 ( 0.214 )
    No statistical analyses for this end point

    Secondary: Change from baseline in CDAI general well-being subscore at Weeks 2, 4, 6, and 10

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    End point title
    		 Change from baseline in CDAI general well-being subscore at Weeks 2, 4, 6, and 10
    End point description
    The Crohn's Disease Activity Index (CDAI) is a measurement of disease activity using multiple disease assessment criteria. The CDAI is a composite scoring index based on the following categories: 1) Number of liquid or very soft stools 2) Abdominal pain 3) General well being 4) Extra-intestinal manifestations of Crohn’s Disease 5) Lomotil/ Imodium/opiates for diarrhea 6) Abdominal mass 7) Hematocrit (%) 8) Body Weight Intent-to-Treat (ITT) Population: all subjects randomized, exposed at least once, and with post-Baseline data for at least one efficacy parameter. Last observation carried forward (LOCF) algorithm was used (ie, to impute a missing value, the last preceding nonmissing value was used).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 10
    End point values
    		 Placebo GLPG0634 200 mg QD
    Number of subjects analysed
    44
    128
    Units: change from baseline
    arithmetic mean (standard error)
        Week 2
    -0.47 ( 0.111 )
    -0.6 ( 0.071 )
        Week 4
    -0.45 ( 0.135 )
    -0.7 ( 0.068 )
        Week 6
    -0.64 ( 0.14 )
    -0.83 ( 0.072 )
        Week 10
    -0.65 ( 0.132 )
    -0.98 ( 0.076 )
    No statistical analyses for this end point

    Secondary: Time to CDAI clinical remission

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    End point title
    		 Time to CDAI clinical remission
    End point description
    The Crohn's Disease Activity Index (CDAI) is a measurement of disease activity using multiple disease assessment criteria. The CDAI is a composite scoring index based on the following categories: 1) Number of liquid or very soft stools 2) Abdominal pain 3) General well being 4) Extra-intestinal manifestations of Crohn’s Disease 5) Lomotil/ Imodium/opiates for diarrhea 6) Abdominal mass 7) Hematocrit (%) 8) Body Weight CDAI clinical remission is defined as a CDAI score of < 150. Intent-to-Treat (ITT) Population: all subjects randomized, exposed at least once, and with post-Baseline data for at least one efficacy parameter.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 10
    End point values
    		 Placebo GLPG0634 200 mg QD
    Number of subjects analysed
    44
    128
    Units: percentage of subjects
    number (not applicable)
        Week 2
    20.5
    21.9
        Week 4
    6.8
    14.8
        Week 6
    9.1
    9.4
        Week 10
    0
    14.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through end of study drug treatment (average exposure 119.4 days) + 14 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Adverse events reported in this group includes all subjects randomized the Placebo group during Weeks 1 - 20. Subjects who switched treatment at Week 10 were included in the other groups of the same dose for adverse events reported during Weeks 11 - 20.

    Reporting group title
    GLPG0634 100 mg QD
    Reporting group description
    		 Adverse events reported in this group includes all subjects randomized to GLPG0634 100 mg QD during Weeks 11 -20.

    Reporting group title
    GLPG0634 200 mg QD
    Reporting group description
    		 Adverse events reported in this group includes all subjects randomized to the GLPG0634 200 mg QD group during Weeks 1 - 20. Subjects who switched treatment at Week 10 were included in the other groups of the same dose or placebo for adverse events reported during Weeks 11 - 20.

    Serious adverse events
    		 Placebo GLPG0634 100 mg QD GLPG0634 200 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 67 (4.48%)
    2 / 52 (3.85%)
    12 / 130 (9.23%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Infusion site thrombosis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 52 (1.92%)
    0 / 130 (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
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 52 (0.00%)
    2 / 130 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 52 (3.85%)
    4 / 130 (3.08%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 52 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 52 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 52 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 52 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 52 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 52 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 52 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         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 GLPG0634 100 mg QD GLPG0634 200 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    64 / 67 (95.52%)
    50 / 52 (96.15%)
    118 / 130 (90.77%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 67 (14.93%)
    5 / 52 (9.62%)
    23 / 130 (17.69%)
         occurrences all number
    31
    18
    38
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 52 (3.85%)
    10 / 130 (7.69%)
         occurrences all number
    2
    2
    12
    Fatigue
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 52 (1.92%)
    7 / 130 (5.38%)
         occurrences all number
    0
    1
    7
    Influenza like illness
         subjects affected / exposed
    4 / 67 (5.97%)
    1 / 52 (1.92%)
    3 / 130 (2.31%)
         occurrences all number
    5
    1
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 67 (2.99%)
    3 / 52 (5.77%)
    7 / 130 (5.38%)
         occurrences all number
    6
    3
    8
    Abdominal pain upper
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 52 (0.00%)
    8 / 130 (6.15%)
         occurrences all number
    2
    0
    10
    Crohn's disease
         subjects affected / exposed
    2 / 67 (2.99%)
    4 / 52 (7.69%)
    16 / 130 (12.31%)
         occurrences all number
    2
    4
    16
    Nausea
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 52 (0.00%)
    11 / 130 (8.46%)
         occurrences all number
    2
    0
    12
    Vomiting
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 52 (0.00%)
    7 / 130 (5.38%)
         occurrences all number
    3
    0
    10
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 67 (2.99%)
    3 / 52 (5.77%)
    2 / 130 (1.54%)
         occurrences all number
    3
    3
    2
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    3 / 67 (4.48%)
    1 / 52 (1.92%)
    7 / 130 (5.38%)
         occurrences all number
    3
    2
    7
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 67 (2.99%)
    3 / 52 (5.77%)
    2 / 130 (1.54%)
         occurrences all number
    2
    3
    2
    Nasopharyngitis
         subjects affected / exposed
    6 / 67 (8.96%)
    4 / 52 (7.69%)
    2 / 130 (1.54%)
         occurrences all number
    6
    4
    2
    Urinary tract infection
         subjects affected / exposed
    5 / 67 (7.46%)
    2 / 52 (3.85%)
    5 / 130 (3.85%)
         occurrences all number
    5
    2
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Feb 2014
    General protocol amendment 1 to incorporate feedback, specific comments, and queries received from Competent Authorities and IECs. In particular, the definition for treatment failure was introduced, more stringent individual stopping criteria applied, and inclusion criteria modified. These changes were in line with the current treatment strategies for CD, beneficial for recruitment, and did not compromise subject safety. In addition, some clarifications and corrections were introduced in the study procedures.
    08 Aug 2014
    General protocol amendment 2, including: - an adjustment of the inclusion/exclusion criteria to better represent the current CD population without compromising the study objective. - an adjustment of the stratification factor related to previous anti-TNF exposure. - a refinement of general study procedures (removal of the urine drug Screening, addition of re-Screening and retesting, …) to provide further guidance to investigators. - an update of the background information on GLPG0634 and the benefit/risk section in accordance with the version of the IB current at the time (Edition 7.0, February 2014); this update included for example the results from a 39-week chronic toxicology study in dogs.
    06 Oct 2014
    General protocol amendment 3, including: - lower threshold for absolute lymphocyte counts for inclusion (inclusion criterion 9d) in order to be eligible for the study. - lower level of absolute lymphocyte counts required for urgent re-testing and discontinuation from treatment with the study medication and withdrawal from the study as listed in predefined individual stopping criteria (Section 10.2.3 of the clinical study protocol).

    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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