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    Clinical Trial Results:
    A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis

    Summary
    EudraCT number
    		 2013-000263-88
    Trial protocol
    		 DE   BE   HU   NL   PL   BG   RO  
    Global end of trial date
    05 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Dec 2016
    First version publication date
    21 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    54781532UCO2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01959282
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research and Development, LLC
    Sponsor organisation address
    Antwerpseweg 15-17, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research and Development, ClinicalTrialsEU@its.jnj.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
    05 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main obective of trial was to evaluate the dose response of JNJ-54781532 at Week 8 in subjects with moderately to severely active ulcerative colitis (UC) and to evaluate the safety of JNJ-54781532 in subjects with moderately to severely active UC.
    Protection of trial subjects
    Safety evaluations included the collection of adverse events (AEs), clinical laboratory tests, vital signs, physical examinations, electrocardiograms (ECG), tuberculosis (TB) evaluations and pregnancy testing.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Nov 2013
    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
    Australia: 11
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Bulgaria: 11
    Country: Number of subjects enrolled
    Canada: 16
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Hungary: 14
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Poland: 18
    Country: Number of subjects enrolled
    Romania: 2
    Country: Number of subjects enrolled
    Russian Federation: 45
    Country: Number of subjects enrolled
    Ukraine: 42
    Country: Number of subjects enrolled
    United States: 26
    Worldwide total number of subjects
    219
    EEA total number of subjects
    76
    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)
    206
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted from 26 November 2013 to 05 December 2015.

    Pre-assignment
    Screening details
    		 A total of 219 subjects were enrolled; among these 176 subjects were randomized to 4 JNJ-54781532 treatment groups and 43 subjects were randomized to the placebo group.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive placebo through Week 32. Subjects not in clinical response at Week 8 received treatment with 150 milligram (mg) JNJ-54781532 orally once daily from Week 8 to Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (i.e., a decrease from baseline of greater than or equal to (>=) 3 in the partial Mayo score) at Week 16 continued to receive 150 mg JNJ-54781532 once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.
    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
    Subjects received placebo once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive placebo through Week 32.

    Arm title
    		 JNJ-54781532 25 mg once daily (QD)
    Arm description
    		 Subjects received 25 mg of JNJ-54781532 orally once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continued to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (i.e. a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ- 54781532 25 mg once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-54781532 25 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 25 mg of JNJ-54781532 once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continued to receive the same dosage through Week 16; subjects who achieved a partial Mayo score response at week 16 continued to receive JNJ-54781532 25 mg once daily through Week 32.

    Arm title
    		 JNJ-54781532 75 mg QD
    Arm description
    		 Subjects received 75 mg of JNJ-54781532 orally once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continued to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (i.e. a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ- 54781532 75 mg once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-54781532 75 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 75 mg of JNJ-54781532 once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continued to receive the same dosage through Week 16; subjects who achieved a partial Mayo score response at week 16 continued to receive JNJ 54781532 75 mg once daily through Week 32.

    Arm title
    		 JNJ-54781532 150 mg QD
    Arm description
    		 Subjects received 150 mg of JNJ-54781532 orally once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continue to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (ie a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ-54781532 150 mg once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-54781532 150 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 150 mg of JNJ-54781532 once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continue to received the same dosage through Week 16; subjects who achieved a partial Mayo score response at week 16 continued to receive JNJ-54781532 150 mg once daily through Week 32.

    Arm title
    		 JNJ-54781532 75 mg twice daily (BID)
    Arm description
    		 Subjects received 75 mg of JNJ-54781532 orally twice daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continued to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (ie a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ- 54781532 75 mg twice daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-54781532 75 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 75 mg of JNJ-54781532 twice daily from Week 0 to Week 8. Subjects in clinical response at Week 8 were continued to receive the same dosage through Week 32 and subjects not in clinical response at Week 8 were continued to receive the same dosage through Week 16. At Week 16, subjects who achieved a partial Mayo score response at Week 16 could continued to receive JNJ-54781532 75 mg twice daily through Week 32.

    Number of subjects in period 1
    		Placebo JNJ-54781532 25 mg once daily (QD) JNJ-54781532 75 mg QD JNJ-54781532 150 mg QD JNJ-54781532 75 mg twice daily (BID)
    Started
    43
    44
    44
    44
    44
    Completed
    39
    40
    40
    40
    39
    Not completed
    4
    4
    4
    4
    5
         Consent withdrawn by subject
    2
    2
    4
    2
    2
         Other
    -
    1
    -
    1
    1
         Lost to follow-up
    2
    1
    -
    -
    1
         Sponsor decision
    -
    -
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive placebo through Week 32. Subjects not in clinical response at Week 8 received treatment with 150 milligram (mg) JNJ-54781532 orally once daily from Week 8 to Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (i.e., a decrease from baseline of greater than or equal to (>=) 3 in the partial Mayo score) at Week 16 continued to receive 150 mg JNJ-54781532 once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.

    Reporting group title
    JNJ-54781532 25 mg once daily (QD)
    Reporting group description
    		 Subjects received 25 mg of JNJ-54781532 orally once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continued to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (i.e. a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ- 54781532 25 mg once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.

    Reporting group title
    JNJ-54781532 75 mg QD
    Reporting group description
    		 Subjects received 75 mg of JNJ-54781532 orally once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continued to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (i.e. a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ- 54781532 75 mg once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.

    Reporting group title
    JNJ-54781532 150 mg QD
    Reporting group description
    		 Subjects received 150 mg of JNJ-54781532 orally once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continue to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (ie a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ-54781532 150 mg once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.

    Reporting group title
    JNJ-54781532 75 mg twice daily (BID)
    Reporting group description
    		 Subjects received 75 mg of JNJ-54781532 orally twice daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continued to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (ie a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ- 54781532 75 mg twice daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.

    Reporting group values
    		 Placebo JNJ-54781532 25 mg once daily (QD) JNJ-54781532 75 mg QD JNJ-54781532 150 mg QD JNJ-54781532 75 mg twice daily (BID) Total
    Number of subjects
    		 43 44 44 44 44 219
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 39 42 41 43 41 206
        From 65 to 84 years
    		 4 2 3 1 3 13
        85 years and over
    		 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.8 ( 14.63 ) 44.2 ( 12.77 ) 42.7 ( 14.35 ) 38 ( 13.69 ) 40.5 ( 13.22 ) -
    Title for Gender
    Units: subjects
        Female
    		 11 19 19 22 18 89
        Male
    		 32 25 25 22 26 130

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive placebo through Week 32. Subjects not in clinical response at Week 8 received treatment with 150 milligram (mg) JNJ-54781532 orally once daily from Week 8 to Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (i.e., a decrease from baseline of greater than or equal to (>=) 3 in the partial Mayo score) at Week 16 continued to receive 150 mg JNJ-54781532 once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.

    Reporting group title
    JNJ-54781532 25 mg once daily (QD)
    Reporting group description
    		 Subjects received 25 mg of JNJ-54781532 orally once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continued to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (i.e. a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ- 54781532 25 mg once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.

    Reporting group title
    JNJ-54781532 75 mg QD
    Reporting group description
    		 Subjects received 75 mg of JNJ-54781532 orally once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continued to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (i.e. a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ- 54781532 75 mg once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.

    Reporting group title
    JNJ-54781532 150 mg QD
    Reporting group description
    		 Subjects received 150 mg of JNJ-54781532 orally once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continue to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (ie a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ-54781532 150 mg once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.

    Reporting group title
    JNJ-54781532 75 mg twice daily (BID)
    Reporting group description
    		 Subjects received 75 mg of JNJ-54781532 orally twice daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continued to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (ie a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ- 54781532 75 mg twice daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.

    Primary: Change From Baseline in Mayo Score at Week 8

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    End point title
    		 Change From Baseline in Mayo Score at Week 8
    End point description
    The Mayo score is the primary tool for assessing ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, findings of endoscopy, and physician's global assessment) which range from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease. Endoscopy subscores are based on the scores assigned by the central readers. The primary efficacy analysis population consisted of all subjects who were randomized in this study. Here "n" signifies the number of subjects analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Week 8
    End point values
    		 Placebo JNJ-54781532 25 mg once daily (QD) JNJ-54781532 75 mg QD JNJ-54781532 150 mg QD JNJ-54781532 75 mg twice daily (BID)
    Number of subjects analysed
    43
    43
    44
    44
    44
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (n= 43,43,44,44,44)
    9 ( 1.14 )
    8.8 ( 1.6 )
    8.6 ( 1.53 )
    8.2 ( 1.61 )
    8.3 ( 1.34 )
        Change from baseline (n=43,43,44,44,44)
    -2.4 ( 2.86 )
    -2.3 ( 2.81 )
    -3.1 ( 2.99 )
    -2.8 ( 2.46 )
    -3 ( 2.61 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v JNJ-54781532 25 mg once daily (QD)
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.88
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - 1 subject in JNJ-54781532 25 mg once daily (QD) did not have baseline Mayo score. Analysis based on pair wise comparisons was presented. The primary analysis to establish a dose-response relationship based on the Multiple Comparison Procedures with modeling techniques (MCP-Mod) method was not significant.
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v JNJ-54781532 75 mg QD
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.232
    Method
    		 ANOVA
    Confidence interval
    Notes
    [2] - Analysis based on pairwise comparisons was presented. The primary analysis to establish a dose-response relationship based on the MCP-Mod method was not significant.
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v JNJ-54781532 150 mg QD
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.517
    Method
    		 ANOVA
    Confidence interval
    Notes
    [3] - Analysis based on pairwise comparisons was presented. The primary analysis to establish a dose-response relationship based on the MCP-Mod method was not significant.
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo v JNJ-54781532 75 mg twice daily (BID)
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.248
    Method
    		 ANOVA
    Confidence interval
    Notes
    [4] - Analysis based on pair wise comparisons was presented. The primary analysis to establish a dose-response relationship based on the MCP-Mod method was not significant. The JNJ-54781532 75 mg twice daily (BID) group was not included in the dose response analysis due to lack of knowledge about its equivalent once daily dose.

    Secondary: Number of Subjects with Clinical Response at Week 8

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    End point title
    		 Number of Subjects with Clinical Response at Week 8
    End point description
    Clinical response is defined as a decrease from baseline in the Mayo score by >= 30 percent (%) and >= 3 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. The primary efficacy analysis population consisted of all subjects including the 75 mg bid group who were randomized in this study.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Placebo JNJ-54781532 25 mg once daily (QD) JNJ-54781532 75 mg QD JNJ-54781532 150 mg QD JNJ-54781532 75 mg twice daily (BID)
    Number of subjects analysed
    43
    44
    44
    44
    44
    Units: Subjects
        number (not applicable)
    17
    15
    24
    24
    24
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v JNJ-54781532 25 mg once daily (QD)
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.974 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [5] - The study was not powered to detect treatment differences for this endpoint.
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v JNJ-54781532 75 mg QD
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.139 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [6] - The study was not powered to detect treatment differences for this endpoint.
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v JNJ-54781532 150 mg QD
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.134 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [7] - The study was not powered to detect treatment differences for this endpoint.
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo v JNJ-54781532 75 mg twice daily (BID)
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.116 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [8] - The study was not powered to detect treatment differences for this endpoint.

    Secondary: Number of Subjects with Clinical Remission at Week 8

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    End point title
    		 Number of Subjects with Clinical Remission at Week 8
    End point description
    Clinical remission is defined as a Mayo score less than or equal to (<=) 2 points, with no individual subscore higher than (>)1. The primary efficacy analysis population consisted of all subjects including the 75 mg bid group who were randomized in this study.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Placebo JNJ-54781532 25 mg once daily (QD) JNJ-54781532 75 mg QD JNJ-54781532 150 mg QD JNJ-54781532 75 mg twice daily (BID)
    Number of subjects analysed
    43
    44
    44
    44
    44
    Units: Subjects
        number (not applicable)
    3
    7
    7
    12
    7
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    JNJ-54781532 25 mg once daily (QD) v Placebo
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.091 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [9] - The study was not powered to detect treatment differences for this endpoint
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v JNJ-54781532 75 mg QD
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.182 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [10] - The study was not powered to detect treatment differences for this endpoint
    Statistical analysis title
    		 statistical analysis 3
    Comparison groups
    Placebo v JNJ-54781532 150 mg QD
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013 [11]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [11] - The study was not powered to detect treatment differences for this endpoint
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo v JNJ-54781532 75 mg twice daily (BID)
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.177 [12]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [12] - The study was not powered to detect treatment differences for this endpoint

    Secondary: Number of Subjects With Mucosal Healing at Week 8

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    End point title
    		 Number of Subjects With Mucosal Healing at Week 8
    End point description
    Mucosal healing is an improvement in the endoscopic appearance of the mucosa. An endoscopy subscore of the Mayo score of 0 or 1. The primary efficacy analysis population consisted of all subjects including the 75 mg bid group who were randomized in this study.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Placebo JNJ-54781532 25 mg once daily (QD) JNJ-54781532 75 mg QD JNJ-54781532 150 mg QD JNJ-54781532 75 mg twice daily (BID)
    Number of subjects analysed
    43
    44
    44
    44
    44
    Units: Subjects
        number (not applicable)
    8
    9
    13
    20
    16
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v JNJ-54781532 25 mg once daily (QD)
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.562 [13]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [13] - The study was not powered to detect treatment differences for this endpoint
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v JNJ-54781532 75 mg QD
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.246 [14]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [14] - The study was not powered to detect treatment differences for this endpoint
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v JNJ-54781532 150 mg QD
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008 [15]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [15] - The study was not powered to detect treatment differences for this endpoint
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo v JNJ-54781532 75 mg twice daily (BID)
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.057 [16]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [16] - The study was not powered to detect treatment differences for this endpoint

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 4 weeks after their last dose of study agent (Final safety visit)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive placebo through Week 32. Subjects not in clinical response at Week 8 received treatment with 150 milligram (mg) JNJ-54781532 orally once daily from Week 8. For subjects who received JNJ-54781532 150 mg QD at Week 8 , adverse events are presented from Week 0 up to Week 8.

    Reporting group title
    JNJ-54781532 25 mg QD
    Reporting group description
    		 Subjects received 25 mg of JNJ-54781532 orally once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continued to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (i.e. a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ- 54781532 25 mg once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.

    Reporting group title
    JNJ-54781532 75 mg QD
    Reporting group description
    		 Subjects received 75 mg of JNJ-54781532 orally once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continued to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (i.e. a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ- 54781532 75 mg once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.

    Reporting group title
    JNJ-54781532 150 mg QD
    Reporting group description
    		 Subjects received 150 mg of JNJ-54781532 orally once daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continue to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (ie a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ-54781532 150 mg once daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication.

    Reporting group title
    JNJ-54781532 75 mg BID
    Reporting group description
    		 Subjects received 75 mg of JNJ-54781532 orally twice daily from Week 0 to Week 8. Subjects in clinical response at Week 8 continued to receive the same dosage through Week 32. Subjects not in clinical response at Week 8 continued to receive the same dosage through Week 16. Among subjects who were not in clinical response at Week 8, subjects who achieved a partial Mayo score response (ie a decrease from baseline >= 3 in the partial Mayo score) at Week 16 continued to receive JNJ- 54781532 75 mg twice daily through Week 32; subjects who did not achieve a partial Mayo score response were discontinued from study medication..

    Reporting group title
    Placebo to JNJ-54781532 150 mg QD
    Reporting group description
    		 Subjects received placebo once daily from Week 0 to Week 8. Subjects not in clinical response at Week 8 received treatment with 150 mg JNJ-54781532 orally once daily from Week 8 to Week 16. Among subjects who were not in clinical response at Week, subjects who achieved a partial Mayo score response (i.e., a decrease from baseline of greater than or equal to (>=) 3 in the partial Mayo score) at Week 16 continued receiving 150 mg JNJ-54781532 orally once daily through Week 32. For subjects who received JNJ-54781532 150 mg QD at Week 8 , adverse events are presented from Week 8 up to final safety visit.

    Serious adverse events
    		 Placebo JNJ-54781532 25 mg QD JNJ-54781532 75 mg QD JNJ-54781532 150 mg QD JNJ-54781532 75 mg BID Placebo to JNJ-54781532 150 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 43 (9.30%)
    3 / 44 (6.82%)
    3 / 44 (6.82%)
    2 / 44 (4.55%)
    4 / 44 (9.09%)
    2 / 21 (9.52%)
         number of deaths (all causes)
    1
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Clostridium Test Positive
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung Neoplasm
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic Neoplasm
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Aortic Valve Incompetence
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral Valve Incompetence
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 44 (4.55%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis Ulcerative
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 44 (2.27%)
    3 / 44 (6.82%)
    1 / 44 (2.27%)
    3 / 44 (6.82%)
    2 / 21 (9.52%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    2 / 5
    0 / 1
    2 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Megacolon
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo JNJ-54781532 25 mg QD JNJ-54781532 75 mg QD JNJ-54781532 150 mg QD JNJ-54781532 75 mg BID Placebo to JNJ-54781532 150 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 43 (30.23%)
    16 / 44 (36.36%)
    23 / 44 (52.27%)
    27 / 44 (61.36%)
    22 / 44 (50.00%)
    6 / 21 (28.57%)
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    1 / 44 (2.27%)
    3 / 44 (6.82%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    2
    4
    1
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    1 / 44 (2.27%)
    4 / 44 (9.09%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    2
    5
    1
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 44 (0.00%)
    10 / 44 (22.73%)
    6 / 44 (13.64%)
    7 / 44 (15.91%)
    2 / 21 (9.52%)
         occurrences all number
    2
    0
    12
    7
    12
    2
    Lymphocyte Count Decreased
         subjects affected / exposed
    0 / 43 (0.00%)
    3 / 44 (6.82%)
    0 / 44 (0.00%)
    2 / 44 (4.55%)
    0 / 44 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    4
    0
    2
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 43 (2.33%)
    4 / 44 (9.09%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    4 / 44 (9.09%)
    0 / 21 (0.00%)
         occurrences all number
    1
    4
    0
    1
    5
    0
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 43 (6.98%)
    3 / 44 (6.82%)
    1 / 44 (2.27%)
    3 / 44 (6.82%)
    4 / 44 (9.09%)
    1 / 21 (4.76%)
         occurrences all number
    3
    4
    1
    5
    4
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
    3 / 44 (6.82%)
    2 / 44 (4.55%)
    1 / 44 (2.27%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    3
    4
    1
    1
    Gastrointestinal disorders
    Colitis Ulcerative
         subjects affected / exposed
    2 / 43 (4.65%)
    4 / 44 (9.09%)
    2 / 44 (4.55%)
    9 / 44 (20.45%)
    6 / 44 (13.64%)
    1 / 21 (4.76%)
         occurrences all number
    2
    5
    2
    17
    6
    1
    Dyspepsia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    3 / 44 (6.82%)
    2 / 44 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    4
    2
    0
    Nausea
         subjects affected / exposed
    0 / 43 (0.00%)
    3 / 44 (6.82%)
    0 / 44 (0.00%)
    2 / 44 (4.55%)
    1 / 44 (2.27%)
    0 / 21 (0.00%)
         occurrences all number
    0
    3
    0
    4
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 44 (2.27%)
    6 / 44 (13.64%)
    2 / 44 (4.55%)
    2 / 44 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    7
    2
    2
    0
    Myalgia
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
    1 / 44 (2.27%)
    1 / 44 (2.27%)
    3 / 44 (6.82%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    1
    1
    3
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
    3 / 44 (6.82%)
    1 / 44 (2.27%)
    1 / 44 (2.27%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    3
    1
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 44 (4.55%)
    3 / 44 (6.82%)
    2 / 44 (4.55%)
    3 / 44 (6.82%)
    2 / 21 (9.52%)
         occurrences all number
    2
    3
    5
    2
    6
    2
    Respiratory Tract Infection Viral
         subjects affected / exposed
    2 / 43 (4.65%)
    3 / 44 (6.82%)
    1 / 44 (2.27%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    0 / 21 (0.00%)
         occurrences all number
    2
    3
    1
    0
    2
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    3 / 44 (6.82%)
    0 / 44 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    1
    3
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 44 (0.00%)
    1 / 44 (2.27%)
    3 / 44 (6.82%)
    1 / 44 (2.27%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    3
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Oct 2013
    Amendment was done to add an ECG at the final safety visit, eligibility criteria were revised to clarify the threshold for glomerular filtration rate, permit fentanyl use during endoscopy, and the ineligibility of subjects who were pregnant, nursing or planning pregnancy. In addition, the amendment clarified that medications that are CYP3A substrates with a narrow therapeutic window are prohibited medications.
    21 Jan 2014
    Amendment was done to exclude subjects with a diagnosis of monoclonal gammopathy of undetermined significance. In addition, criteria for discontinuation of study agent for subjects who develop an opportunistic infection or worsening of ulcerative colitis was provided.
    31 Jul 2014
    Amendment was done to allow subjects with appropriately treated latent tuberculosis (TB) and persistently indeterminate QuantiFERON (QFT)-TB Gold test results to enter study. Eligibility criteria were updated to reference the first dose of study agent for the duration of stable dosing for allowed ulcerative colitis (UC) medications or discontinuation of prohibited medications. A maximal threshold for screening creatine kinase levels was removed and guidance for targeted examinations following identification of abnormal CK levels and discontinuation of study agent related to CK elevations was updated. Additionally, a discontinuation criterion for elevated serum creatinine in the presence of reduced glomerular filtration was added.
    02 Dec 2014
    Amendment included an update to an eligibility criterion to exclude subjects with a shortened QT interval or who were taking medications that are known to shorten the QT interval. Additionally, the minimum duration of required treatment for latent TB prior to the first dose of study agent was clarified.

    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 limited by its small sample size. The study was powered at 80% for detecting a dose response signal for JNJ-54781532 based on the primary endpoint, and was not powered to detect treatment differences for the major secondary endpoints.
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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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