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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

    Summary
    EudraCT number
    2015-000319-41
    Trial protocol
    DE   SK   HU   CZ   NL   GB   BE   BG   PL   HR   LV   AT   GR   ES   IT  
    Global end of trial date
    17 Jun 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Jul 2021
    First version publication date
    03 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RPC01-3101
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb International Corporation, EU Study Start-up Unit, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.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
    04 Aug 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the RPC1063 clinical development program in UC is to demonstrate that RPC1063 administered orally is safe and effective in inducing and maintaining remission in patients with moderate to severe UC.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Oct 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
    Australia: 9
    Country: Number of subjects enrolled
    Belarus: 18
    Country: Number of subjects enrolled
    Canada: 33
    Country: Number of subjects enrolled
    Georgia: 30
    Country: Number of subjects enrolled
    Argentina: 3
    Country: Number of subjects enrolled
    Israel: 25
    Country: Number of subjects enrolled
    Korea, Republic of: 48
    Country: Number of subjects enrolled
    Moldova, Republic of: 21
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    Russian Federation: 102
    Country: Number of subjects enrolled
    Serbia: 64
    Country: Number of subjects enrolled
    South Africa: 9
    Country: Number of subjects enrolled
    Ukraine: 99
    Country: Number of subjects enrolled
    United States: 214
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Belgium: 19
    Country: Number of subjects enrolled
    Bulgaria: 22
    Country: Number of subjects enrolled
    Croatia: 6
    Country: Number of subjects enrolled
    Germany: 33
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Hungary: 26
    Country: Number of subjects enrolled
    Italy: 60
    Country: Number of subjects enrolled
    Latvia: 4
    Country: Number of subjects enrolled
    Netherlands: 17
    Country: Number of subjects enrolled
    Poland: 76
    Country: Number of subjects enrolled
    Romania: 21
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Czechia: 33
    Country: Number of subjects enrolled
    United Kingdom: 13
    Worldwide total number of subjects
    1012
    EEA total number of subjects
    323
    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)
    958
    From 65 to 84 years
    54
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    1012 randomized and treated

    Period 1
    Period 1 title
    Induction 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
    RPC1063 Cohort 1 (Induction Period)
    Arm description
    - Blinded -On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) -On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) -On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
    Arm type
    Experimental

    Investigational medicinal product name
    Ozanimod HCL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.25mg

    Investigational medicinal product name
    Ozanimod HCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.5mg (2 x 0.25mg)

    Investigational medicinal product name
    Ozanimod HCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1mg

    Arm title
    Placebo (Induction Period)
    Arm description
    Placebo Blinded
    Arm type
    Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.25mg

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1mg

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.5mg

    Arm title
    RPC1063 Cohort 2 (Induction Period)
    Arm description
    - Open Label -On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) -On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) -On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
    Arm type
    Experimental

    Investigational medicinal product name
    Ozanimod HCL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.25mg

    Investigational medicinal product name
    Ozanimod HCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.5mg (2 x 0.25mg)

    Investigational medicinal product name
    Ozanimod HCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1mg

    Number of subjects in period 1
    RPC1063 Cohort 1 (Induction Period) Placebo (Induction Period) RPC1063 Cohort 2 (Induction Period)
    Started
    429
    216
    367
    Transition to Maintenance Period
    233 [1]
    69 [2]
    224 [3]
    Treated in Maintenance Period
    0 [4]
    69 [5]
    0 [6]
    Completed
    401
    192
    324
    Not completed
    28
    24
    43
         Other Reason
    1
    -
    -
         non compliance with protocol
    2
    -
    1
         Physician decision
    -
    -
    1
         Lack of efficacy
    4
    10
    9
         Adverse event, non-fatal
    11
    6
    12
         Consent withdrawn by subject
    10
    8
    20
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects from this arm were re randomized to the maintenance period
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects from this arm either were re randomized to the maintenance period, or continued in this arm throughout the study
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects from this arm were re randomized to the maintenance period
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects from this arm were re randomized to the maintenance period
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects from this arm were re randomized to the maintenance period
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects from this arm were re randomized to the maintenance period
    Period 2
    Period 2 title
    Maintenance Period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    This population was re-randomized and blinded from subjects which were treated in the induction period.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    RPC01063 Maintenance Period
    Arm description
    -Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)
    Arm type
    Experimental

    Investigational medicinal product name
    Ozanimod HCL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1mg

    Arm title
    Placebo Maintenance Period
    Arm description
    Placebo Blinded
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1mg

    Arm title
    Placebo
    Arm description
    Subjects from Induction period placebo arm who continued on placebo during maintenance
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1mg

    Number of subjects in period 2
    RPC01063 Maintenance Period Placebo Maintenance Period Placebo
    Started
    230
    227
    69
    Completed
    184
    124
    45
    Not completed
    46
    103
    24
         discontinued treatment
    12
    22
    2
         entered open label extension
    34
    81
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RPC1063 Cohort 1 (Induction Period)
    Reporting group description
    - Blinded -On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) -On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) -On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

    Reporting group title
    Placebo (Induction Period)
    Reporting group description
    Placebo Blinded

    Reporting group title
    RPC1063 Cohort 2 (Induction Period)
    Reporting group description
    - Open Label -On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) -On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) -On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

    Reporting group values
    RPC1063 Cohort 1 (Induction Period) Placebo (Induction Period) RPC1063 Cohort 2 (Induction Period) Total
    Number of subjects
    429 216 367 1012
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    410 202 346 958
        From 65-84 years
    19 14 21 54
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    41.4 ± 13.54 41.9 ± 13.64 42.1 ± 13.72 -
    Sex: Female, Male
    Units: Participants
        Female
    184 73 153 410
        Male
    245 143 214 602
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0
        Asian
    36 17 12 65
        Native Hawaiian or Other Pacific Islander
    0 0 0 0
        Black or African American
    14 4 10 28
        White
    370 192 336 898
        Unknown or Not Reported
    9 3 9 21
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    26 8 16 50
        Not Hispanic or Latino
    403 208 351 962
        Unknown or Not Reported
    0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    RPC1063 Cohort 1 (Induction Period)
    Reporting group description
    - Blinded -On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) -On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) -On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

    Reporting group title
    Placebo (Induction Period)
    Reporting group description
    Placebo Blinded

    Reporting group title
    RPC1063 Cohort 2 (Induction Period)
    Reporting group description
    - Open Label -On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) -On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) -On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)
    Reporting group title
    RPC01063 Maintenance Period
    Reporting group description
    -Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)

    Reporting group title
    Placebo Maintenance Period
    Reporting group description
    Placebo Blinded

    Reporting group title
    Placebo
    Reporting group description
    Subjects from Induction period placebo arm who continued on placebo during maintenance

    Primary: Percentage of Participants in Clinical Remission at 10 weeks

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    End point title
    Percentage of Participants in Clinical Remission at 10 weeks
    End point description
    Percentage of participants that are in Clinical remission at 10 weeks
    End point type
    Primary
    End point timeframe
    At 10 Weeks
    End point values
    RPC1063 Cohort 1 (Induction Period) Placebo (Induction Period) RPC1063 Cohort 2 (Induction Period)
    Number of subjects analysed
    429
    216
    367
    Units: Percentage
        number (not applicable)
    18.4
    6.0
    21.0
    Statistical analysis title
    RPC1063 vs Placebo in Induction Period
    Comparison groups
    Placebo (Induction Period) v RPC1063 Cohort 1 (Induction Period)
    Number of subjects included in analysis
    645
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.586
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.938
         upper limit
    6.636

    Primary: Percentage of Participants in Clinical Remission at 52 weeks

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    End point title
    Percentage of Participants in Clinical Remission at 52 weeks
    End point description
    Percentage of participants that are in Clinical remission at 52 weeks
    End point type
    Primary
    End point timeframe
    At 52 Weeks
    End point values
    RPC01063 Maintenance Period Placebo Maintenance Period Placebo
    Number of subjects analysed
    230
    227
    69
    Units: Percentage
        number (not applicable)
    37.0
    18.5
    24.6
    Statistical analysis title
    SAP of RPC01063 vs Placebo in Maintenance Period
    Comparison groups
    RPC01063 Maintenance Period v Placebo Maintenance Period
    Number of subjects included in analysis
    457
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.755
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.767
         upper limit
    4.294

    Secondary: Percentage of Participants with clinical response at 10 weeks

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    End point title
    Percentage of Participants with clinical response at 10 weeks
    End point description
    Percentage of participants that are in Clinical response at 10 weeks
    End point type
    Secondary
    End point timeframe
    At 10 Weeks
    End point values
    RPC1063 Cohort 1 (Induction Period) Placebo (Induction Period) RPC1063 Cohort 2 (Induction Period)
    Number of subjects analysed
    429
    216
    367
    Units: Percentage
        number (not applicable)
    47.8
    25.9
    52.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants with endoscopic improvement at 10 weeks

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    End point title
    Percentage of Participants with endoscopic improvement at 10 weeks
    End point description
    Percentage of participants with endoscopic improvement at 10 weeks
    End point type
    Secondary
    End point timeframe
    At 10 Weeks
    End point values
    RPC1063 Cohort 1 (Induction Period) Placebo (Induction Period) RPC1063 Cohort 2 (Induction Period)
    Number of subjects analysed
    429
    216
    367
    Units: Percentage
        number (not applicable)
    27.3
    12.0
    27.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants with mucosal healing at 10 weeks

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    End point title
    Percentage of Participants with mucosal healing at 10 weeks
    End point description
    Percentage of participants with mucosal healing at 10 weeks
    End point type
    Secondary
    End point timeframe
    At 10 Weeks
    End point values
    RPC1063 Cohort 1 (Induction Period) Placebo (Induction Period) RPC1063 Cohort 2 (Induction Period)
    Number of subjects analysed
    429
    216
    367
    Units: Percentage
        number (not applicable)
    12.6
    3.7
    11.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants in Clinical Response at 52 weeks

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    End point title
    Percentage of Participants in Clinical Response at 52 weeks
    End point description
    Percentage of participants that are in Clinical response at 52 weeks
    End point type
    Secondary
    End point timeframe
    At 52 Weeks
    End point values
    RPC01063 Maintenance Period Placebo Maintenance Period Placebo
    Number of subjects analysed
    230
    227
    69
    Units: Percentage
        number (not applicable)
    60.0
    41.0
    39.1
    No statistical analyses for this end point

    Secondary: Percentage of participants with endoscopic improvement at 52 weeks

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    End point title
    Percentage of participants with endoscopic improvement at 52 weeks
    End point description
    Percentage of participants with endoscopic improvement at 52 weeks
    End point type
    Secondary
    End point timeframe
    At 52 Weeks
    End point values
    RPC01063 Maintenance Period Placebo Maintenance Period Placebo
    Number of subjects analysed
    230
    227
    69
    Units: Percentage
        number (not applicable)
    45.7
    26.4
    29.0
    No statistical analyses for this end point

    Secondary: Percentage of participants in clinical remission at week 52 who were in remission at week 10

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    End point title
    Percentage of participants in clinical remission at week 52 who were in remission at week 10
    End point description
    Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10
    End point type
    Secondary
    End point timeframe
    At 52 Weeks
    End point values
    RPC01063 Maintenance Period Placebo Maintenance Period Placebo
    Number of subjects analysed
    230
    227
    69
    Units: Percentage
        number (not applicable)
    51.9
    29.3
    41.7
    No statistical analyses for this end point

    Secondary: Percentage of participants with corticosteroid free remission at 52 weeks

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    End point title
    Percentage of participants with corticosteroid free remission at 52 weeks
    End point description
    Percentage of participants with corticosteroid free remission at 52 weeks
    End point type
    Secondary
    End point timeframe
    At 52 Weeks
    End point values
    RPC01063 Maintenance Period Placebo Maintenance Period Placebo
    Number of subjects analysed
    230
    227
    69
    Units: Percentage
        number (not applicable)
    31.7
    16.7
    24.6
    No statistical analyses for this end point

    Secondary: Percentage of participants with Mucosal Healing at 52 weeks

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    End point title
    Percentage of participants with Mucosal Healing at 52 weeks
    End point description
    Percentage of participants with Mucosal Healing at 52 weeks
    End point type
    Secondary
    End point timeframe
    At 52 Weeks
    End point values
    RPC01063 Maintenance Period Placebo Maintenance Period Placebo
    Number of subjects analysed
    230
    227
    69
    Units: Percentage
        number (not applicable)
    29.6
    14.1
    10.1
    No statistical analyses for this end point

    Secondary: Percentage of participants with durable clinical remission at 52 weeks

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    End point title
    Percentage of participants with durable clinical remission at 52 weeks
    End point description
    Percentage of participants with durable clinical remission at 52 weeks
    End point type
    Secondary
    End point timeframe
    At 52 Weeks
    End point values
    RPC01063 Maintenance Period Placebo Maintenance Period Placebo
    Number of subjects analysed
    230
    227
    69
    Units: Percentage
        number (not applicable)
    17.8
    9.7
    7.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately up to 52 Weeks
    Adverse event reporting additional description
    Participant overlap due to re randomization occuring before maintenance phase
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Cohort 1 (Induction Period): RPC1063 1mg
    Reporting group description
    - Blinded -On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) -On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) -On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

    Reporting group title
    Cohort 1: Placebo
    Reporting group description
    Placebo Blinded

    Reporting group title
    Cohort 2 (Induction Period): RPC1063 1mg
    Reporting group description
    - Open Label -On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) -On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) -On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)

    Reporting group title
    RPC01063 Maintenance Period
    Reporting group description
    -Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)

    Reporting group title
    Placebo (Maintenance Period): Placebo
    Reporting group description
    Placebo Blinded

    Serious adverse events
    Cohort 1 (Induction Period): RPC1063 1mg Cohort 1: Placebo Cohort 2 (Induction Period): RPC1063 1mg RPC01063 Maintenance Period Placebo (Maintenance Period): Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 429 (3.96%)
    11 / 216 (5.09%)
    23 / 367 (6.27%)
    12 / 230 (5.22%)
    18 / 227 (7.93%)
         number of deaths (all causes)
    0
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    1 / 230 (0.43%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    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
    Breast cancer
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    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
    Cervix carcinoma stage 0
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    1 / 367 (0.27%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    1 / 230 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    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
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    1 / 230 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    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
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 216 (0.46%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    1 / 367 (0.27%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    1 / 367 (0.27%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck injury
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    1 / 367 (0.27%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    1 / 367 (0.27%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    1 / 230 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    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
    Investigations
    Respiratory syncytial virus test positive
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    1 / 367 (0.27%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    1 / 367 (0.27%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    1 / 367 (0.27%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    1 / 230 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    1 / 367 (0.27%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 429 (0.93%)
    0 / 216 (0.00%)
    1 / 367 (0.27%)
    1 / 230 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    1 / 230 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    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
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    1 / 230 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    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
    Photophobia
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    6 / 429 (1.40%)
    5 / 216 (2.31%)
    9 / 367 (2.45%)
    1 / 230 (0.43%)
    9 / 227 (3.96%)
         occurrences causally related to treatment / all
    0 / 6
    2 / 5
    0 / 9
    0 / 1
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 216 (0.46%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 216 (0.46%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 216 (0.46%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    1 / 367 (0.27%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    1 / 367 (0.27%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Proctitis ulcerative
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    1 / 230 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    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
    Vomiting
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    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
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 216 (0.46%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    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
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    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
    Cholelithiasis
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 216 (0.46%)
    1 / 367 (0.27%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 216 (0.00%)
    2 / 367 (0.54%)
    0 / 230 (0.00%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 216 (0.46%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    1 / 230 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    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
    Complicated appendicitis
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    2 / 227 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    2 / 367 (0.54%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    1 / 230 (0.43%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    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
    Large intestine infection
         subjects affected / exposed
    0 / 429 (0.00%)
    1 / 216 (0.46%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Measles
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    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
    Nasopharyngitis
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    1 / 367 (0.27%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    1 / 367 (0.27%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    1 / 429 (0.23%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Yersinia infection
         subjects affected / exposed
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 367 (0.00%)
    0 / 230 (0.00%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Cohort 1 (Induction Period): RPC1063 1mg Cohort 1: Placebo Cohort 2 (Induction Period): RPC1063 1mg RPC01063 Maintenance Period Placebo (Maintenance Period): Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 429 (3.50%)
    13 / 216 (6.02%)
    15 / 367 (4.09%)
    2 / 230 (0.87%)
    4 / 227 (1.76%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    15 / 429 (3.50%)
    13 / 216 (6.02%)
    15 / 367 (4.09%)
    2 / 230 (0.87%)
    4 / 227 (1.76%)
         occurrences all number
    20
    14
    19
    2
    5

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Dec 2017
     The number of investigators was updated to more accurately reflect the current number of investigators planned in this study.  The estimated date of last patient completed was updated based on the current estimated enrollment rate.  The proportion of patients in Cohort 1 and Cohort 2 have been adjusted to allow us to reinstate the original limit of ≤ 30% of patients who have received anti-TNF from RPC01-3101 protocol version 2.0, 2.1, 2.2, and 2.3. It is planned that the total sample size of the trial will remain unchanged.  The original limit of ≤ 30% of patients who have received anti-TNF from RPC01-3101 protocol version 2.0, 2.1, 2.2, and 2.3 has been reinstated for Cohort 1. A limit of ≤ 50% has been established for Cohort 2. These limits have been established based on ongoing development programs in UC that have confirmed that patients with anti-TNF experience achieve limited clinical response.  Study procedures have been clarified to allow for continuous enrollment of patients who have received anti-TNF therapy.
    07 Dec 2017
     A clarification was made to allow access to OCT images especially in case of suspicion of macular edema.  Clarification was made to allow sites with qualified personnel to perform the pulmonary function test onsite under the supervision of a pulmonologist.  A change was made to underscore that it is the choice of the patient to receive the VZV vaccination.  A correction was made for patients who test positive for HBs antigen. While patients who test positive for HBs antigen will still be excluded, the presence of the HBs antibody alone is the result of vaccination so these patients will be eligible for the trial.  A clarification was made in order to precisely define the timing of unblinding for Cohort 1 and the randomized component of the Maintenance Period.  A statement was added to clarify that treatment group assignment during the Maintenance Period for patients who received placebo in Cohort 1 will be unblinded to the Sponsor during the Maintenance Period.  Sections were added to clarify that analyses will be performed after the last patient has had their last visit in Cohort 1, Cohort 2 and the Maintenance Period, respectively.  The abbreviation list has been updated based on changes in this amendment
    29 May 2018
    A clarification was made that Cohort 2 may need to be increased to ensure adequate powering of the Maintenance Period. The visit window for Visit Induction 3, Maintenance (M) 2, M 3, M 4, and M 5 was increased for operational efficiency. Added Safety Follow-Up section for consistency with other ongoing RPC1063 protocols. Revised instructions for elevated LFTs for consistency with other ongoing RPC1063 protocols. Added guidance for further liver function evaluation if a patient discontinues investigational drug due to elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5x ULN, or ALT or AST > 3x ULN and bilirubin > 2x ULN for additional clarification for the investigator. Changed “titration” to “dose escalation” throughout the protocol for consistency with other ongoing RPC1063 protocols. Added nomenclature and dose equivalency between RPC1063/ozanimod HCl (0.25 mg, 0.5 mg, and 1 mg) and ozanimod (0.23 mg, 0.46 mg, and 0.92 mg) for consistency across RPC1063 protocols. A change to the analysis method was made from the LOCF method to the NRI method Removed hemoglobin A1c from the chemistry panel because it is not needed for routine evaluation of patient safety. Minor editorial changes and changes for clarification were made.

    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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