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    Clinical Trial Results:
    Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

    Summary
    EudraCT number
    		 2017-004292-31
    Trial protocol
    		 LV   CZ   DE   BG   ES   NO   BE   DK   PL   IE   GB   HR   FR   IT   RO  
    Global end of trial date
    01 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RPC01-3201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03440372
    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, Global Submission Management, Clinical Trials, mg-gsm-ct@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, mg-gsm-ct@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
    01 Oct 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Proportion of subjects with a CDAI score < 150 at Week 12
    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 participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Feb 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 14
    Country: Number of subjects enrolled
    India: 22
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Country: Number of subjects enrolled
    Belarus: 2
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 1
    Country: Number of subjects enrolled
    Bulgaria: 8
    Country: Number of subjects enrolled
    Croatia: 7
    Country: Number of subjects enrolled
    Czechia: 38
    Country: Number of subjects enrolled
    Georgia: 2
    Country: Number of subjects enrolled
    Latvia: 3
    Country: Number of subjects enrolled
    Moldova, Republic of: 21
    Country: Number of subjects enrolled
    Poland: 73
    Country: Number of subjects enrolled
    Romania: 19
    Country: Number of subjects enrolled
    Russian Federation: 43
    Country: Number of subjects enrolled
    Serbia: 2
    Country: Number of subjects enrolled
    Ukraine: 116
    Country: Number of subjects enrolled
    Canada: 14
    Country: Number of subjects enrolled
    Mexico: 6
    Country: Number of subjects enrolled
    United States: 71
    Country: Number of subjects enrolled
    Argentina: 5
    Country: Number of subjects enrolled
    Chile: 11
    Country: Number of subjects enrolled
    Israel: 12
    Country: Number of subjects enrolled
    Saudi Arabia: 11
    Country: Number of subjects enrolled
    Türkiye: 5
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 31
    Country: Number of subjects enrolled
    Ireland: 7
    Country: Number of subjects enrolled
    Italy: 39
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Switzerland: 7
    Country: Number of subjects enrolled
    United Kingdom: 9
    Worldwide total number of subjects
    625
    EEA total number of subjects
    247
    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)
    593
    From 65 to 84 years
    32
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 625 participants were randomized and of these 623 received at least one dose of study treatment.

    Period 1
    Period 1 title
    Pre-Treatment
    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
    		 Treatment 1
    Arm description
    		 Participants received ozanimod 0.92 mg
    Arm type
    		 Experimental

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

    Arm title
    		 Treatment 2
    Arm description
    		 Participants received ozanimod matching placebo
    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
    0.92 mg daily

    Number of subjects in period 1
    		Treatment 1 Treatment 2
    Started
    417
    208
    Completed
    416
    207
    Not completed
    1
    1
         Not Completed
    1
    1
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment 1
    Arm description
    		 Participants received ozanimod 0.92 mg
    Arm type
    		 Experimental

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

    Arm title
    		 Treatment 2
    Arm description
    		 Participants received ozanimod matching placebo
    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
    0.92 mg daily

    Number of subjects in period 2
    		Treatment 1 Treatment 2
    Started
    416
    207
    Completed
    378
    185
    Not completed
    38
    22
         Consent withdrawn by subject
    12
    8
         Adverse event, non-fatal
    16
    8
         Pregnancy
    1
    -
         Other Reason
    2
    3
         Study Terminated by Sponsor
    2
    1
         Lost to follow-up
    1
    -
         Lack of efficacy
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment 1
    Reporting group description
    		 Participants received ozanimod 0.92 mg

    Reporting group title
    Treatment 2
    Reporting group description
    		 Participants received ozanimod matching placebo

    Reporting group values
    		 Treatment 1 Treatment 2 Total
    Number of subjects
    		 417 208 625
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 394 199 593
        >=65 years
    		 23 9 32
    Sex: Female, Male
    Units: Participants
        Female
    		 210 97 307
        Male
    		 207 111 318
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1
        Asian
    		 21 9 30
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 2 4 6
        White
    		 378 188 566
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 16 6 22
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 20 14 34
        Not Hispanic or Latino
    		 391 190 581
        Unknown or Not Reported
    		 6 4 10

    End points

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    End points reporting groups
    Reporting group title
    Treatment 1
    Reporting group description
    		 Participants received ozanimod 0.92 mg

    Reporting group title
    Treatment 2
    Reporting group description
    		 Participants received ozanimod matching placebo
    Reporting group title
    Treatment 1
    Reporting group description
    		 Participants received ozanimod 0.92 mg

    Reporting group title
    Treatment 2
    Reporting group description
    		 Participants received ozanimod matching placebo

    Primary: Percent of Participants with a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12

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    End point title
    		 Percent of Participants with a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12
    End point description
    Crohn’s Disease Activity Index (CDAI) is a composite score used to measure the clinical activity of Crohn’s disease. CDAI uses 8 variables: number of soft/liquid stools, severity of abdominal pain (0=none to 3=severe), general well-being (0=well to 4=terrible), presence of complications, need for antidiarrheal drugs, presence of abdominal mass, hematocrit, and change in body weight. Scores for stool number, abdominal pain, and well-being are summed over the 7 days before each visit. The other factors are also recorded and weighted to create a total CDAI score, which ranges from 0–600, with higher scores indicating worse disease (score 150–219 = mild, 220–450 = moderate, >450 = severe). This measure reports the percentage of participants whose CDAI score was below 150 at 12 weeks.
    End point type
    Primary
    End point timeframe
    At Week 12
    End point values
    		 Treatment 1 Treatment 2
    Number of subjects analysed
    416
    207
    Units: Percentage of Participants
    number (not applicable)
        Responders
    31.3
    20.8
        Non-Responders
    64.4
    73.4
        Imputed Non-Responders
    4.3
    5.8
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Treatment 1 v Treatment 2
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0049
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.19
         upper limit
    		 2.7

    Secondary: Percent of Participants with Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points with Abdominal Pain and Stool Frequency no Worse than Baseline at Week 12

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    End point title
    		 Percent of Participants with Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points with Abdominal Pain and Stool Frequency no Worse than Baseline at Week 12
    End point description
    Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as an average daily abdominal pain score ≤1 and average daily stool frequency ≤3, with AP and SF no worse than baseline at Week 12. AP was graded on a scale from 0 (none) to 3 (severe), and SF was defined as the number of liquid or soft stools per day. This measure reports the percentage of participants who, by Week 12, had low abdominal pain (score ≤1) and three or fewer bowel movements per day, without worsening symptoms compared to when they started the study. Participants began using the diary at the first visit and continued throughout the study.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Treatment 1 Treatment 2
    Number of subjects analysed
    416
    207
    Units: Percentage of Participants
    number (not applicable)
        Responders
    30.5
    21.7
        Non-Responders
    66.3
    72.5
        Imputed Non-Responders
    3.1
    5.8
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Treatment 1 v Treatment 2
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0179
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.09
         upper limit
    		 2.43

    Secondary: Percent of Participants with a Simple Endoscopic Score for Crohn’s Disease (SES-CD) Score Decrease from Baseline of ≥ 50% at Week 12

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    End point title
    		 Percent of Participants with a Simple Endoscopic Score for Crohn’s Disease (SES-CD) Score Decrease from Baseline of ≥ 50% at Week 12
    End point description
    The Simple Endoscopic Score for Crohn’s Disease (SES-CD) is used to assess the degree of inflammation in patients with Crohn’s disease. The SES-CD evaluates four components—size of ulcers, ulcerated surface, affected surface, and presence of narrowing—each scored from 0 (none) to 3 (severe). These components are assessed across five intestinal segments: ileum, right colon, transverse colon, left colon, and rectum. The total SES-CD score is the sum of the individual component scores across all segments, ranging from 0 to 12 per segment and 0 to 60 overall, with higher scores indicating greater inflammation. Baseline is defined as the last assessment prior to the first drug administration (based on the time of measurement, if available; otherwise, the last assessment prior to or on the date of first drug administration). This measure reports the percentage of participants whose SES-CD score improved by 50% or more from baseline to Week 12.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Treatment 1 Treatment 2
    Number of subjects analysed
    416
    207
    Units: Percentage of Participants
    number (not applicable)
        Responders
    22.1
    18.4
        Non-Responders
    71.6
    77.3
        Imputed Non-Responders
    6.3
    4.3
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Treatment 1 v Treatment 2
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.272
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.93

    Secondary: Percent of Participants with Crohn's Disease Activity Index (CDAI) Reduction from Baseline of ≥ 100 Points or CDAI Score < 150 at Week 12

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    End point title
    		 Percent of Participants with Crohn's Disease Activity Index (CDAI) Reduction from Baseline of ≥ 100 Points or CDAI Score < 150 at Week 12
    End point description
    The Crohn's Disease Activity Index (CDAI) is a composite score used to measure the clinical activity of Crohn's disease. CDAI is calculated using 8 variables: number of soft/liquid stools, severity of abdominal pain (0 [none] to 3 [severe]), general well-being (0 [well] to 4 [terrible]), presence of complications, use of antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Scores for stool frequency, pain, and well-being are summed over the 7 days prior to each visit. The remaining variables are also weighted and included in the total CDAI score, which ranges from 0–600, with higher scores indicating worse disease activity (score 150–219 = mild, 220–450 = moderate, >450 = severe). This measure reports the percentage of participants whose CDAI score improved by at least 100 points, or was below 150, at 12 weeks.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Treatment 1 Treatment 2
    Number of subjects analysed
    416
    207
    Units: Percentage of Participants
    number (not applicable)
        Responders
    48.8
    39.1
        Non-Responders
    46.9
    55.1
        Imputed Non-Responders
    4.3
    5.8
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Treatment 1 v Treatment 2
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0193
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 2.15

    Secondary: Percent of Participants with Crohn's Disease Activity Index (CDAI) Reduction from Baseline of ≥ 100 Points or CDAI Score < 150 and Simple Endoscopic Score for Crohn’s Disease (SES-CD) Decrease from Baseline of ≥ 50% at Week 12

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    End point title
    		 Percent of Participants with Crohn's Disease Activity Index (CDAI) Reduction from Baseline of ≥ 100 Points or CDAI Score < 150 and Simple Endoscopic Score for Crohn’s Disease (SES-CD) Decrease from Baseline of ≥ 50% at Week 12
    End point description
    The Crohn's Disease Activity Index (CDAI) is a composite score used to measure clinical activity in Crohn's disease. CDAI is based on 8 variables: number of soft/liquid stools, severity of abdominal pain (0 [none] to 3 [severe]), general well-being (0 [well] to 4 [terrible]), presence of complications, use of antidiarrheal drugs, abdominal mass, hematocrit, and deviation in body weight. Scores for stool frequency, pain, and well-being are summed over 7 days prior to each visit. The total CDAI score ranges from 0–600, with higher scores indicating worse disease activity (score 150–219 = mild, 220–450 = moderate, >450 = severe). This measure reports the percentage of participants whose Crohn’s disease improved at 12 weeks, defined as a CDAI decrease of at least 100 points or a score below 150, along with at least a 50% reduction in intestinal inflammation (SES-CD score).
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Treatment 1 Treatment 2
    Number of subjects analysed
    416
    207
    Units: Percentage of Participants
    number (not applicable)
        Responders
    16.6
    13.5
        Non-Responders
    78.6
    84.1
        Imputed Non-Responders
    4.8
    2.4
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Treatment 1 v Treatment 2
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3167
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 2.05

    Secondary: Percent of Participants with Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 and Simple Endoscopic Score for Crohn’s Disease (SES-CD) Decrease from Baseline of ≥ 50% at Week 12

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    End point title
    		 Percent of Participants with Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 and Simple Endoscopic Score for Crohn’s Disease (SES-CD) Decrease from Baseline of ≥ 50% at Week 12
    End point description
    This endpoint measured the percentage of participants who achieved both clinical remission and significant endoscopic improvement at Week 12. Clinical remission was defined as a Crohn’s Disease Activity Index (CDAI) score of less than 150 at Week 12. Endoscopic improvement was defined as a decrease of at least 50% from baseline in the Simple Endoscopic Score for Crohn’s Disease (SES-CD) at Week 12. The CDAI was a composite score assessing disease activity based on symptoms and laboratory values, while the SES-CD evaluated endoscopic findings in the intestinal mucosa. Achieving both criteria indicated substantial improvement in both symptoms and intestinal inflammation.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Treatment 1 Treatment 2
    Number of subjects analysed
    416
    207
    Units: Percent of Participants
    number (not applicable)
        Responders
    16.6
    13.5
        Non-Responders
    78.6
    84.1
        Imputed Non-Responders
    4.8
    2.4
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Treatment 1 v Treatment 2
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3167
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 2.05

    Secondary: Percent of Participants with an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points with Abdominal Pain and Stool Frequency no Worse than Baseline and an SES-CD ≤ 4 Points and Decrease ≥ 2 Points at Week 12

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    End point title
    		 Percent of Participants with an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points with Abdominal Pain and Stool Frequency no Worse than Baseline and an SES-CD ≤ 4 Points and Decrease ≥ 2 Points at Week 12
    End point description
    This measure reports the percentage of participants whose Crohn’s disease symptoms and gut inflammation improved at 12 weeks. It includes those with mild or no belly pain (score ≤1), no more than three bowel movements per day (score ≤3), and no worsening from baseline. It also includes participants whose gut inflammation, measured by SES-CD, was low (score ≤4) and improved by at least 2 points. SES-CD assesses inflammation based on four components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing, each scored from 0 (none) to 3 (severe) across five segments (ileum, right colon, transverse colon, left colon, rectum). The total SES-CD score ranges from 0–12 per segment and 0–60 overall, with higher scores indicating greater inflammation.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Treatment 1 Treatment 2
    Number of subjects analysed
    416
    207
    Units: Percentage of Participants
    number (not applicable)
        Responders
    8.7
    6.3
        Non-Responders
    88.0
    91.3
        Imputed Non-Responders
    3.4
    2.4
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Treatment 1 v Treatment 2
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2978
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 2.77

    Secondary: Percent of Participants with an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points with Abdominal Pain and Stool Frequency Score no Worse than Baseline and an SES-CD Decrease from Baseline of ≥ 50% at Week 12

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    End point title
    		 Percent of Participants with an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points with Abdominal Pain and Stool Frequency Score no Worse than Baseline and an SES-CD Decrease from Baseline of ≥ 50% at Week 12
    End point description
    This measure reports the percentage of participants whose Crohn’s disease symptoms and gut inflammation improved at 12 weeks. It includes those with mild or no belly pain (score ≤1), no more than three bowel movements per day (score ≤3), and no worsening from baseline. It also includes participants whose gut inflammation, measured by SES-CD, improved by at least 50% from baseline. SES-CD assesses inflammation based on four components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing, each scored from 0 (none) to 3 (severe) across five segments (ileum, right colon, transverse colon, left colon, rectum). The total SES-CD score ranges from 0–12 per segment and 0–60 overall, with higher scores indicating greater inflammation.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Treatment 1 Treatment 2
    Number of subjects analysed
    416
    207
    Units: Percentage of Participants
    number (not applicable)
        Responders
    11.1
    7.7
        Non-Responders
    85.6
    89.9
        Imputed Non-Responders
    3.4
    2.4
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Treatment 1 v Treatment 2
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1895
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 2.72

    Secondary: Histologic Improvement Based on Differences between Ozanimod and Placebo in Histologic Disease Activity Scores (ie, Global Histologic Activity Score (GHAS) Changes) at Week 12

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    End point title
    		 Histologic Improvement Based on Differences between Ozanimod and Placebo in Histologic Disease Activity Scores (ie, Global Histologic Activity Score (GHAS) Changes) at Week 12
    End point description
    This measure evaluated improvement in gut inflammation at 12 wks using Global Histologic Activity Score (GHAS). GHAS was assessed for each ileal & colonic segment (ileum, right colon, transverse colon, left colon-descending/sigmoid colon & rectum). Segment subscores were calculated by adding scores for epithelial damage/tissue changes(0–2), cellular infiltration for mononuclear & polymorphonuclear cells(0–2 each), presence of certain cells(0–3) & erosion, ulcers, granulomas(0 or 1). GHAS score within each segment ranged from 0–16 & across five segments ranged from 0–80. Higher scores indicated more inflammation. Responders with histologic remission was defined as GHAS score ≤8 (each segment) [meeting criteria: epithelial damage(0), architectural changes(0–2), mononuclear cell infiltration(0–2), polymorphonuclear cell infiltration(0), polymorphonuclear cells in epithelium(0), erosion/ulcers(0), granuloma(0–1) & affected biopsy specimens(0–3)] & ≤40 (across all segments).
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Treatment 1 Treatment 2
    Number of subjects analysed
    416
    207
    Units: Percentage of Participants
    number (not applicable)
        Responders
    14.9
    9.2
        Non-Responders
    78.4
    85.5
        Imputed Non-Responders
    6.7
    5.3
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Treatment 1 v Treatment 2
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0452
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 2.97

    Secondary: Percent of Participants with Crohn's Disease Activity Index (CDAI) Reduction from Baseline of ≥ 70 Points at Week 12

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    End point title
    		 Percent of Participants with Crohn's Disease Activity Index (CDAI) Reduction from Baseline of ≥ 70 Points at Week 12
    End point description
    This measure reports the percentage of participants whose Crohn’s disease symptoms improved meaningfully after 12 weeks of treatment, defined as a decrease of at least 70 points in their Crohn’s Disease Activity Index (CDAI) score from baseline. The CDAI is a composite score used to assess clinical activity in Crohn’s disease, based on 8 variables: number of soft/liquid stools, severity of abdominal pain (0 [none] to 3 [severe]), general well-being (0 [well] to 4 [terrible]), presence of complications, use of antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Scores for stool frequency, pain, and well-being are summed over 7 days prior to each visit. The total CDAI score ranges from 0–600, with higher scores indicating more severe disease (score 150–219 = mild, 220–450 = moderate, >450 = severe).
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Treatment 1 Treatment 2
    Number of subjects analysed
    416
    207
    Units: Percentage of Participants
    number (not applicable)
        Responders
    55.3
    45.4
        Non-Responders
    40.4
    48.8
        Imputed Non-Responders
    4.3
    5.8
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Treatment 1 v Treatment 2
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0173
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.08
         upper limit
    		 2.14

    Secondary: Percent of Participants with Absence of Ulcers ≥ 0.5 cm with No Segment with Any Ulcerated Surface ≥ 10% at Week 12

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    End point title
    		 Percent of Participants with Absence of Ulcers ≥ 0.5 cm with No Segment with Any Ulcerated Surface ≥ 10% at Week 12
    End point description
    This measure shows the percentage of participants have no longer any large ulcers (bigger than 0.5 cm) in their gut and in any section of the gut, less than 10% of the surface has ulcers at 12 weeks. This helps to understand how well the treatment is healing the gut and reducing ulceration.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Treatment 1 Treatment 2
    Number of subjects analysed
    416
    207
    Units: Percentage of Participants
    number (not applicable)
        Responders
    26.9
    20.3
        Non-Responders
    66.8
    75.4
        Imputed Non-Responders
    6.3
    4.3
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Treatment 1 v Treatment 2
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.067
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 2.2

    Secondary: Percent of Participants with a Crohn’s Disease Endoscopic Index of Severity (CDEIS) Decrease from Baseline of ≥ 50% at Week 12

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    End point title
    		 Percent of Participants with a Crohn’s Disease Endoscopic Index of Severity (CDEIS) Decrease from Baseline of ≥ 50% at Week 12
    End point description
    CDEIS is an index used to determine Crohn's disease severity by endoscopic exam of the ileum and colon. The intestine is divided into 5 segments: rectum, sigmoid/left colon, transverse colon, right colon, and ileum. In each segment, four variables are assessed: deep ulceration, superficial ulceration, percentage of ulcerated surface, and percentage of surface affected by Crohn’s disease, using 10-cm visual analogue scales. The presence of ulcerated and nonulcerated stenosis is also evaluated across the entire intestine. These factors are weighted and summed for a total score from 0–44, with higher scores indicating more severe disease. This measure reports the percentage of participants whose CDEIS score improved by at least 50% at 12 weeks, based on endoscopic exam.
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 Treatment 1 Treatment 2
    Number of subjects analysed
    416
    207
    Units: Percentage of Participants
    number (not applicable)
        Responders
    25.5
    19.3
        Non-Responders
    68.3
    76.3
        Imputed Non-Responders
    6.3
    4.3
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Treatment 1 v Treatment 2
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0835
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 2.16

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Participants were assessed for Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were assessed from first dose of study medication until study completion (assessed up to approximately 79 months 5 days).
    Adverse event reporting additional description
    Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Treatment 2
    Reporting group description
    		 Participants received ozanimod matching placebo

    Reporting group title
    Treatment 1
    Reporting group description
    		 Participants received ozanimod 0.92 mg

    Serious adverse events
    		 Treatment 2 Treatment 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 207 (4.83%)
    27 / 416 (6.49%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Heart rate irregular
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniofacial fracture
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site haemorrhage
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Depressed level of consciousness
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumoperitoneum
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    4 / 207 (1.93%)
    10 / 416 (2.40%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 207 (0.00%)
    2 / 416 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 207 (0.00%)
    1 / 416 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 416 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment 2 Treatment 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 207 (10.63%)
    22 / 416 (5.29%)
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    11 / 207 (5.31%)
    9 / 416 (2.16%)
         occurrences all number
    12
    9
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    11 / 207 (5.31%)
    13 / 416 (3.13%)
         occurrences all number
    11
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Sep 2017
    Protocol Version 1
    19 Dec 2017
    Protocol Version 02 (• A general statement was made to note that additional detailed statistical information can be found in the study Statistical Analysis Plan. Therefore, details were removed from Section 9 (Statistical Considerations). • Abbreviations lists in footnotes were updated. • The list of references has been updated based on changes in this amendment. • Minor typographical corrections have been made.)
    18 Jun 2018
    Protocol Amendment 03 (• A 75-day (±10 days) Safety Follow-up Visit was added throughout the document and to the Table of Events to ensure adequate collection of adverse events that could be associated with investigational product. The timing of the visit is based on the estimated time needed to clear the major active metabolite of ozanimod (RPC1063, which is 5 half-lives of CC112273). • The term “patient” was changed to “subject” throughout the document in order to maintain consistency throughout the protocol. • The terms “investigational drug” and “study drug” were changed to “investigational product” throughout the document to comply with regulatory guidances and maintain consistency throughout the protocol • The term “disease remission” was changed to “clinical remission” throughout the document in order to maintain consistency with the rest of the protocol • Abbreviations lists in footnotes were updated. • The list of references has been updated based on changes in this amendment. • Minor typographical corrections have been made. • Minor editorial changes and changes for clarification were made.)
    10 Jun 2019
    Protocol Amendment 04 (• Revisions to reflect the addition of adolescent subjects • Change to safety follow up from 75 days to 90-day (±10 days) Safety Follow-up Visit to ensure adequate collection of adverse events that could be associated with investigational drug. The timing of the visit is based on the estimated time needed to clear the major active metabolites of RPC1063 in the vast majority of patients (ie, 5 half-lives of CC112273 and CC1084037 and accounting for variation of half-life duration in a human population). • Extended the requirements for contraception in females after treatment discontinuation from the 75-day Safety Follow-up Visit to the 90-day Safety Follow-up Visit. • Minor editorial changes to enhance clarity of the protocol, and update study personnel names.)
    27 Aug 2020
    Protocol Amendment 05 (• Adjustment of Sample Size • Refinement of Per-Protocol Population • Update Summary of Clinical Studies in Inflammatory Bowel Disease (IBD) • Update of Exploratory, Endoscopic Remission Endpoint • Exclusion Criterion for Subjects with Cardiovascular Conditions • Addition of Exclusion Criteria and Testing for SARS-CoV-2 Subjects • Pharmacodynamic (PD) Biomarker Blood and Stool Sampling to Occur at Baseline • First Dose Monitoring Will Be Required Only in Subjects Identified as at Risk for Cardiac Events • Optical Coherence Tests and Pulmonary Function Tests Will Only Be Required in Subjects Identified as At Risk • Instructions for Missed Doses • Prohibited Medication Clarifications • Inclusion of Progressive Multifocal Leukoencephalopathy (PML) and Posterior Reversible Encephalopathy Syndrome (PRES) as Adverse Events of Special Interest and Study Discontinuation Criteria • Update to Liver Function Testing and Discontinuation Criteria • Removal of Pregnant Partner • Minor administrative changes to enhance clarity of the protocol and update study personnel names.)
    14 Jun 2021
    Protocol Amendment 06 (• Removal of Adolescent Subjects • Update Summary of Clinical Studies in Inflammatory Bowel Disease (IBD) • Addition of SARS-CoV-2 Guidance • Modification of Cardiac Exclusion Criteria • Pulmonary Function Tests for all Subjects • Revision of Ocular Testing Requirements • Modification of First Dose Monitoring Requirements • Biomarker Clarifications • Product Quality Complaint Notification Update • Minor editorial changes were made to enhance clarity of the protocol, as well as an update to sponsor address, abbreviations, and references.)

    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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