Trial Outcomes & Findings for A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease (NCT NCT03464097)

Last Updated: 2025-10-09

Results Overview

The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

550 participants

Primary outcome timeframe

Week 52

Results posted on

2025-10-09

Participant Flow

This study was a maintenance study.

Participants who completed initial 12 weeks of treatment in induction studies RPC01-3201 (NCT03440372) or RPC01-3202 (NCT03440385) and are in clinical response (CDAI \[Crohn's Disease Activity Index\] reduction from baseline ≥100 points or CDAI score\<150),clinical remission (CDAI score \< 150),and/or have an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤1with abdominal pain and stool frequency no worse than baseline were eligible to participate.

Participant milestones

Participant milestones
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Overall Study STARTED	188	188	174
Overall Study Safety Population	188	188	174
Overall Study COMPLETED	96	93	70
Overall Study NOT COMPLETED	92	95	104

Reasons for withdrawal

Reasons for withdrawal
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Overall Study Withdrawal by Subject	15	13	11
Overall Study Study terminated by sponsor	47	44	40
Overall Study Pregnancy	0	1	0
Overall Study Other reasons	5	12	14
Overall Study Lost to Follow-up	0	1	1
Overall Study Lack of Efficacy	11	18	30
Overall Study Death	1	0	0
Overall Study Adverse Event	13	6	8

Baseline Characteristics

A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=188 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=188 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=174 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.	Total n=550 Participants Total of all reporting groups
Age, Continuous	40.46 years STANDARD_DEVIATION 13.623 • n=93 Participants	38.71 years STANDARD_DEVIATION 13.916 • n=4 Participants	38.68 years STANDARD_DEVIATION 13.744 • n=27 Participants	39.30 years STANDARD_DEVIATION 13.762 • n=483 Participants
Sex: Female, Male Female	91 Participants n=93 Participants	91 Participants n=4 Participants	83 Participants n=27 Participants	265 Participants n=483 Participants
Sex: Female, Male Male	97 Participants n=93 Participants	97 Participants n=4 Participants	91 Participants n=27 Participants	285 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants	28 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	180 Participants n=93 Participants	175 Participants n=4 Participants	157 Participants n=27 Participants	512 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	6 Participants n=4 Participants	3 Participants n=27 Participants	10 Participants n=483 Participants
Race/Ethnicity, Customized WHITE	170 Participants n=93 Participants	166 Participants n=4 Participants	153 Participants n=27 Participants	489 Participants n=483 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	3 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	5 Participants n=483 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized ASIAN	10 Participants n=93 Participants	13 Participants n=4 Participants	16 Participants n=27 Participants	39 Participants n=483 Participants
Race/Ethnicity, Customized OTHER	4 Participants n=93 Participants	4 Participants n=4 Participants	2 Participants n=27 Participants	10 Participants n=483 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=93 Participants	4 Participants n=4 Participants	1 Participants n=27 Participants	5 Participants n=483 Participants

PRIMARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=147 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=151 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=141 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 52 as Observed	44.2 percentage of participants	33.1 percentage of participants	35.5 percentage of participants

PRIMARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis.

The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=144 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=154 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=140 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline ≥ 50% Based on Observed Cases and Robarts Observed Scores	24.3 percentage of participants	17.5 percentage of participants	16.4 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=147 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=151 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=141 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 at Week 52 as Observed	51.0 percentage of participants	41.7 percentage of participants	41.1 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=147 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=151 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=141 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants With Average Daily Abdominal Pain Score ≤1point and Average Daily Stool Frequency ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 52	41.5 percentage of participants	32.5 percentage of participants	31.9 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases remaining corticosteroid free in the 12 weeks prior to Week 52 were included in the analysis.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=93 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=93 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=85 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among All Participants at Maintenance Day 1	48.4 percentage of participants	34.4 percentage of participants	45.9 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases with CDAI score \<150 at Maintenance Day 1 were included in the analysis.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=54 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=58 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=56 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants With CDAI Score < 150 at Week 52 in Participants With CDAI Score <150 at Maintenance Day 1	37.0 percentage of participants	31.0 percentage of participants	19.6 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis.

The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for ulcer size, ulcerated surface, inflamed surface, and stenosis. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=144 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=154 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=140 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 Points and SES-CD Decrease From Baseline ≥ 2points With no SES-CD Subscore > 1 Point at Week 52 Based on Observed Cases	9.0 percentage of participants	4.5 percentage of participants	8.6 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis.

CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=144 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=151 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=140 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants With CDAI Score < 150 and SES-CD Decrease From Baseline ≥50% at Week 52 Based on Observed Cases and Robarts Observed Scores	19.4 percentage of participants	11.9 percentage of participants	12.9 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis.

Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. The SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). In SES-CD, each of 4 components are assessed in the five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=144 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=151 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=140 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants With Average Daily AP Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With AP and SF no Worse Than Baseline and SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore >1 Point at Week 52	8.3 percentage of participants	3.3 percentage of participants	7.9 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=144 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=151 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=140 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 and SES-CD Decrease From Baseline ≥ 50% at Week 52	20.8 percentage of participants	13.9 percentage of participants	16.4 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=147 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=151 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=141 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants With CDAI Reduction From Baseline ≥ 70 Points at Week 52 Based on Observed Cases	50.3 percentage of participants	43.0 percentage of participants	43.3 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=146 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=150 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=141 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among Subjects Using Corticosteroids at Maintenance Day 1	39.7 percentage of participants	29.3 percentage of participants	30.5 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=143 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=151 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=139 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants With Mucosal Healing (SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore > 1 Point) and Histologic Improvement Based on Robarts Histologic Index (RHI) at Week 52	4.9 percentage of participants	1.3 percentage of participants	2.2 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=188 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=188 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=174 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Time to Relapse (an Increase in CDAI Score From Maintenance Day 1 ≥100 Points and CDAI Score >220, SES-CD ≥ 6 [or ≥4 if Isolated Ileal Disease]), and Exclusion of Other Causes of an Increase in Disease Activity Unrelated to Underlying CD	NA days Not estimable due to insufficient number of events.	NA days Not estimable due to insufficient number of events.	NA days Not estimable due to insufficient number of events.

SECONDARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product.

CDEIS is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon. The CDEIS divides the intestine into 5 segments: rectum, sigmoid and left colon, transverse colon, right colon, and ileum. Four variables are assessed in each segment: the presence of deep ulceration, the presence of superficial ulceration, the percentage of ulcerated surface, and the percentage of surface affected by CD, indicated on 10-cm visual analogue scales. In addition, the presence of ulcerated stenosis and the presence of nonulcerated stenosis are also assessed over the entire intestine. These factors are weighted and summed to calculate the total score ranging from 0- 44, with higher scores indicating more severe disease.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=144 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=154 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=140 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline ≥ 50% at Week 52	25.7 percentage of participants	15.6 percentage of participants	19.3 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Participants with with Clinical Remission at Maintenance Day 1 were included in the analysis.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=93 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=93 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=85 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage of Participants With CDAI Score < 150 at Week 52 and at ≥ 80% of Visits Between Week 8 and Week 52, Inclusive, in Participants With CDAI Score < 150 at Maintenance Day 1	32.3 percentage of participants	31.2 percentage of participants	40.0 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤3 times with AP and SF no worse than baseline. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease.

Outcome measures

Outcome measures
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=144 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=151 Participants Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=140 Participants Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Percentage 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 and SES-CD Decrease From Baseline ≥ 50% at Week 52	20.1 percentage of participants	11.3 percentage of participants	12.9 percentage of participants

Adverse Events

Ozanimod 0.92 mg / Ozanimod 0.92 mg

Serious events: 12 serious events

Other events: 27 other events

Deaths: 1 deaths

Ozanimod 0.92 mg / Placebo

Serious events: 17 serious events

Other events: 43 other events

Deaths: 0 deaths

Placebo / Placebo

Serious events: 19 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Ozanimod 0.92 mg / Ozanimod 0.92 mg n=188 participants at risk Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation.	Ozanimod 0.92 mg / Placebo n=189 participants at risk Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.	Placebo / Placebo n=173 participants at risk Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion.
Gastrointestinal disorders Crohn's disease	7.4% 14/188 • Adverse events were collected from first dose of Maintenance Study and 90 days after the last dose (up to 731 days). All-cause mortality was collected until 327 weeks. All-cause mortality, SAEs and Non-SAES were collected for safety population. 1 participant randomized to Placebo/Placebo was actually dosed to Ozanimod 0.92 mg /placebo.	12.2% 23/189 • Adverse events were collected from first dose of Maintenance Study and 90 days after the last dose (up to 731 days). All-cause mortality was collected until 327 weeks. All-cause mortality, SAEs and Non-SAES were collected for safety population. 1 participant randomized to Placebo/Placebo was actually dosed to Ozanimod 0.92 mg /placebo.	14.5% 25/173 • Adverse events were collected from first dose of Maintenance Study and 90 days after the last dose (up to 731 days). All-cause mortality was collected until 327 weeks. All-cause mortality, SAEs and Non-SAES were collected for safety population. 1 participant randomized to Placebo/Placebo was actually dosed to Ozanimod 0.92 mg /placebo.
Infections and infestations COVID-19	5.9% 11/188 • Adverse events were collected from first dose of Maintenance Study and 90 days after the last dose (up to 731 days). All-cause mortality was collected until 327 weeks. All-cause mortality, SAEs and Non-SAES were collected for safety population. 1 participant randomized to Placebo/Placebo was actually dosed to Ozanimod 0.92 mg /placebo.	7.4% 14/189 • Adverse events were collected from first dose of Maintenance Study and 90 days after the last dose (up to 731 days). All-cause mortality was collected until 327 weeks. All-cause mortality, SAEs and Non-SAES were collected for safety population. 1 participant randomized to Placebo/Placebo was actually dosed to Ozanimod 0.92 mg /placebo.	4.6% 8/173 • Adverse events were collected from first dose of Maintenance Study and 90 days after the last dose (up to 731 days). All-cause mortality was collected until 327 weeks. All-cause mortality, SAEs and Non-SAES were collected for safety population. 1 participant randomized to Placebo/Placebo was actually dosed to Ozanimod 0.92 mg /placebo.
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 4/188 • Adverse events were collected from first dose of Maintenance Study and 90 days after the last dose (up to 731 days). All-cause mortality was collected until 327 weeks. All-cause mortality, SAEs and Non-SAES were collected for safety population. 1 participant randomized to Placebo/Placebo was actually dosed to Ozanimod 0.92 mg /placebo.	6.3% 12/189 • Adverse events were collected from first dose of Maintenance Study and 90 days after the last dose (up to 731 days). All-cause mortality was collected until 327 weeks. All-cause mortality, SAEs and Non-SAES were collected for safety population. 1 participant randomized to Placebo/Placebo was actually dosed to Ozanimod 0.92 mg /placebo.	2.3% 4/173 • Adverse events were collected from first dose of Maintenance Study and 90 days after the last dose (up to 731 days). All-cause mortality was collected until 327 weeks. All-cause mortality, SAEs and Non-SAES were collected for safety population. 1 participant randomized to Placebo/Placebo was actually dosed to Ozanimod 0.92 mg /placebo.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

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Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
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