Trial Outcomes & Findings for Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease (NCT NCT03440385)

Last Updated: 2024-12-05

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

COMPLETED

Study phase

PHASE3

Target enrollment

606 participants

Primary outcome timeframe

Week 12

Results posted on

2024-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Ozanimod Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Overall Study STARTED	403	203
Overall Study Safety Population	404	202
Overall Study COMPLETED	360	183
Overall Study NOT COMPLETED	43	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Ozanimod Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Overall Study Other Reason	4	1
Overall Study Site Closed	1	0
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	12	6
Overall Study Lack of Efficacy	9	2
Overall Study Adverse Event	15	11

Baseline Characteristics

Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ozanimod n=403 Participants Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=203 Participants Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.	Total n=606 Participants Total of all reporting groups
Age, Continuous	39.8 years STANDARD_DEVIATION 13.69 • n=5 Participants	37.7 years STANDARD_DEVIATION 13.79 • n=7 Participants	39.1 years STANDARD_DEVIATION 13.75 • n=5 Participants
Sex: Female, Male Female	182 Participants n=5 Participants	90 Participants n=7 Participants	272 Participants n=5 Participants
Sex: Female, Male Male	221 Participants n=5 Participants	113 Participants n=7 Participants	334 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	378 Participants n=5 Participants	188 Participants n=7 Participants	566 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized WHITE	329 Participants n=5 Participants	166 Participants n=7 Participants	495 Participants n=5 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized ASIAN	47 Participants n=5 Participants	29 Participants n=7 Participants	76 Participants n=5 Participants
Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized OTHER	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized NOT REPORTED	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intent to Treat population included all the randomized participants.

Outcome measures

Outcome measures
Measure	Ozanimod n=403 Participants Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=203 Participants Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150	29.8 percentage of participants	30.5 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat Population included all the randomized participants.

Abdominal pain and stool frequency clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 with abdominal pain and stool frequency no worse than baseline at Week 12. Participants entered the responses in diaries daily. The 7 days entries prior to Week 12 visit were considered for calculating average abdominal pain score and stool frequency. The abdominal pain was graded on severity of 0 (none) to 3 (severe) scale and stool frequency was defined number of liquid or soft stools per day. 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 n=403 Participants Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=203 Participants Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission	29.0 percentage of participants	26.6 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat population included all the randomized participants.

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 n=403 Participants Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=203 Participants Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%	25.6 percentage of participants	21.2 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to treat population included all the randomized participants.

Outcome measures

Outcome measures
Measure	Ozanimod n=403 Participants Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=203 Participants Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Percentage of Participants With Reduction From Baseline in the Crohn's Disease Activity Index (CDAI) Score of >= 100 Points or a Total CDAI Score < 150	46.2 percentage of participants	47.3 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat population included all the randomized participants. 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

CDAI include 8 components number of soft/liquid stools, severity of abdominal pain, wellbeing, complications, need antidiarrheal drugs, abdominal mass, hematocrit, deviation in body wt. Subscores of numbers 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 visit. The others weighted to create the total CDAI score ranging 0-600 with higher score indicating worse outcome. 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 n=403 Participants Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=203 Participants Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and SES-CD Decrease From Baseline of ≥ 50%	16.9 percentage of participants	14.3 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Ozanimod n=403 Participants Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=203 Participants Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%	11.7 percentage of participants	11.3 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat population included all the randomized subjects. 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.

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 n=403 Participants Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=203 Participants Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission and a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score <= 4 Points and Decrease >= 2 Points	10.4 percentage of participants	8.4 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to treat population included all the randomized participants.

GHAS assesses the inflammation and mucosal damage. GHAS has 8 components Epithelial damage, Architectural changes, Infiltration of mononuclear cells in the lamina propria, Infiltration of polymorphonuclear cells in the lamina propria, Polymorphonuclear cells in epithelium, Presence of erosion and/or ulcers, Presence of granuloma and number of biopsy specimens affected. Each of these components was scored on a scale of 0 (none/unaffected) to 2 (worst). Each of these 8 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. Within each segment, the GHAS score has a range of 0 - 16, and the total GHAS score has a range of 0 - 80. Higher numbers correspond to more inflammation and more mucosal damage. 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 n=403 Participants Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=203 Participants Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Percentage of Participants With Global Histologic Activity Score (GHAS) Remission	13.6 percentage of participants	10.8 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to treat population included all the randomized participants.

Outcome measures

Outcome measures
Measure	Ozanimod n=403 Participants Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=203 Participants Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Percentage of Participants With CDAI Reduction From Baseline of >=70 Points	52.9 percentage of participants	51.7 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to treat participants included all the randomized participants.

The ulcerated surface were assessed via endoscopy.

Outcome measures

Outcome measures
Measure	Ozanimod n=403 Participants Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=203 Participants Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Percentage of Participants With Absence of Ulcers ≥ 0.5 cm With no Segment With Any Ulcerated Surface ≥10%	25.3 percentage of partiicpants	24.1 percentage of partiicpants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat included all the randomized participants. 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.

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 n=403 Participants Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=203 Participants Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50%	27.5 percentage of participants	21.7 percentage of participants

SECONDARY outcome

Timeframe: Week 12

AP and SF clinical remission is 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. 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 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). Endoscopic Response is defined as \>= 50% decrease from baseline in SES-CD. In SES-CD, each of 4 components are assessed in five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was sum of individual scores of each of components across five segments. 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 n=403 Participants Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=203 Participants Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission and an Endoscopic (50%) Response	11.7 percentage of particpants	9.4 percentage of particpants

SECONDARY outcome

Timeframe: Week 12

Population: Intent-to-treat population included all the randomized participants. 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.

RHI mucosal healing was defined as RHI remission combined with SES-CD \<= 4 points and a SES-CD decrease from baseline \>= 2 points with no SES-CD sub-score \>1 point. RHI Remission is defined as no active inflammation in any measured segment. 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.

Outcome measures

Outcome measures
Measure	Ozanimod n=403 Participants Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=203 Participants Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Percentage of Participants With Robarts Histologic Index (RHI) Mucosal Healing at Week 12	4.0 percentage of participants	4.9 percentage of participants

Adverse Events

Ozanimod

Serious events: 24 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo

Serious events: 11 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Ozanimod n=404 participants at risk Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. 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) from Day 8 to Week 12.	Placebo n=202 participants at risk Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12.
Gastrointestinal disorders Crohn's disease	3.7% 15/404 • All cause mortality, non serious adverse events and serious adverse events were collected from the first dose and up to approximately 31 weeks. Treated population include all the participants who were treated with at least one dose of study drug. 1 participant earlier randomized or pre-assigned to Placebo arm in error received Ozanimod and was included in Ozanimod' arm.	5.4% 11/202 • All cause mortality, non serious adverse events and serious adverse events were collected from the first dose and up to approximately 31 weeks. Treated population include all the participants who were treated with at least one dose of study drug. 1 participant earlier randomized or pre-assigned to Placebo arm in error received Ozanimod and was included in Ozanimod' arm.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

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.
Publication restrictions are in place

Restriction type: OTHER