Trial Outcomes & Findings for Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease (NCT NCT03440372)
NCT ID: NCT03440372
Last Updated: 2025-11-04
Results Overview
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.
TERMINATED
PHASE3
625 participants
At Week 12
2025-11-04
Participant Flow
A total of 625 participants were randomized and of these 623 received at least one dose of study treatment.
Participant milestones
| Measure |
Treatment 1
Participants received ozanimod 0.92 mg
|
Treatment 2
Participants received ozanimod matching placebo
|
|---|---|---|
|
Pre-Treatment
STARTED
|
417
|
208
|
|
Pre-Treatment
COMPLETED
|
416
|
207
|
|
Pre-Treatment
NOT COMPLETED
|
1
|
1
|
|
Treatment
STARTED
|
416
|
207
|
|
Treatment
COMPLETED
|
378
|
185
|
|
Treatment
NOT COMPLETED
|
38
|
22
|
Reasons for withdrawal
| Measure |
Treatment 1
Participants received ozanimod 0.92 mg
|
Treatment 2
Participants received ozanimod matching placebo
|
|---|---|---|
|
Treatment
Adverse Event
|
16
|
8
|
|
Treatment
Lack of Efficacy
|
4
|
2
|
|
Treatment
Withdrawal by Subject
|
12
|
8
|
|
Treatment
Lost to Follow-up
|
1
|
0
|
|
Treatment
Pregnancy
|
1
|
0
|
|
Treatment
Study Terminated by Sponsor
|
2
|
1
|
|
Treatment
Other Reason
|
2
|
3
|
Baseline Characteristics
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
Treatment 1
n=417 Participants
Participants received ozanimod 0.92 mg
|
Treatment 2
n=208 Participants
Participants received ozanimod matching placebo
|
Total
n=625 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
394 Participants
n=15 Participants
|
199 Participants
n=161 Participants
|
593 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=15 Participants
|
9 Participants
n=161 Participants
|
32 Participants
n=100 Participants
|
|
Sex: Female, Male
Female
|
210 Participants
n=15 Participants
|
97 Participants
n=161 Participants
|
307 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
207 Participants
n=15 Participants
|
111 Participants
n=161 Participants
|
318 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=15 Participants
|
14 Participants
n=161 Participants
|
34 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
391 Participants
n=15 Participants
|
190 Participants
n=161 Participants
|
581 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=15 Participants
|
4 Participants
n=161 Participants
|
10 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=15 Participants
|
9 Participants
n=161 Participants
|
30 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=15 Participants
|
4 Participants
n=161 Participants
|
6 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
378 Participants
n=15 Participants
|
188 Participants
n=161 Participants
|
566 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=15 Participants
|
6 Participants
n=161 Participants
|
22 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: At Week 12Population: Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug
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.
Outcome measures
| Measure |
Treatment 1
n=416 Participants
Participants received ozanimod 0.92 mg
|
Treatment 2
n=207 Participants
Participants received ozanimod matching placebo
|
|---|---|---|
|
Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12
Responders
|
31.3 Percentage of Participants
|
20.8 Percentage of Participants
|
|
Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12
Non-Responders
|
64.4 Percentage of Participants
|
73.4 Percentage of Participants
|
|
Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12
Imputed Non-Responders
|
4.3 Percentage of Participants
|
5.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 12Population: Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug
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.
Outcome measures
| Measure |
Treatment 1
n=416 Participants
Participants received ozanimod 0.92 mg
|
Treatment 2
n=207 Participants
Participants received ozanimod matching placebo
|
|---|---|---|
|
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
Responders
|
30.5 Percentage of Participants
|
21.7 Percentage of Participants
|
|
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
Non-Responders
|
66.3 Percentage of Participants
|
72.5 Percentage of Participants
|
|
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
Imputed Non-Responders
|
3.1 Percentage of Participants
|
5.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 12Population: Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug
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): score ranges from 0-12 across four components and 0-60 overall across five segments (ileum, right colon, transverse colon, left colon, rectum). The total higher SES-CD score 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.
Outcome measures
| Measure |
Treatment 1
n=416 Participants
Participants received ozanimod 0.92 mg
|
Treatment 2
n=207 Participants
Participants received ozanimod matching placebo
|
|---|---|---|
|
Percent of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50% at Week 12
Responders
|
22.1 Percentage of Participants
|
18.4 Percentage of Participants
|
|
Percent of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50% at Week 12
Non-Responders
|
71.6 Percentage of Participants
|
77.3 Percentage of Participants
|
|
Percent of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50% at Week 12
Imputed Non-Responders
|
6.3 Percentage of Participants
|
4.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 12Population: Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug
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.
Outcome measures
| Measure |
Treatment 1
n=416 Participants
Participants received ozanimod 0.92 mg
|
Treatment 2
n=207 Participants
Participants received ozanimod matching placebo
|
|---|---|---|
|
Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 at Week 12
Responders
|
48.8 Percentage of Participants
|
39.1 Percentage of Participants
|
|
Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 at Week 12
Non-Responders
|
46.9 Percentage of Participants
|
55.1 Percentage of Participants
|
|
Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 at Week 12
Imputed Non-Responders
|
4.3 Percentage of Participants
|
5.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 12Population: Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug
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).
Outcome measures
| Measure |
Treatment 1
n=416 Participants
Participants received ozanimod 0.92 mg
|
Treatment 2
n=207 Participants
Participants received ozanimod matching placebo
|
|---|---|---|
|
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
Non-Responders
|
78.6 Percentage of Participants
|
84.1 Percentage of Participants
|
|
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
Imputed Non-Responders
|
4.8 Percentage of Participants
|
2.4 Percentage of Participants
|
|
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
Responders
|
16.6 Percentage of Participants
|
13.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 12Population: Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug
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.
Outcome measures
| Measure |
Treatment 1
n=416 Participants
Participants received ozanimod 0.92 mg
|
Treatment 2
n=207 Participants
Participants received ozanimod matching placebo
|
|---|---|---|
|
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
Responders
|
16.6 Percent of Participants
|
13.5 Percent of Participants
|
|
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
Non-Responders
|
78.6 Percent of Participants
|
84.1 Percent of Participants
|
|
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
Imputed Non-Responders
|
4.8 Percent of Participants
|
2.4 Percent of Participants
|
SECONDARY outcome
Timeframe: At Week 12Population: Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug
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.
Outcome measures
| Measure |
Treatment 1
n=416 Participants
Participants received ozanimod 0.92 mg
|
Treatment 2
n=207 Participants
Participants received ozanimod matching placebo
|
|---|---|---|
|
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
Responders
|
8.7 Percentage of Participants
|
6.3 Percentage of Participants
|
|
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
Imputed Non-Responders
|
3.4 Percentage of Participants
|
2.4 Percentage of Participants
|
|
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
Non-Responders
|
88.0 Percentage of Participants
|
91.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 12Population: Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug
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): score ranges from 0-12 across four components and 0-60 overall across five segments (ileum, right colon, transverse colon, left colon, rectum). The total higher SES-CD score indicating greater inflammation.
Outcome measures
| Measure |
Treatment 1
n=416 Participants
Participants received ozanimod 0.92 mg
|
Treatment 2
n=207 Participants
Participants received ozanimod matching placebo
|
|---|---|---|
|
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
Responders
|
11.1 Percentage of Participants
|
7.7 Percentage of Participants
|
|
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
Non-Responders
|
85.6 Percentage of Participants
|
89.9 Percentage of Participants
|
|
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
Imputed Non-Responders
|
3.4 Percentage of Participants
|
2.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 12Population: Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug
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).
Outcome measures
| Measure |
Treatment 1
n=416 Participants
Participants received ozanimod 0.92 mg
|
Treatment 2
n=207 Participants
Participants received ozanimod matching placebo
|
|---|---|---|
|
Histologic Improvement Based on Differences Between Ozanimod and Placebo in Histologic Disease Activity Scores (ie, Global Histologic Activity Score (GHAS) Changes) at Week 12
Imputed Non-Responders
|
6.7 Percentage of Participants
|
5.3 Percentage of Participants
|
|
Histologic Improvement Based on Differences Between Ozanimod and Placebo in Histologic Disease Activity Scores (ie, Global Histologic Activity Score (GHAS) Changes) at Week 12
Responders
|
14.9 Percentage of Participants
|
9.2 Percentage of Participants
|
|
Histologic Improvement Based on Differences Between Ozanimod and Placebo in Histologic Disease Activity Scores (ie, Global Histologic Activity Score (GHAS) Changes) at Week 12
Non-Responders
|
78.4 Percentage of Participants
|
85.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 12Population: Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug
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).
Outcome measures
| Measure |
Treatment 1
n=416 Participants
Participants received ozanimod 0.92 mg
|
Treatment 2
n=207 Participants
Participants received ozanimod matching placebo
|
|---|---|---|
|
Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 70 Points at Week 12
Imputed Non-Responders
|
4.3 Percentage of Participants
|
5.8 Percentage of Participants
|
|
Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 70 Points at Week 12
Responders
|
55.3 Percentage of Participants
|
45.4 Percentage of Participants
|
|
Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 70 Points at Week 12
Non-Responders
|
40.4 Percentage of Participants
|
48.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 12Population: Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug
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.
Outcome measures
| Measure |
Treatment 1
n=416 Participants
Participants received ozanimod 0.92 mg
|
Treatment 2
n=207 Participants
Participants received ozanimod matching placebo
|
|---|---|---|
|
Percent of Participants With Absence of Ulcers ≥ 0.5 cm With No Segment With Any Ulcerated Surface ≥ 10% at Week 12
Imputed Non-Responders
|
6.3 Percentage of Participants
|
4.3 Percentage of Participants
|
|
Percent of Participants With Absence of Ulcers ≥ 0.5 cm With No Segment With Any Ulcerated Surface ≥ 10% at Week 12
Responders
|
26.9 Percentage of Participants
|
20.3 Percentage of Participants
|
|
Percent of Participants With Absence of Ulcers ≥ 0.5 cm With No Segment With Any Ulcerated Surface ≥ 10% at Week 12
Non-Responders
|
66.8 Percentage of Participants
|
75.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 12Population: Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug
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.
Outcome measures
| Measure |
Treatment 1
n=416 Participants
Participants received ozanimod 0.92 mg
|
Treatment 2
n=207 Participants
Participants received ozanimod matching placebo
|
|---|---|---|
|
Percent of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50% at Week 12
Responders
|
25.5 Percentage of Participants
|
19.3 Percentage of Participants
|
|
Percent of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50% at Week 12
Non-Responders
|
68.3 Percentage of Participants
|
76.3 Percentage of Participants
|
|
Percent of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50% at Week 12
Imputed Non-Responders
|
6.3 Percentage of Participants
|
4.3 Percentage of Participants
|
Adverse Events
Treatment 1
Treatment 2
Serious adverse events
| Measure |
Treatment 1
n=416 participants at risk
Participants received ozanimod 0.92 mg
|
Treatment 2
n=207 participants at risk
Participants received ozanimod matching placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Anal fistula
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Crohn's disease
|
2.4%
10/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
4/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Anal abscess
|
0.48%
2/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pyelonephritis
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Heart rate irregular
|
0.00%
0/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.48%
1/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Epilepsy
|
0.24%
1/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Treatment 1
n=416 participants at risk
Participants received ozanimod 0.92 mg
|
Treatment 2
n=207 participants at risk
Participants received ozanimod matching placebo
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
13/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
11/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Crohn's disease
|
2.2%
9/416 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
11/207 • Participants were assessed for All-Cause Mortality, 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).
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
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