Trial · NCT03440372
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
NCT03440372, Phase 3, Terminated, Celgene; results first posted 2025-11-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease. Trials, record NCT03440372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03440372
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
- NCT number
- NCT03440372
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 625 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Crohn Disease
- Interventions
- Ozanimod, Placebo
- First posted
- 2018-02-22
- Last updated
- 2025-11-04
- Other registries' IDs
- eudract:2017-004292-31
- Results first posted
- 2025-11-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 | At Week 12 | 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. |
| Secondary | Percent of Participants With Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 12 | At Week 12 | 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. |
| Secondary | Percent of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50% at Week 12 | At Week 12 | 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. |
| Secondary | Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 at Week 12 | At Week 12 | 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. |
| Secondary | Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% at Week 12 | At Week 12 | 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). |
| Secondary | Percent of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% at Week 12 | At Week 12 | 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. |
| Secondary | Percent of Participants With an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline and an SES-CD ≤ 4 Points and Decrease ≥ 2 Points at Week 12 | At Week 12 | 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. |
| Secondary | Percent of Participants With an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency Score no Worse Than Baseline and an SES-CD Decrease From Baseline of ≥ 50% at Week 12 | At Week 12 | 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. |
| Secondary | Histologic Improvement Based on Differences Between Ozanimod and Placebo in Histologic Disease Activity Scores (ie, Global Histologic Activity Score (GHAS) Changes) at Week 12 | At Week 12 | 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). |
| Secondary | Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 70 Points at Week 12 | At Week 12 | 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). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 | At Week 12 | Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug | Percentage of Participants | NUMBER |
| SECONDARY | Percent of Participants With Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 12 | At Week 12 | Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug | Percentage of Participants | NUMBER |
| SECONDARY | Percent of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50% at Week 12 | At Week 12 | Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug | Percentage of Participants | NUMBER |
| SECONDARY | Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 at Week 12 | At Week 12 | Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug | Percentage of Participants | NUMBER |
| SECONDARY | Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% at Week 12 | At Week 12 | Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug | Percentage of Participants | NUMBER |
| SECONDARY | Percent of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% at Week 12 | At Week 12 | Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug | Percent of Participants | NUMBER |
| SECONDARY | Percent of Participants With an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline and an SES-CD ≤ 4 Points and Decrease ≥ 2 Points at Week 12 | At Week 12 | Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug | Percentage of Participants | NUMBER |
| SECONDARY | Percent of Participants With an Average Daily Abdominal Pain Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With Abdominal Pain and Stool Frequency Score no Worse Than Baseline and an SES-CD Decrease From Baseline of ≥ 50% at Week 12 | At Week 12 | Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug | Percentage of Participants | NUMBER |
| SECONDARY | Histologic Improvement Based on Differences Between Ozanimod and Placebo in Histologic Disease Activity Scores (ie, Global Histologic Activity Score (GHAS) Changes) at Week 12 | At Week 12 | Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug | Percentage of Participants | NUMBER |
| SECONDARY | Percent of Participants With Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 70 Points at Week 12 | At Week 12 | Intent to treat population consist of all randomized participants that received at least 1 dose of investigational drug | Percentage of Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 | Treatment 1 | Responders | 31.3 | Percentage of Participants | |
| Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 | Treatment 2 | Responders | 20.8 | Percentage of Participants | |
| Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 | Treatment 1 | Non-Responders | 64.4 | Percentage of Participants | |
| Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 | Treatment 2 | Non-Responders | 73.4 | Percentage of Participants | |
| Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 | Treatment 1 | Imputed Non-Responders | 4.3 | Percentage of Participants | |
| Percent of Participants With a Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 | Treatment 2 | Imputed Non-Responders | 5.8 | 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 | Treatment 1 | Responders | 30.5 | 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 | Treatment 2 | Responders | 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 | Treatment 1 | Non-Responders | 66.3 | 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 | Treatment 2 | Non-Responders | 72.5 | Percentage of Participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-Treatment | STARTED | Treatment 1 | 417 | |
| Pre-Treatment | STARTED | Treatment 2 | 208 | |
| Pre-Treatment | COMPLETED | Treatment 1 | 416 | |
| Pre-Treatment | COMPLETED | Treatment 2 | 207 | |
| Pre-Treatment | NOT COMPLETED | Treatment 1 | 1 | |
| Pre-Treatment | NOT COMPLETED | Treatment 2 | 1 | |
| Treatment | STARTED | Treatment 1 | 416 | |
| Treatment | STARTED | Treatment 2 | 207 | |
| Treatment | COMPLETED | Treatment 1 | 378 | |
| Treatment | COMPLETED | Treatment 2 | 185 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Crohn's disease | Gastrointestinal disorders | Treatment 1 | 9 | 416 | |
| other | Crohn's disease | Gastrointestinal disorders | Treatment 2 | 11 | 207 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Treatment 1 | 13 | 416 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Treatment 2 | 11 | 207 | |
| serious | Anaemia | Blood and lymphatic system disorders | Treatment 1 | 1 | 416 | |
| serious | Anaemia | Blood and lymphatic system disorders | Treatment 2 | 0 | 207 | |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | Treatment 1 | 1 | 416 | |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | Treatment 2 | 0 | 207 | |
| serious | Cardiac arrest | Cardiac disorders | Treatment 1 | 1 | 416 | |
| serious | Cardiac arrest | Cardiac disorders | Treatment 2 | 0 | 207 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment 1 | 0 | 416 |
| Total, all-cause mortality | Treatment 2 | 0 | 207 |
| Total, other adverse events | Treatment 1 | 22 | 416 |
| Total, other adverse events | Treatment 2 | 22 | 207 |
| Total, serious adverse events | Treatment 1 | 27 | 416 |
| Total, serious adverse events | Treatment 2 | 10 | 207 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36208720 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment 1 vs Treatment 2: deaths from any cause | Trial comparisons |
| Treatment 1 vs Treatment 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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