NCT03464097

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

Terminated Phase 3 Results posted Last updated 9 October 2025

What this trial tests

Phase 3 trial testing Ozanimod in Crohn Disease in 550 participants. Terminated before completion.

Timeline

27 June 2018

Primary endpoint
3 October 2024

3 October 2024

Quick facts

Lead sponsor	Celgene
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	550
Start date	27 June 2018
Primary completion	3 October 2024
Estimated completion	3 October 2024
Sites	765 locations across Hong Kong, Colombia, Finland, Italy, Taiwan, Ireland, Poland, South Korea

Drugs / interventions tested

• Ozanimod (OZANIMOD) — full drug profile →
• Placebo

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →

Sponsor

Celgene — full company profile →

Who can join

Adults 18 to 75, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 52 as Observed Primary · Week 52

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. Addition

Group	Value	95% CI
Ozanimod 0.92 mg / Ozanimod 0.92 mg	44.2
Ozanimod 0.92 mg / Placebo	33.1
Placebo / Placebo	35.5

Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline ≥ 50% Based on Observed Cases and Robarts Observed Scores Primary · Week 52

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

Group	Value	95% CI
Ozanimod 0.92 mg / Ozanimod 0.92 mg	24.3
Ozanimod 0.92 mg / Placebo	17.5
Placebo / Placebo	16.4

Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 at Week 52 as Observed Secondary · Week 52

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. Addition

Group	Value	95% CI
Ozanimod 0.92 mg / Ozanimod 0.92 mg	51.0
Ozanimod 0.92 mg / Placebo	41.7
Placebo / Placebo	41.1

Percentage of Participants With Average Daily Abdominal Pain Score ≤1point and Average Daily Stool Frequency ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 52 Secondary · Week 52

Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤3 times with AP and SF no worse than baseline 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.

Group	Value	95% CI
Ozanimod 0.92 mg / Ozanimod 0.92 mg	41.5
Ozanimod 0.92 mg / Placebo	32.5
Placebo / Placebo	31.9

Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among All Participants at Maintenance Day 1 Secondary · Week 52

Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤3 times with AP and SF no worse than baseline 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.

Group	Value	95% CI
Ozanimod 0.92 mg / Ozanimod 0.92 mg	48.4
Ozanimod 0.92 mg / Placebo	34.4
Placebo / Placebo	45.9

Percentage of Participants With CDAI Score < 150 at Week 52 in Participants With CDAI Score <150 at Maintenance Day 1 Secondary · Week 52

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. Addition

Group	Value	95% CI
Ozanimod 0.92 mg / Ozanimod 0.92 mg	37.0
Ozanimod 0.92 mg / Placebo	31.0
Placebo / Placebo	19.6

Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 Points and SES-CD Decrease From Baseline ≥ 2points With no SES-CD Subscore > 1 Point at Week 52 Based on Observed Cases Secondary · Week 52

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

Group	Value	95% CI
Ozanimod 0.92 mg / Ozanimod 0.92 mg	9.0
Ozanimod 0.92 mg / Placebo	4.5
Placebo / Placebo	8.6

Percentage of Participants With CDAI Score < 150 and SES-CD Decrease From Baseline ≥50% at Week 52 Based on Observed Cases and Robarts Observed Scores Secondary · Week 52

CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Remaining predictors were also noted and weighted

Group	Value	95% CI
Ozanimod 0.92 mg / Ozanimod 0.92 mg	19.4
Ozanimod 0.92 mg / Placebo	11.9
Placebo / Placebo	12.9

Percentage of Participants With Average Daily AP Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With AP and SF no Worse Than Baseline and SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore >1 Point at Week 52 Secondary · Week 52

Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 times with AP and SF no worse than baseline 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

Group	Value	95% CI
Ozanimod 0.92 mg / Ozanimod 0.92 mg	8.3
Ozanimod 0.92 mg / Placebo	3.3
Placebo / Placebo	7.9

Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 and SES-CD Decrease From Baseline ≥ 50% at Week 52 Secondary · Week 52

CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Remaining predictors were also noted and weighted

Group	Value	95% CI
Ozanimod 0.92 mg / Ozanimod 0.92 mg	20.8
Ozanimod 0.92 mg / Placebo	13.9
Placebo / Placebo	16.4

Percentage of Participants With CDAI Reduction From Baseline ≥ 70 Points at Week 52 Based on Observed Cases Secondary · Week 52

CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Remaining predictors were also noted and weighted

Group	Value	95% CI
Ozanimod 0.92 mg / Ozanimod 0.92 mg	50.3
Ozanimod 0.92 mg / Placebo	43.0
Placebo / Placebo	43.3

Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among Subjects Using Corticosteroids at Maintenance Day 1 Secondary · Week 52

CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. Sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Remaining predictors were also noted and weighted

Group	Value	95% CI
Ozanimod 0.92 mg / Ozanimod 0.92 mg	39.7
Ozanimod 0.92 mg / Placebo	29.3
Placebo / Placebo	30.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from first dose of Maintenance Study and 90 days after the last dose (up to 731 days). All-cause mortality was collected until 327 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ozanimod 0.92 mg / Ozanimod 0.92 mg

Serious: 12/188 (6%)

Deaths: 1/188

Ozanimod 0.92 mg / Placebo

Serious: 17/189 (9%)

Deaths: 0/189

Placebo / Placebo

Serious: 19/173 (11%)

Deaths: 0/173

Serious adverse events (38 terms)

Reaction	System	Ozanimod 0.92 mg / Ozanimo…	Ozanimod 0.92 mg / Placebo	Placebo / Placebo
Crohn's disease	Gastrointestinal disorders	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—
Anal abscess	Infections and infestations	—	—	—
COVID-19 pneumonia	Infections and infestations	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—
Atrioventricular block second degree	Cardiac disorders	—	—	—
Ischaemic cardiomyopathy	Cardiac disorders	—	—	—
Microvascular coronary artery disease	Cardiac disorders	—	—	—
Ventricular extrasystoles	Cardiac disorders	—	—	—
Anal fistula	Gastrointestinal disorders	—	—	—
Enterocolonic fistula	Gastrointestinal disorders	—	—	—
Ileal perforation	Gastrointestinal disorders	—	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—
Proctitis	Gastrointestinal disorders	—	—	—
Subileus	Gastrointestinal disorders	—	—	—
Liver injury	Hepatobiliary disorders	—	—	—
Abdominal abscess	Infections and infestations	—	—	—
Appendicitis	Infections and infestations	—	—	—
COVID-19	Infections and infestations	—	—	—
Clostridium difficile colitis	Infections and infestations	—	—	—
Colonic abscess	Infections and infestations	—	—	—
Peritonitis	Infections and infestations	—	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Ozanimod 0.92 mg / Ozanimo…	Ozanimod 0.92 mg / Placebo	Placebo / Placebo
Crohn's disease	Gastrointestinal disorders	—	—	—
COVID-19	Infections and infestations	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—

Most-reported serious reactions: Crohn's disease, Small intestinal obstruction, Anal abscess, COVID-19 pneumonia, Anaemia, Iron deficiency anaemia, Atrioventricular block second degree, Ischaemic cardiomyopathy.

Data from ClinicalTrials.gov NCT03464097 adverse events section.

Sponsor's own description

This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting Sphingosine-1-Phosphate Signaling in Immune-Mediated Diseases: Beyond Multiple Sclerosis.
   Pérez-Jeldres T, Alvarez-Lobos M, Rivera-Nieves J. · · 2021 · cited 150× · PMID 33983615 · DOI 10.1007/s40265-021-01528-8
2. Novel and Emerging Therapies for Inflammatory Bowel Disease.
   Al-Bawardy B, Shivashankar R, Proctor DD. · · 2021 · cited 117× · PMID 33935763 · DOI 10.3389/fphar.2021.651415
3. Perspectives on Current and Novel Treatments for Inflammatory Bowel Disease.
   Na SY, Moon W. · · 2019 · cited 99× · PMID 31195433 · DOI 10.5009/gnl19019
4. History of Inflammatory Bowel Diseases.
   Actis GC, Pellicano R, Fagoonee S, Ribaldone DG. · · 2019 · cited 87× · PMID 31739460 · DOI 10.3390/jcm8111970
5. New biologics and small molecules in inflammatory bowel disease: an update.
   Sabino J, Verstockt B, Vermeire S, Ferrante M. · · 2019 · cited 73× · PMID 31205488 · DOI 10.1177/1756284819853208
6. The S1P-S1PR Axis in Neurological Disorders-Insights into Current and Future Therapeutic Perspectives.
   Lucaciu A, Brunkhorst R, Pfeilschifter JM, Pfeilschifter W, et al · · 2020 · cited 53× · PMID 32580348 · DOI 10.3390/cells9061515
7. Histological Scores in Patients with Inflammatory Bowel Diseases: The State of the Art.
   Vespa E, D'Amico F, Sollai M, Allocca M, et al · · 2022 · cited 52× · PMID 35207211 · DOI 10.3390/jcm11040939
8. Inflammatory Bowel Disease: Emerging Therapies and Future Treatment Strategies.
   Bretto E, Ribaldone DG, Caviglia GP, Saracco GM, et al · · 2023 · cited 38× · PMID 37626745 · DOI 10.3390/biomedicines11082249