Trial Outcomes & Findings for Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease (NCT NCT02531113)

NCT ID: NCT02531113

Last Updated: 2021-01-22

Results Overview

The simple endoscopy score (SES-CD) assesses 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 are scored on a scale of 0 to 3. In the SES-CD, each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right, transverse, left (descending and sigmoid), and rectum. The SES-CD is the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores is 0 - 12 for each segment, and 0 - 56 for the overall SES-CD score, with larger scores indicating greater severity of disease.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 69 participants
• Primary outcome timeframe: Baseline to Week 12
• Results posted on: 2021-01-22

Participant Flow

Sixty-nine adult participants were enrolled from 28 sites located in Europe and North America.

Eligible participants must have had a Crohn's Disease Activity Index (CDAI) score of 220 to 450 inclusive with an Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 and an average daily stool score ≥ 4 points and/or an average daily abdominal pain score of ≥ 2 points.

Participant milestones

Measure	Ozanimod Hydrochloride (HCl) 1 mg Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
Induction Period: Week 0 to 12 STARTED	69
Induction Period: Week 0 to 12 COMPLETED	58
Induction Period: Week 0 to 12 NOT COMPLETED	11
Extension Period: Week 12 up to Week 160 STARTED	52
Extension Period: Week 12 up to Week 160 COMPLETED	14
Extension Period: Week 12 up to Week 160 NOT COMPLETED	38

Reasons for withdrawal

Measure	Ozanimod Hydrochloride (HCl) 1 mg Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
Induction Period: Week 0 to 12 Adverse Event	4
Induction Period: Week 0 to 12 Lack of Efficacy	4
Induction Period: Week 0 to 12 Withdrawal by Subject	3
Extension Period: Week 12 up to Week 160 Physician Decision	2
Extension Period: Week 12 up to Week 160 Adverse Event	5
Extension Period: Week 12 up to Week 160 Lack of Efficacy	19
Extension Period: Week 12 up to Week 160 Withdrawal by Subject	11
Extension Period: Week 12 up to Week 160 Pregnancy	1

Baseline Characteristics

Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease

Baseline characteristics by cohort

Measure	Ozanimod Hydrochloride (HCl) 1 mg n=69 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
Age, Continuous	37.7 Years STANDARD_DEVIATION 11.97 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Race/Ethnicity, Customized White	60 Participants n=5 Participants
Years Since Crohn's Disease Diagnosis	8.9 Years STANDARD_DEVIATION 8.53 • n=5 Participants
Crohn's Disease Activity Index (CDAI) Score at Baseline	322.8 Units on a Scale STANDARD_DEVIATION 59.19 • n=5 Participants
Daily Stool Frequency (SF) at Baseline	6.15 Stools/day STANDARD_DEVIATION 2.792 • n=5 Participants
Daily Abdominal Pain Score at Baseline	2.05 Units on a Scale STANDARD_DEVIATION 0.526 • n=5 Participants
Prior Corticosteroid Use Prior Use of Corticosteroids	62 Participants n=5 Participants
Prior Corticosteroid Use No Prior Use of Corticosteroids	7 Participants n=5 Participants
Simple Endoscopic Score for Crohn's Disease (SES-CD) at Baseline	13.28 Units on a Scale STANDARD_DEVIATION 6.584 • n=5 Participants
Prior Use of Immunomodulator Prior Use of Immunomodulator	38 Participants n=5 Participants
Prior Use of Immunomodulator No Prior Use of Immunomodulator	31 Participants n=5 Participants
Fecal Calprotectin at Baseline	1158.17 μg/g STANDARD_DEVIATION 1231.267 • n=5 Participants
C-reactive Protein (mg/L) at Baseline	18.2 (mg/L) STANDARD_DEVIATION 25.36 • n=5 Participants
Disease Location Ileum Only	11 Participants n=5 Participants
Disease Location Colon Only	26 Participants n=5 Participants
Disease Location Ileocolonic (Ileum and Colon)	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: The intent to treat population = all enrolled participants who received at least one dose of ozanimod. For paired segment scores, any missing segment scores, were imputed by non-missing score used in previous visit. Analysis for change from baseline includes those with data available at baseline and visit.

The simple endoscopy score (SES-CD) assesses 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 are scored on a scale of 0 to 3. In the SES-CD, each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right, transverse, left (descending and sigmoid), and rectum. The SES-CD is the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores is 0 - 12 for each segment, and 0 - 56 for the overall SES-CD score, with larger scores indicating greater severity of disease.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=56 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) (Paired Segments) From Baseline at Week 12 as Determined by a Blinded Central Reader.

-2.3 Units on a Scale Standard Deviation 6.20

SECONDARY outcome

Timeframe: From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years

Population: The Safety population included all enrolled participants who received at least one dose of ozanimod.

A TEAE = any event with an onset date on or after the first dose date, or any ongoing event on the first dose date that worsens in severity or after the first dose date and until 90 days following the last dose of study drug treatment. An AE = untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which that does not necessarily have a causal relationship with the investigational treatment. An AE can be any unfavorable or unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not considered related to the investigational medicinal product.

A serious AE (experience) or reaction is any untoward medical occurrence that at any dose

• Results in death
• Is life-threatening
• Requires inpatient hospitalization or prolongation of existing hospitalization
• Results in persistent or significant disability/incapacity, or
• Is a congenital abnormality/birth defect

Outcome measures

Measure	Ozanimod Hydrochloride (HCl) 1 mg n=69 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period ≥ 1 TEAE	59 Participants
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period ≥ 1 Moderate or Severe TEAE	43 Participants
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period ≥ 1 Severe TEAE	15 Participants
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period ≥ 1 Possible, Probable or Related TEAE	24 Participants
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period ≥ 1 Related TEAE	7 Participants
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period ≥ 1 Serious TEAE	18 Participants
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period ≥ 1 Possible, Probable or Related Serious TEAE	4 Participants
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period ≥ 1 Related Serious TEAE	1 Participants
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period ≥ 1 TEAE Leading to Discontinuation of Ozanimod	11 Participants
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period ≥ 1 TEAE Leading to Study Withdrawal	11 Participants
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period Death	1 Participants
The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period Death Possible, Probable or Related to Ozanimod	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 12

Population: The ITT included all enrolled participants and received at least one dose of ozanimod. Analysis for change from baseline includes participants with data available at baseline and visit.

The Crohn's Disease Activity Index is a composite score that is used to measure the clinical activity of Crohn's disease. The CDAI includes uses 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, General well-being for 7 days, Presence of complications, Taking diarrhea medication, Abdominal mass, Hematocrit and Percentage deviation from standard weight. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity. Baseline was defined as the last non-missing record on or before the first dose of study drug.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=54 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Change in the Crohn's Disease Activity Index (CDAI) Score From Baseline at Week 12

-141.5 Units on a Scale Standard Deviation 99.42

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12

Population: The ITT included all enrolled participants and received at least one dose of ozanimod. If CDAI score was missing, then non-responder imputation (NRI) was applied.

Clinical Remission is defined as a CDAI score of < 150. The Crohn's Disease Activity Index is a composite score that is used to measure the clinical activity of Crohn's disease. The CDAI includes uses 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, General well-being for 7 days, Presence of complications, Taking diarrhea medication, Abdominal mass, Hematocrit and Percentage deviation from standard weight. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=69 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Percentage of Participants With Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12

33.3 Percentage of Participants Interval 22.44 to 45.71

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12

Population: The ITT included all enrolled participants and received at least one dose of ozanimod. If CDAI score was missing, then non-responder imputation (NRI) was applied.

Clinical Response is defined as a CDAI reduction from baseline of ≥ 100 points. The Crohn's Disease Activity Index is a composite score that is used to measure the clinical activity of Crohn's disease. The CDAI includes uses 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, General well-being for 7 days, Presence of complications, Taking diarrhea medication, Abdominal mass, Hematocrit and Percentage deviation from standard weight. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=69 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Percentage of Participants Who Achieved a Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Week 12

50.7 Percentage of Participants Interval 38.41 to 62.98

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12

Population: The ITT included all enrolled participants and received at least one dose of ozanimod. If stool frequency and abdominal pain were missing, then non-reesponder imputation (NRI) was applied.

The PRO2 is a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency (SF) and abdominal pain (AP) (rated on a scale of 0-3) assessed for 7 days. Clinical Remission (SF and AP remission) was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=69 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Percentage of Participants Who Achieved Clinical Remission Based on Patient-Reported Outcome (PRO2) Measure Definitions at Week 12

20.3 Percentage of Participants Interval 11.56 to 31.69

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12

Population: The ITT included all enrolled participants and received at least one dose of ozanimod. If PRO2 CD score was missing, then non-responder imputation (NRI) was applied.

Clinical response based on PRO2 was defined as PRO2 decrease of ≥50% from baseline. The PRO2 is a composite score based on 2 components of the Crohn's Disease Activity Index, the number of liquid or soft stools/day for 7 days and the abdominal pain (rated on a scale of 0-3) assessed for 7 days. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=69 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Percentage of Participants Who Achieved a Clinical Response Based on Patient Reported Outcome (PRO2) Measures From Baseline at Week 12

29.0 Percentage of Participants Interval 18.69 to 41.16

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12

Population: The ITT = all enrolled participants who received at least one dose of ozanimod. For paired segments analysis, any missing segment scores in the presence of at least 1 non-missing segmental SES-CD score were imputed by non-missing score used in the previous visit. If post-baseline SES-CD score was missing, then NRI was applied.

Endoscopic remission is defined as SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points with no SES-CD sub-score >1point. The SES-CD assesses 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 are scored on a scale of 0 to 3. In the SES-CD, each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right, transverse, left (descending and sigmoid), and rectum. The SES-CD is the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores is 0 - 12 for each segment, and 0 - 56 for the overall SES-CD score, with larger scores indicating greater severity of disease. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=69 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Percentage of Participants of Participants Who Achieved Endoscopic Remission Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Definitions at Week 12 (Paired Segments)

10.1 Percentage of Participants Interval 4.18 to 19.79

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12

Population: The ITT included all enrolled participants and received at least one dose of ozanimod. For paired segments analysis, any missing segment scores in the presence of at least 1 non-missing segmental SES-CD score were imputed by non-missing score used in the previous visit. If post-baseline SES-CD score was missing, then NRI was applied.

Endoscopic Response is defined as a SES-CD decrease from baseline of ≥ 50%. The SES-CD assesses 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 are scored on a scale of 0 to 3. In the SES-CD, each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right, transverse, left (descending and sigmoid), and rectum. The SES-CD is the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores is 0 - 12 for each segment, and 0 - 56 for the overall SES-CD score, with larger scores indicating greater severity of disease. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=69 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Percentage of Participants Who Achieved an Endoscopic Response-50 (Paired Segment) Based on Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Definitions at Week 12

23.2 Percentage of Participants Interval 13.87 to 34.91

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12

Population: The ITT population = all enrolled participants who received at least one dose of ozanimod. For paired segment analysis, any missing segment scores in the presence of at least 1 non-missing segmental SES-CD score were imputed by non-missing score used in the previous visit. Analysis includes participants with data available at baseline and visit.

Changes in intestinal mucosa histopathologic features and disease activity were assessed by blinded pathologists. Robarts Histopathology Index (RHI) had a maximum total score of 165, with higher scores indicating more severe histological disease. Baseline was defined as the last non-missing record on or before the first dose of study drug.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=51 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Change in Roberts Intestinal Histopathology Index From Baseline (Paired Segments) at Week 12

-10.2 Units on a Scale Standard Deviation 25.83

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12

Population: This endpoint was omitted because there were too few study participants with perianal or enterocutaneous fistulas at baseline to allow for meaningful evaluation. No analysis performed.

The assessment is based on two parameters: whether the fistula is draining and whether it's open or closed. This is assessment was only on participants that had a fistula at baseline.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Population: The ITT = all enrolled participants who received at least one dose of ozanimod. For Robarts Observed Score, the SES-CD score was determined based on all available segments at a given visit without adjusting for the segments available at baseline. Observed Cases.

Endoscopic remission is defined as SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points with no SES-CD sub-score >1point. The SES-CD assesses 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 are scored on a scale of 0 to 3. In the SES-CD, each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right, transverse, left (descending and sigmoid), and rectum. The SES-CD is the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores is 0 - 12 for each segment, and 0 - 56 for the overall SES-CD score, with larger scores indicating greater severity of disease. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=30 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Percentage of Participants Who Achieved Endoscopic Remission Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Definitions at Week 52 - Observed Cases

16.7 Percentage of Participants Interval 5.64 to 34.72

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Population: The intent to treat population (ITT) = all enrolled participants who received at least one dose of ozanimod. For Robarts Observed Score, the SES-CD score is determined based on all available segments at a given visit without adjusting for the segments available at baseline.Observed cases.

Endoscopic Response is defined as a SES-CD decrease from baseline of ≥ 50%. The SES-CD assesses 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 are scored on a scale of 0 to 3. In the SES-CD, each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right, transverse, left (descending and sigmoid), and rectum. The SES-CD is the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores is 0 - 12 for each segment, and 0 - 56 for the overall SES-CD score, with larger scores indicating greater severity of disease. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method..

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=30 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Percentage of Participants Who Achieved an Endoscopic Response-50 Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Definitions at Week 52

30.0 Percentage of Participants Interval 14.73 to 49.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Population: The ITT population included all enrolled participants who received at least one dose of ozanimod. Observed Cases.

Clinical Remission is defined as a CDAI score of < 150. The CDAI includes uses 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, General well-being for 7 days, Presence of complications, Taking diarrhea medication, Abdominal mass, Hematocrit and Percentage deviation from standard weight. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=32 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Percentage of Participants Who Achieved Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 52

65.6 Percentage of Participants Interval 46.81 to 81.43

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Population: The ITT population included all enrolled participants who received at least one dose of ozanimod. Observed Cases.

Clinical Response is defined as a CDAI reduction from baseline of ≥ 100 points. The CDAI includes uses 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, General well-being for 7 days, Presence of complications, Taking diarrhea medication, Abdominal mass, Hematocrit and Percentage deviation from standard weight. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=32 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Percentage of Participants Who Achieved a Clinical Response Based on CDAI at Week 52

93.8 Percentage of Participants Interval 79.19 to 99.23

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Population: The ITT population included all enrolled participants who received at least one dose of ozanimod. Observed cases.

Clinical Remission is defined as the participants with the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point. The PRO2 is a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days and the abdominal pain (rated on a scale of 0-3) assessed for 7 days.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=32 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Percentage of Participants Who Achieved Clinical Remission Based on Patient-Reported Outcome (PRO2) Measure Definitions at Week 52

53.1 Percentage of Participants Interval 34.74 to 70.91

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Population: The ITT included all enrolled participants and received at least one dose of ozanimod. Observed Cases.

Clinical response based on PRO2 was defined as PRO2 decrease of ≥50% from baseline. The PRO2 is a composite score based on 2 components of the Crohn's Disease Activity Index, the number of liquid or soft stools/day for 7 days and the abdominal pain (rated on a scale of 0-3) assessed for 7 days. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=32 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Percentage of Participants Who Achieved a Clinical Response Based on Patient Reported Outcome (PRO2) Measures From Baseline at Week 52

65.6 Percentage of Participants Interval 46.81 to 81.43

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Population: The ITT population included all enrolled participants who received at least one dose of ozanimod. Participants who were taking corticosteroids at baseline. Observed cases.

Clinical Remission is defined as CDAI score of < 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease. The CDAI uses a questionnaire with responses scored numerically and weighted. The weighted sum of the 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, general well-being for 7 days, presence of complications, taking diarrhea medication, abdominal mass, hematocrit and percentage deviation from standard weight. The typical range of CDAI score is 0 to > 600. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=16 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Percentage of Participants in Clinical Remission Based on CDAI and PRO2 Definitions Who Were Off Corticosteroids at Week 52 of Those on Corticosteroids

18.8 Percentage of Participants Interval 4.05 to 45.65

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4 and 8

Population: The ITT population included all enrolled participants who received at least one dose of ozanimod. Non-responder imputed. (NRI).

Clinical Remission is defined as a CDAI score of < 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease. The CDAI includes uses 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, General well-being for 7 days, Presence of complications, Taking diarrhea medication, Abdominal mass, Hematocrit and Percentage deviation from standard weight. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure	Ozanimod Hydrochloride (HCl) 1 mg n=69 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
Percentage of Participants With Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Weeks 4 and 8 Week 4	15.9 Percentage of Participants
Percentage of Participants With Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Weeks 4 and 8 Week 8	23.2 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4 and 8

Population: The ITT population included all enrolled participants who received at least one dose of ozanimod. If CDAI score was missing, then non-responder imputation was applied.

Clinical Response is defined as a CDAI reduction from baseline of ≥ 100 points. The CDAI includes uses 8 components: Number of liquid or soft stools for 7 days, Abdominal pain for 7 days, General well-being for 7 days, Presence of complications, Taking diarrhea medication, Abdominal mass, Hematocrit and Percentage deviation from standard weight. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity. 95% CI was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure	Ozanimod Hydrochloride (HCl) 1 mg n=69 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
Percentage of Participants Who Achieved a Clinical Response Based on CDAI at Weeks 4 and 8 Weeks 4	37.7 Percentage of Participants
Percentage of Participants Who Achieved a Clinical Response Based on CDAI at Weeks 4 and 8 Weeks 8	52.2 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4 and 8

Population: The ITT population included all enrolled participants who received at least one dose of ozanimod. If stool frequency and abdominal pain were missing, then non-reesponder imputation (NRI) was applied.

The PRO2 is a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency (SF) and abdominal pain (AP) (rated on a scale of 0-3) assessed for 7 days. Clinical Remission (SF and AP remission) was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure	Ozanimod Hydrochloride (HCl) 1 mg n=69 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
Percentage of Participants Who Achieved Clinical Remission Based on Patient-Reported Outcome (PRO2) Measure Definitions at Weeks 4 and 8 Week 4	11.6 Percentage of Participants
Percentage of Participants Who Achieved Clinical Remission Based on Patient-Reported Outcome (PRO2) Measure Definitions at Weeks 4 and 8 Week 8	26.1 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 4 and Week 8

Population: The ITT population included all enrolled participants who received at least one dose of ozanimod. If PRO2 CD score is missing, then Non-responder imputation (NRI) was applied.

Clinical response based on PRO2 was defined as PRO2 decrease of ≥50%. The PRO2 is a composite score based on 2 components of the Crohn's Disease Activity Index, the number of liquid or soft stools/day for 7 days and the abdominal pain (rated on a scale of 0-3) assessed for 7 days. 95% confidence interval (CI) was created using the Clopper-Pearson Exact Method.

Outcome measures

Measure	Ozanimod Hydrochloride (HCl) 1 mg n=69 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
Percentage of Participants Who Achieved a Clinical Response Based on Patient Reported Outcome (PRO2) Measures at Weeks 4 and 8 Week 4	20.3 Percentage of Participants
Percentage of Participants Who Achieved a Clinical Response Based on Patient Reported Outcome (PRO2) Measures at Weeks 4 and 8 Week 8	33.3 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Population: The ITT population = all enrolled participants who received at least one dose of ozanimod. Observed cases.. Analysis includes participants with data available at baseline and visit.

Changes from baseline in intestinal mucosa histopathologic features and disease activity were assessed by blinded pathologists. Robarts Histopathology Index (RHI) had a maximum total score of 165, with higher scores indicating more severe histological disease. Baseline was defined as the last non-missing record on or before the first dose of study drug.

The Robarts Histopathology Index (RHI) is a recently validated instrument that measures histological disease activity in ulcerative colitis.

RHI Mucosal Healing was defined as a composite endpoint of being a responder for endoscopic remission and RHI remission.

Outcome measures

Measure

Ozanimod Hydrochloride (HCl) 1 mg n=28 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).

Percentage of Participants With RHI Healing at Week 52

14.3 Percentage of Participants Interval 4.03 to 32.67

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Weeks 12 and Week 52

Population: The intent to treat population (ITT) includes all enrolled participants who received at least one dose of ozanimod. Analysis for change from baseline includes participants with data available at baseline and visit.

Change in fecal calprotectin (observed cases) determined by comparing measurements at weeks 12 and 52 to baseline measurement.

Outcome measures

Measure	Ozanimod Hydrochloride (HCl) 1 mg n=46 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
Change in Fecal Calprotectin (Observed Cases) at Weeks 12 and 52 Week 12	-41.0 μg/g Interval -3518.0 to 4791.0
Change in Fecal Calprotectin (Observed Cases) at Weeks 12 and 52 Week 52	-103.3 μg/g Interval -4450.0 to 19534.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Weeks 12 and 52

Population: The intent to treat population (ITT) includes all enrolled participants who received at least one dose of ozanimod. Analysis for change from baseline includes participants with data available at baseline and visit.

Change in Serum C-Reactive Protein was determined by comparing to baseline.

Outcome measures

Measure	Ozanimod Hydrochloride (HCl) 1 mg n=53 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
Change in Serum C-Reactive Protein (CRP) Levels From Baseline (Observed Cases) at Weeks 12 and 52 Week 12	1.0 mg/L Interval -56.0 to 72.0
Change in Serum C-Reactive Protein (CRP) Levels From Baseline (Observed Cases) at Weeks 12 and 52 Week 52	-0.5 mg/L Interval -59.0 to 41.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12, Week 52

Population: The intent to treat population = all enrolled participants who received at least one dose of ozanimod. If any scores are missing then non-responder imputation is applied.

The percentage of participants with a CRP Response-10 was assessed.

CRP Response-10 is defined as C-reactive protein < 10 mg/L.

Outcome measures

Measure	Ozanimod Hydrochloride (HCl) 1 mg n=69 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
Changes in Biomarkers: Percentage of Participants With CRP Response-10 - Non-responder Imputation Week 12	39.1 Percentage of participants Interval 27.6 to 51.63
Changes in Biomarkers: Percentage of Participants With CRP Response-10 - Non-responder Imputation Week 52	23.2 Percentage of participants Interval 13.87 to 34.91

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12, Week 52

Population: The intent to treat population = all enrolled participants who received at least one dose of ozanimod. If any Fecal Calprotectin are missing then non-responder imputation is applied.

The percentage of participants with a FCP Response-250 was assessed.

FCP Response-250 is defined as Fecal calprotectin < 250 ug/g.

Outcome measures

Measure	Ozanimod Hydrochloride (HCl) 1 mg n=69 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
Changes in Biomarkers: Percentage of Participants With FCP Response-250 - Non-responder Imputation Week 12	30.4 Percentage of participants Interval 19.92 to 42.69
Changes in Biomarkers: Percentage of Participants With FCP Response-250 - Non-responder Imputation Week 52	11.6 Percentage of participants Interval 5.14 to 21.57

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 4 and 8

Population: This endpoint was omitted because there were too few study participants with perianal or enterocutaneous fistulas at baseline to allow for meaningful evaluation. No analysis performed.

The assessment is based on two parameters: whether the fistula is draining and whether it's open or closed. This is assessment was only on participants that had a fistula at baseline.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From Day 1 to Week 52

Population: The intent to treat population = all enrolled participants who received at least one dose of ozanimod.

Summary of concentrations of Ozanimod in RPC01-2201 by scheduled visit.

Outcome measures

Measure	Ozanimod Hydrochloride (HCl) 1 mg n=66 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
Pharmacokinetic Plasma Concentration of Ozanimod Day 1, post-dose	48 pg/mL Standard Deviation 19
Pharmacokinetic Plasma Concentration of Ozanimod Week 4	228 pg/mL Standard Deviation 116
Pharmacokinetic Plasma Concentration of Ozanimod Week 8	195 pg/mL Standard Deviation 102
Pharmacokinetic Plasma Concentration of Ozanimod Week 12	165 pg/mL Standard Deviation 126
Pharmacokinetic Plasma Concentration of Ozanimod Week 24	190 pg/mL Standard Deviation 109
Pharmacokinetic Plasma Concentration of Ozanimod Week 52	154 pg/mL Standard Deviation 98

OTHER_PRE_SPECIFIED outcome

Timeframe: From Day 1 to Week 52

Population: The intent to treat population = all enrolled participants who received at least one dose of ozanimod.

Summary of concentrations of CC-112273 in RPC01-2201 by scheduled visit.

Outcome measures

Measure	Ozanimod Hydrochloride (HCl) 1 mg n=66 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
PK Plasma Concentration of Active Metabolite CC-112273 Day 1, post-dose	58 pg/mL Standard Deviation 41
PK Plasma Concentration of Active Metabolite CC-112273 Week 4	2348 pg/mL Standard Deviation 1289
PK Plasma Concentration of Active Metabolite CC-112273 Week 8	3138 pg/mL Standard Deviation 2129
PK Plasma Concentration of Active Metabolite CC-112273 Week 12	3507 pg/mL Standard Deviation 2337
PK Plasma Concentration of Active Metabolite CC-112273 Week 24	4259 pg/mL Standard Deviation 3322
PK Plasma Concentration of Active Metabolite CC-112273 Week 52	4055 pg/mL Standard Deviation 3569

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Weeks 4, 8 and 12

Population: The safety population included all enrolled participants who received at least one dose of ozanimod.

Change in Absolute Lymphocyte Count (ALC) from baseline was determined by comparied to baseline.

Outcome measures

Measure	Ozanimod Hydrochloride (HCl) 1 mg n=65 Participants Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204 (NCT03467958).
Change From Baseline in Absolute Lymphocyte Count (ALC) Derived From Hematology Laboratory Results at Weeks 4, 8 and 12 Week 4	-0.946 10 ^9 cells/L Standard Deviation 0.783
Change From Baseline in Absolute Lymphocyte Count (ALC) Derived From Hematology Laboratory Results at Weeks 4, 8 and 12 Week 8	-1.086 10 ^9 cells/L Standard Deviation 0.778
Change From Baseline in Absolute Lymphocyte Count (ALC) Derived From Hematology Laboratory Results at Weeks 4, 8 and 12 Week 12	-1.092 10 ^9 cells/L Standard Deviation 0.783

Adverse Events

Ozanimod

Serious events: 18 serious events

Other events: 47 other events

Deaths: 1 deaths

Serious adverse events

Measure	Ozanimod n=69 participants at risk Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204.
Gastrointestinal disorders Abdominal pain upper	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Anal fistula	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Crohn's disease	8.7% 6/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Enterocolonic fistula	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Enterocutaneous fistula	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Fistula of small intestine	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Intestinal fistula	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Intestinal obstruction	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Pancreatitis acute	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Small intestinal obstruction	2.9% 2/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
General disorders Pyrexia	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Infections and infestations Abdominal abscess	2.9% 2/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Infections and infestations Anal abscess	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Infections and infestations Campylobacter infection	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Infections and infestations Diverticulitis	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Infections and infestations Sepsis	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Metabolism and nutrition disorders Dehydration	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Renal and urinary disorders Renal colic	1.4% 1/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years

Other adverse events

Measure	Ozanimod n=69 participants at risk Participants received ozanimod 1 mg capsules daily for the first 12 weeks of the induction period (an initial 7-day dose escalation regimen that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) daily followed by 3 days of ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) daily, with the final dose of ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) daily dose reached on Day 8. Participants who completed the induction period had the opportunity at Week 12 to continue to receive ozanimod 1 mg capsules daily during the extension period up to an additional 148 weeks, provided that the investigator determined that the participant should continue. Participants in the extension period continued to receive ozanimod 1 mg capsules daily through Week 160. Participants who completed the Week 160 visit had the option to continue open-label ozanimod 1 mg capsules by immediately entering the open-label extension Phase 3 Crohn's Disease Study RPC01-3204.
Blood and lymphatic system disorders Anaemia	7.2% 5/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Blood and lymphatic system disorders Lymphopenia	13.0% 9/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Abdominal pain	14.5% 10/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Abdominal pain lower	5.8% 4/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Abdominal pain upper	8.7% 6/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Crohn's disease	21.7% 15/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Diarrhoea	7.2% 5/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Nausea	13.0% 9/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Gastrointestinal disorders Vomiting	7.2% 5/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Infections and infestations Sinusitis	7.2% 5/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Infections and infestations Upper respiratory tract infection	7.2% 5/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Infections and infestations Urinary tract infection	7.2% 5/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Investigations Alanine aminotransferase increased	8.7% 6/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Investigations Aspartate aminotransferase increased	7.2% 5/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Investigations C-reactive protein increased	5.8% 4/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Investigations Gamma-glutamyltransferase increased	7.2% 5/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Metabolism and nutrition disorders Decreased appetite	5.8% 4/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Musculoskeletal and connective tissue disorders Arthralgia	13.0% 9/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Nervous system disorders Dizziness	5.8% 4/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Nervous system disorders Headache	5.8% 4/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years
Nervous system disorders Paraesthesia	5.8% 4/69 • From the first day of ozanimod up to 90 days after the last dose of ozanimod; mean duration of exposure of study drug was 1.305 years

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: please email:

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Results from a center cannot be submitted for publication before results of multicenter study are published unless it is \> 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
• Publication restrictions are in place

Restriction type: OTHER