| Primary | 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. | 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Change in the Crohn's Disease Activity Index (CDAI) Score From Baseline at Week 12 | 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants With Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants Who Achieved a Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Week 12 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants Who Achieved Clinical Remission Based on Patient-Reported Outcome (PRO2) Measure Definitions at Week 12 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants Who Achieved a Clinical Response Based on Patient Reported Outcome (PRO2) Measures From Baseline at Week 12 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | 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) | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | 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 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Change in Roberts Intestinal Histopathology Index From Baseline (Paired Segments) at Week 12 | 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. | 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. | Posted | | Mean | Standard Deviation | Units on a Scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Improvement in Perianal and Enterocutaneous Fistulas | 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. | 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. | Posted | | | | | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants Who Achieved Endoscopic Remission Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Definitions at Week 52 - 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 52 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants Who Achieved an Endoscopic Response-50 Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Definitions at Week 52 | 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.. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 52 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants Who Achieved Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 52 | 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. | The ITT population included all enrolled participants who received at least one dose of ozanimod. Observed Cases. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 52 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants Who Achieved a Clinical Response Based on CDAI at Week 52 | 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. | The ITT population included all enrolled participants who received at least one dose of ozanimod. Observed Cases. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 52 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants Who Achieved Clinical Remission Based on Patient-Reported Outcome (PRO2) Measure Definitions at Week 52 | 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. | The ITT population included all enrolled participants who received at least one dose of ozanimod. Observed cases. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 52 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants Who Achieved a Clinical Response Based on Patient Reported Outcome (PRO2) Measures From Baseline at Week 52 | 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. | The ITT included all enrolled participants and received at least one dose of ozanimod. Observed Cases. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 52 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants in Clinical Remission Based on CDAI and PRO2 Definitions Who Were Off Corticosteroids at Week 52 of Those on Corticosteroids | 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. | The ITT population included all enrolled participants who received at least one dose of ozanimod. Participants who were taking corticosteroids at baseline. Observed cases. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 52 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants With Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Weeks 4 and 8 | 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. | The ITT population included all enrolled participants who received at least one dose of ozanimod. Non-responder imputed. (NRI). | Posted | | Number | | Percentage of Participants | | Weeks 4 and 8 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants Who Achieved a Clinical Response Based on CDAI at Weeks 4 and 8 | 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. | 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. | Posted | | Number | | Percentage of Participants | | Weeks 4 and 8 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants Who Achieved Clinical Remission Based on Patient-Reported Outcome (PRO2) Measure Definitions at Weeks 4 and 8 | 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. | 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. | Posted | | Number | | Percentage of Participants | | Weeks 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants Who Achieved a Clinical Response Based on Patient Reported Outcome (PRO2) Measures at Weeks 4 and 8 | 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. | 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. | Posted | | Number | | Percentage of Participants | | Weeks 4 and Week 8 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Percentage of Participants With RHI Healing at Week 52 | 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 52 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Change in Fecal Calprotectin (Observed Cases) at Weeks 12 and 52 | Change in fecal calprotectin (observed cases) determined by comparing measurements at weeks 12 and 52 to baseline measurement. | 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. | Posted | | Median | Full Range | μg/g | | Baseline to Weeks 12 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
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| Other Pre-specified | Change in Serum C-Reactive Protein (CRP) Levels From Baseline (Observed Cases) at Weeks 12 and 52 | Change in Serum C-Reactive Protein was determined by comparing to baseline. | 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. | Posted | | Median | Full Range | mg/L | | Baseline to Weeks 12 and 52 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
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| Other Pre-specified | Changes in Biomarkers: Percentage of Participants With CRP Response-10 - Non-responder Imputation | The percentage of participants with a CRP Response-10 was assessed. CRP Response-10 is defined as C-reactive protein < 10 mg/L. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 12, Week 52 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Changes in Biomarkers: Percentage of Participants With FCP Response-250 - Non-responder Imputation | The percentage of participants with a FCP Response-250 was assessed. FCP Response-250 is defined as Fecal calprotectin < 250 ug/g. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 12, Week 52 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Improvement in Perianal and Enterocutaneous Fistulas in Participants With Fistula's From Baseline at Weeks 4 and 8 | 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. | 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. | Posted | | | | | | Baseline to Week 4 and 8 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Pharmacokinetic Plasma Concentration of Ozanimod | Summary of concentrations of Ozanimod in RPC01-2201 by scheduled visit. | The intent to treat population = all enrolled participants who received at least one dose of ozanimod. | Posted | | Mean | Standard Deviation | pg/mL | | From Day 1 to Week 52 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | PK Plasma Concentration of Active Metabolite CC-112273 | Summary of concentrations of CC-112273 in RPC01-2201 by scheduled visit. | The intent to treat population = all enrolled participants who received at least one dose of ozanimod. | Posted | | Mean | Standard Deviation | pg/mL | | From Day 1 to Week 52 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Other Pre-specified | Change From Baseline in Absolute Lymphocyte Count (ALC) Derived From Hematology Laboratory Results at Weeks 4, 8 and 12 | Change in Absolute Lymphocyte Count (ALC) from baseline was determined by comparied to baseline. | The safety population included all enrolled participants who received at least one dose of ozanimod. | Posted | | Mean | Standard Deviation | 10 ^9 cells/L | | Baseline up to Weeks 4, 8 and 12 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Secondary | The Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction and Extension Period | 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
| The Safety population included all enrolled participants who received at least one dose of ozanimod. | Posted | | Count of Participants | | Participants | | 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 | | | | ID | Title | Description |
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| OG000 | 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). |
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