Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy (NCT NCT05470985)
NCT ID: NCT05470985
Last Updated: 2025-04-22
Results Overview
The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. The PCDAI score is average of 11 variables scoring range of 0 to 100. Mild disease corresponds to scores of 11 to 30; moderate to severe disease corresponds to scores \> 30. Remission (no disease activity) is defined as a PCDAI score \< 10.
TERMINATED
PHASE2/PHASE3
5 participants
Week 64
2025-04-22
Participant Flow
Participant milestones
| Measure |
Ozanimod 0.46 mg
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.46 mg of Ozanimod capsule orally.
|
Ozanimod 0.92 mg
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.92 mg of Ozanimod capsule orally.
|
|---|---|---|
|
Double Blind Treatment Period
STARTED
|
3
|
2
|
|
Double Blind Treatment Period
COMPLETED
|
2
|
1
|
|
Double Blind Treatment Period
NOT COMPLETED
|
1
|
1
|
|
Long Term Extension
STARTED
|
2
|
1
|
|
Long Term Extension
COMPLETED
|
0
|
0
|
|
Long Term Extension
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Ozanimod 0.46 mg
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.46 mg of Ozanimod capsule orally.
|
Ozanimod 0.92 mg
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.92 mg of Ozanimod capsule orally.
|
|---|---|---|
|
Double Blind Treatment Period
Study terminated by sponsor
|
1
|
0
|
|
Double Blind Treatment Period
Physician Decision
|
0
|
1
|
|
Long Term Extension
Adverse Event
|
0
|
1
|
|
Long Term Extension
Study terminated by sponsor
|
2
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy
Baseline characteristics by cohort
| Measure |
Ozanimod 0.46 mg
n=3 Participants
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.46 mg of Ozanimod capsule orally.
|
Ozanimod 0.92 mg
n=2 Participants
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.92 mg of Ozanimod capsule orally.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 64Population: Data was not collected as no participants completed Week 64 visit.
The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. The PCDAI score is average of 11 variables scoring range of 0 to 100. Mild disease corresponds to scores of 11 to 30; moderate to severe disease corresponds to scores \> 30. Remission (no disease activity) is defined as a PCDAI score \< 10.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 64Population: Data was not collected as no participants completed Week 64 visit.
SES-CD assesses the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right colon, transverse colon, left (descending and sigmoid) colon, and rectum, and is scored on a scale of severity 0 (Normal) to 3 (High). Sub-scores for each segment will be derived by adding component scores within segments. Total SES-CD score is the sum of the sub-scores across the five segments. The sum of each component across all segments ranges from 0 to 15, except for the presence of narrowing where it varies from 0 to 11. The range of the overall SES-CD score is 0-56, with larger scores indicating greater severity of disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Participants who completed Week 12 visit were only included in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit.
The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. The PCDAI score is average of 11 variables scoring range of 0 to 100. Mild disease corresponds to scores of 11 to 30; moderate to severe disease corresponds to scores \> 30. Remission (no disease activity) is defined as a PCDAI score \< 10.
Outcome measures
| Measure |
Ozanimod 0.92 mg
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.92 mg of Ozanimod capsule orally.
|
Ozanimod 0.46 mg
n=1 Participants
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.46 mg of Ozanimod capsule orally.
|
|---|---|---|
|
Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) < 10 at Week 12 Based on Data as Observed
|
—
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 64Population: Data was not collected as no participants completed Week 64 visit.
SES-CD assesses the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right colon, transverse colon, left (descending and sigmoid) colon, and rectum, and is scored on a scale of severity 0 (Normal) to 3 (High). Sub-scores for each segment will be derived by adding component scores within segments. Total SES-CD score is the sum of the sub-scores across the five segments. The sum of each component across all segments ranges from 0 to 15, except for the presence of narrowing where it varies from 0 to 11. The range of the overall SES-CD score is 0-56, with larger scores indicating greater severity of disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Only participants who completed week 12 visit are included in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit.
SES-CD assesses the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right colon, transverse colon, left (descending and sigmoid) colon, and rectum, and is scored on a scale of severity 0 (Normal) to 3 (High). Sub-scores for each segment will be derived by adding component scores within segments. Total SES-CD score is the sum of the sub-scores across the five segments. The sum of each component across all segments ranges from 0 to 15, except for the presence of narrowing where it varies from 0 to 11. The range of the overall SES-CD score is 0-56, with larger scores indicating greater severity of disease.
Outcome measures
| Measure |
Ozanimod 0.92 mg
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.92 mg of Ozanimod capsule orally.
|
Ozanimod 0.46 mg
n=1 Participants
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.46 mg of Ozanimod capsule orally.
|
|---|---|---|
|
Percentage of Participants Who Achieve Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% (ER-50) at Week 12 Based on Data as Observed
|
—
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 64Population: Data was not collected as no participants completed Week 64 visit.
The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. The PCDAI score is average of 11 variables scoring range of 0 to 100. Mild disease corresponds to scores of 11 to 30; moderate to severe disease corresponds to scores \> 30. Remission (no disease activity) is defined as a PCDAI score \< 10.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Participants who completed Week 12 visit were only included in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit.
The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. The PCDAI score is average of 11 variables scoring range of 0 to 100. Mild disease corresponds to scores of 11 to 30; moderate to severe disease corresponds to scores \> 30. Remission (no disease activity) is defined as a PCDAI score \< 10.
Outcome measures
| Measure |
Ozanimod 0.92 mg
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.92 mg of Ozanimod capsule orally.
|
Ozanimod 0.46 mg
n=1 Participants
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.46 mg of Ozanimod capsule orally.
|
|---|---|---|
|
Percentage of Participants Who Achieve Reduction in Pediatric Crohn's Disease Activity Index (PCDAI) Score ≥ 12.5 and a Total PCDAI Score of < 30 Points at Week 12 Based on Data as Observed
|
—
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Participants who completed Week 12 visit were only included in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit.
Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤1 point, and average daily stool frequency ≤ 3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day.
Outcome measures
| Measure |
Ozanimod 0.92 mg
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.92 mg of Ozanimod capsule orally.
|
Ozanimod 0.46 mg
n=1 Participants
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.46 mg of Ozanimod capsule orally.
|
|---|---|---|
|
Percentage of Adolescents Who Achieve an Average Daily Abdominal Pain Score ≤ 1 Point and an Average Daily Stool Frequency ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 12 Based on Data as Observed
|
—
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 64Population: Data was not collected as no participants in the study completed Week 64 visit.
Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤1 point, and average daily stool frequency ≤ 3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 64Population: Data was not collected as no participants completed Week 64 visit. Pre-specified to assess change at Week 64.
SF was defined number of liquid or soft stools per day.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 64Population: Data was not collected as no participants completed Week 64 visit. Pre-specified to assess change at Week 64.
Participants entered Reponses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score. The AP score was graded on severity of 0 (none) to 3 (severe) scale.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Participants who completed week 12 visit were included in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit.
The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Outcome measures
| Measure |
Ozanimod 0.92 mg
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.92 mg of Ozanimod capsule orally.
|
Ozanimod 0.46 mg
n=1 Participants
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.46 mg of Ozanimod capsule orally.
|
|---|---|---|
|
Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 Based on Data as Observed
|
—
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 64Population: Data was not collected as no participants completed Week 64 visit.
The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 64Population: Data was not collected as no participants completed Week 64 visit.
The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Participants who completed week 12 visit were included in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit.
The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Outcome measures
| Measure |
Ozanimod 0.92 mg
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.92 mg of Ozanimod capsule orally.
|
Ozanimod 0.46 mg
n=1 Participants
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.46 mg of Ozanimod capsule orally.
|
|---|---|---|
|
Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 at Week 12 Based on Data as Observed
|
—
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 64Population: Data was not collected as no participants completed Week 64 visit.
The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. The PCDAI score is average of 11 variables scoring range of 0 to 100. Mild disease corresponds to scores of 11 to 30; moderate to severe disease corresponds to scores \> 30. Remission (no disease activity) is defined as a PCDAI score \< 10.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 64Population: Data was not collected as no participants completed Week 64 visit.
The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD. The PCDAI consists of the following 11 variables: Abdominal pain, stools per day, wellbeing, weight, height velocity, abdominal tenderness, peri-rectal disease, extra-intestinal manifestation, hematocrit, erythrocyte sedimentation rate and albumin. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. The PCDAI score is average of 11 variables scoring range of 0 to 100. Mild disease corresponds to scores of 11 to 30; moderate to severe disease corresponds to scores \> 30. Remission (no disease activity) is defined as a PCDAI score \< 10.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 64Population: Data was not collected as no participants completed Week 64 visit.
The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Participants who completed week 12 visit were included in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit.
SES-CD assesses the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these 4 components are assessed in the five segments of the ileum and colon: ileum, right colon, transverse colon, left (descending and sigmoid) colon, and rectum, and is scored on a scale of severity 0 (Normal) to 3 (High). Sub-scores for each segment will be derived by adding component scores within segments. Total SES-CD score is the sum of the sub-scores across the five segments. The sum of each component across all segments ranges from 0 to 15, except for the presence of narrowing where it varies from 0 to 11. The range of the overall SES-CD score is 0-56, with larger scores indicating greater severity of disease.
Outcome measures
| Measure |
Ozanimod 0.92 mg
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.92 mg of Ozanimod capsule orally.
|
Ozanimod 0.46 mg
n=1 Participants
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.46 mg of Ozanimod capsule orally.
|
|---|---|---|
|
Percentage of Participants Achieving Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 2 or SES-CD ≤ 4 Points With no SES-CD Subscore > 1 Point at Week 12 Based on Data as Observed
|
—
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 20 and up to end of study (Week 64)Population: Data was not collected as no participants completed Week 64 visit.
Blood samples were collected to assess steady state exposure of ozanimod.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug. Participants who completed Week 12 visit were only considered in the analysis. No participants in Ozanimod 0.46 mg arm completed Week 12 visit.
Blood samples were collected to assess lymphocyte count.
Outcome measures
| Measure |
Ozanimod 0.92 mg
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.92 mg of Ozanimod capsule orally.
|
Ozanimod 0.46 mg
n=1 Participants
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.46 mg of Ozanimod capsule orally.
|
|---|---|---|
|
Absolute Lymphocyte Count at Week 12 Based on Data as Observed
|
—
|
0.66 10^9 cells per liter
Standard Deviation NA
Insufficient number of participants to calculate SD
|
SECONDARY outcome
Timeframe: Week 64Population: Data was not collected as no participants completed Week 64 visit.
Blood samples were collected to assess lymphocyte count.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose (Day 1) and up to Week 12Population: The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect.
Outcome measures
| Measure |
Ozanimod 0.92 mg
n=2 Participants
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.92 mg of Ozanimod capsule orally.
|
Ozanimod 0.46 mg
n=3 Participants
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.46 mg of Ozanimod capsule orally.
|
|---|---|---|
|
Number of Participants With Adverse Events
Adverse Events
|
2 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
Serious Adverse Events
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Adverse events leading to Discontinuation
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Adverse Events of Special Interest
|
0 Participants
|
0 Participants
|
Adverse Events
Ozanimod 0.46mg
Ozanimod 0.92mg
Serious adverse events
| Measure |
Ozanimod 0.46mg
n=3 participants at risk
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.46 mg of Ozanimod capsule orally.
|
Ozanimod 0.92mg
n=2 participants at risk
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.92 mg of Ozanimod capsule orally.
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
50.0%
1/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
50.0%
1/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
50.0%
1/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
Other adverse events
| Measure |
Ozanimod 0.46mg
n=3 participants at risk
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.46 mg of Ozanimod capsule orally.
|
Ozanimod 0.92mg
n=2 participants at risk
Participants with moderately to severely active Crohn's Disease with an inadequate response to conventional therapy were administered with 0.92 mg of Ozanimod capsule orally.
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
33.3%
1/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
0.00%
0/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
1/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
0.00%
0/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Eye disorders
Conjunctivitis allergic
|
33.3%
1/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
0.00%
0/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
50.0%
1/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Gastrointestinal disorders
Crohn's disease
|
33.3%
1/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
50.0%
1/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
50.0%
1/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
50.0%
1/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
50.0%
1/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
50.0%
1/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
100.0%
2/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Infections and infestations
Gastroenteritis viral
|
33.3%
1/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
0.00%
0/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
0.00%
0/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
0.00%
0/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
0.00%
0/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
0.00%
0/2 • All cause mortality, serious adverse events and non serious adverse events were collected from Day 1 to Week 12.
The Intent to Treat population consist of all randomized participants that receive at least 1 dose of investigational drug.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER