Trial · NCT05470985
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
NCT05470985, Phase 2, Phase 3, Terminated, Bristol-Myers Squibb; results first posted 2025-04-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT05470985. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05470985
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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 number
- NCT05470985
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 5 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Crohn Disease
- Interventions
- Ozanimod
- First posted
- 2022-07-22
- Last updated
- 2025-04-22
- Other registries' IDs
- eudract:2021-005019-30
- Results first posted
- 2025-04-22
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) Score < 10 at Week 64 | Week 64 | 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. |
| Primary | 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 64 | Week 64 | 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. |
| Secondary | Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) < 10 at Week 12 Based on Data as Observed | Week 12 | 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. |
| Secondary | Percentage of Participants Who Achieve Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% (ER-50) at Week 64 | Week 64 | 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. |
| Secondary | 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 | Week 12 | 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. |
| Secondary | 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 64 | Week 64 | 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. |
| Secondary | 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 | Week 12 | 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. |
| Secondary | 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 | Week 12 | 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. |
| Secondary | 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 64 | Week 64 | 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. |
| Secondary | Change From Baseline in Stool Frequency (SF) Score at Week 64 | Baseline and Week 64 | SF was defined number of liquid or soft stools per day. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) Score < 10 at Week 64 | Week 64 | Data was not collected as no participants completed Week 64 visit. | ||
| PRIMARY | 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 64 | Week 64 | Data was not collected as no participants completed Week 64 visit. | ||
| SECONDARY | Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) < 10 at Week 12 Based on Data as Observed | Week 12 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve Simple Endoscopic Score for Crohn's Disease (SES-CD) Decrease From Baseline of ≥ 50% (ER-50) at Week 64 | Week 64 | Data was not collected as no participants completed Week 64 visit. | ||
| SECONDARY | 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 | Week 12 | 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. | percentage of participants | NUMBER |
| SECONDARY | 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 64 | Week 64 | Data was not collected as no participants completed Week 64 visit. | ||
| SECONDARY | 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 | Week 12 | 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. | percentage of participants | NUMBER |
| SECONDARY | 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 | Week 12 | 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. | percentage of participants | NUMBER |
| SECONDARY | 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 64 | Week 64 | Data was not collected as no participants in the study completed Week 64 visit. | ||
| SECONDARY | Change From Baseline in Stool Frequency (SF) Score at Week 64 | Baseline and Week 64 | Data was not collected as no participants completed Week 64 visit. Pre-specified to assess change at Week 64. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) < 10 at Week 12 Based on Data as Observed | Ozanimod 0.92 mg | 0 | Percentage of participants | ||
| 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 | Ozanimod 0.92 mg | 0 | percentage of participants | ||
| 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 | Ozanimod 0.92 mg | 0 | percentage of participants | ||
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 | Ozanimod 0.92mg | 0 | percentage of participants | ||
| Percentage of Adolescents Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 12 Based on Data as Observed | Ozanimod 0.92mg | 0 | percentage of participants | ||
| 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 | Ozanimod 0.92mg | 0 | percentage of participants | ||
| 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 | Ozanimod 0.92mg | 0 | percentage of participants | ||
| Absolute Lymphocyte Count at Week 12 Based on Data as Observed | Ozanimod 0.92mg | 0.66 | Standard Deviation NA | 10^9 cells per liter | |
| Number of Participants With Adverse Events | Ozanimod 0.46 mg | Adverse Events | 3 | Participants | |
| Number of Participants With Adverse Events | Ozanimod 0.92mg | Adverse Events | 2 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Treatment Period | STARTED | Ozanimod 0.46 mg | 3 | |
| Double Blind Treatment Period | STARTED | Ozanimod 0.92 mg | 2 | |
| Double Blind Treatment Period | COMPLETED | Ozanimod 0.46 mg | 2 | |
| Double Blind Treatment Period | COMPLETED | Ozanimod 0.92 mg | 1 | |
| Double Blind Treatment Period | NOT COMPLETED | Ozanimod 0.46 mg | 1 | |
| Double Blind Treatment Period | NOT COMPLETED | Ozanimod 0.92 mg | 1 | |
| Long Term Extension | STARTED | Ozanimod 0.46 mg | 2 | |
| Long Term Extension | STARTED | Ozanimod 0.92 mg | 1 | |
| Long Term Extension | COMPLETED | Ozanimod 0.46 mg | 0 | |
| Long Term Extension | COMPLETED | Ozanimod 0.92 mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Ozanimod 0.46mg | 1 | 3 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Ozanimod 0.92mg | 0 | 2 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ozanimod 0.46mg | 1 | 3 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ozanimod 0.92mg | 0 | 2 | |
| other | Conjunctivitis allergic | Eye disorders | Ozanimod 0.46mg | 1 | 3 | |
| other | Conjunctivitis allergic | Eye disorders | Ozanimod 0.92mg | 0 | 2 | |
| other | Colitis ulcerative | Gastrointestinal disorders | Ozanimod 0.46mg | 0 | 3 | |
| other | Colitis ulcerative | Gastrointestinal disorders | Ozanimod 0.92mg | 1 | 2 | |
| other | Crohn's disease | Gastrointestinal disorders | Ozanimod 0.46mg | 1 | 3 | |
| other | Crohn's disease | Gastrointestinal disorders | Ozanimod 0.92mg | 1 | 2 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ozanimod 0.46mg | 0 | 3 |
| Total, all-cause mortality | Ozanimod 0.92mg | 0 | 2 |
| Total, other adverse events | Ozanimod 0.46mg | 2 | 3 |
| Total, other adverse events | Ozanimod 0.92mg | 2 | 2 |
| Total, serious adverse events | Ozanimod 0.46mg | 0 | 3 |
| Total, serious adverse events | Ozanimod 0.92mg | 1 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ozanimod 0.46mg vs Ozanimod 0.92mg: deaths from any cause | Trial comparisons |
| Ozanimod 0.46mg vs Ozanimod 0.92mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05470985
GET https://conductscience.org/api/trials/v1/NCT05470985/registered?page=2