Trial · NCT05369832
An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
NCT05369832, Phase 4, Terminated, Bristol-Myers Squibb; results first posted 2026-02-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice. Trials, record NCT05369832. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05369832
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
- NCT number
- NCT05369832
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 139 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Colitis, Ulcerative
- Interventions
- Ozanimod
- First posted
- 2022-05-11
- Last updated
- 2026-02-10
- Results first posted
- 2026-02-10
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 1 at Week 12 | At week 12 | Clinical response is defined as meeting all of the following improvements from baseline in the Modified Mayo Score: * Decrease from baseline ≥ 2 points, * Decrease from baseline ≥ 35%, * Decrease from baseline in the Rectal Bleeding (RB) subscore ≥ 1 point or absolute RB subscore ≤ 1 The Modified Mayo Score is a tool that helps doctors measure how active ulcerative colitis is. It combines three components: * Stool Frequency (SF): scored 0-3 (higher score = more frequent stools), * Rectal Bleeding (RB): scored 0-3 (higher score = more bleeding), * Endoscopic Subscore (ES): scored 0-3 (higher score = more severe inflammation seen during endoscopy). The total score ranges from 0 to 9, with higher scores meaning more severe disease activity and lower scores meaning less disease activity and better clinical condition. |
| Primary | Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 2 at Week 26 | At week 26 | Clinical response is defined as meeting all of the following improvements from baseline in the Modified Mayo Score: * Decrease from baseline ≥ 2 points, * Decrease from baseline ≥ 35%, * Decrease from baseline in the Rectal Bleeding (RB) subscore ≥ 1 point or absolute RB subscore ≤ 1 The Modified Mayo Score is a tool that helps doctors measure how active ulcerative colitis is. It combines three components: * Stool Frequency (SF): scored 0-3 (higher score = more frequent stools), * Rectal Bleeding (RB): scored 0-3 (higher score = more bleeding), * Endoscopic Subscore (ES): scored 0-3 (higher score = more severe inflammation seen during endoscopy). The total score ranges from 0 to 9, with higher scores meaning more severe disease activity and lower scores meaning less disease activity and better clinical condition. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) | An Adverse Event (AE) is any new medical problem or worsening of a preexisting condition in a study participant who receives the study treatment. It does not have to be caused by the treatment. An AE can be any unfavorable and unintended sign (such as an abnormal lab finding), symptom, or disease that happens around the time the study treatment is used, whether or not it is related to the treatment. A Treatment Emergent Adverse Event (TEAE) is an AE that meets any of the following: * Starts after the first dose of the study treatment (or within 84 days after stopping it) and was not present before; or * Was already present before treatment but gets worse after the first dose (or within 84 days after stopping it); or * Has missing onset and end dates, making it unclear whether it occurred outside the treatment-emergent period. Participants meeting any of these conditions are counted as having at least one TEAE. |
| Secondary | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, is a congenital anomaly/birth defect, requires in-patient hospitalization or causes prolongation of existing hospitalization, or results in persistent/significant disability/incapacity. Treatment Emergent Serious Adverse Event (TE SAE) is a SAE that meets any of the following: * Starts after the first dose of the study treatment (or within 84 days after stopping it) and was not present before; or * Was already present before treatment but gets worse after the first dose (or within 84 days after stopping it); or * Has missing onset and end dates, making it unclear whether it occurred outside the treatment-emergent period. Participants meeting any of these conditions are counted as having at least one TESAE. |
| Secondary | Number of Participants With Treatment Emergent Adverse Event of Interest | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) | This endpoint reports the number of participants who experienced Adverse Events of Interest (AEIs) during the study. AEIs include bradycardia, heart conduction abnormalities (second-degree and higher atrioventricular block), macular edema, malignancy, serious or opportunistic infection, pulmonary effects, hepatic effects, posterior reversible encephalopathy syndrome, progressive multifocal leukoencephalopathy (PML), and events associated with orthostatic hypotension (e.g., dizziness, lightheadedness, syncope, seizure). The Sponsor may request additional information for nonserious AEIs. A Treatment Emergent AEI is an AEI that starts after the first dose (or within 84 days after stopping), worsens relative to baseline in this period (or within 84 days after stopping), or has missing dates making the timing unclear. Participants meeting any of these conditions are counted as having at least one AEI. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events Leading to Discontinuation | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) | This endpoint measures the number of participants who experienced Treatment Emergent Adverse Events (TEAEs) that resulted in discontinuation of study treatment. An Adverse Event (AE) is any new medical problem or worsening of a preexisting condition in a study participant who receives the study treatment. It does not have to be caused by the treatment. An AE can be any unfavorable and unintended sign (such as an abnormal lab finding), symptom, or disease that happens around the time the study treatment is used, whether or not it is related to the treatment. A TEAE is an AE that: starts after the first dose (or within 84 days after stopping) and was not present before; or was preexisting but worsens after the first dose (or within 84 days after stopping); or has missing dates that prevent determining whether it occurred outside the treatment emergent period. |
| Secondary | Number of Participants With Clinically Significant Changes in Laboratory Assessments | From first dose of study medication through end of study (Up to approximately 728 days) | Number of participants experiencing clinically significant abnormalities in laboratory testing including hematology, chemistry and urinalysis. |
| Secondary | Percent of Participants Achieving Clinical Remission by Partial Mayo Score at Week 52 and 104 | At week 52 and week 104 | Clinical remission is defined as a Partial Mayo Score of ≤ 2.5. The Partial Mayo Score is a tool that helps doctors measure how active ulcerative colitis is without using endoscopy. It combines three components: * Stool Frequency (SF) subscore: range 0-3 (higher score = more frequent stools) * Rectal Bleeding (RB) subscore: range 0-3 (higher score = more bleeding) * Physician's Global Assessment (PGA): range 0-3 (higher score = worse overall condition based on physician's judgment) The total score ranges from 0 to 9, with lower scores meaning fewer symptoms and better disease control, and higher scores meaning more severe disease activity. A score of 2.5 or below suggests the disease is in remission. |
| Secondary | Percent of Participants Achieving Corticosteroid-free Clinical Remission by Partial Mayo Score at Week 52 and 104 | At week 52 and week 104 | Corticosteroid-free Clinical Remission (Partial Mayo Score) is defined as: * Meeting the criteria for clinical remission by Partial Mayo Score \<=2.5, and * No use of oral systemic corticosteroids in the prior 90 days. The Partial Mayo Score is a tool that helps doctors measure ulcerative colitis activity without endoscopy. It combines three components: * Stool Frequency (SF) subscore: range 0-3 (higher score = more frequent stools) * Rectal Bleeding (RB) subscore: range 0-3 (higher score = more bleeding) * Physician's Global Assessment (PGA): range 0-3 (higher score = worse overall condition based on physician's judgment) The total score ranges from 0 to 9, with lower scores meaning fewer symptoms and better disease control, and higher scores meaning more severe disease activity |
| Secondary | Percent of Participants Achieving Clinical Response by Partial Mayo Score at Week 52 and 104 | At week 52 and week 104 | Clinical Response by Partial Mayo Score is defined as: * Decrease in partial Mayo score ⩾ 2 points and ⩾ 30% from baseline, and * Decrease in rectal bleeding subscore \> 1 point or absolute rectal bleeding score \< 1 This represents a marked improvement in disease activity. The Partial Mayo Score is a tool that helps doctors measure ulcerative colitis activity without endoscopy. It combines three components: * Stool Frequency (SF) subscore: range 0-3 (higher score = more frequent stools) * Rectal Bleeding (RB) subscore: range 0-3 (higher score = more bleeding) * Physician's Global Assessment (PGA): range 0-3 (higher score = worse overall condition based on physician's judgment) The total score ranges from 0 to 9, with lower scores meaning fewer symptoms and better disease control, and higher scores meaning more severe disease activity. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 1 at Week 12 | At week 12 | Treated participants with observed cases and non responder imputation. Pre-specified to be reported for Cohort 1 only. | Percent of Participants | NUMBER |
| PRIMARY | Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 2 at Week 26 | At week 26 | Treated participants with observed cases. Pre-specified to be reported for Cohort 2 only. | Percent of Participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) | Treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) | Treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Event of Interest | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) | Treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events Leading to Discontinuation | From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days) | Treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Laboratory Assessments | From first dose of study medication through end of study (Up to approximately 728 days) | Treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent of Participants Achieving Clinical Remission by Partial Mayo Score at Week 52 and 104 | At week 52 and week 104 | Treated participants with observed cases | Percent of Participants | NUMBER |
| SECONDARY | Percent of Participants Achieving Corticosteroid-free Clinical Remission by Partial Mayo Score at Week 52 and 104 | At week 52 and week 104 | Treated participants with observed cases | Percent of Participants | NUMBER |
| SECONDARY | Percent of Participants Achieving Clinical Response by Partial Mayo Score at Week 52 and 104 | At week 52 and week 104 | Treated participants with observed cases | Percent of Participants | NUMBER |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 1 at Week 12 | Cohort 1: Ozanimod Advanced Therapy Naïve | Observed Cases | 65.8 | 95% Confidence Interval 54.0 to 76.3 | Percent of Participants |
| Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 1 at Week 12 | Cohort 1: Ozanimod Advanced Therapy Naïve | Non Responder Imputation | 50.5 | 95% Confidence Interval 40.3 to 60.7 | Percent of Participants |
| Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 2 at Week 26 | Cohort 2: Ozanimod Advanced Therapy Exposed | 88.0 | 95% Confidence Interval 68.8 to 97.5 | Percent of Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Cohort 1: Ozanimod Advanced Therapy Naïve | 61 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Cohort 2: Ozanimod Advanced Therapy Exposed | 22 | Participants | ||
| Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | Cohort 1: Ozanimod Advanced Therapy Naïve | 7 | Participants | ||
| Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | Cohort 2: Ozanimod Advanced Therapy Exposed | 4 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Event of Interest | Cohort 1: Ozanimod Advanced Therapy Naïve | 7 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Event of Interest | Cohort 2: Ozanimod Advanced Therapy Exposed | 4 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events Leading to Discontinuation | Cohort 1: Ozanimod Advanced Therapy Naïve | 5 | Participants |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Ozanimod Advanced Therapy Naïve | 99 | |
| Overall Study | STARTED | Cohort 2: Ozanimod Advanced Therapy Exposed | 40 | |
| Overall Study | COMPLETED | Cohort 1: Ozanimod Advanced Therapy Naïve | 0 | |
| Overall Study | COMPLETED | Cohort 2: Ozanimod Advanced Therapy Exposed | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1: Ozanimod Advanced Therapy Naïve | 99 | |
| Overall Study | NOT COMPLETED | Cohort 2: Ozanimod Advanced Therapy Exposed | 40 |
Source ClinicalTrials.gov
Adverse events32
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 | Colitis ulcerative | Gastrointestinal disorders | Cohort 1: Ozanimod Advanced Therapy Naive | 13 | 99 | |
| other | Colitis ulcerative | Gastrointestinal disorders | Cohort 2: Ozanimod Advanced Therapy Exposed | 4 | 40 | |
| other | Nasopharyngitis | Infections and infestations | Cohort 1: Ozanimod Advanced Therapy Naive | 5 | 99 | |
| other | Nasopharyngitis | Infections and infestations | Cohort 2: Ozanimod Advanced Therapy Exposed | 1 | 40 | |
| other | Sinusitis | Infections and infestations | Cohort 1: Ozanimod Advanced Therapy Naive | 0 | 99 | |
| other | Sinusitis | Infections and infestations | Cohort 2: Ozanimod Advanced Therapy Exposed | 4 | 40 | |
| other | Upper respiratory tract infection | Infections and infestations | Cohort 1: Ozanimod Advanced Therapy Naive | 7 | 99 | |
| other | Upper respiratory tract infection | Infections and infestations | Cohort 2: Ozanimod Advanced Therapy Exposed | 1 | 40 | |
| other | Headache | Nervous system disorders | Cohort 1: Ozanimod Advanced Therapy Naive | 5 | 99 | |
| other | Headache | Nervous system disorders | Cohort 2: Ozanimod Advanced Therapy Exposed | 0 | 40 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Ozanimod Advanced Therapy Naive | 1 | 99 |
| Total, all-cause mortality | Cohort 2: Ozanimod Advanced Therapy Exposed | 0 | 40 |
| Total, other adverse events | Cohort 1: Ozanimod Advanced Therapy Naive | 28 | 99 |
| Total, other adverse events | Cohort 2: Ozanimod Advanced Therapy Exposed | 9 | 40 |
| Total, serious adverse events | Cohort 1: Ozanimod Advanced Therapy Naive | 7 | 99 |
| Total, serious adverse events | Cohort 2: Ozanimod Advanced Therapy Exposed | 4 | 40 |
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1: Ozanimod Advanced Therapy Naïve vs Cohort 2: Ozanimod Advanced Therapy Exposed: Number of Participants With Treatment Emergent Adverse Events Leading to Discontinuation | Trial comparisons |
| Cohort 1: Ozanimod Advanced Therapy Naïve vs Cohort 2: Ozanimod Advanced Therapy Exposed: Number of Participants With Treatment Emergent Adverse Event of Interest | Trial comparisons |
| Cohort 1: Ozanimod Advanced Therapy Naïve vs Cohort 2: Ozanimod Advanced Therapy Exposed: Number of Participants With Clinically Significant Changes in Laboratory Assessments | Trial comparisons |
| Cohort 1: Ozanimod Advanced Therapy Naïve vs Cohort 2: Ozanimod Advanced Therapy Exposed: Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | Trial comparisons |
| Cohort 1: Ozanimod Advanced Therapy Naive vs Cohort 2: Ozanimod Advanced Therapy Exposed: deaths from any cause | Trial comparisons |
| Cohort 1: Ozanimod Advanced Therapy Naïve vs Cohort 2: Ozanimod Advanced Therapy Exposed: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Trial comparisons |
| Cohort 1: Ozanimod Advanced Therapy Naive vs Cohort 2: Ozanimod Advanced Therapy Exposed: 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/NCT05369832
GET https://conductscience.org/api/trials/v1/NCT05369832/registered?page=2