Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03467958) involved people with Crohn's disease, a long-term inflammatory bowel condition. The study was made up of several related parts, with participants across different groups ranging from 13 to 329 people per group. The trial measured ozanimod (0.92 mg) against a placebo (an inactive treatment), tracking disease activity using a scoring tool called the Crohn's Disease Activity Index (CDAI) — essentially a questionnaire covering symptoms like bowel frequency, abdominal pain, and general wellbeing, where a higher score means worse symptoms. A score below 150 was used to define "clinical remission," meaning very low disease activity. The reported data shows that in the main placebo-controlled part of the trial, 19.6% of participants in the placebo group and 21.0% in the ozanimod group reached clinical remission. For measuring a meaningful improvement in symptoms (called "clinical response" — either a score below 150 or a drop of at least 100 points), the reported figures were 26.8% for placebo and 29.2% for ozanimod. In a separate longer-term follow-on part of the study, remission rates were notably higher across all groups, ranging from roughly 56% to 61% among those who completed that phase. The reported data also shows that adverse events (unexpected medical occurrences during the trial) were recorded in 140 out of 179 placebo participants and 247 out of 329 ozanimod participants in the main part; serious adverse events were recorded in 38 and 59 participants respectively in those same groups, though the data does not break down the nature of those events further. Regarding the secondary measure of abdominal pain and stool frequency remission, the reported figures for the main placebo-controlled part were 16.2% (placebo) and 21.3% (ozanimod). In the longer-term follow-on completers, figures ranged from approximately 45% to 53% across groups. Note that completion data for all sub-groups was not fully reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 36208720) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Crohn's Disease and Colitis Trial, Terminated
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- You did not fully respond to (or achieve remission from) a related induction study after 12 weeks of treatment
- You experienced a return of symptoms (relapse) during or after completing a related maintenance study
- You have already completed a study of ozanimod for Crohn's Disease and meet the specific requirements to continue into this study
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- You have a serious ongoing condition affecting the liver, nervous system, lungs, eyes, hormones, mental health, or another major body system that could make the study unsafe or difficult to carry out (confirm with trial site)
- You have a suspected or confirmed collection of infection (abscess) inside the abdomen or around the anal area that has not been properly treated
- You are currently taking certain medications, specifically drugs known as CYP2C8 inducers or monoamine oxidase inhibitors (confirm with trial site if you are unsure whether your medications fall into these categories)
- There may be additional requirements not listed here, as other criteria from the study protocol also apply (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Trial contact details on record
Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 25 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Percentage of Participants With Clinical Remission; Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Other options
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.