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 looked at a medication called ozanimod in people with Crohn's disease, which is a condition causing ongoing inflammation in the digestive tract. A total of 403 people were assigned to receive ozanimod and 203 people received a placebo (an inactive dummy treatment) — giving roughly 606 participants overall. The trial tracked several measures of disease activity, including a detailed scoring system called the CDAI (which combines things like stool frequency, abdominal pain, and general wellbeing into a single number) as well as a camera-based score of gut inflammation called the SES-CD. The reported data shows that for the main (primary) outcome — the proportion of participants whose CDAI score fell below 150, which is considered a low-activity threshold — 29.8% of people in the ozanimod group reached that point, compared with 30.5% in the placebo group. For the secondary outcomes, the reported figures were similarly close between the two groups: around 29.0% of the ozanimod group versus 26.6% of the placebo group met a separate measure of remission based on abdominal pain and stool frequency alone. When looking at gut inflammation on camera, 25.6% of the ozanimod group showed at least a 50% reduction in their inflammation score, compared with 21.2% in the placebo group. For a combined measure of both symptom improvement and reduced gut inflammation, 16.9% of the ozanimod group and 14.3% of the placebo group met the threshold. Another combined measure showed 11.7% versus 11.3% respectively. The reported data shows that across all the measured outcomes, the percentage differences between the ozanimod and placebo groups were relatively small. No conclusions about whether ozanimod "works" can be drawn from these numbers alone, and this summary does not represent a full analysis of the trial's findings — for example, statistical testing results were not included in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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, Completed
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 have been diagnosed with Crohn's disease for at least 3 months, confirmed by a camera examination of the gut (endoscopy) and tissue sample (biopsy)
- Previous treatments have not worked well enough for you, or have stopped working — including steroids, immune-suppressing medicines, and/or biologic medicines
- Your Crohn's disease activity falls within a specific moderate-to-severe range, measured by a standard scoring system called the CDAI (confirm with trial site)
- You are experiencing on average 4 or more loose stools per day and/or significant abdominal pain on a daily basis
- A camera examination of your gut shows a certain level of inflammation, measured by a scoring system called the SES-CD (confirm with trial site)
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 been diagnosed with a different type of bowel condition, such as ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or you have a narrowing in your bowel that needs a procedure to treat it
- You have had a large portion of your small bowel removed (more than 100cm), have a condition called short bowel syndrome, or need to receive all your nutrition through a drip into a vein
- You currently have a stoma bag, a surgically created internal pouch, or an abnormal tunnel (fistula) in or around your bowel
- There may be additional criteria not listed here that could affect your eligibility (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.
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 13 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 Crohn's Disease Activity Index (CDAI) Score < 150
Other options
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.