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 (NCT05470985) enrolled a very small number of children and adolescents with Crohn's disease — just 3 participants in the ozanimod 0.46 mg group and 2 in the ozanimod 0.92 mg group during the main double-blind treatment phase. The trial was measuring disease activity using two tools: the Pediatric Crohn's Disease Activity Index (PCDAI), which is a scoring system based on symptoms, growth, and blood tests, and the Simple Endoscopic Score for Crohn's Disease (SES-CD), which measures inflammation seen during a camera examination of the bowel. The trial had a main treatment period and a longer follow-up extension phase. The reported data shows that for the two primary (main) outcome measures — the proportion of participants reaching low disease activity scores on both the PCDAI and the SES-CD at Week 64 — no numerical results were submitted to ClinicalTrials.gov. Similarly, most of the secondary (additional) outcome measures also have no figures recorded. The only numbers reported were for the ozanimod 0.92 mg group at Week 12: 0% of participants in that group reached the PCDAI remission threshold (a score below 10), and 0% achieved a 50% or greater reduction in their endoscopy inflammation score. Data for the 0.46 mg group at Week 12, and results for both groups at Week 64 for the secondary measures, were not reported. It is worth noting that with only 5 participants enrolled in total — an extremely small number — the trial was very limited in scope, and the absence of most reported figures makes it difficult to draw any picture of what was observed across the full study period. 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 ↗
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
- Your child's Crohn's disease must be rated as moderately to severely active based on a specific symptom score (called PCDAI), AND a camera examination of the gut (called an endoscopy) must show a certain level of inflammation based on a scoring system called SES-CD (confirm with trial site for exact score details)
- Your child must have already tried at least one treatment for Crohn's disease — such as steroids, immune-suppressing medicines, or biologic therapies — and either it didn't work well enough, stopped working, or caused problems they couldn't tolerate
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.
- Your child's doctor believes they are likely to need surgery to remove part of the bowel within the next 12 weeks
- Your child currently has a stoma (an opening in the abdomen connected to a bag), a specific type of bowel reconnection surgery, or a fistula (an abnormal tunnel between body parts) that may need treatment or surgery within the next 12 weeks
- Your child has had a large portion of the small bowel removed (more than 100 cm), has been diagnosed with short bowel syndrome, or needs to be fed entirely through a drip into a vein
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 1 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 Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) Score < 10 at Week 64; 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
Other options
Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.