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 (NCT04877990) enrolled people with one of two bowel conditions — Crohn's Disease or Ulcerative Colitis. In the Crohn's Disease group, 26 people started the pre-treatment stage and 24 moved into the treatment stage. In the Ulcerative Colitis group, 41 people started and all 41 moved into the treatment stage. The trial was primarily measuring things related to monitoring participants' wellbeing during treatment, including any unwanted medical events (called adverse events), blood and urine test results, heart tracing (ECG) readings, and vital signs such as blood pressure and pulse. The reported data shows that, when it came to unwanted medical events during treatment, 18 out of 24 Crohn's Disease participants and 19 out of 41 Ulcerative Colitis participants experienced at least one such event. Serious events — meaning those involving hospitalisation, being life-threatening, or similarly significant — were reported for 2 participants in each group. One participant in each group stopped the study due to an unwanted event. Regarding heart tracings (ECGs), some changes from the starting point were recorded — for example, average heart rate changed by about minus 1.4 beats per minute in the Crohn's Disease group and plus 2.6 beats per minute in the Ulcerative Colitis group during one measurement period. The reported data shows that no participants in either group had abnormal blood or urine chemistry results flagged, though some ECG and vital sign abnormalities were noted across both groups. Some laboratory values such as lipid (fat) levels in the blood showed small numerical changes from the starting point, but a number of individual measurements within this outcome were not reported in the data provided. 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 2 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 must have already taken part in and completed a previous related study (called a "parent study") for Crohn's disease or ulcerative colitis, where the treatment was given in an open, non-blinded way.
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.
- Women who are currently pregnant or breastfeeding.
- People who have been found to have abnormal or pre-cancerous growths in the colon (polyps or abnormal cell changes), either found during the final examination of the previous related study, or found during that study and not yet fully treated or removed.
Important: There may be additional criteria not listed here that could affect your eligibility — 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
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs); Number of Participants With Laboratory Abnormalities; Number of Participants With Electrocardiogram (ECG) Abnormalities; Number of Participants With Vital Signs Abnormalities; Change From Baseline in Laboratory Parameters; Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate; Change From Baseline in Electrocardiogram (ECG) Parameters; Change From Baseline in Vital Signs Parameters - Heart Rate; Change From Baseline in Vital Signs Parameters
Other options
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.