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 (NCT03599622) enrolled 239 people with Crohn's disease across four groups: a placebo group (60 people) and three groups receiving different doses of the study drug BMS-986165 — 3 mg (86 people), 6 mg (84 people), and 12 mg (9 people). The trial was measuring two main things at 12 weeks: how many participants reached "clinical remission" (a standard symptom score dropping below a threshold suggesting low disease activity) and how many showed an "endoscopic response" (a meaningful improvement seen on a bowel camera examination). A pre-treatment screening period came before the main treatment period, and relatively small numbers completed the full treatment phase across all groups. The reported data shows that for the first primary measure — the proportion of participants reaching clinical remission at 12 weeks — the figures were 28.3% in the placebo group, 32.6% in the 3 mg group, 21.4% in the 6 mg group, and 22.2% in the 12 mg group. For the second primary measure — the proportion showing an endoscopic response at 12 weeks — the reported figures were 8.3% for placebo, 23.3% for the 3 mg group, 16.7% for the 6 mg group, and 33.3% for the 12 mg group (noting this last figure is based on only 9 participants). For the secondary measures, the reported data shows clinical response rates of 40.0%, 47.7%, 38.1%, and 55.6% respectively across the four groups; patient-reported symptom remission rates of 25.0%, 32.6%, 20.2%, and 33.3%; and average changes in the bowel camera severity score of −1.5, −2.5, −3.7, and −5.6 points (where a negative number means the score went down from the starting point). 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, 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 have been diagnosed with Crohn's Disease for at least 3 months before the screening visit, affecting the small intestine, large intestine, or both
- You have tried one or more standard treatments for Crohn's Disease but they did not work well enough, stopped working, or you could not tolerate them
- Your Crohn's Disease is currently active and considered moderate to severe
- If applicable, you are willing to use specific methods of birth control during the trial (both men and women)
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 colitis is very severe or rapidly worsening in a way that is likely to need surgery or a hospital stay
- You have been diagnosed with another type of colitis (such as ulcerative colitis, an infection-related colitis, or others) instead of, or alongside, Crohn's Disease
- You have previously taken the study drug (BMS-986165) in any other study
- You have a serious illness or an unstable health condition affecting organs such as the kidneys, liver, lungs, or mental health, or you have an active infection that the trial doctor believes would put you at significant risk
Please note: There may be additional eligibility requirements not listed here.
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 9 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Percent of Participants Achieving Clinical Remission at Week 12; Percent of Participants Achieving Endoscopic Response at Week 12
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.