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 (NCT03733314) enrolled 25 people with Crohn's disease — 12 in the group that received the investigational drug E6011 at a dose of 10 mg/kg, and 13 in a group that started on a placebo (an inactive treatment) before later switching to E6011. The trial used a scoring system called the CDAI (Crohn's Disease Activity Index), which combines eight factors such as abdominal pain, bowel frequency, and general wellbeing into a single number from 0 to 600, where a higher score means more severe disease. The main thing the trial was measuring was the proportion of participants whose CDAI score dropped by 100 points or more by week 12 — a marker called a "clinical response." The reported data shows that at week 12, approximately 33% of participants in the E6011 group and approximately 23% in the placebo-then-E6011 group met that 100-point reduction target. For a slightly smaller reduction of 70 points or more at week 12, the reported figures were approximately 45% and 23%, respectively. For what is described as "remission" — a CDAI score falling below 150 points — the reported data shows 0% in the E6011 group and approximately 8% in the placebo group at week 12, rising to 20% and approximately 31% respectively by week 24. In a separate assessment looking at bowel symptoms and pain as reported directly by participants (a tool called PRO2), the reported figures for meaningful improvement ranged broadly across the different time points and groups. For an endoscopy-based measure (looking directly at the gut lining), approximately 8% of the E6011 group and approximately 15% of the placebo group showed a 50% or greater improvement at week 12. 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 have been diagnosed with Crohn's disease (affecting the small intestine, large intestine, or both) for at least 12 weeks before agreeing to take part.
- Your Crohn's disease is currently moderate to severe, based on two specific scoring systems used by doctors (confirm with trial site for exact score details).
- A camera examination of your bowel (colonoscopy) during the screening period showed a certain level of disease activity, including the presence of at least one ulcer, as confirmed by a central review team.
- You have previously tried steroid or immune-suppressing medicines but they did not work well enough, you could not tolerate them, or you became dependent on steroids; or you have tried a biologic medicine that either never worked, stopped working over time, or caused side effects you could not tolerate.
- If you are currently taking certain anti-inflammatory medicines or antibiotics for Crohn's disease, your dose has not changed in at least the last 4 weeks.
- If you are currently taking a low dose of oral steroid medication (such as prednisolone or budesonide), your dose has not changed in at least the last 4 weeks.
- If you are currently taking certain immune-suppressing medicines (such as azathioprine, 6-mercaptopurine, or methotrexate), your dose has not changed in at least the last 8 weeks.
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 ulcerative colitis or a type of bowel disease that is unclear between Crohn's and ulcerative colitis (called indeterminate colitis).
- You have been diagnosed with abnormal or pre-cancerous changes in the lining of your digestive tract.
- You currently have, or are suspected to have, a pocket of infection (abscess) in your abdomen.
- You have a stoma bag (artificial opening for waste), an ileo-anal pouch, or a fistula (an abnormal channel between body parts).
- You have a significant or symptomatic narrowing in your bowel that requires a procedure to widen it, or has been rated as severely narrow during your colonoscopy assessment.
- You have had part of your small bowel surgically removed and as a result have difficulty absorbing enough nutrition (known as short bowel syndrome).
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, and 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 Response (CR) 100 (CR100) at Week 12
Other options
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.