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 enrolled 51 people with moderate-to-severe Crohn's disease — a condition causing inflammation and ulcers in the gut — whose symptoms were not controlled by standard treatments. Twenty-six participants were given a placebo (a dummy treatment with no active ingredient) and 25 were given the study drug, ITF2357. The trial was measuring whether the drug could heal ulcers in the gut lining, as seen by a camera examination (endoscopy), over eight weeks. Nineteen people in the placebo group and 18 in the ITF2357 group completed the study. The reported data shows that for the main (primary) goal — complete disappearance of gut ulcers — 0 out of 26 participants in the placebo group and 1 out of 25 in the ITF2357 group met that measure. For the secondary measures, which used a gut-severity scoring system called CDEIS (where a lower score means less inflammation), the reported data shows: 2 placebo participants and 1 ITF2357 participant reached the strictest remission threshold (score of 3 or below); 3 placebo and 5 ITF2357 participants reached a broader remission threshold (score of 6 or below); and 6 placebo and 7 ITF2357 participants showed a meaningful improvement in their score from the start of the trial. The average change in CDEIS score from the beginning to week 8 was −2.5 points in the placebo group and −2.4 points in the ITF2357 group. A similar scoring tool called SES-CD showed an average change of −2.6 points for placebo and −2.0 points for ITF2357. 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 must be over 18 years old.
- You must have been diagnosed with Crohn's disease, confirmed by a camera test of the gut, an X-ray, or surgery within the last 3 years.
- Your Crohn's disease must have been in an active flare for at least 2 weeks before the screening visit.
- Your disease activity must fall within a specific range, measured by a scoring system called the CDAI (score between 220 and 450) (confirm with trial site).
- Your gut inflammation must score above 8 on a separate endoscopy-based scoring system called the CDEIS (confirm with trial site).
- You must have ulcers larger than small surface-level sores in at least one part of your bowel, from the lower small intestine to the rectum.
- If you are taking steroid medicines (such as prednisone or budesonide), your dose must be at or below a set level, and you must have been on a stable dose for at least 2 weeks before joining.
- If you are taking immune-suppressing medicines (such as azathioprine, 6-mercaptopurine, or methotrexate), you must have been taking them for at least 3 months before joining.
- If you are taking a type of anti-inflammatory medicine called 5-aminosalicylates, you must have been taking more than 2g per day for at least 4 weeks before joining.
- If you are a woman who could become pregnant, you must have a negative pregnancy test before joining.
- You must be willing to sign a consent form agreeing to take part in the trial.
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 treated with certain anti-inflammatory biological medicines called anti-TNF-alpha antibodies in the last 2 months, or with other immune-targeting or experimental drugs in the last 3 months.
- You previously tried anti-TNF-alpha antibody treatment and it did not work for you at all.
- You currently have a blockage in your bowel, a hole in your bowel, or serious bowel bleeding, or you have a condition that puts you at risk of these problems.
- You are expected to need bowel surgery during the time the study is running.
- You have had a stoma (an opening in the abdomen for waste) or a large portion of your bowel removed.
- You have tested positive for hepatitis C, HIV, or have signs of an active hepatitis B infection.
- You have another ongoing significant viral infection (such as shingles, Epstein-Barr virus, or CMV), a widespread fungal infection, or a history of repeated serious bacterial infections.
- You have severe, worsening, or poorly controlled problems with your kidneys, liver, blood, hormone glands, lungs, heart, nerves, or brain.
- You have any history of heart disease, irregular heart rhythm, or heart failure, no matter how mild.
- Your heart's electrical activity (measured by an ECG) shows a reading called QTc above 450 milliseconds (confirm with trial site).
- Your blood levels of magnesium or potassium are below the normal range before starting treatment.
- Your platelet count (a measure of clotting cells in your blood) is below a certain level before starting treatment.
- You have any history of kidney problems, no matter how mild.
- You must take a medicine that is known to carry a risk of causing a specific type of dangerous heart rhythm called Torsades de Pointes.
- You have received a transplanted organ.
- You have a history of cancer and cannot show at least 5 years of being cancer-free.
- You have a history of tuberculosis.
- You have severe lactose intolerance.
- You are pregnant or breastfeeding.
- You are a woman who could become pregnant and are not using a reliable form of contraception.
- You have taken part in another clinical trial within 30 days before starting this study.
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
Number of Patients Achieving Complete Healing of Mucosal Ulcerations of Ileum and/or Colon
Other options
Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.