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 (NCT04130919) looked at a medicine called tilpisertib in people with ulcerative colitis, a condition causing inflammation in the large bowel. The trial had two stages: a blinded phase (where participants didn't know which treatment they were getting) and an open-label phase (where everyone received tilpisertib). In the blinded phase, 7 people received tilpisertib 300 mg, 6 received tilpisertib 100 mg, and 6 received a placebo (a dummy treatment with no active ingredient). Of those, 5, 4, and 3 people respectively completed that phase. A smaller group then continued into the open-label phase, with 10 participants in total starting it, though only 2 finished it. The trial was measuring things like whether participants reached "remission" (very low disease activity) and whether their bowel lining showed improvement on camera (endoscopy) at 10 weeks. The reported data shows that for the main goal — clinical remission at Week 10, measured using a scoring system that combines bowel camera findings, bleeding, stool frequency, and the doctor's overall assessment — 0% of participants in all three blinded-phase groups (tilpisertib 300 mg, tilpisertib 100 mg, and placebo) met that standard. Similarly, 0% in all three groups reached the stricter "MCS remission" measure. For endoscopic response (improvement seen on the bowel camera), the reported figures were 14.3% in the tilpisertib 300 mg group, 16.7% in the tilpisertib 100 mg group, and 0% in the placebo group. For a broader measure of overall disease response (MCS response), figures were 28.6%, 16.7%, and 16.7% respectively. When looking at tissue samples under a microscope (histologic remission), the reported rates were 16.7%, 16.7%, and 25.0% across the three groups. The trial also tracked unwanted events (adverse events) experienced during treatment; in the blinded phase, 57.1% of the tilpisertib 300 mg group, 50.0% of the tilpisertib 100 mg group, and 50.0% of the placebo group reported at least one such event. It is worth noting that this was a very small trial — fewer than 20 people in the blinded phase — so these percentages are based on very small numbers of individuals. The reported data shows no statistical analysis was included in the submitted results, so no conclusions about differences between groups can be drawn from these figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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
Who may 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 might be able to join this trial:
- You are a man, or a woman who is not pregnant or breastfeeding, and are at least 18 years old.
- You have been diagnosed with ulcerative colitis (UC) for at least 3 months, confirmed by a camera examination of the bowel (endoscopy) and tissue sample (biopsy) at some point in the past, and the disease affects at least 15 cm of the bowel from the bottom of the digestive tract.
- Your UC is considered moderately to severely active, based on specific scores measured during a camera examination of your bowel at the screening stage.
- You have previously tried a type of medication called a TNF-alpha inhibitor (such as infliximab, adalimumab, golimumab, or similar medicines) and it either did not work well enough or stopped working over time.
- If you are already taking other UC medications, the dose must have been stable for a set period of time before joining the trial.
- You must show no signs of active or untreated tuberculosis (TB), confirmed through a specific TB blood test and a chest X-ray taken recently.
- Your blood test results at screening must fall within acceptable ranges for liver function, kidney function, red blood cells, white blood cells, platelets, and other blood cell counts.
Who may not be able to join:
- You are currently experiencing a sudden, severe flare-up of colitis, an extremely serious bowel condition called fulminant colitis, or a dangerous complication called toxic megacolon (confirm with trial site).
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 is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Who Achieved Clinical Remission Per Modified Mayo Clinic Score (MCS) at Week 10
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.