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 330 people with ulcerative colitis — a condition causing inflammation in the large bowel. Participants were split into two groups: 164 people received a lower dose of the study drug SHP647 (75 mg) and 166 received a higher dose (225 mg). The trial was measuring how participants' bodies responded to the drug over time, including any unwanted medical events they experienced, whether the bowel lining showed signs of healing at 16 weeks, and how much of the drug was detectable in the blood. Of those who started the trial, 93 people in the lower-dose group and 83 in the higher-dose group completed it. The reported data shows that when it came to unwanted medical events (called "adverse events" — meaning any health issue that occurred during the trial, whether or not it was thought to be related to the drug), 146 out of 164 participants in the 75 mg group and 147 out of 166 in the 225 mg group experienced at least one such event. Serious adverse events — those involving hospitalisation, life-threatening situations, or lasting disability — were recorded in 34 people in the lower-dose group and 40 in the higher-dose group. Twelve people in the 75 mg group and 23 in the 225 mg group stopped taking the drug due to these events. Regarding bowel lining appearance at week 16, the reported data shows that 27.4% of the lower-dose group and 29.5% of the higher-dose group met the study's definition of mucosal healing (a bowel lining score of 0 or 1 on a standard scale). The trial also tracked whether participants developed antibodies against the drug itself; small numbers in both groups did, with figures ranging from 0 to 9 participants depending on the time point and measurement type. 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
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 between 18 and 66 years old
- You were previously part of a specific related study (called A7281009 / NCT01620255) and have completed the full 12-week starting phase of that study
Who may not be able to join:
- You finished the 12-week phase of the previous study but had serious side effects linked to the study drug, have an unstable health condition, or the doctor running the trial has another reason to think you should not take part (confirm with trial site)
- You are currently taking any amount of Azathioprine, 6-mercaptopurine, or Methotrexate (these are medicines often used to reduce the activity of the immune system)
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.
Contact this trial
Principal Investigator: Shire Director, Takeda
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs)
Can't join this trial?
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.