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 (NCT04779307) enrolled 121 children and teenagers with ulcerative colitis — a condition causing ongoing inflammation of the large bowel. Participants received the medicine vedolizumab, with the dose adjusted to their body weight: 150 mg for those weighing 10–15 kg (3 participants), 200 mg for those weighing over 15 kg up to 30 kg (27 participants), and 300 mg for those weighing 30 kg or more (91 participants). The trial was measuring how many participants reached "clinical remission" — meaning their bowel symptoms and bowel-lining appearance on camera (endoscopy) had improved to near-normal levels — at two time points: around 14 weeks (roughly 3 months) and 54 weeks (roughly one year). The reported data shows that at the 14-week mark, roughly 33% of the lightest weight group, 44% of the middle weight group, and 32% of the heaviest weight group had reached clinical remission. By 54 weeks, participants had been re-grouped into a "low dose" group (47 participants) and a "high dose" group (46 participants) for the maintenance phase. The reported data shows that at 54 weeks, about 51% of the low-dose group and about 44% of the high-dose group were in clinical remission. For participants who had already reached remission at 14 weeks and were then checked again at 54 weeks (called "sustained remission"), approximately 30% of the low-dose group and 28% of the high-dose group maintained that remission. Looking at endoscopy results specifically, around 36% of the low-dose group and 30% of the high-dose group showed sustained improvement in their bowel lining at 54 weeks, while endoscopic response (any measurable improvement on camera) at 54 weeks was reported at about 60% for the low-dose group and 48% for the high-dose group. 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 3 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 have moderately to severely active ulcerative colitis (UC) that is not responding well to your current treatment, or you cannot tolerate your current treatment.
- You weigh at least 10 kg (about 22 pounds) at the time of screening.
- You have been diagnosed with UC for at least 1 month before screening, and tests (including a camera examination of your colon) confirm your disease is moderately to severely active.
- You have previously tried at least one common UC treatment — such as steroids, immunosuppressants (like azathioprine or methotrexate), or a TNF-blocking medication (like infliximab or adalimumab) — and it either stopped working, never worked, or caused problems you couldn't tolerate. This also includes people who need steroids just to keep symptoms under control but get worse when trying to reduce the dose.
- Your UC affects more of your colon than just the very last section (the rectum).
- If you have had widespread UC for more than 8 years, or left-sided UC for more than 12 years, you must have had a colonoscopy with no signs of abnormal cell changes within the past 12 months.
- Your routine childhood vaccinations are up to date according to the schedule used in your country.
Who may not be able to join:
- You have previously been treated with certain medications that target the immune system's "integrin" pathway, including natalizumab, efalizumab, etrolizumab, abrilumab, MAdCAM-1 blockers, or rituximab.
- You have recently received an experimental biologic drug (within 60 days or 5 half-lives, whichever is longer) or an approved biologic drug (within 2 weeks) before the study drug would start.
- You have an active brain or nervous system condition, or a history of serious neurological problems such as stroke, multiple sclerosis, a brain tumor, or a degenerative nerve disease.
- You have had a significant infection (such as pneumonia or COVID-19) within the 30 days before starting the study drug.
- You have received a live vaccine within the 30 days before starting the study drug.
- You currently need surgery for your UC, or it is expected that you will need surgery during the study.
- You have previously had a large portion of your colon removed, or you have a stoma bag, intestinal pouch, or a known permanent narrowing of the intestine.
- You have been diagnosed with "indeterminate colitis" (where doctors are unsure whether it is UC or Crohn's disease).
- Your symptoms suggest a rare, inherited form of inflammatory bowel disease that starts in very early childhood (confirm with trial site).
- You have active or latent (inactive/hidden) tuberculosis (TB), confirmed by a TB blood test or skin test done within 30 days of screening.
- You have signs of an active hepatitis B infection based on blood tests. (Note: people who are immune to hepatitis B may still be eligible — confirm with trial site.)
- You have active, ongoing hepatitis C infection. (Note: people who have cleared or been successfully cured of hepatitis C may still be eligible — confirm with trial site.)
- You have a history of cancer, or signs of abnormal pre-cancerous cells, other than certain successfully treated skin cancers or a localised cervical abnormality that has been fully treated.
- Your stool samples at screening test positive for parasites or harmful bacteria.
- Your stool test at screening comes back positive for a C. difficile infection (a type of gut bacterial infection).
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
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
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With Clinical Remission at Week 54 Based on Modified Mayo Score
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.