Phase 3 Crohn's Disease and Colitis Trial, Not Yet Recruiting
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
- Adults aged between 18 and 80 years old, of any gender.
- Willing and able to sign a consent form agreeing to take part in the trial.
- Diagnosed with a specific form of Crohn's disease that causes scarring and narrowing of the bowel (fibrostenosing Crohn's disease), confirmed by camera examination of the bowel (endoscopy) and tissue analysis (histology).
- Experiencing symptoms related to bowel narrowing, such as cramping, changes to diet, vomiting after eating, or abdominal pain.
- Bowel narrowing confirmed by endoscopy or medical imaging, where the narrowing was not caused by a previous stretching (dilation) or stent procedure.
- The narrowed section of bowel is less than 10 cm long, and there are no more than 2 narrowed sections in the same part of the bowel.
- Experiencing signs of bowel blockage or partial blockage.
- Previous treatments for Crohn's disease (such as azathioprine, 6-mercaptopurine, methotrexate, or TNF-α inhibitors) have not worked well enough, have caused unacceptable side effects, or cannot be used due to other health reasons.
- Planning to receive treatment with risankizumab or ustekinumab for the first time.
- Has never previously used risankizumab or ustekinumab; if other biological medicines have been used, they must have been stopped for long enough before joining (for TNF-α inhibitors, at least 8 weeks must have passed).
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.
- People younger than 18 or older than 80 years of age.
- People who are unwilling or unable to sign a consent form.
- People who do not have symptoms of fibrostenosing Crohn's disease, such as cramping, dietary changes, vomiting after eating, or abdominal pain.
- People who have had a stent placed or a bowel-stretching (dilation) procedure for their narrowing within the past year.
- People who are pregnant, breastfeeding, or planning to become pregnant.
- People for whom a bowel camera examination (endoscopy) cannot be performed, or who have a health condition that makes endoscopy unsafe.
- People who have abscesses, fistulas, or active complex narrowing of the bowel.
- People whose bowel narrowing is 10 cm or longer, or who have more than 2 narrowed sections in the same part of the bowel.
- People with serious blood clotting problems, indicated by very low platelet counts or abnormal clotting test results (confirm with trial site).
- People with severe failure of a major organ, HIV infection, uncontrolled infections, or a history of cancer within the past 5 years.
- People who have already started or received treatment with risankizumab or ustekinumab.
- People whom the trial investigators consider unsuitable for participation for other medical reasons.
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
Phone: +86 13857709707
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Primary endpoints
Radiological Composite Endpoint
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Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.