Printed from Voxsanity (voxsanity.com.au) — NCT06257706 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 4 Crohn's Disease and Colitis Trial, Recruiting
NCT06257706
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 are between 18 and 80 years old
- You have moderately to severely active Crohn's disease, based on specific scoring measurements your doctor uses to assess disease activity (confirm with trial site)
- An ultrasound of your bowel shows thickening of the bowel wall in certain areas of your intestine (confirm with trial site)
- You have either never been treated with a biologic or advanced medication for Crohn's disease, or you have tried no more than one such medication in the past 5 years
- You are taking a stable dose of a medication called 5-ASA for Crohn's disease that was started at least 4 weeks before screening
- If you are able to become pregnant, you must have a negative pregnancy test before joining and use a highly effective form of contraception throughout the study
- You are able to fully participate in all parts of the trial
- You are willing and able to give written consent to take part
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 previously been treated with vedolizumab, etrolizumab, or natalizumab (specific medications for Crohn's disease)
- You have previously been treated with two or more advanced biologic or small molecule medications for Crohn's disease
- Your steroid medication dose has recently changed in the 2 weeks before joining, or your dose is higher than the equivalent of 40 mg of prednisone
- Your Crohn's disease inflammation is only in a part of the bowel that cannot be reached by a standard camera procedure (colonoscopy)
- You have a serious Crohn's complication, such as a significant blockage in the small bowel that needs a medical procedure to treat
- You have had a large portion of your colon removed, or have had certain specific bowel surgeries (confirm with trial site)
- You have a stoma bag or a surgically created internal pouch
- You have short bowel syndrome (a condition where much of the small intestine is missing or not working)
- You have a bowel narrowing caused only by scarring with no active inflammation, including any blockage that cannot be passed during examination
- You have an abscess (a pocket of infection) larger than 2 cm found by ultrasound or camera examination
- You have another serious health condition that, in the doctor's opinion, could affect your ability to take part safely
- You have tested positive for a harmful gut infection called Clostridioides difficile
- You are known to have HIV, hepatitis B, or hepatitis C infection
- You have active or latent (dormant) tuberculosis (TB)
- You have another significant systemic or opportunistic infection, or have had recurring infections within the past 6 months
- You have, or have had, a serious brain or nervous system condition called progressive multifocal leukoencephalopathy (PML) (confirm with trial site)
- You have a known allergy or intolerance to vedolizumab or any of its ingredients
- You currently have a serious active infection such as blood poisoning (sepsis) or certain other severe infections
- You are unwilling to stop taking medications that are not allowed during the trial
- You have taken part in another clinical trial and received an experimental treatment within the past 30 days
- You have a history of alcohol or drug misuse that, in the doctor's opinion, may affect your ability to follow the study procedures
- You have previously enrolled in this same study and already received the study treatment
- You are pregnant, breastfeeding, planning to become pregnant, or planning to donate eggs or sperm during the study or within 18 weeks after the last dose
- You have received a live vaccine within 4 weeks before joining, or plan to receive one during the study
- You are currently doing mandatory military service, are in custody, living in a care home, or are legally prevented from joining a clinical study
- You are an immediate family member or dependent of someone working at the study site who is involved in running this trial
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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.
Contact this trial
Principal Investigator: Vipul Jairath, MD, Alimentiv Inc.
Phone: 31205630316
Australian sites
Concord Repatriation General Hospital, Concord, New South Wales
Mater Misericordiae Ltd, South Brisbane, Queensland
Calvary Adelaide Hospital, Adelaide, South Australia
Royal Adelaide Hospital, Adelaide, South Australia
The Queen Elizabeth Hospital, Woodville, South Australia
Northern Hospital Epping, Epping, Victoria
Austin Health, Heidelberg, Victoria
The Alfred Hospital, Melbourne, Victoria
Royal Melbourne Hospital, Melbourne, Victoria
Harry Perkins institute of Medical Research - Fiona Stanley Hospital, Murdoch, Western Australia
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
Status
Recruiting
Phase
Phase 4
Sponsor
Alimentiv Inc.
Registry
ClinicalTrials.gov
Start date
7 August 2024
Est. completion
3 January 2029
Where this trial is recruiting
🇦🇺 Australia
🇧🇪 Belgium
🇨🇦 Canada
🇨🇿 Czechia
🇩🇰 Denmark
🇫🇷 France
🇩🇪 Germany
🇮🇹 Italy
🇳🇱 Netherlands
🇵🇱 Poland
🇵🇹 Portugal
🇬🇧 United Kingdom
🇺🇸 United States
10 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of participants with Corticosteroid-free Endoscopic remission in group 1 and group 2 at week 48
Can't join this trial?
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.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.