Printed from Voxsanity (voxsanity.com.au) — NCT07665294 — 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, Not Yet Recruiting
NCT07665294
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
- People aged 18 to 80 years old at the time of signing the consent form.
- People who are able to understand and sign a written consent form before any trial procedures begin.
- People who have had a confirmed diagnosis of ulcerative colitis (UC) for more than 3 months.
- People with currently active UC, based on specific disease activity scores measured by symptoms and a camera examination of the bowel (confirm with trial site).
- People whose UC affects a section of bowel starting at least 5 cm inside the body from the back passage.
- People who are taking certain medications at a stable, unchanged dose for the required period before the trial starts, including: oral steroids at a stable dose for more than 2 weeks (at doses no higher than 20 mg/day of prednisone, 9 mg/day of budesonide, or an equivalent); methotrexate, azathioprine, or 6-mercaptopurine at a stable dose for more than 4 weeks before screening and throughout the study; oral 5-aminosalicylates, mesalamine, or sulfasalazine at a stable dose for more than 4 weeks before screening and throughout the study; and probiotics or anti-diarrhoeal medicines at a stable dose for at least 2 weeks before screening and throughout the study.
- People who have had UC for 8 years or more must have completed up-to-date bowel cancer screening according to local guidelines before being assigned to a treatment group in the trial.
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 diagnosed with an unclassified form of inflammatory bowel disease or Crohn's colitis (rather than ulcerative colitis).
- People who have previously been treated with vedolizumab (VDZ) or etrolizumab (both are a type of medication called anti-integrin biologics).
- People who have been taking steroid medicines at a dose higher than 20 mg/day of prednisone in the two weeks before enrolling.
- People who have previously been treated with more than one advanced therapy medicine (such as a biologic or small molecule drug) before joining the trial.
- People who are currently receiving, or planning to receive, certain other advanced therapies at the same time as the trial medication (confirm specific medicines with trial site).
- People who have used calcineurin inhibitor medicines (such as cyclosporine or tacrolimus) within 4 weeks before screening.
- People with a known hepatitis B or hepatitis C infection.
- People with active or latent tuberculosis that has not been adequately treated.
- People who currently have any active infection.
- People whose stool sample tests positive for a bowel infection at screening.
- People who have previously had their colon surgically removed or have had a specific type of bowel surgery called ileal pouch anal anastomosis.
- People who currently have or have been hospitalised in the past 2 weeks for a severe flare of UC, including conditions called fulminant UC or toxic megacolon.
- People with significantly abnormal blood test results, including low red blood cell levels, low protein levels, low platelet counts, or elevated liver markers (confirm specific values with trial site).
- People with a history of bowel cancer or certain pre-cancerous bowel changes that have not been adequately treated.
- People with another serious underlying illness or unstable medical condition that the trial doctor believes could interfere with participation or safety, including serious heart failure or certain neurological conditions.
- People with a history of a liver condition called primary sclerosing cholangitis.
- People with reduced kidney function, specifically an estimated filtration rate below 60 mL/min.
- People with a history of chronic liver disease, such as autoimmune hepatitis or cirrhosis.
- People who currently require nutrition delivered directly into a vein (total parenteral nutrition).
- People who have previously had a solid organ transplant (such as a kidney or liver transplant).
- People with a history of cancer or a blood/lymph system disorder in the past 5 years, with some exceptions for certain fully treated, non-spreading skin or cervical conditions (confirm with trial site).
- People with a history of blood clots in the veins (such as deep vein thrombosis or pulmonary embolism) or a known condition that causes the blood to clot too easily.
- People currently taking blood-thinning or anti-clotting medicines, other than aspirin.
- People with a history of HIV infection.
- People who are pregnant, breastfeeding, or actively trying to become pregnant.
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: Ryan Ungaro, MD MS, Icahn School of Medicine at Mount Sinai
Phone: 212-468-2174
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
Not Yet Recruiting
Phase
Phase 4
Sponsor
Ryan C Ungaro
Registry
ClinicalTrials.gov
Start date
1 October 2026
Est. completion
23 June 2027
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Number of participants with clinical remission
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.