Phase 4 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
- People who have been diagnosed with ulcerative colitis (a type of inflammatory bowel disease) for at least 6 months, confirmed through clinical, endoscopic, lab, or imaging tests.
- People aged 18 years or older, of any gender.
- People who have been taking a JAK inhibitor medication (tofacitinib, upadacitinib, or filgotinib) for more than 12 months.
- People who have been on a stable, unchanged dose of one of these three medications for at least 6 months (at specific doses as determined by the trial site).
- People whose ulcerative colitis has been in remission (well controlled, with no bleeding) for at least 6 months without the use of steroids, based on a standard symptom scoring system.
- People whose bowel lining appears fully healed on a camera examination (endoscopy) at the time of joining the trial.
- People whose stool test result (fecal calprotectin, a marker of gut inflammation) is at or below 150μg/g.
- People who have no known risk factors for blood clots in the veins.
- People who have no known risk factors for serious heart or stroke-related events.
- People who have no known risk factors for cancer.
- Women who could become pregnant, and men whose partners could become pregnant, who are willing to use effective contraception throughout the trial and for at least 4 weeks after it ends, as recommended for JAK inhibitor use.
- People who are able to understand the information given to them and willing to sign a written consent form to take part.
- People who are affiliated with a social security scheme (confirm with trial site, as this may apply specifically to the country where the trial is conducted).
- People who are in good general health based on their medical history and a physical examination.
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 who have used steroid medications within the 6 months before joining the trial.
- People who are currently being treated with steroids, immune-suppressing medications, or biologic therapies.
- People who are pregnant or planning to become pregnant during the study.
- People who are breastfeeding.
- People who are unlikely to follow the study schedule and requirements consistently.
- People who have had a bad reaction or intolerance to JAK inhibitor medications, including any of their ingredients.
- People for whom JAK inhibitor medications are medically unsuitable (contraindicated).
- People with known risk factors for blood clots in the veins.
- People with known risk factors for serious heart or stroke-related events.
- People with an active cancer, or a history of cancer diagnosed within the last 5 years.
- People currently participating in another interventional clinical study (with a possible exception for a specific category of low-risk studies — confirm with trial site).
- People with severe liver problems.
- People with severe or advanced kidney problems.
- People with active tuberculosis, serious infections such as blood poisoning, or infections that occur due to a weakened immune system.
- People who have not given, or who refuse to give, informed consent to participate.
- People under legal guardianship or a court-appointed protection order.
- People currently receiving psychiatric care.
- People whose freedom has been restricted by a court or government order.
- People who have difficulty understanding information or who have a cognitive (thinking or memory) disorder.
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: Lucas GUILLO, DR, AP-HM
Phone: +33 04 91 38 12 45
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
Primary endpoints
The primary endpoint of this study will be a composite criterion of treatment safety, efficacy, and patient satisfaction during the first 52 weeks of the follow-up.; The primary endpoint of this study will be a composite criterion of treatment safety, efficacy, and patient satisfaction during the first 52 weeks of the follow-up.; The primary endpoint of this study will be a composite criterion of treatment safety, efficacy, and patient satisfaction during the first 52 weeks of the follow-up.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.