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 75 years, of any gender.
- People who have been diagnosed with ulcerative colitis at least 3 months before the screening visit, with the diagnosis confirmed by endoscopy or radiology and tissue testing.
- People whose ulcerative colitis is currently moderate to severe and active, as measured by a specific scoring system (modified Mayo score of 6 or higher).
- People whose ulcerative colitis has not responded well to, or who could not tolerate, at least one standard treatment (such as aminosalicylic acids, steroids, or immunomodulators) or a biologic medication (such as anti-TNF, anti-integrin, or anti-IL-12/23 drugs), as determined by the trial doctor.
- People who are taking oral aminosalicylic acids or oral steroids must have been on a stable dose for at least 2 weeks before joining and must keep that dose stable throughout the study.
- People who are willing to give their informed consent voluntarily and agree to follow all study procedures and complete the trial as required.
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 other types of colitis or bowel diseases, such as infectious colitis, ischemic colitis, fulminant colitis, toxic megacolon, Crohn's disease, intestinal tuberculosis, radiation enteritis, or intestinal Behçet's disease, rather than ulcerative colitis alone.
- People who have never received any previous treatment for ulcerative colitis.
- People who have taken part in another clinical trial within the 3 months before screening (except those who only went through screening for another trial but did not receive any experimental treatment).
- People with a history of alcohol or drug abuse who have not been fully abstinent for at least 6 months before joining the trial.
- People who have received a live vaccine within 6 weeks before joining, or who plan to receive a live vaccine during the study or within 6 weeks after the last dose of the trial drug.
- People who have had a major injury or major surgery within 4 weeks before joining.
- People who have other digestive conditions that may affect how oral medications are absorbed, or who have had stomach removal or gastric bypass surgery.
- People who the trial doctor determines need or are receiving full nutritional support through a drip (total parenteral or total enteral nutrition).
- People who are allergic to the trial drug or any of its ingredients.
- People who have already had surgery for ulcerative colitis (such as a stoma, bowel reconnection, or bowel removal), or for whom such surgery is expected to be needed during the trial.
- Women who are pregnant or breastfeeding; women of childbearing age who have a positive pregnancy blood test at screening; women who plan to become pregnant during the trial or within 3 months after the study ends; or women unwilling to use at least one form of physical contraception during the trial and for 3 months after it ends.
- People whom the trial doctor considers unsuitable for participation for any other reason, or who have other conditions that could affect how the safety, tolerability, or drug levels of the trial medication are assessed.
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: 029-84777551
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
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Primary endpoints
Adverse events (AE) and Serious Adverse Events (SAE);; Tmax of ENC1018 and its major metabolites in patients with moderate-to-severe active ulcerative colitis (UC).; Cmax of ENC1018 and its major metabolites in patients with moderate-to-severe active ulcerative colitis (UC).; AUC of ENC1018 and its major metabolites in patients with moderate-to-severe active ulcerative colitis (UC).
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.