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
- People aged 18 to 80 years old at the time of giving consent.
- People who are willing to give written consent to take part in the trial voluntarily.
- People who have been diagnosed with ulcerative colitis (UC) for at least 3 months before the screening visit, confirmed by camera examination of the bowel and tissue sample results.
- People whose UC is currently active, confirmed by bowel camera examination, and falls into a moderate or extensive category based on how much of the bowel is affected.
- People whose UC is moderately to severely active, based on specific scoring of symptoms and bowel camera results, with the camera examination done within 14 days before being entered into the trial.
- People who have not responded well to, lost response to, or could not tolerate at least one previous UC treatment — either a conventional therapy (such as anti-inflammatory tablets, steroids, or immune-suppressing medicines), or an advanced therapy (such as biologic injections or newer tablet-based treatments like JAK inhibitors) — where that treatment must have been approved for UC in the country where the person was treated and given for an adequate period according to local guidelines.
- Women who could become pregnant must agree to avoid heterosexual intercourse or use adequate contraception, and agree not to donate eggs or undergo fertility treatment, during the treatment period and for 30 days after the last dose of the study drug (Hemay005); men must agree to avoid heterosexual intercourse or use a condom, and agree not to donate sperm, during the treatment period and for 30 days after the last dose.
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 currently diagnosed with Crohn's disease, certain bowel fistulas or abscesses, indeterminate colitis, unclassified inflammatory bowel disease, microscopic colitis, colitis caused by reduced blood flow, infection-related colitis, radiation-related colitis, or active diverticular disease.
- People with severe UC, including those who were hospitalised for UC treatment within 2 weeks before screening, or who the doctor believes are likely to need hospitalisation or surgery during the study; those with current signs of extremely severe bowel inflammation (fulminant colitis or toxic megacolon), or a history of toxic megacolon or bowel perforation within the past 6 months; or those who have previously had most or all of the large bowel surgically removed.
- People with a past or current history of any cancer in the digestive tract, or any other cancer diagnosed within the 5 years before screening — with the exception of certain early-stage skin cancers or cervical changes that have been fully treated with surgery.
- People with past or current evidence of pre-cancerous cell changes or growths in the bowel that have not been completely removed.
- People with significant uncontrolled medical conditions (such as heart, lung, kidney, liver, hormonal, or mental health conditions) that, in the doctor's judgement, could affect the study results, put the person at risk, or affect their ability to consent or follow trial procedures.
- People with evidence of certain infections, including C. difficile, cytomegalovirus (CMV), HIV, Hepatitis B, or Hepatitis C.
- People with evidence of active tuberculosis (TB).
- People who have any condition that would prevent a bowel camera examination from being carried out safely.
- People who have taken certain medicines that are not permitted by the trial protocol before the baseline assessment, or who have not waited long enough after stopping those medicines before entering the 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.
Contact this trial
Principal Investigator: Minhu Chen, M.D, First Affiliated Hospital, Sun Yat-Sen University
Phone: 86-22-24929530
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
Induction Phase: Percentage of Participants With Clinical Remission at Week 12.; Maintenance Phase: Percentage of Participants With Clinical Remission at Week 40.
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.