Printed from Voxsanity (voxsanity.com.au) — NCT06725017 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Crohn's Disease and Colitis Trial, Not Yet Recruiting
NCT06725017
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 are willing to sign a consent form and are able to follow the study rules and procedures.
- Adults aged 18 to 75 years (inclusive) at the time of signing the consent form, of any gender.
- People who have been diagnosed with ulcerative colitis (UC) for at least 3 months, confirmed through standard clinical assessment, endoscopy, and tissue analysis.
- People with active mild to moderate UC, as measured by a specific scoring system (modified Mayo Score of 4–10), where the endoscopy score is at least 2 and the rectal bleeding score is at least 1.
- People whose UC affects an area of the colon that extends more than 15 cm from the end of the bowel (confirmed by colonoscopy).
- People who have not responded to, had only a partial response to, or could not tolerate standard 5-ASA treatment (a common UC medication, including local forms); people who are currently taking a stable, unchanged dose of 5-ASA for at least 4 weeks before joining may also be eligible.
- Female participants who are not breastfeeding and who are either past menopause (for at least 1 year), have had a sterilisation procedure, or are using at least one highly effective form of contraception throughout the study and for at least 3 months after the last dose; female participants of childbearing potential must also have a negative pregnancy blood test within 7 days before the first dose.
- Male participants whose partner could become pregnant must agree to use at least one highly effective form of contraception from the time of signing the consent form until at least 3 months 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 with other types of bowel conditions such as Crohn's disease, radiation colitis, diverticulitis, ischemic colitis, microscopic colitis, colitis caused by medications, indeterminate colitis, or findings on endoscopy/biopsy suggesting Crohn's disease.
- People who currently have, or have had, cancer within the past 5 years, with the exception of certain treated skin cancers (basal cell or squamous cell) that have been fully removed with no signs of return.
- People who had surgery within 30 days before the first study dose, or who expect to have surgery during the study.
- People with other bowel conditions such as abnormal tissue changes in the colon, bowel narrowing, tumours, bowel fistulas, bowel blockages, or coeliac disease.
- People with any active or long-term recurring infections.
- People who have previously had their colon removed, have a stoma, a J-pouch, or have had other bowel surgery (not including gallbladder or appendix removal).
- People with severe, worsening, or uncontrolled conditions affecting the kidneys, liver, blood, hormones, immune system, heart, lungs, nervous system, or mental health.
- People with serious additional health conditions that the study doctor considers unsafe for participation, including: advanced liver cirrhosis; a history of pancreatitis; certain abnormal heart rhythm measurements on an ECG; a history of bone marrow transplant; known low antibody levels in the blood; known severe immune deficiency; certain abnormal liver or kidney blood test results; or a very low level of a specific type of white blood cell (neutrophils).
- People who test positive for hepatitis C antibodies, HIV antibodies, or hepatitis B surface antigen and require antiviral treatment during the screening period.
- People with a known or suspected allergy to the study drug or any of its ingredients (maltodextrin, silicon dioxide, or magnesium stearate).
- People who are unable to stop taking steroid medications (such as budesonide MMX), whether taken by mouth or applied locally (e.g. suppositories or enemas), at least 2 weeks before the first dose.
- People who are unable to stop taking other medications that affect how the bowel works — such as antibiotics or anti-diarrhoeal medicines — at least 2 weeks before the first dose.
- People who have taken probiotic medicines or had a faecal transplant within 30 days before the first dose.
- People who have received biological therapies (such as infliximab, adalimumab, vedolizumab, or similar) within 8 weeks before the first dose, or certain non-biological immune-suppressing medications (such as cyclosporine, methotrexate, or tofacitinib) within 30 days before the first dose.
- People who have received a live or weakened live vaccine within 4 weeks before the first dose, or who plan to receive one during the study or follow-up period.
- People who have taken part in another clinical trial within 3 months before the screening visit.
- People with a history of alcohol or drug misuse.
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.
Contact this trial
Phone: China: 020-82515346
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 2
Sponsor
Guangzhou Zhiyi Biotechnology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 July 2025
Est. completion
1 July 2027
Primary endpoints
Proportion of subjects achieving clinical remission at Week 8
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 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.