Phase 4 Crohn's Disease and Colitis Trial, Not Yet Recruiting NCT05813860 Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University Condition: Crohn's Disease and Colitis
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Phase 4 Crohn's Disease and Colitis Trial, Not Yet Recruiting

NCT05813860
Not Yet Recruiting Phase 4

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 Crohn's disease according to a specific set of recognised diagnostic guidelines (Beijing Consensus, 2018).
  • People whose condition meets the accepted medical criteria for treatment with infliximab (IFX).
  • People aged 18 or older with a Crohn's Disease Activity Index (CDAI) score between 220 and 450, which indicates moderately to severely active disease.
  • People, or their family members, who are able to understand the study plan and are willing to take part by signing a written consent form.

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 a specific genetic variation known as NUDT15 CT or TT genotype, or who have previously been treated with infliximab (IFX) or any other anti-TNF biologic medication.
  • People who are planning to become pregnant, are pregnant, or are breastfeeding within the 12-month study period.
  • People who cannot tolerate immunosuppressive medications or for whom such medications are medically unsuitable.
  • People who have serious ongoing conditions affecting the heart, lungs, liver, kidneys, nervous system, or mental health, or who have issues with alcohol or drug dependence, other ongoing active illnesses, or who require long-term use of hormonal or immunosuppressive drugs.
  • People with active infectious diseases, such as tuberculosis.
  • People with cancer-related conditions, such as lymphoma or gastrointestinal tumours.
  • People with any other medical condition, recent surgery, current medication, or abnormal test results that the trial investigators believe could affect the study results.
  • People who are unwilling or unable to follow the trial requirements, including attending scheduled visits and completing required examinations.

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.
Last synced 15 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

GP referral letter

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Trial details

Status
Not Yet Recruiting
Phase
Phase 4
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Registry
ClinicalTrials.gov
Start date
30 April 2023
Est. completion
31 May 2026

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

Clinical remission without corticosteroid use at 102 weeks

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 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.

View original record on ClinicalTrials.gov