Crohn's Disease and Colitis Trial, Not Yet Recruiting NCT07344428 Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Not Yet Recruiting

NCT07344428
Not Yet Recruiting Not Applicable

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 18 or older.
  • People who have been diagnosed with Crohn's disease, confirmed through a camera examination of the gut (endoscopy) and tissue testing (histopathology), with the disease currently active based on a standard scoring measure.
  • People whose doctor has determined they need to start a specific type of medication called an anti-TNF-α biologic (either infliximab or adalimumab), and who have never taken either of these medications before.
  • People who are willing and able to sign a written consent form agreeing to take part.
  • People who are able to understand and follow the study's requirements, including following a specific diet and attending scheduled check-up appointments.

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 serious complications from their Crohn's disease that require surgery, such as a blocked bowel, an abscess inside the abdomen, or an abnormal tunnel connecting parts of the bowel (fistula).
  • People with serious problems affecting the heart, liver, or kidneys, as measured by specific medical tests (confirm with trial site).
  • People who currently have active tuberculosis (TB), active hepatitis B, HIV, or other serious infections that take advantage of a weakened immune system.
  • People who currently have or have previously had cancer, with the exception of certain types of non-dangerous skin cancer.
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study period.
  • People who have used certain immune-suppressing medications or high-dose steroid tablets within the past three months (confirm specific medications and doses with trial site).
  • People who have severe food allergies, coeliac disease, serious malnutrition (as measured by body weight relative to height), or who would not be able to follow the study's required diet plan.
  • People who are already taking part in another clinical trial, or anyone the trial's doctor considers unsuitable for any other reason.

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 31 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
1 May 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Mucosal healing rate at week 14 (SES-CD=0)

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: 31 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