Phase 4 Crohn's Disease and Colitis Trial, Recruiting NCT05043870 Sponsor: Children's Hospital of Fudan University Condition: Crohn's Disease and Colitis
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Phase 4 Crohn's Disease and Colitis Trial, Recruiting

NCT05043870
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

  • Children and teenagers between 6 and 18 years old
  • People who have been diagnosed with Crohn's Disease
  • People whose Crohn's Disease was measured as significantly active before treatment began, based on standard scoring tools used by doctors (PCDAI score above 30, or SES-CD score above 10)
  • People who have already tried a first-line treatment (either a liquid-only nutrition program or steroid medications) but whose disease is still showing meaningful activity on those same scoring tools afterward (PCDAI score above 10, or SES-CD score of 3 or higher)
  • People for whom the patient themselves, or their legal guardian, has signed the required consent forms agreeing to take part

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 previously been treated with a type of medication called a biologic that targets a substance in the body known as TNF (tumor necrosis factor)
  • People who have had surgery related to their Crohn's Disease
  • People who currently have an infection
  • People who have or have had a tumour

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

Contact this trial

Principal Investigator: Ying Huang, Children's Hospital of Fudan University

Phone: +8613817510412

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
Recruiting
Phase
Phase 4
Sponsor
Children's Hospital of Fudan University
Registry
ClinicalTrials.gov
Start date
10 October 2022
Est. completion
31 October 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

clinical remission; endoscopic remission

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