Phase 4 Crohn's Disease and Colitis Trial, Recruiting NCT07216014 Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University Condition: Crohn's Disease and Colitis
Back to Crohns Disease And Colitis

Phase 4 Crohn's Disease and Colitis Trial, Recruiting

NCT07216014
Recruiting Phase 4

Who may 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 might be able to join this trial:

  • You are between 18 and 65 years old
  • You have been diagnosed with Crohn's Disease or Ulcerative Colitis according to specific Chinese medical guidelines
  • If you are a woman who could become pregnant, you must take a pregnancy test at the start of the trial and agree to use contraception throughout the study (women who have gone through menopause or have had a permanent sterilisation procedure do not need a pregnancy test)
  • You fully understand the purpose of the trial, are aware of how the study drugs work and their possible side effects, and are willing to sign a consent form and follow the study rules

Who may not be able to join:

  • You have been diagnosed with another type of bowel inflammation, such as ischemic enteritis, infection-related bowel disease, radiation-related bowel disease, bowel disease caused by anti-inflammatory painkillers (NSAIDs), or other immune-related bowel conditions
  • You are unable to receive the study medication regularly by intravenous drip (into a vein) or injection under the skin
  • You showed signs of a serious bowel complication called toxic megacolon during initial screening (confirm with trial site)
  • You have previously had surgery to remove part or all of your small or large intestine, rectum, or have had a stoma (ileostomy or colostomy)
  • You need surgery because of your condition now, or you plan to have any non-emergency surgery during the study
  • You have serious liver or kidney problems
  • You have an active bacterial or viral infection, or a long-lasting (chronic) infection
  • You have certain conditions that make a type of medication called biologic agents unsafe for you — for example, active or recent tuberculosis, a heart attack, heart failure, or a nerve/brain condition called demyelinating disease
  • You have had a serious or repeated opportunistic infection during screening (these are infections that occur when the immune system is weakened, such as severe shingles, cytomegalovirus, or certain fungal infections)
  • You have a history of abnormal cell growth in the digestive tract, any pre-cancerous changes found during a camera test of the bowel (except for fully removed low-grade lesions), a history of lymphoma or other lymph-related cancers, signs of lymph node or spleen swelling suggesting such disease, or any current or past cancer

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 27 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

Phone: +8613826462890

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
Sixth Affiliated Hospital, Sun Yat-sen University
Registry
ClinicalTrials.gov
Start date
1 December 2025
Est. completion
30 September 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Steroid-Free Clinical 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: 27 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