Crohn's Disease and Colitis Trial, Recruiting NCT07198113 Sponsor: University of North Carolina, Chapel Hill Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT07198113
Recruiting Not Applicable

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:

  • The person being considered must be under 18 years old at the time of enrolling in the study
  • They must have been diagnosed with Crohn's disease, ulcerative colitis, or a form of inflammatory bowel disease that hasn't been fully classified, based on standard medical tests
  • Their body must have stopped responding to, or never responded to, at least one anti-TNF medication (a type of medication commonly used to treat inflammatory bowel disease)
  • Their doctor must be planning to start them on one of these specific medications: vedolizumab, ustekinumab, risankizumab, guselkumab, mirikizumab, tofacitinib, or upadacitinib — including approved copycat versions of these medicines
  • A parent or guardian must be able to give written consent in English or Spanish, and the child must be able to give their own agreement if required by local rules

Who may not be able to join:

  • People whose care is expected to move to a different medical centre within the next year
  • People who have previously taken any of the specific medications listed above — only those starting one of these medications for the first time after anti-TNF treatment would be considered
  • People for whom any of the medications being studied are medically unsuitable (confirm with trial site)
  • People with ulcerative colitis or unclassified inflammatory bowel disease who have already had their colon surgically removed
  • People who currently have a stoma bag (an opening on the abdomen used to divert waste from the bowel)

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 26 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.

Contact this trial

Principal Investigator: Michael D Kappelman, MD, Universty of North Carolina, Chapel Hill

Phone: 833-850-2848

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 November 2025
Est. completion
1 September 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Measure of Crohn's disease (CD) impact on patients' daily lives (TUMMY CD); Measures of ulcerative colitis (UC) impact on patients' daily lives (TUMMY UC); PROMIS Symptom Measure of Irritable Bowel Disease (IBD); Change in Pediatric PROMIS® Patient-Reported Outcome (PRO) Pain Interference Score for Crohn's Disease and Ulcerative Colitis (CD and UC); Change in Pediatric PROMIS® Fatigue Score for Crohn's Disease and Ulcerative Colitis (CD and UC); Change in Pediatric PROMIS® Anxiety Score for Crohn's Disease and Ulcerative Colitis (CD and UC); Change in Pediatric PROMIS® Depression Score for Cro...

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: 26 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