Crohn's Disease and Colitis Trial, Recruiting NCT07237516 Sponsor: University of North Carolina, Chapel Hill Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT07237516
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:

  • You are 18 years of age or older and have been diagnosed with Crohn's disease, ulcerative colitis, or a form of inflammatory bowel disease that doctors haven't been able to classify as either one.
  • You are either just starting a specific injectable medication called Zymfentra after completing an initial course of intravenous infliximab treatment, or you are already on intravenous infliximab maintenance treatment and are switching over to Zymfentra.
  • Your diagnosis of inflammatory bowel disease has been confirmed through a combination of your symptoms, imaging, camera examinations of your gut (such as colonoscopy), and tissue samples, following established medical guidelines.
  • Your symptoms have included one or more of the following: diarrhea, rectal bleeding, stomach pain, fever, anal complications, symptoms affecting other parts of the body, or unexplained weight loss.
  • Your symptoms have either occurred on more than one occasion at least 8 weeks apart, or have lasted continuously for at least 6 weeks.
  • Your doctors expect to continue monitoring and caring for you at the participating clinic for at least the next 12 months.

Who may not be able to join:

  • You are not able or willing to give your informed consent to take part in the study.
  • You do not speak English.
  • You are only visiting the clinic for a single one-time consultation and are not an ongoing patient there.

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 2 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
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
20 November 2025
Est. completion
3 November 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Clinical remission as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes.; Clinical remission as evaluated by the Simple Crohn's Disease Activity Index (sCDAI for the patient-reported outcomes.

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: 2 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