Crohn's Disease and Colitis Trial, Recruiting NCT06249555 Sponsor: Alimentiv Inc. Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT06249555
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 old or older and have been diagnosed with Crohn's disease based on standard medical tests such as scans, biopsies, or a camera examination of the gut.
  • Your Crohn's disease is currently active, and your doctor has decided to start you on one of these medications for the first time: vedolizumab, ustekinumab, risankizumab, guselkumab, or mirikizumab (if approved for Crohn's disease during the study period).
  • You have scored 15 or higher on a specific pain questionnaire called the PROMIS Pain Interference Short Form, which measures how much pain affects your daily life (confirm with trial site).
  • You have already completed all the standard health checks required before starting your new medication, such as tests for tuberculosis, ongoing infections, and checking your vaccination history.
  • You are able to take part in all parts of this observational study and have fully understood and signed the consent form.

Who may not be able to join:

  • You have Crohn's disease-related surgery planned or expected at any point during the study.
  • You have previously been treated with certain advanced Crohn's disease medications (other than anti-TNF drugs like infliximab, adalimumab, or certolizumab pegol), or you have tried and failed or could not tolerate two or more anti-TNF medications within the past three years.
  • You currently have an active infection that requires antibiotic treatment given directly into a vein (intravenously).
  • You have recently tested positive for a gut infection called Clostridioides difficile, are being treated for it, or have another bacterial gut infection within the last two weeks before your screening visit.
  • You have long-term pain that is not caused by inflammatory bowel disease.

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 28 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

Phone: 226-919-6959

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
Sponsor
Alimentiv Inc.
Registry
ClinicalTrials.gov
Start date
20 March 2024
Est. completion
1 June 2026

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

To assess time of onset of biologic therapy in pain interference

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: 28 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