Crohn's Disease and Colitis Trial, Recruiting NCT07245394 Sponsor: TIDHI Innovation Inc. Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT07245394
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:

  • Adults aged 18 or older, of any gender
  • People who have had a confirmed diagnosis of inflammatory bowel disease (IBD) — either Crohn's disease, ulcerative colitis, or a type called IBDU — for at least 6 months before the study starts
  • People who have been on a medication called ustekinumab for at least 14 weeks, or who stopped taking it within the past 12 weeks
  • People who stopped ustekinumab and have not started any other advanced IBD medication since stopping
  • People whose IBD has not responded well enough to ustekinumab, and whose treating doctor has decided to start them on a medication called guselkumab
  • People who have had a recent bowel camera test (colonoscopy) within the past 3 months showing active signs of disease — with specific activity scores or visible ulcers, depending on whether the diagnosis is Crohn's disease or ulcerative colitis (confirm with trial site for exact score thresholds)
  • People who are willing and able to give written consent and follow the study requirements

Who may not be able to join:

  • People who have previously taken certain IBD medications called anti-p19 inhibitors, specifically risankizumab or mirikizumab
  • People for whom guselkumab is medically unsuitable according to the official drug guidelines
  • People who did not receive the standard starting doses (induction) of guselkumab, or who are taking it in a non-standard way
  • People who have a stoma (a surgically created opening in the abdomen) or an internal pouch created after bowel surgery
  • People who have had bowel surgery within the 6 months before the study starts
  • People who have had signs of a severe flare-up of ulcerative colitis, a very serious bowel inflammation (fulminant colitis), or a dangerous bowel complication (toxic megacolon) within the past 3 months
  • People whose IBD doctor expects them to need bowel surgery within the year of joining the trial
  • People currently taking more than one biologic medication at the same time
  • People with a history of precancerous changes or cancer in the colon (note: a result of "indefinite for dysplasia" does not automatically exclude someone — confirm with trial site)
  • People who are unable or unwilling to have a bowel camera examination (colonoscopy)
  • People whom the trial doctor considers unsuitable for the study for any reason

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

Principal Investigator: Laura E. Targownik, MD, MSHS, FRCPC, TIDHI Innovation Inc.

Phone: 647-812-2113

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
TIDHI Innovation Inc.
Registry
ClinicalTrials.gov
Start date
29 January 2026
Est. completion
1 November 2027

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Rate of participants achieving deep remission in IBD patients treated with guselkumab after switching from ustekinumab; Rate of participants achieving deep remission, stratified by cohorts

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