Phase 3 Crohn's Disease and Colitis Trial, Recruiting
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:
- People who weigh at least 10 kilograms
- People who have active Crohn's disease that has been confirmed by a camera examination of the bowel (a procedure called ileocolonoscopy)
- People whose Crohn's disease is considered moderately to severely active, based on specific scoring systems used by doctors to measure disease activity and bowel inflammation, confirmed through a centrally reviewed bowel examination
- People whose Crohn's disease has not responded well enough to, stopped responding to, or caused problems when taking at least one previous treatment — such as anti-inflammatory medicines, steroids, immune-suppressing medicines, or more advanced treatments including biologics or JAK inhibitors
Who may not be able to join:
- People whose bowel disease is caused by a rare inherited genetic condition present from infancy
- People who have had three or more bowel removal surgeries, meaning more than two sections of the bowel have been removed
- People currently diagnosed with ulcerative colitis, indeterminate colitis, microscopic colitis, or other specific types of bowel inflammation or infection — or who have fistulas, abscesses, or active diverticular disease
- People who have bowel narrowings causing symptoms, a severe sudden flare of colitis, or a dangerous condition called toxic megacolon
- People who currently have an abscess in the abdomen or around the anal area
- People currently diagnosed with, or suspected of having, a liver condition called primary sclerosing cholangitis
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.
Contact this trial
Principal Investigator: Clinical Trials, Hoffmann-La Roche
Phone: 888-662-6728 (U.S. and Canada)
Australian sites
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
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI); Percentage of Participants With Endoscopic Response
Can't join this trial?
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.