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:
- You have a confirmed diagnosis of ulcerative colitis (UC)
- Your UC is considered moderately to severely active, based on a specific scoring system used by doctors
- You weigh at least 40 kilograms (about 88 pounds)
- You are up to date with bowel cancer screening, as recommended in your local area
- Previous treatments for UC (either standard or newer/advanced therapies) have not worked well enough, stopped working, or caused side effects you could not tolerate
- If you are male or female and able to have children, you must agree to follow the trial's specific contraception requirements during the study
Who may not be able to join:
- You currently have serious complications of UC, such as a severe flare-up affecting the whole colon or a dangerously swollen colon
- You have been diagnosed with Crohn's disease, indeterminate colitis, or other specific types of colitis (such as microscopic, ischemic, infectious, or radiation-related colitis)
- You have a stoma bag or an internal pouch created after bowel surgery
- You have been diagnosed with, or are suspected of having, a liver condition called primary sclerosing cholangitis
- You are currently pregnant, breastfeeding, or planning to become pregnant during the study
- You have been found to have pre-cancerous cell changes or growths in your colon that have not been fully removed
- You have had a cancer diagnosis within the last 5 years (some exceptions may apply for certain minor, fully treated skin cancers or cervical changes — confirm with trial site)
- You have a current infection with certain viruses or bacteria, including C. difficile, CMV, HIV, Hepatitis B, or Hepatitis C
- You have active tuberculosis (TB), or latent (inactive) TB that has not been successfully or fully treated
- You have previously received or are currently taking certain medicines that are not allowed in this trial, including any treatment targeting a specific protein called TL1A (confirm with trial site)
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
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants with Clinical Remission
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.