Phase 3 Crohn's Disease and Colitis Trial, Recruiting NCT06588855 Sponsor: Hoffmann-La Roche Condition: Crohn's Disease and Colitis
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Phase 3 Crohn's Disease and Colitis Trial, Recruiting

NCT06588855
Recruiting Phase 3 🇦🇺 Australian site

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.

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 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Phone: 888-662-6728 (U.S. and Canada)

Australian sites

Macquarie University Hospital, Macquarie Park, New South Wales
Coral Sea Clinical Research Institute, Mackay, Queensland
Footscray Hospital, Footscray, Victoria
Royal Melbourne Hospital, Parkville, Victoria

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
Phase 3
Registry
ClinicalTrials.gov
Start date
11 December 2024
Est. completion
30 January 2027

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal Puerto Rico 🇷🇸 Serbia 🇸🇰 Slovakia 🇪🇸 Spain 🇹🇼 Taiwan 🇹🇭 Thailand 🇬🇧 United Kingdom 🇺🇸 United States

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?

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: 27 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