Phase 3 Crohn's Disease and Colitis Trial, Recruiting NCT06819878 Sponsor: Hoffmann-La Roche Condition: Crohn's Disease and Colitis
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Phase 3 Crohn's Disease and Colitis Trial, Recruiting

NCT06819878
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 Crohn's disease (CD)
  • Your Crohn's disease is considered moderately to severely active
  • You weigh at least 40 kilograms (about 88 pounds)
  • You have tried at least one standard or advanced Crohn's disease treatment but it did not work well enough, stopped working, or you could not tolerate it
  • If you are male or female and able to have children, you must agree to follow the trial's specific birth control requirements

Who may not be able to join:

  • You have been diagnosed with ulcerative colitis, indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, or microscopic colitis (a different type of bowel condition)
  • You have had 3 or more bowel removal surgeries where more than 2 sections of your bowel were removed
  • You have been diagnosed with short bowel syndrome (a condition where much of the small intestine is missing or not working)
  • You currently have an ileostomy, colostomy, or an ileoanal pouch (surgically created openings or pouches related to your bowel)
  • You have painful or dangerous bowel blockages, severe colitis, or a life-threatening condition called toxic megacolon
  • You currently have an abscess (a pocket of infection) in your abdomen or around your back passage
  • You have certain types of abnormal connections (fistulas) between your bowel and other organs, or fistulas around your back passage with more than 3 openings
  • You have or are suspected to have a liver condition called primary sclerosing cholangitis
  • You are currently pregnant, breastfeeding, or planning to become pregnant during the study
  • You have a current or past diagnosis of cancer in your digestive tract, or certain pre-cancerous changes in your colon
  • You have a history of cancer outside the digestive tract, except for certain treated skin cancers or treated early-stage cervical cancer
  • You have shown signs of infection with C. difficile, cytomegalovirus (CMV), HIV, Hepatitis B, or Hepatitis C during the screening process
  • You have active tuberculosis (TB), untreated latent TB, or TB that has not been properly treated
  • You have previously received or are currently taking a type of medication called anti-TL1A therapy, or other medicines listed as prohibited in the trial (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 19 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

The Canberra Hospital, Garran, Australian Capital Territory
Royal Prince Alfred Hospital, Sydney, New South Wales
Royal Brisbane and Women's Hospital, Herston, Queensland
Mater Misericordiae Limited, South Brisbane, Queensland
Princess Alexandra Hospital, Woolloongabba, Queensland
Flinders Medical Center, Adelaide, South Australia
Lyell McEwin Hospital, Adelaide, South Australia
Northern Hospital, Epping, Victoria
Fiona Stanley Hospital, Murdoch, Western Australia
Royal Perth Hospital, Perth, Western Australia

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
17 March 2025
Est. completion
31 December 2028

Where this trial is recruiting

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

10 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score; Percentage of Participants with Endoscopic Response

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: 19 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