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NCT06819891

NCT06819891
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been officially diagnosed with Crohn's disease (CD)
  • Your Crohn's disease is considered moderately to severely active
  • You weigh at least 40 kilograms (about 88 pounds)
  • Previous treatments for Crohn's disease (either standard or newer therapies) have not worked well enough, stopped working, or caused you problems you could not tolerate
  • 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 a different type of bowel inflammation, such as ulcerative colitis, indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, or microscopic colitis
  • 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 too much of the small intestine is missing or not working)
  • You currently have an ileostomy, colostomy, or ileoanal pouch (surgical openings or pouches created to redirect waste from the bowel)
  • You have a narrowing in your bowel causing symptoms, a very severe bowel inflammation (fulminant colitis), or a life-threatening bowel complication called toxic megacolon
  • You currently have an abscess (a pocket of infection) in your abdomen or around your back passage (perianal area)
  • You have certain types of abnormal tunnels or connections (fistulas) between the bowel and other organs or skin, including some types around the back passage with more than 3 openings
  • You have been diagnosed with, or are suspected to have, a liver condition called primary sclerosing cholangitis
  • You are currently pregnant, breastfeeding, or planning to become pregnant during the trial
  • You have, or have had in the past, cancer of the digestive tract, or certain types of abnormal cell changes in the colon
  • You have a history of cancer outside the digestive tract — with the exception of certain treated skin cancers or treated cervical cancer that has not spread
  • During the screening process, you show signs of certain infections, including C. difficile (a gut infection), CMV, HIV, Hepatitis B, or Hepatitis C
  • You have active tuberculosis (TB), or latent (inactive) TB that has not been fully and successfully treated
  • You have previously received or are currently taking specific medications that are not allowed in this trial, including any treatment that targets a 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.

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.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Hoffmann-La Roche
Registry
clinicaltrials_gov
Start date
12 May 2025
Est. completion
31 December 2028

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇴 Colombia 🇭🇷 Croatia 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇰 Slovakia 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 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 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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov