Phase 3 Crohn's Disease and Colitis Trial, Recruiting NCT07158242 Sponsor: Hoffmann-La Roche Condition: Crohn's Disease and Colitis
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Phase 3 Crohn's Disease and Colitis Trial, Recruiting

NCT07158242
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 weigh at least 10 kilograms (about 22 pounds)
  • You have been confirmed to have ulcerative colitis (UC)
  • You have tried one or more of the following types of treatment — steroid medicines, immune-suppressing medicines, and/or biologic therapies — and either they did not work well enough for you or you could not tolerate them

Who may not be able to join:

  • You have a rare genetic condition related to inflammatory bowel disease that started in infancy (confirm with trial site)
  • You have been diagnosed with Crohn's disease, indeterminate colitis, microscopic colitis, or other specific types of bowel conditions such as infectious, ischemic, or radiation-related colitis, or active diverticular disease, or you have tunnels or pockets of infection in or around the abdomen or anal area
  • You have had surgery to create an ostomy (a bag to collect waste) or an ileoanal pouch (an internal pouch created after bowel removal)
  • You currently have, or are suspected of having, a condition affecting the bile ducts called primary sclerosing cholangitis
  • You have had a major surgery within the last 6 weeks before the study screening, or you are planning to have a major surgery during the study
  • You currently have an active tuberculosis (TB) infection, as shown by a positive TB test, symptoms, or chest scan results

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 21 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

Mater Hospital Brisbane, South Brisbane, Queensland
Royal Children's Hospital, Parkville, Victoria
Perth Children's Hospital, Nedlands, 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
15 April 2026
Est. completion
31 March 2030

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China 🇿🇦 South Africa 🇹🇼 Taiwan 🇹🇭 Thailand 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percentage of Participants with Clinical Remission at Week 12; Percentage of Participants with Clinical Remission at Week 52

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: 21 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