Phase 3 Crohn's Disease and Colitis Trial, Recruiting NCT07298421 Sponsor: Hoffmann-La Roche Condition: Crohn's Disease and Colitis
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Phase 3 Crohn's Disease and Colitis Trial, Recruiting

NCT07298421
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:

  • People who weigh at least 10 kilograms
  • People who have active Crohn's disease that has been confirmed by a camera examination of the bowel (a procedure called ileocolonoscopy)
  • People whose Crohn's disease is considered moderately to severely active, based on specific scoring systems used by doctors to measure disease activity and bowel inflammation, confirmed through a centrally reviewed bowel examination
  • People whose Crohn's disease has not responded well enough to, stopped responding to, or caused problems when taking at least one previous treatment — such as anti-inflammatory medicines, steroids, immune-suppressing medicines, or more advanced treatments including biologics or JAK inhibitors

Who may not be able to join:

  • People whose bowel disease is caused by a rare inherited genetic condition present from infancy
  • People who have had three or more bowel removal surgeries, meaning more than two sections of the bowel have been removed
  • People currently diagnosed with ulcerative colitis, indeterminate colitis, microscopic colitis, or other specific types of bowel inflammation or infection — or who have fistulas, abscesses, or active diverticular disease
  • People who have bowel narrowings causing symptoms, a severe sudden flare of colitis, or a dangerous condition called toxic megacolon
  • People who currently have an abscess in the abdomen or around the anal area
  • People currently diagnosed with, or suspected of having, a liver condition called primary sclerosing cholangitis

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 28 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

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
31 August 2026
Est. completion
31 May 2030

Where this trial is recruiting

🇦🇺 Australia 🇹🇼 Taiwan 🇹🇭 Thailand 🇬🇧 United Kingdom

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

Primary endpoints

Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI); 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: 28 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