Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT06958536 Sponsor: Sanofi Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT06958536
Recruiting Phase 2 🇦🇺 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 have been diagnosed with Crohn's Disease (a type of inflammatory bowel condition) for at least 3 months before the screening visit
  • People whose Crohn's Disease has been confirmed as moderate-to-severe
  • People who have previously tried at least one standard treatment (such as certain anti-inflammatory medications, steroids, immune-suppressing drugs, or antibiotics) or more advanced therapies (such as biologics or newer targeted medications), and either did not respond well, stopped responding over time, or could not tolerate the treatment
  • People who have been on a stable dose of their current Crohn's Disease medications before the screening visit
  • People who are using contraception in line with local guidelines for those taking part in clinical studies (applies to both men and women)

Who may not be able to join:

  • People who have active Ulcerative Colitis, indeterminate colitis, certain types of colon growths that have not been removed, abnormal changes in the lining of the colon, or short bowel syndrome
  • People whose Crohn's Disease affects only the stomach, the first or second part of the small intestine, or the area around the anus, without involving the colon or the lower part of the small intestine
  • People who are currently experiencing certain serious complications of Crohn's Disease, including: a condition that may require bowel surgery during the study period; having a stoma (an opening in the abdomen) or a surgically created internal pouch; any condition that could affect how the body absorbs medication (including short bowel syndrome); or having had bowel surgery in the 3 months before screening, or a history of more than 3 bowel surgeries in total
  • People with any other health condition that the trial doctor believes would put them at risk by participating in the study

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 26 July 2026
Phase 2: approximately ~30% 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

Phone: 800-633-1610

Australian sites

Investigational Site Number: 0360002, Brisbane, Queensland
Investigational Site Number: 0360004, Kurralta Park, South Australia
Investigational Site Number: 0360001, Footscray,

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 2
Sponsor
Registry
ClinicalTrials.gov
Start date
3 June 2025
Est. completion
17 December 2026

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇳 China 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇯🇵 Japan 🇵🇱 Poland 🇿🇦 South Africa 🇪🇸 Spain 🇬🇧 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 who achieve endoscopic response at Week 16

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: 26 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