Phase 2 study for people with Crohn's Disease and Colitis

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor Sanofi
Registry number NCT06958536
Started 3 June 2025 Today 16 October 2026 Estimated completion 17 December 2026

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Investigational Site Number: 0360002 Brisbane QLD Recruiting
Investigational Site Number: 0360004 Kurralta Park SA Recruiting
Investigational Site Number: 0360001 Footscray VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 18 Years to 75 Years
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 99

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening

* Confirmed diagnosis of moderate-to-severe CD

* History of prior exposure to standard treatment and having inadequate response to, loss of response to or intolerance to standard therapy with any of the following compounds: (5-Amino Salicylates (5-ASAs), 6-Mercaptopurine (6-MP), Azathioprine (AZA), Methotrexate (MTX), oral or corticosteroids or advanced therapies (ATs) (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies

* On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, AZA, 6-MP, or MTX, or Antibiotics, etc.)

* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria:

* Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome

* Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement

* Participants with following ongoing known complications of CD:

* Any manifestation that might require bowel surgery while enrolled in the study

* Participant with ostomy or ileoanal pouch

* Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndrome

* Participant with surgical bowel resection within the past three months prior to screening, or a history of \>3 bowel resections

* History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Dates on the record

Started 3 June 2025
Estimated completion 17 December 2026
Registry last updated 15 October 2026
Checked by Voxsanity 15 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 15 October 2026.
  • This page last checked by Voxsanity: 15 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.