Phase 3 study for people with Crohn's Disease and Colitis

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Sanofi
Registry number NCT07184931
Started 1 October 2025 Today 16 October 2026 Estimated completion 14 May 2029

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Investigational Site Number : 0360005 Birtinya QLD Recruiting
Investigational Site Number : 0360006 Nedlands WA Recruiting
Investigational Site Number : 0360001 South Brisbane QLD Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 16 Years to 80 Years
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 980

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:

* Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \<18 years of age who meet the definition of Tanner Stage 5 for development

* Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baseline

* Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)

Exclusion Criteria:

* Participants with Ulcerative Colitis (UC) or indeterminate colitis

* Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum

* Prior or current high-grade gastrointestinal (GI) dysplasia

* Participants on treatment with but not on stable doses of conventional therapy prior to baseline

* Participants receiving prohibited medications or therapies

* Participants with previous exposure to anti-TL1A investigational therapy

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

Dates on the record

Started 1 October 2025
Estimated completion 14 May 2029
Registry last updated 23 September 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 23 September 2026.
  • This page last checked by Voxsanity: 11 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.