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 Bristol-Myers Squibb
Registry number NCT05076175
Started 30 May 2022 Today 16 October 2026 Estimated completion 12 July 2032

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
The Children's Hospital at Westmead Westmead NSW Recruiting
Monash Health Clayton VIC Recruiting
Local Institution - 0086 Murdoch WA Withdrawn
Local Institution - 0106 Nedlands WA Not yet recruiting

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

Who can join

Age 2 Years to 17 Years
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 120

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

* Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit

* Evidence of UC extending beyond the rectum, as determined by baseline endoscopy

* Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy

Exclusion Criteria

* Diagnosis of Crohn's disease or indeterminate colitis

* Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool

* Apheresis within 2 weeks of randomization

* History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis

* Other protocol-defined inclusion/exclusion criteria apply

Dates on the record

Started 30 May 2022
Estimated completion 12 July 2032
Registry last updated 24 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: 24 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.