Phase 3 study for people with Crohn's Disease and Colitis
Recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
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voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ISRCTN registry. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion criteria:
1. At the time of informed consent, must be ≥18 years of age 2. Have a diagnosis of Crohn's disease (CD) or fistulizing CD established >=12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD 3. Have moderately to severely active CD based on Crohn’s Disease Activity Index (CDAI) criteria defined as a baseline CDAI >=220 but <=450 and either 3.1. Mean daily stool frequency (SF) count >= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools, or 3.2. Mean daily AP score >=2.0, based on the unweighted CDAI component of abdominal pain (AP) 4. Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on Simple Endoscopic Score for Crohn’s Disease (SES-CD) criteria 5. Have an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies
Exclusion criteria:
1. Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, UC or clinical findings highly suggestive of UC or clinical findings highly suggestive of UC 2. Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study. 3. Presence of draining (that is, functioning) stoma or ostomy 4. Has a history of short bowel syndrome, is missing >2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to assess efficacy assessment tools (such as CDAI) to assess response to study intervention. 5. Currently has or is suspected of having an abscess
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ISRCTN registry – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ISRCTN registry – the record this page reformats
- 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.