Voxsanity

Who may be able to join

Who might be able to join this trial:

Your child's Crohn's disease must be rated as moderately to severely active based on a specific symptom score (called PCDAI), AND a camera examination of the gut (called an endoscopy) must show a certain level of inflammation based on a scoring system called SES-CD (confirm with trial site for exact score details)
Your child must have already tried at least one treatment for Crohn's disease — such as steroids, immune-suppressing medicines, or biologic therapies — and either it didn't work well enough, stopped working, or caused problems they couldn't tolerate

Who may not be able to join:

Your child's doctor believes they are likely to need surgery to remove part of the bowel within the next 12 weeks
Your child currently has a stoma (an opening in the abdomen connected to a bag), a specific type of bowel reconnection surgery, or a fistula (an abnormal tunnel between body parts) that may need treatment or surgery within the next 12 weeks
Your child has had a large portion of the small bowel removed (more than 100 cm), has been diagnosed with short bowel syndrome, or needs to be fed entirely through a drip into a vein

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.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status

Terminated

Phase

Phase 3

Sponsor

Bristol-Myers Squibb

Registry

clinicaltrials_gov

Start date

22 August 2023

Est. completion

13 September 2024

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇵🇱 Poland 🇪🇸 Spain 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants Who Achieve Pediatric Crohn's Disease Activity Index (PCDAI) Score < 10 at Week 64; Percentage of Participants Achieving Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 2 or SES-CD ≤ 4 Points With no SES-CD Subscore > 1 Point at Week 64

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov