Phase 3 Crohn's Disease and Colitis Trial, Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- You (or your child) must have been diagnosed with Crohn's Disease (including a type that causes tunnels or tracts, called fistulizing Crohn's Disease), affecting the large intestine, small intestine, or both, confirmed at some point in the past through clinical assessment, a camera examination of the gut, and tissue samples.
- The Crohn's Disease must currently be moderately to severely active, based on a specific scoring system for children called the Pediatric Crohn's Disease Activity Index (PCDAI), with a score of 30 or higher.
- A recent camera examination of the gut (within 1 month of starting the study) must show signs of active Crohn's Disease, with a score of 6 or higher on a specific scale (or 4 or higher if the disease only affects the lower part of the small intestine).
- Previous treatments must not have worked well enough, must have stopped working over time, or must have caused side effects — this includes medications that calm the immune system, steroids (taken by mouth or given through a drip), biologic medicines, or a specific newer type of drug called a JAK inhibitor; OR you/your child must have become dependent on steroids; OR a liquid-only diet (called exclusive enteral nutrition) must not have worked well enough.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- You/your child must not have certain complications of Crohn's Disease, such as narrowings in the gut causing symptoms, short bowel syndrome, or other problems that are likely to need surgery.
- You/your child must not currently have a pocket of infection (abscess) related to the condition.
- You/your child must not have had surgery to remove part of the bowel within the last 26 weeks, or any other surgery inside the abdomen within the last 12 weeks before the study begins.
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.
Contact this trial
Principal Investigator: Clinical Trial, Janssen Research & Development, LLC
Phone: 844-434-4210
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants with Clinical Remission at Week 52; Percentage of Participants Who Achieve Endoscopic Response at Week 52
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.