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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT02186275

NCT02186275
Completed Phase 3

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with Crohn's disease, confirmed through clinical assessments, a camera examination of the gut, and tissue samples
  • You are between 9 and 18 years old at the time of joining the trial
  • Your diagnosis was made between 2 weeks and 6 months before joining the trial
  • Your Crohn's disease is currently considered mild or in low activity, based on a standard scoring system used for children (called the PCDAI score of 30 or below)
  • You are already being treated with one or more standard Crohn's disease medications, such as steroids, nutritional therapy through a feeding tube or formula, azathioprine, 6-mercaptopurine, methotrexate, 5-ASA, infliximab, or adalimumab

Who may not be able to join:

  • You have a severe and complex type of tunnel-like opening (fistula) near the back passage that was present at the time of diagnosis
  • You have a known long-term liver condition involving a specific type of bile build-up in the body (confirm with trial site)
  • You have known kidney problems that require regular dialysis, or your kidney function test results are above a certain level
  • You have a known condition affecting bone development from birth
  • You have cystic fibrosis or another condition that means your pancreas does not produce enough digestive enzymes
  • You are currently taking certain anti-seizure medications that are processed by the body in a specific way (confirm with trial site)
  • You are unable to swallow oral capsules

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
Completed
Phase
Phase 3
Sponsor
St. Justine's Hospital
Registry
clinicaltrials_gov
Start date
1 February 2016
Est. completion
20 December 2019

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Occurrence of at least one relapse within 52 weeks after randomization in the trial.

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