NCT02394028
Who may be able to join
Who might be able to join this trial:
- You have been diagnosed with moderately to severely active Crohn's Disease, confirmed through symptom scoring, patient-reported symptoms, and a camera examination (endoscopy) of the small intestine and/or colon
- You have tried steroids, immune-suppressing medications, or anti-TNF medications (a type of biologic drug) within the last 5 years, and either could not tolerate them or they did not work well enough for you
- You are using an effective form of birth control as required by the study guidelines (confirm with trial site)
Who may not be able to join:
- You have, or have had, certain other bowel or digestive conditions such as ulcerative colitis, unclassified colitis, abdominal or perianal abscesses, certain colon growths (polyps) that have not been removed, abnormal colon tissue changes, or a significantly shortened bowel
- You are planning to have surgery for your Crohn's Disease
- You have a stoma bag (an ileostomy or colostomy)
- You have recently taken certain specific medications used for bowel inflammation, including natalizumab, vedolizumab, or efalizumab (confirm with trial site for full list)
- You have received the drug ustekinumab within the 14 weeks before joining the study
- You currently have, or have had, chronic hepatitis B or C, HIV, or active or hidden tuberculosis (those who received a BCG vaccine in the past will need to meet specific screening requirements — confirm with trial site)
- You have an infected skin tract with signs of active infection, such as discharge of pus (note: fistulas related to Crohn's Disease alone do not exclude you)
- You have previously been treated with a specific type of medication called anti-adhesion molecules (confirm with trial site for examples)
- You had a serious infection requiring intravenous (IV) antibiotics within the last 8 weeks, or oral antibiotics within the last 4 weeks (note: antibiotics taken as part of Crohn's Disease treatment without a confirmed infection do not exclude you)
- You were admitted to hospital for a non-planned, non-elective reason within the 4 weeks before joining the study
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.
Trial details
Where this trial is recruiting
15 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Induction Phase: Cohort 1: Percentage of Participants With Clinical Remission at Week 14; Induction Phase: Cohort 2 and 3: Percentage of Participants With Clinical Remission at Week 14; Induction Phase: Cohort 1: Percentage of Participants With Endoscopic Improvement at Week 14; Induction Phase: Cohort 2 and 3: Percentage of Participants With Endoscopic Improvement at Week 14; Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66; Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 66
Can't join this trial?
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.