Phase 3 Crohn's Disease and Colitis Trial, Recruiting
Who may 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 might be able to join this trial:
- You have been diagnosed with Crohn's disease (CD) or Crohn's disease with fistulas (tunnels forming between body parts), and this diagnosis was confirmed at least 12 weeks before the study screening, with both a camera examination of the gut and a tissue sample supporting that diagnosis.
- Your Crohn's disease is considered moderate to severe, based on a scoring system called CDAI (a score between 220 and 450), and you also have either frequent loose/very soft stools (an average of 4 or more per day) or notable abdominal pain (an average pain score of 2 or more per day).
- A camera examination of your small intestine and colon (ileocolonoscopy), reviewed centrally, confirms that you have moderately to severely active Crohn's disease in your small intestine and/or colon.
- You have previously tried approved treatments for Crohn's disease that either did not work well enough, stopped working over time, or caused side effects you could not tolerate.
Who may not be able to join:
- You have been diagnosed with a different type of bowel condition, such as indeterminate colitis, microscopic colitis, ischemic colitis, or ulcerative colitis, or your symptoms strongly suggest ulcerative colitis.
- You have complications from Crohn's disease, such as significant narrowing of the bowel, or any other issue that might require bowel surgery during the study.
- You currently have a working stoma or ostomy (an opening in your abdomen used to divert waste into a bag).
- You have short bowel syndrome, are missing more than 2 of the 5 sections of your lower intestine, or have another medical condition that would make it difficult to accurately measure your response to the study treatment using standard tools like the CDAI score (confirm with trial site).
- You currently have, or are suspected of having, an abscess (a pocket of infection/pus) in your body.
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: Janssen Research & Development, LLC 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
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Co-Primary: Percentage of Participants with Clinical Remission at Week 48; Co-Primary: Percentage of Participants with Endoscopic Remission at Week 48
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.