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) for at least 12 weeks before screening, confirmed by both a camera examination of the gut (endoscopy) and a tissue sample test (biopsy).
- Your Crohn's disease is considered moderately to severely active, based on a specific scoring system (CDAI score between 220 and 450), and you are having at least 4 loose stools per day on average, or significant abdominal pain on average.
- Your Crohn's disease is also confirmed as moderately to severely active through a camera examination of the gut, showing active ulcers in the small intestine and/or large intestine, based on specific scoring thresholds.
- If you are a woman who could become pregnant, you must have a negative pregnancy blood test at screening and a negative pregnancy urine test at the start of the study, and agree to further pregnancy tests during the trial.
- You have either not responded well enough to, or could not tolerate, standard treatments or more advanced treatments (such as biologics or certain oral medicines) for Crohn's disease.
Who may not be able to join:
- You have complications from Crohn's disease — such as narrowing of the bowel, short gut syndrome, or other issues — that may require surgery during the trial or make it hard to measure how well the treatment is working.
- You have a stoma or ostomy (a surgically created opening in the abdomen for waste removal).
- You have had part of your large bowel (colon) removed within the last 24 weeks, or any other major surgery within the last 12 weeks before the start of the study.
- A camera examination of your bowel found certain types of bowel growths (adenomatous polyps) in areas not affected by colitis that were not removed before joining the trial.
Note: Participants with active fistulas (abnormal tunnels connecting parts of the bowel) may still be considered eligible, as long as no surgery is needed for them — confirm with the trial site.
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
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Induction Study 1: Number of Participants with Clinical Response at Week 12; Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint); Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint); Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint); Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.