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 ulcerative colitis (UC) for at least 12 weeks before the screening visit, confirmed by both a camera examination of the bowel and a tissue sample test
- Your UC is considered moderately to severely active, based on a specific scoring system measured during a bowel camera examination reviewed by a central team
- Your bowel camera examination shows a score of 2 or higher out of 3 on the inflammation rating scale, as reviewed by a central team
- If you are a teenager taking part, you must weigh at least 40 kilograms (about 88 pounds) at the start of the study
- If you are a woman or teenage girl 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 to, or could not tolerate, standard treatments for UC — and have never tried advanced treatments (such as biologic medicines); OR you have tried advanced treatments but they did not work well enough or you could not tolerate them
Who may not be able to join:
- You currently have serious UC complications such as a severely inflamed colon (fulminant colitis), a dangerously swollen colon (toxic megacolon), or any condition that may require colon surgery during the study
- You currently have a stoma (a surgically created opening in the abdomen for waste removal)
- You currently have, or have previously had, a fistula (an abnormal tunnel connecting body parts, related to your bowel condition)
- You have had colon surgery in the 24 weeks before the study start, or any other major abdominal or significant surgery within the 12 weeks before the study start
- You have had a large portion of your colon removed (less than 30 cm remaining), or a colon removal that would make it difficult to accurately measure how active your UC is (confirm with 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
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12; DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40; Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40
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.