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 3 months before the screening visit, confirmed by a camera examination of the gut and a tissue sample analysis.
- Your Crohn's disease is considered moderately to severely active, based on a specific scoring system called the CDAI (with a score between 220 and 450).
- There is visible inflammation in the lining of your gut, confirmed by a specialist review of your camera examination results.
- Previous treatments for your Crohn's disease — such as steroids, immune-suppressing medications, or biologic therapies — have not worked well enough, have stopped working, or you were unable to tolerate them.
Who may not be able to join:
- You have been diagnosed with ulcerative colitis or a form of bowel disease that doctors have not been able to clearly classify.
- You have had an infection recently that required treatment with intravenous (drip) antibiotics or antifungals in the last 30 days, or oral/injected antibiotics in the last 14 days.
- You currently have an active infection, had a significant infection in the last 30 days before screening, or have a long-term ongoing infection.
- You have a history of shingles that came back more than once or spread widely through your body, or a history of a widespread herpes simplex infection (even a single episode).
- You currently have certain serious complications of Crohn's disease, such as an abscess (a pocket of infection in the abdomen or around the back passage), a bowel blockage causing symptoms, large sections of the bowel missing, a severely inflamed colon, or any other complication that might require surgery during the study (confirm with trial site).
- You have a stoma bag or a surgically created internal pouch (ileoanal pouch).
- Your kidneys are severely affected, meaning they are working at less than 30% of normal function.
- You have severe liver disease (known as Child-Pugh Class C).
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: Study Director, Takeda
Phone: +1-877-825-3327
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
Primary endpoints
Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12; Percentage of Participants Exhibiting an Endoscopic Response Based on Simple Endoscopic Score for CD (SES-CD) at Week 12
Can't join this trial?
Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.