Phase 2 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 are willing and able to understand and follow all trial procedures and requirements, including using digital tools and apps, and you have signed and dated a consent form agreeing to take part.
- You have completed 52 weeks (about one year) in the related earlier trial (called TAK-279-CD-2001 or TAK-279-UC-2001) and have valid diary data recorded at that point.
- If you were in the Crohn's disease (CD) earlier trial: your symptoms showed meaningful improvement at week 52, meaning at least a 30% reduction in very soft or liquid stools and/or at least a 30% reduction in abdominal pain compared to when you started that trial.
- If you were in the ulcerative colitis (UC) earlier trial: your symptoms showed meaningful improvement at week 52, based on a recognised scoring system showing at least a 30% reduction in overall score and improvement in rectal bleeding.
- If you were in a specific Crohn's disease trial (TAK-279-CD-2003): a camera examination of your gut (endoscopy) at week 12 of the earlier trial showed more than 50% improvement in your gut inflammation score (or met specific reduced score targets if your disease was limited to one area).
- You are able to follow the trial's guidelines around contraception.
Who may not be able to join:
- The trial doctor has concerns about your ability to follow the trial rules or take medications as directed.
- You were found to have any signs of cancer or abnormal tissue growth during a gut camera examination (endoscopy) at any point during the earlier trial or at the start of this new trial phase.
- Certain blood or laboratory test results fall outside the limits set in the trial rules (confirm with trial site).
- If you were in the CD or UC earlier trials: you were taking steroid tablets (such as prednisolone) for your condition at or after week 48 of the earlier trial.
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
All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs); All Cohorts: Number of Participants With Clinically Significant Changes in Vital Sign Values; All Cohorts: Number of Participants With Clinically Significant Changes in Clinical Laboratory Values; Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Values
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.