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:
- Adults aged 18 to 80 years old at the time of screening, or in some locations, people aged 16 to 17 who have reached full physical maturity (confirm with trial site)
- People who have had a confirmed diagnosis of moderately to severely active Crohn's Disease for at least 3 months before the study start date
- People whose Crohn's Disease has not responded well to standard treatments or more advanced treatments, or who have been unable to tolerate those treatments
Who may not be able to join:
- People who have been diagnosed with Ulcerative Colitis or a related condition called indeterminate colitis
- People who are missing two or more complete sections of their large or small intestine (confirm with trial site)
- People who have had, or currently have, high-grade abnormal cell changes in their digestive tract
- People who are taking standard Crohn's treatments but have not yet been on a consistent, stable dose before the study start date
- People who are taking certain medications or therapies that are not allowed during this trial
- People who have previously taken part in a trial or received any investigational treatment that targets a protein called TL1A
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
Phone: 800-633-1610
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
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12; Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving endoscopic response (Simple Endoscopic Score for Crohn's Disease [SES-CD]) at Week 12; Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12; Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12
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.