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:
- People who have been diagnosed with Crohn's disease (CD) or a form of Crohn's disease that causes tunnels or fistulas to form, affecting the large intestine, small intestine, or both, confirmed at some point in the past through clinical assessment, a camera examination of the gut, and tissue analysis.
- People whose Crohn's disease is considered moderately to severely active, based on a specific scoring system used to measure disease activity in children and adolescents (a baseline PCDAI score of 30 or higher).
- People who have had a camera examination of the gut within one month before starting the study treatment, showing signs of active Crohn's disease based on a specific scoring system (SES-CD score of 6 or higher, or 4 or higher for those whose disease only affects the lower part of the small intestine).
- People who have a documented history of not responding well to, losing response to, or not tolerating at least one Crohn's disease medication — which may include immune-suppressing drugs, steroid tablets or infusions, a biologic therapy, or a JAK inhibitor.
Who may not be able to join:
- People who have complications of Crohn's disease such as narrowings in the bowel causing symptoms, short gut syndrome, or other complications that doctors think may require surgery.
- People who currently have an abscess (a pocket of infection).
- People who have had part of their bowel surgically removed within the past 26 weeks, or any other abdominal surgery within the past 12 weeks before the start of the study.
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: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Phone: 1-317-615-4559
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 with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52; Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.