Phase 3 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from the ISRCTN registry eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with Crohn's Disease (a condition causing inflammation in the digestive tract) for at least 12 weeks, affecting the large intestine, small intestine, or both, confirmed in the past through imaging, tissue samples, or a camera examination of the gut.
• People whose Crohn's Disease is considered moderately to severely active, based on a specific scoring system called the Crohn's Disease Activity Index (CDAI), with a score between 220 and 450.
• People whose gut camera examination (endoscopy) at the screening visit shows active ulcers in the small or large intestine, meeting specific minimum scores on a scoring tool called the Simple Endoscopic Score for Crohn's Disease (SES-CD) — at least 4 for those with disease only in the small intestine, or at least 6 for those with disease in the large intestine or both areas, with minimum scores recorded for ulcer size and the surface area affected by ulcers.
• People whose treating doctor considers their disease suitable to be managed with the dosing schedules used in this study.
• People who are able to follow the rules about other medications for Crohn's Disease as set out in the study guidelines.

Who may not be able to join:

• People who have complications from Crohn's Disease such as narrowing of the bowel causing symptoms, short gut syndrome, an active draining stoma, significant fistula (abnormal tunnels between organs) disease, or any other condition likely to require surgery within the next year, or that could make it difficult to accurately measure how well treatment is working.
• People who currently have, or are suspected to have, an abscess (a pocket of infection) in the body.
• People who have an active fistula at the time of screening or at the start of the study that is expected to need surgical treatment.
• People who have had any bowel surgery within the past 24 weeks, or any other major surgery inside the abdomen or elsewhere within the past 12 weeks, before the first dose of the study treatment.
• People who currently have cancer, or who have had cancer at any point in the five years before the screening visit.

Important: Always verify eligibility with the trial site directly before applying.