Phase 4 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov 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 a confirmed diagnosis of Crohn's disease (CD)
• People whose Crohn's disease is currently active, measured by a standard scoring tool called the CDAI (score of 220 or higher), and who also have either frequent loose stools (4 or more per day on average) or significant abdominal pain (a score of 2 or higher on average)
• People who have already received at least two doses of a medication called ustekinumab, given in the standard way (a drip into a vein at the start, followed by an injection under the skin at week 8)
• People whose Crohn's disease improved at first with ustekinumab but has since stopped responding to it
• People who are currently taking ustekinumab as either their first or second biologic medication during the screening period

Who may not be able to join:

• People who responded well to ustekinumab but were given it in a non-standard way (for example, receiving multiple drip doses instead of the approved method)
• People whose Crohn's disease is so severe that it requires urgent surgery or a procedure to look inside the bowel, or who are planned to have non-urgent surgery within the next 2 months
• People who are already taking part in another interventional clinical trial
• People who have complications from Crohn's disease such as significant narrowing of the bowel or a condition where the bowel is too short to absorb food properly
• People who currently have, or are suspected to have, a pocket of infection (abscess) in the body

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