Phase 2 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:

• You have been diagnosed with Crohn's disease affecting the lower part of the small intestine (terminal ileum) and/or the colon, confirmed by a camera examination (endoscopy) at least 3 months before joining the trial.
• Your Crohn's disease is considered moderately to severely active, based on a symptom score (CDAI between 220 and 450) and findings from an endoscopy.
• Previous treatments have not worked well enough for you, shown by at least one of the following:
• Steroid medicines (such as prednisolone or budesonide) taken at the required dose for at least 2 weeks did not adequately control your symptoms.
• Your symptoms returned or got worse when your steroid dose was reduced or stopped (sometimes called "steroid dependence").
• Immune-suppressing medicines (such as azathioprine, 6-mercaptopurine, or methotrexate) taken at the required dose for at least 12 weeks did not adequately control your symptoms.
• Certain advanced treatments (biologics such as TNF-alpha blockers, anti-integrins, or IL-12/23 blockers, or a targeted medicine called upadacitinib) never worked for you in the first place.
• Certain advanced treatments (biologics or upadacitinib) worked at first but then stopped working over time.
• You had to stop one or more previous treatments (steroids, immune suppressants, biologics, or upadacitinib) because of side effects or intolerance.
• Any steroid medicines you are currently taking have been at a stable dose for at least 2 weeks before joining, and any immune-suppressing medicines have been at a stable dose for at least 4 weeks before joining.

Who may not be able to join:

• You have been diagnosed with, or currently have, another type of bowel condition such as ulcerative colitis, unspecified colitis, ischemic colitis, radiation colitis, microscopic colitis, or a complicated form of diverticular disease.
• You have a history of a liver condition called primary sclerosing cholangitis.
• You currently have an active abscess (a pocket of infection) inside your abdomen or around the anal area.
• You currently have a narrowing or blockage in your intestine that was confirmed by endoscopy.
• You have a history of a severely swollen colon (toxic megacolon), a blocked intestine, or a hole in the intestine (not caused by injury or appendicitis).
• You have or have had abnormal cell changes (dysplasia) anywhere in your digestive tract.
• You have had large sections of your small intestine surgically removed (more than 100 cm total) or more than 2 sections of your large intestine removed.
• You currently have or need a stoma (an opening in the abdomen for waste) or an artificial rectum.
• You have already tried and failed 3 or more different classes of biologic/targeted medicines, or 4 or more individual biologic/targeted medicines in total.
• You have used certain medicines too recently before joining the trial, including: TNF-alpha blockers within the past 8 weeks; anti-integrins or IL-12/23 blockers within the past 12 weeks; upadacitinib within the past 2 weeks; high-dose oral steroids or budesonide above certain levels within the past 2 weeks; steroid injections within the past 4 weeks; certain other immune-suppressing medicines (such as tacrolimus, cyclosporine, or similar) within the past 4 weeks.
• You have regularly taken non-steroidal anti-inflammatory painkillers (such as ibuprofen) 3 or more times per week for 6 or more weeks, within the 2 weeks before joining.
• You are currently taking part in another clinical trial or have taken an experimental medicine within the past 8 weeks (or within 5 half-lives of that medicine, whichever is longer).

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