Phase 3 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 with moderately to severely active Crohn's disease that has not responded to, or has been unable to be tolerated by, their current standard treatment.
• People who weigh at least 10 kg at the time of screening and enrolling in the study.
• People who have been diagnosed with Crohn's disease for at least 1 month before screening, with disease activity confirmed as moderate to severe based on specific scoring tools used during a medical assessment and a camera examination of the bowel.
• People whose Crohn's disease has not responded to, stopped responding to, or could not be tolerated with at least one of the following treatments: steroids, certain immune-suppressing medications (such as azathioprine, 6-mercaptopurine, or methotrexate), or certain anti-inflammatory biologic medicines (such as infliximab or adalimumab). This also includes people who rely on steroids or special liquid nutrition to manage symptoms and whose disease worsens when trying to reduce or stop these.
• People with long-standing inflammation affecting large portions of the colon (more than 8 years for extensive disease, or more than 12 years for left-sided disease) must have had a bowel cancer surveillance colonoscopy with a clear result within the past 12 months.
• People whose childhood vaccinations are up to date according to the recommended schedule in their country.

Who may not be able to join:

• People who have recently received an experimental biologic medicine within 60 days or 5 half-lives before screening (whichever is longer), or an approved biologic or similar medicine within 2 weeks before the first study dose or at any point during the screening period.
• People with active brain or nervous system disease, any history or signs of a serious brain infection called progressive multifocal leukoencephalopathy (PML), or other major neurological conditions such as stroke, multiple sclerosis, brain tumour, or degenerative brain disease.
• People who have had a significant infection (such as pneumonia, a serious kidney infection, or COVID-19) within 30 days before the first study dose.
• People who have received a live vaccine within 30 days before the first study dose.
• People who currently need surgery for their Crohn's disease or are expected to need surgery during the study.
• People who have had most or all of their large bowel removed, or who have a surgical opening in the bowel (such as a stoma or pouch), a known fixed narrowing of the bowel, short bowel syndrome, or more than 3 small bowel removal surgeries.
• People currently diagnosed with a bowel condition where it is unclear whether it is Crohn's disease or another type of inflammatory bowel disease (called indeterminate colitis).
• People whose symptoms suggest a rare, genetically caused form of inflammatory bowel disease that begins very early in life.
• People with active or latent (inactive but present) tuberculosis, based on a positive or repeatedly unclear TB test result taken within 30 days of screening.
• People who test positive for certain hepatitis B markers (confirm with trial site for specific testing details, as some results may still allow eligibility depending on further testing).
• People with ongoing (chronic) hepatitis C infection confirmed by specific blood tests (confirm with trial site, as people who have cleared or been successfully treated for hepatitis C may still be considered eligible).
• People with a known inherited or acquired condition that weakens the immune system, such as a common variable immune deficiency, HIV, or having received an organ transplant.
• People with pre-cancerous cell changes (dysplasia) or a history of cancer, except for certain skin cancers or a localised cervical abnormality that has been successfully treated.
• People whose stool samples test positive for parasites or certain bacterial infections at the screening visit.
• People whose stool samples test positive for a bacteria called Clostridioides difficile (C. difficile) at the screening visit.

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