NCT06257706

Who might be able to join this trial:

• You are between 18 and 80 years old
• You have moderately to severely active Crohn's disease, based on specific scoring measurements your doctor uses to assess disease activity (confirm with trial site)
• An ultrasound of your bowel shows thickening of the bowel wall in certain areas of your intestine (confirm with trial site)
• You have either never been treated with a biologic or advanced medication for Crohn's disease, or you have tried no more than one such medication in the past 5 years
• You are taking a stable dose of a medication called 5-ASA for Crohn's disease that was started at least 4 weeks before screening
• If you are able to become pregnant, you must have a negative pregnancy test before joining and use a highly effective form of contraception throughout the study
• You are able to fully participate in all parts of the trial
• You are willing and able to give written consent to take part

Who may not be able to join:

• You have previously been treated with vedolizumab, etrolizumab, or natalizumab (specific medications for Crohn's disease)
• You have previously been treated with two or more advanced biologic or small molecule medications for Crohn's disease
• Your steroid medication dose has recently changed in the 2 weeks before joining, or your dose is higher than the equivalent of 40 mg of prednisone
• Your Crohn's disease inflammation is only in a part of the bowel that cannot be reached by a standard camera procedure (colonoscopy)
• You have a serious Crohn's complication, such as a significant blockage in the small bowel that needs a medical procedure to treat
• You have had a large portion of your colon removed, or have had certain specific bowel surgeries (confirm with trial site)
• You have a stoma bag or a surgically created internal pouch
• You have short bowel syndrome (a condition where much of the small intestine is missing or not working)
• You have a bowel narrowing caused only by scarring with no active inflammation, including any blockage that cannot be passed during examination
• You have an abscess (a pocket of infection) larger than 2 cm found by ultrasound or camera examination
• You have another serious health condition that, in the doctor's opinion, could affect your ability to take part safely
• You have tested positive for a harmful gut infection called Clostridioides difficile
• You are known to have HIV, hepatitis B, or hepatitis C infection
• You have active or latent (dormant) tuberculosis (TB)
• You have another significant systemic or opportunistic infection, or have had recurring infections within the past 6 months
• You have, or have had, a serious brain or nervous system condition called progressive multifocal leukoencephalopathy (PML) (confirm with trial site)
• You have a known allergy or intolerance to vedolizumab or any of its ingredients
• You currently have a serious active infection such as blood poisoning (sepsis) or certain other severe infections
• You are unwilling to stop taking medications that are not allowed during the trial
• You have taken part in another clinical trial and received an experimental treatment within the past 30 days
• You have a history of alcohol or drug misuse that, in the doctor's opinion, may affect your ability to follow the study procedures
• You have previously enrolled in this same study and already received the study treatment
• You are pregnant, breastfeeding, planning to become pregnant, or planning to donate eggs or sperm during the study or within 18 weeks after the last dose
• You have received a live vaccine within 4 weeks before joining, or plan to receive one during the study
• You are currently doing mandatory military service, are in custody, living in a care home, or are legally prevented from joining a clinical study
• You are an immediate family member or dependent of someone working at the study site who is involved in running this trial

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