NCT02611817

Who might be able to join this trial:

• You were diagnosed with Crohn's disease (CD) at least 3 months before the study screening, confirmed by a camera examination of the gut and a tissue sample analysis.
• Your Crohn's disease is moderately to severely active, based on a specific scoring system (called CDAI, scored between 220 and 450), plus at least one of the following: a raised inflammation marker in your blood (CRP above 2.87 mg/L), a camera examination showing a certain number of ulcers in your gut, or a stool test showing high inflammation levels along with an imaging scan confirming ulcers.
• Your Crohn's disease affects your small intestine (ileum) and/or your large intestine (colon).
• Previous treatments for your Crohn's disease — such as steroids, immune-suppressing medicines, or TNF-blocking medicines — have not worked well enough, have stopped working, or you were unable to tolerate them.

Who may not be able to join:

• You have a pocket of infection (abscess) in your abdomen found at screening.
• You have had a large portion or all of your large intestine surgically removed.
• You have had more than 3 surgeries to remove parts of your small intestine, or you have been diagnosed with short bowel syndrome.
• You have a stoma bag (ileostomy or colostomy) or a known, fixed, symptom-causing narrowing of your intestine.
• You have taken certain non-biological treatments for your condition (such as cyclosporine, tacrolimus, thalidomide, or tofacitinib) within roughly the last 30 days or longer before screening (confirm with trial site).
• You have taken any biological or biosimilar medication (lab-made treatments that target the immune system) within roughly the last 60 days or longer before screening (confirm with trial site).
• You have previously been treated with a medicine called vedolizumab.
• You are expected to need surgery for your Crohn's disease at any point during the study.
• You have colon polyps (growths) that have not been removed, or there are signs of abnormal cell changes in your colon lining.
• You have, or are suspected to have, another type of bowel condition such as ulcerative colitis or certain other forms of colitis.
• You currently have an active infection of any kind.
• You have a long-term hepatitis B or C infection, active or latent tuberculosis, or a condition that weakens your immune system (either from birth or developed later). Note: if you are immune to hepatitis B but not actively infected, you may still be eligible (confirm with trial site).
• You have a history of a serious neurological condition, such as a stroke, multiple sclerosis, a brain tumour, or a degenerative brain disease.

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