NCT02367183

Who might be able to join this trial:

• You are 18 years old or older.
• You are willing and able to understand and sign a consent form before any study activities begin.
• You are able to attend all required study visits and follow the study rules.
• You have been diagnosed with Crohn's Disease (CD) for at least 3 months before the screening visit.
• Your Crohn's Disease affects the small intestine, the area where the small and large intestine meet, or the large intestine — confirmed by a scope, MRI, CT scan, or similar test done within the past 2 years (note: disease limited only to the left side of the large intestine is not allowed).
• Your Crohn's Disease is currently active, based on a specific scoring system used by doctors (confirm with trial site).
• A recent camera scope of your gut shows a certain level of inflammation, measured by a specific scoring system (confirm with trial site).
• You have previously tried at least one Crohn's Disease treatment that did not work well enough or caused side effects you could not tolerate — this includes certain anti-inflammatory drugs, steroids, immune-suppressing drugs, or biological medicines that block a protein called TNF-α (such as infliximab or adalimumab).
• If you are currently taking certain anti-inflammatory tablets (aminosalicylates), your dose has been stable for at least 2 weeks before screening, and you agree to keep it stable throughout the study.
• If you are currently taking steroid tablets, your dose is within specific limits and has been stable for at least 3 weeks before screening (confirm with trial site for exact dose limits).
• If you are currently taking immune-suppressing drugs (such as azathioprine or methotrexate), you have been on them for at least 12 weeks, and the dose has been stable for at least 8 weeks before the study starts.
• Your blood test results fall within acceptable ranges, including your white blood cell count, platelet count, kidney function, liver function, bilirubin level, haemoglobin, and blood clotting level (confirm with trial site for exact values).
• If you are a woman who could become pregnant, you have a negative pregnancy test at screening and agree to use effective contraception during the study and for at least 28 days after it ends.
• If you are a man, you agree to use a condom during the study and for at least 28 days after it ends.

Who may not be able to join:

• You have been diagnosed with a type of Crohn's colitis limited only to the left side of the large intestine, ulcerative colitis, indeterminate colitis, or other specific types of bowel inflammation (such as microscopic colitis or radiation colitis).
• You have complications of Crohn's Disease such as narrowings (strictures), abscesses, fistulas, or short bowel syndrome that may require surgery or make it hard to measure the treatment's effect.
• You have had bowel surgery within the past 6 months, or any abdominal surgery within the past 3 months.
• You have a stoma bag (ileostomy or colostomy).
• A stool test at screening shows signs of a bowel infection or a bacteria called C. difficile.
• You have a history of bowel cancer or pre-cancerous changes in the bowel.
• You have previously been treated for Crohn's Disease with certain specific medications (such as tacrolimus, cyclosporine, or thalidomide), or used these medications for any other reason within 8 weeks of screening (confirm with trial site for full list).
• You have received steroid treatment through a drip (intravenously) within the past 2 weeks.
• You have used steroid or anti-inflammatory enemas or suppositories within the past 2 weeks.
• You have taken antibiotics to treat your Crohn's Disease within the past 3 weeks.
• You have taken a medicine called cholestyramine within the past 3 weeks.
• You have previously been treated with more than 2 different TNF-α blocking medicines.
• You have previously been treated with medicines called integrin antagonists (such as natalizumab or vedolizumab).
• You have used a TNF-α blocking medicine within the past 12 weeks.
• You have received nutrition through a drip