NCT01536418

Who might be able to join this trial:

• You are 18 years of age or older
• You are willing and able to give written consent before any screening procedures begin
• You have been diagnosed with Crohn's disease for more than 4 months, affecting your small bowel and/or colon
• Your Crohn's disease is currently moderately to severely active, based on a specific disease activity score (called the CDAI, scored between 220 and 450)
• Blood or stool tests show signs of active inflammation in your body
• You have previously tried corticosteroids or immunosuppressants (medicines that reduce immune system activity) for Crohn's disease, but they did not work well enough or you had to stop due to side effects
• You are on stable doses of any currently permitted Crohn's disease medications, or you are not currently taking any Crohn's disease medications
• You are able to record your Crohn's disease symptoms using an automated phone system provided by the trial
• If you are a woman who could become pregnant, you are not currently pregnant or breastfeeding, and you agree to use a highly reliable form of contraception (less than 1% failure rate per year) during the trial

Who may not be able to join:

• You have been diagnosed with coeliac disease, follow a gluten-free diet due to suspected coeliac disease, or tested positive for coeliac disease markers at screening
• You have been diagnosed with ulcerative colitis or indeterminate colitis (a related but different bowel condition)
• You have fistulas (abnormal tunnels from the bowel) involving the skin, abdomen, or pelvis that are infected or likely to need surgery during the trial
• You have had bowel surgery (other than appendix removal) within the 12 weeks before screening, or are expected to need bowel surgery during the trial
• You have had a large portion or all of your colon surgically removed
• You currently have a stoma bag (ileostomy or colostomy) or a surgically created internal pouch
• You have a fixed, symptomatic narrowing (blockage) in your small bowel or colon
• You have had more than 3 small bowel surgeries or have been diagnosed with short bowel syndrome
• You use narcotic (opioid) pain medications every day
• You have recently used certain medications that are not allowed in this trial, including (within the timeframes listed):
  • Biologic medicines such as infliximab, adalimumab, certolizumab, or natalizumab within 10 weeks before starting the trial
  • Steroid injections within 4 weeks before screening
  • Certain immune-suppressing medicines (cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil) within 4 weeks before screening
  • Intravenous (IV) antibiotics for Crohn's disease within 4 weeks before screening
  • Tube or liquid elemental feeding within 2 weeks before screening
  • Rectal treatments such as enemas or suppositories containing steroids or 5-aminosalicylates within 2 weeks before screening
  • A blood-filtering treatment called leukocytapheresis or granulocytapheresis within 2 weeks before screening
  • More than 2 grams per day of paracetamol (acetaminophen)
  • Regular daily opioid painkillers for worsening Crohn's pain for more than 3 days
  • Digoxin or similar heart medicines within 7 days before screening
  • You have previously taken part in a clinical trial of the study drug (called GSK1605786A or CCX282-B)
• You have tested positive for a bacterial infection called Clostridium difficile
• You have a known HIV infection
• You have had chickenpox, shingles, or another serious viral infection within 6 weeks of screening
• You have received a live vaccine within 4 weeks before screening (flu vaccines are an exception)
• You have tested positive for hepatitis B or hepatitis C
• You have active or latent (hidden) tuberculosis, based on a specific blood test (QuantiFERON TB Gold)
• You currently have sepsis or an infection requiring IV antibiotics for more than 2 weeks