A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease

Inclusion Criteria

• Male or female subjects aged 18 years or older
• Written informed consent
• Diagnosis of Crohn's disease for greater than 4 months duration with small bowel and/or colonic involvement
• Confirmation of Crohn's disease established by visualisation of the gastrointestinal tract within the 12 months prior to screening or by screening endoscopy at study entry
• History of inadequate response and/or intolerance/adverse event leading to discontinuation of either corticosteroids or immunosuppressants
• Moderately-to-severely active disease characterised by a CDAI score between 220 and 450, inclusive, at Baseline
• Confirmation of current active Crohn's disease by screening endoscopy or inflammatory biomarkers [elevated C-reactive protein (greater than upper limit of normal) plus positive test for faecal calprotectin] at Screening
• Stable doses of permitted concomitant medications or having previously received, but are not currently receiving, medications for Crohn's disease
• Demonstrated ability to comply with Crohn's disease symptom recording using the interactive voice response system
• Females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with a failure rate of less than 1% for the duration of this study

Exclusion Criteria

• If female: pregnant, has a positive pregnancy test or is breast-feeding
• Diagnosis of coeliac disease, follow a gluten-free diet to manage symptoms, or positive test for coeliac disease
• Diagnosis of ulcerative or indeterminate colitis
• Enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period
• Bowel surgery, other than appendectomy, within 12 weeks prior to screen and/or has surgery planned or deemed likely for Crohn's disease during the study period
• Extensive colonic resection, subtotal or total colectomy
• Presence of ileostomies, colostomies or rectal pouches
• Known fixed symptomatic stenoses
• History of more than 3 small bowel resections or diagnosis of short bowel syndrome
• Chronic use of narcotics for chronic pain defined as daily use of one or more doses of narcotic containing medication
• Use of prohibited medications, including enteral feeding or elemental diet, within their specified time frames
• Biologic use: Use of any biologic (tumour necrosis factor inhibitor or natalizumab) within 8 weeks prior to screening
• Corticosteroid use: Use of parenteral glucocorticoids within 4 weeks prior to screening
• Immunospressant use: Use of cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 4 weeks prior to screening
• Intravenous antibiotic use: Use of intravenous antibiotics for Crohn's disease within 4 weeks prior to screening
• Use of rectal treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks prior to screening
• Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 2 weeks prior to screening
• Leukocytapheresis or granulocytapheresis within 2 weeks prior to screening
• Positive immunoassay for Clostridium difficile
• Known human immunodeficiency virus (HIV) infection
• Known varicella, herpes zoster, or other severe viral infection within 6 weeks of screening
• Immunisation with a live vaccine within 4 weeks of screening, with the exception of influenza vaccine
• Active or latent tuberculosis infection
• Current sepsis or infections requiring intravenous antibiotic therapy for more than 2 weeks
• Evidence of hepatic dysfunction, viral hepatitis, or current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH)
• Positive test for Hepatitis B or Hepatitis C antibody at screening
• Corrected QT interval of ECG (electrocardiogram) greater than or equal to 450 milliseconds
• Concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical