Clinical trial NCT01277666 (phase 3, status: completed)
Conditions: crohn's disease
ICD codes: K50.90, K50.913, K50.914, K50.911, K50.912, K50.918, K50.919
Drugs: gsk1605786a, gsk1605786a, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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

               1. Biologic use: Use of any biologic (tumour necrosis factor inhibitor or
                  natalizumab) within 8 weeks prior to screening

               2. Corticosteroid use: Use of parenteral glucocorticoids within 4 weeks prior to
                  screening

               3. Immunospressant use: Use of cyclosporine, tacrolimus, sirolimus or mycophenolate
                  mofetil within 4 weeks prior to screening

               4. Intravenous antibiotic use: Use of intravenous antibiotics for Crohn's disease
                  within 4 weeks prior to screening

               5. Use of rectal treatment with 5-ASA or corticosteroid enemas/suppositories within
                  2 weeks prior to screening

               6. Use of tube or enteral feeding, elemental diet, or parenteral alimentation within
                  2 weeks prior to screening

               7. 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 study

          -  History or evidence of adenomatous colonic polyps that have not been removed

          -  History of evidence of colonic mucosal dysplasia

          -  Current evidence of, or has been treated for a malignancy within the past five years
             (other than localised basal cell, squamous cell skin cancer, cervical dysplasia, or
             any cancer in situ that has been resected)

          -  Any previous participation in a clinical study of GSK1605786A (formerly ChemoCentryx
             compound CCX282-B)

          -  Medical history of sensitivity to any of the components of GSK1605786A

          -  Use of any investigational product within 30 days prior to screening