ulcerative colitis
Conditions
Interventions
Treatment with GSK1605786A or placebo.
Sponsors
GlaxoSmithKline BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Male and female patients 18 years or above with a history of UC for at least 3 months who remain symptomatic despite receiving oral aminosalicylate (with or without topical aminosalicylate) at a dose of >2.4mg/day mesalazine/mesalamine or equivalent for at least 2 weeks. * At screening: active ulcerative colitis with spread at least 15 cm from the anal verge and MAYO score of 5-10 inclusive. * Safe contraception for women of childbearing potential.
Exclusion criteria
Exclusion criteria: * Breastfeeding, pregnancy. * Known coeliac disease, those who follow a gluten-free diet to manage symptoms of suspected coeliac disease and subjects with a positive screening test for celiac disease. * Known or suspicion of CD, indeterminate colitis, microscopic colitis, ischaemic colitis or radiation-induced colitis. * Imminent need for surgery for UC. * Bowel surgery in the past that might interfere with MAYO score. * Use of prohibited medications (see protocol for details). * Usual exclusion criteria for biologicals. * QTc *450 msec (480 msec for those with Bundle Branch Block)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ordinal response (remission, response, or no response) to treatment as assessed by the MAYO score at week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, remission, response, endoscopic remission, time to withdrawal/rescue medication, quality of life (IBDQ questionnaire), biomarkers, PK, receptor occupancy, TECK/CCL25 and CCR9 expression. | — |
Countries
Netherlands
Outcome results
None listed