Efficacy and safety of GSK1605786 in patients with ulcerative colitis

• Research type

  Research Study

• Full title

  A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis

• IRAS ID

  90477

• Contact name

  Simon Travis

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2011-002818-37

• ISRCTN Number

  na

• Research summary

  Does GSK1605786 improve ulcerative colitis symptoms compared to placebo and is it safe when given to patients at a dose of 500 mg twice a day for 16 weeks? There is a need for more effective therapies for ulcerative colitis, as many patients do not respond to current oral medicines and some experience side effects. The body makes a chemical called CCR9 on the surface of certain type of white blood cell. It is thought that CCR9 is involved in taking these white blood cells from the blood system to the intestine where they may worsen the symptoms of ulcerative colitis. It is thought that a drug that binds to CCR9 like GSK1605786 would reduce the location of these white blood cells in the intestine and may reduce the symptoms of ulcerative colitis possibly with fewer side effects than some of the current medicines. This study will investigate how well GSK1605786 works to treat ulcerative colitis and how safe it is. This study will also help us to understand the mechanism by which GSK1605786 works and blood and tissue samples will be taken to investigate this. This study will recruit adults who have symptoms of ulcerative colitis despite taking specific medicines. It will be conducted at Oxford, Cambridge and Southampton. Subjects will be involved in the study for between 20-24 weeks (16 weeks dosing) and will need to visit the study centre for 12 outpatient visit. At these visits they will need to have blood samples taken and complete questionnaires. They will also have to provide faecal samples. At two visits they will have an endoscopy (a small tube will be inserted into their bottom). A video will be recorded and small samples of their large intestine will be taken. Subjects will complete a symptom diary card every day.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  11/SC/0478

• Date of REC Opinion

  8 Feb 2012

• REC opinion

  Further Information Favourable Opinion