A study in moderate to severe active Crohn's Disease

• Research type

  Research Study

• Full title

  A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease

• IRAS ID

  62849

• Contact name

  Drisatish Keshav

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2010-022382-10

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this study is to test the safety and efficacy of GSK1605786A in Crohn's Disease.patients with Crohn's Disease can have high levels of CCR9 T Lymphocytes (a type of White Blood Cell) in the GI tract which causes inflammation. GSK1605786A is an oral CCR9 Antagonist which works by blocking these T cells from reaching the intestine and causing inflammation there in Crohn's Disease.Suitable subjects will receive 12 weeks of oral treatment with one of 2 doses of GSK1605786A (500 mg once daily or 500 mg twice daily) or placebo (capsule that does not contain study drug).treatments will be allocated randomly, and neither the patient nor their doctor will know which treatment is being given.Subjects must have active Crohn's disease to enter the trial, confirmed by a test, which includes, but is not limited to endoscopy (a test where the doctor uses an instrument to look at your bowels) within the last 12 months. Study drug is taken twice daily for 12 weeks.patients will attend fortnightly formsome blood tests (including pregnancy tests for women who can become pregnant) and will see a doctor every 4 weeksOther tests/procedures include-Physical examination & medical history, heart monitoring-Pharmacokinetic blood tests (5 samples) to measure the amount of study drug in the blood-Vital signs: weight, height, blood Pressure and pulse-IVRS (subjectswill be asked to use a telephone system, daily during the screening period and 8 days before each visit to the study doctor, to answer the some questions about theirdisease)-Stool sample to assess Crohn's disease-Subject questionnaires Subjects completing the study are eligible for long term studies.Subjects not participating in the long term studies will require a follow-up visit 4 weeks after the end of treatment.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  10/H0606/78

• Date of REC Opinion

  6 Jan 2011

• REC opinion

  Further Information Favourable Opinion