114643: Study of GSK1605786A in Subjects with Crohn’s Disease

• Research type

  Research Study

• Full title

  A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease

• IRAS ID

  115292

• Contact name

  John Mansfield

• Sponsor organisation

  GlaxoSmithKline Research and Development Limited

• Eudract number

  2010-022382-10

• Clinicaltrials.gov Identifier

  NCT01536418

• 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. The study is planned to randomise approximately 900 subjects with active Crohn's disease with approximately 60 participants expected to be recruited in the UK. Participants will be in the study for a maximum of 22 weeks and will be required to attend the hospital for a maximum of 9 study visits. 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). Treatments will be allocated randomly, and neither the patient nor their doctor will know which treatment is being given. Study drug is taken once or twice daily for 12 weeks. Patients will attend fortnightly for some blood tests (including pregnancy tests for women who can become pregnant) and will see a doctor every 4 weeks Other tests/procedures include ?½ Physical examination & medical history, heart monitoring ?½ Pharmacokinetic blood tests (5 samples) to measure the amount of study drug in the blood ?½ Vital signs: weight, height, blood pressure and pulse ?½ IVRS (subjects will 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 their disease) ?½ Stool sample to assess Crohn??s disease ?½ 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

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  12/NE/0367

• Date of REC Opinion

  16 Jan 2013

• REC opinion

  Further Information Favourable Opinion