Phase 2/3 study of GS-5745 in patients with Ulcerative Colitis

• Research type

  Research Study

• Full title

  A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis.

• IRAS ID

  184910

• Contact name

  Satish Keshav

• Contact email

  satish.keshav@ndm.ox.ac.uk

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2014-005217-24

• Duration of Study in the UK

  2 years, 0 months, 11 days

• Research summary

  Ulcerative colitis (UC) is a chronic relapsing and remitting inflammatory bowel disease which ultimately can lead to surgical removal of the large intestine. Patients who fail to respond to first line therapy with mesalazine are generally treated with steroids followed by immunosuppressants and biologic treatments to maintain remission, and avoid relapse. Approximately 20% achieve long term remission without steroids with current treatment. GS-5745 may be an alternative treatment option in these patients. GS-5754 blocks the action of MMP9 (matrix metalloproteinase 9), which contributes to the pathology in UC by degrading proteins that maintain the structure of the intestinal lining.
  The purpose of this study is to assess the safety and efficacy of GS-5745 in treating adults with moderate to severe UC. This is a randomised, double-blind, placebo-controlled study with an optional open label treatment arm. It includes an Induction Study (Cohort 1) consisting of Part A (150 subjects) and Part B (up to 510 additional subjects and a Maintenance Study (Cohort 2). Enrolment into Cohort 1 will be halted between Parts A and B and results will be reviewed by a Data Monitoring Committee to assess whether to continue on to Part B, or modify, or discontinue the study. Using data from Cohort 1 to choose the optimal induction treatment, enrolment into Cohort 2 will be initiated (940 new subjects). Patients will be enrolled in Cohorts 1 and 2 for about 12 weeks plus a screening period of up to 30 days. If participants meet criteria for, and choose to, they will continue to the blinded maintenance phase, which will last about 55 weeks, plus a screening period of up to 30 days. Patients will receive a maximum of 52 weeks of study drug.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  15/SC/0580

• Date of REC Opinion

  27 Nov 2015

• REC opinion

  Further Information Favourable Opinion