Dataset from A Multicentre, Randomised, Double-blind (Sponsor Unblinded), Placebo-controlled Study With Open Label Extension to Investigate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2982772 in Subjects With Active Ulcerative Colitis

This study is the first experience with GSK2982772, a receptor-interacting protein-1 (RIP1)
kinase inhibitor, in subjects with active ulcerative colitis (UC). The primary objective will
be to investigate the safety and tolerability of repeat oral doses of GSK2982772 60 mg or
placebo three times daily for 42 days (Part A) followed by open label with GSK298772 60 mg
three times daily for 42 days (Part B). In addition to pharmacokinetics (PK), a number of
experimental and clinical endpoints will be employed to obtain information on the
pharmacodynamics (PD), and preliminary efficacy in subjects with active UC. Although no
formal hypothesis will be tested, these endpoints will enable a broader understanding of the
mechanism of action and potential for clinical efficacy of GSK2982772 in UC. Within 30 Days
of screening visit, subjects will be randomized to receive either GSK2982772 60 mg or placebo
orally three times daily for 42 Days (6 weeks) in a 2:1 ratio in Part A study. Subjects who
complete the Part A study will move to open label Part B study to receive GSK2982772 60 mg
three times daily for an additional 42 Days (6 weeks). After the open label (Part B)
treatment period, subjects will enter the Follow-up period which lasts for 28 Days (+/- 3
Days) post the last administration of study medication. The total duration of participation
in the study will be approximately 20 Weeks from screening to the last study visit.