3 results
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
Primary: efficacy of GSK1605786 at week 12 following twice daily administration at 500 mg in patients with active ulcerative colitis. Secondary: safety and tolerability, time course of the efficacy of GSK1605786 continued for up to 16 weeks, anti-…
Primary Objective:* confirm the dose of nomacopan and sample size for Part B and evaluate the rank order of secondary endpointsOther Objectives:* compare nomacopan with adjunct OCS to placebo with adjunct OCS in achievement of Complete Remission of…