56
Participants
Start Date
March 31, 2009
Primary Completion Date
June 30, 2014
Study Completion Date
August 31, 2014
AMG 811
Part A of the study will enroll SLE without GN (non-renal) subjects into 3 cohorts (6 AMG 811: 2 placebo). All subjects will receive a dose of AMG 811 or placebo every 4 weeks beginning with day 1 (D1) for a total of 3 injections. Subjects will be followed through to study day 197, 5 months from the last dose of study medication. Part B of the study will enroll SLE subjects with GN into Cohorts 4, 5 and 6 (6 AMG 811: 2 placebo). Similar to Part A, subjects in Cohorts 4, 5 and 6 will be dosed every 4 weeks with AMG 811 or placebo for a total of 3 injections followed by a 5 month follow-up period. For Cohort 6, subjects will be followed by a 6 month follow-up period.
Research Site, New York
Research Site, Manhasset
Research Site, Mexico City
Research Site, Duncansville
Research Site, Kuala Lumpur
Research Site, Kansas City
Research Site, Dallas
Research Site, Paris
Research Site, Amarillo
Research Site, Phoenix
Research Site, Danbury
Research Site, Hong Kong
Lead Sponsor
Amgen
INDUSTRY