Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis

PHASE1CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

June 30, 2014

Study Completion Date

August 31, 2014

Conditions
NephritisSystemic Lupus Erythematosus
Interventions
DRUG

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.

Trial Locations (12)

10003

Research Site, New York

11030

Research Site, Manhasset

14000

Research Site, Mexico City

16635

Research Site, Duncansville

50603

Research Site, Kuala Lumpur

66160

Research Site, Kansas City

75231

Research Site, Dallas

75651

Research Site, Paris

79106

Research Site, Amarillo

85013

Research Site, Phoenix

06810

Research Site, Danbury

Unknown

Research Site, Hong Kong

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT00818948 - Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis | Biotech Hunter | Biotech Hunter