Safety Study of AMG 557 in Subjects With Subacute Cutaneous Lupus Erythematosus

PHASE1TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Cutaneous LupusLupus
Interventions
DRUG

AMG 557

AMG 557 (210 mg) or (140 mg ) will be administered as subcutaneous injections in the anterior abdomen of the subjects. Twelve subjects will be randomized to receive AMG 557. Beginning on Day 1, subjects will receive either 210 mg AMG 557 or 140 mg AMG 557 once weekly for 3 weeks on Day 1, Day 8, and Day 15 and following with 6 additional doses of AMG 557 every other week on Day 29, Day 43, Day 57, Day 71, Day 85, and Day 99. Subjects will be followed out to Day 253 for safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) assessments.

DRUG

AMG 557 Placebo

AMG 557 Placebo (210 mg) or (140 mg )will be administered as subcutaneous injections in the anterior abdomen of the subjects. Twelve subjects will be randomized to receive placebo. Beginning on Day 1, subjects will receive placebo once weekly for 3 weeks on Day 1, Day 8, and Day 15 and following with 6 additional doses of placebo every other week on Day 29, Day 43, Day 57, Day 71, Day 85, and Day 99. Subjects will be followed out to Day 253 for safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) assessments.

Trial Locations (10)

3053

Research Site, Carlton

4102

Research Site, Woolloongabba

19104

Research Site, Philadelphia

35233

Research Site, Birmingham

48103

Research Site, Ann Arbor

75231

Research Site, Dallas

Dallas

75235

Research Site, Dallas

78705

Research Site, Austin

K9J 1Z2

Research Site, Peterborough

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY