Safety Study of AMG 557 in Subjects With Lupus Arthritis

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

• Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria

• Presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) ≥ 6 at screening;

• Other inclusion criteria may apply.

Exclusion Criteria:

• Presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years

• Any disorder (including psychiatric), condition, clinically significant disease, disease activity related to SLE

• Positive for HIV antibodies, hepatitis B surface antigen or anti-HBc, or hepatitis C antibodies

• Known residential exposure to an individual with tuberculosis or positive Quantiferon test or PPD test at screening

• Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study

• Other exclusion criteria may apply