A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus

Amgen

Status and phase

Completed

Phase 1

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: AMG 623

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02411136

20040250

Details and patient eligibility

About

This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. All subjects will receive 4 weekly doses of study drug over a 3 week period, and then will be followed for an additional 28 weeks, for total study duration of 31 weeks.

Enrollment

64 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men and women between the ages of 18 and 65 years old
Diagnosis of SLE
Stable disease; defined as no change in SLE therapy within the previous 30 days. Up to 5 mg/day incremental changes of prednisone therapy is allowed during the 30 days prior to randomization
SLE disease duration of at least 1 year, as diagnosed by a physician

Exclusion criteria

Current renal disease
Signs or symptoms of viral or bacterial infection within 30 days of enrollment
Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere the study evaluation, completion and/or procedures per the investigator's discretion
Administration of more than 10 mg/day prednison (or equivalent) in the 30 days prior to randomization