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

Amgen

Status and phase: Completed; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Placebo; Drug: AMG 623

Study type: Interventional

Funder types: Industry

Identifiers

NCT02443506

20040147

Details and patient eligibility

About

This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. The study consists of a 21 day screening period followed by administration of the investigational product and up to 70 day follow up period.

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women, between the ages of 18 and 55
• Diagnosis of SLE
• Have had a disease duration of at least 1 year, as diagnosed by a physician

Exclusion criteria

• Have a disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere with the study evaluation, completion and/or procedures per the investigator's discretion
• Have active vasculitis, active CNS lupus requiring therapy, active acute renal disease, uncontrolled hypertension, uncontrolled diabetes or active systemic infection
• Have had signs or symptoms of viral or bacterial infection within 30 days of enrollment
• Have received a daily dose of greater than 10 mg prednisone (or equivalent) in the prior 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

AMG 623

Experimental group

Description:

Single dose of AMG 623 administered as subcutaneous and intravenous doses

Treatment:

Drug: AMG 623

Placebo

Placebo Comparator group

Description:

Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses

Treatment:

Drug: Placebo