A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

Amgen

Status and phase: Completed; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: AMG 557; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02391259

20060132

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts

Enrollment: 57 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of SLE with positive ANA
• Stable disease with no change in SLE therapy within the previous 30 days
• BMI from 18 to 38 kg/m2

Exclusion criteria

• Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization
• Evidence of renal disease or liver disease
• Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis
• Prior administration of any other biologic that primarily targets the immune system

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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57 participants in 2 patient groups, including a placebo group

AMG 557

Experimental group

Description:

AMG 557 administered as subcutaneous and intravenous doses.

Treatment:

Drug: AMG 557

Placebo

Placebo Comparator group

Description:

No active drug

Treatment:

Drug: Placebo