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

Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02391259

Enrollment

Registered

2015-03-18

Start date

2006-11-30

Completion date

2011-11-30

Last updated

2015-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Brief summary

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

Interventions

DRUGAMG 557

AMG 557 is for the treatment of sybjects with systemic lupus erythematosus

DRUGPlacebo

contains no active drug

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability	From 29 days to 169 days	Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs

Secondary

Measure	Time frame	Description
Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax	From 29 days to 169 days	Serum concentration and derived PK parameters including Tmax, AUClast and Cmax

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026