A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus
- Registration Number
- NCT02391259
- Lead Sponsor
- Amgen
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AMG 557 AMG 557 AMG 557 administered as subcutaneous and intravenous doses. Placebo Placebo No active drug
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom