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OpenTrials
Completed

NCT Number: NCT02391259

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

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

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 557

Drug

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

Placebo

Drug

contains no active drug

Primary outcomes

  1. Safety and tolerability

    Time frame: From 29 days to 169 days

    Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs

Secondary outcomes

  1. Pharmacokinetic profile of AMG 557 including Tmax, AUClast and Cmax

    Time frame: From 29 days to 169 days

    Serum concentration and derived PK parameters including Tmax, AUClast and Cmax

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Mar 18, 2015
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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