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OpenTrials
Completed

NCT Number: NCT02291588

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus

This first-in-human, multicenter study to evaluate the administration of placebo or AMG 811 single subcutaneous and intravenous dose to subjects with SLE

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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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of SLE ncluding a positive antinuclear antibodies (ANA) test at least 6 months before randomization; any concurrent SLE pharmacologic regimen (including leflunomide, methotrexate, and anti-malarials) was stable for at least 30 days before randomization; prednisone ≤ 20 mg/day (or equivalent) was permitted; 1 increase or decrease of ≤ 5mg/day prednisone equivalent was allowed within 30 days before randomization

Exclusion criteria

  • Subjects who, in the clinical judgment of the investigator, had severe disease; subject who had at least 1 BILAG 'A' score or 2 BILAG 'B' scores in any of the organ systems at screening; signs or symptoms of a viral or bacterial infection within 30 days of study randomization, or recent history of repeated infections, evidence of liver disease; concurrent receipt of mycophenolate mofetil or azathioprine; prior administration of another biologic that primarily targets the immune system within 1 year

Treatment and study plan

AMG 811

Drug

A single dose of AMG 811 or placebo will be adminstered.

Placebo

Drug

contains no active drug

Primary outcomes

  1. Safety and tolerability as measured by subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, and ECGs

    Time frame: between 84 and 196 days

    Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, and ECGs

Secondary outcomes

  1. Pharmacokinetic profile of AMG 811 including tmax, AUClast and Cmax

    Time frame: between 84 and 196 days

    Serum concentration and derived PK parameters

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 14, 2014
Registry last updated
Nov 14, 2014

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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