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

Phase 1

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Placebo; Drug: AMG 811

• Registration Number: NCT02291588
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2010-03
• Study Completion: 2010-06
• Status Verified: 2014-11
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-11
• Last Update Submitted: 2014-11-11
• Study First Posted: 2014-11-14
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	No active drug
AMG 811	AMG 811	AMG 811 administered as subcutaneous and intravenous doses

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Pharmacokinetic profile of AMG 811 including tmax, AUClast and Cmax	between 84 and 196 days	Serum concentration and derived PK parameters