A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Intravenous Dose of MEDI-546, a Human Monoclonal Antibody Directed Against Type I Interferon Receptor (IFNAR), in Japanese Subjects With Active Systemic Lupus Erythematosus (SLE).

AstraZeneca1 site in 1 country17 target enrollmentApril 20, 2012

ConditionsSystemic Lupus Erythematosus

InterventionsMEDI-546

DrugsMEDI-546

Overview

Phase: Phase 2
Intervention: MEDI-546
Conditions: Systemic Lupus Erythematosus
Sponsor: AstraZeneca
Enrollment: 17
Locations: 1
Primary Endpoint: Overall Summary of Adverse Events
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.

Detailed Description

A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus erythematosus (SLE)

Registry

clinicaltrials.gov

Start Date

April 20, 2012

End Date

February 21, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.
•Weight greater than or equal to 40.0 kg.
•Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for ≥ 24 weeks prior to screening.
•Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives.
•Active moderate to severe SLE disease based on SLE disease activity score.

Exclusion Criteria

•Active severe or unstable neuropsychiatric SLE.
•Active severe SLE-driven renal disease or unstable renal disease.
•Clinically significant active infection including ongoing and chronic infections.
•Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus infection or splenectomy that predisposes the subject to infection.
•Confirmed positive tests for hepatitis B or positive test for hepatitis C.

Arms & Interventions

1

MEDI-546 100 mg IV

Intervention: MEDI-546

2

MEDI-546 300 mg IV

Intervention: MEDI-546

3

MEDI-546 1000 mg IV

Intervention: MEDI-546

Outcomes

Primary Outcomes

Overall Summary of Adverse Events

Time Frame: Stage I (up to 48 weeks)

Secondary Outcomes

Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax(Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29)
Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast(Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29)
Anti-drug Antibody (ADA)(Stage I (up to Week 48))