Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-20

Study Completion Date

2017-02-21

Brief Summary

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

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Detailed Description

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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)

Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

MEDI-546 100 mg IV

Group Type EXPERIMENTAL

MEDI-546

Intervention Type DRUG

Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks

2

MEDI-546 300 mg IV

Group Type EXPERIMENTAL

MEDI-546

Intervention Type DRUG

Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks

3

MEDI-546 1000 mg IV

Group Type EXPERIMENTAL

MEDI-546

Intervention Type DRUG

Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV.

Interventions

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MEDI-546

Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks

Intervention Type DRUG

MEDI-546

Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks

Intervention Type DRUG

MEDI-546

Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No