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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: MEDI-546

Study type: Interventional

Funder types: Industry

Identifiers

NCT01559090

D3461C00002

Details and patient eligibility

About

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

Full 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)

Enrollment: 17 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 3 patient groups

1

Experimental group

Description:

MEDI-546 100 mg IV

Treatment:

Drug: MEDI-546

Drug: MEDI-546

Drug: MEDI-546

2

Experimental group

Description:

MEDI-546 300 mg IV

Treatment:

Drug: MEDI-546

Drug: MEDI-546

Drug: MEDI-546

3

Experimental group

Description:

MEDI-546 1000 mg IV

Treatment:

Drug: MEDI-546

Drug: MEDI-546

Drug: MEDI-546