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

• Status: Completed
• Trial end date: 2017-02-21
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: MedImmune LLC
• Treatments: Antibodies, Monoclonal

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.