A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safetyand 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
- Systemic Lupus Erythematosus
- Registration Number
- JPRN-jRCT2080221785
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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 or more 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method