Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
- Registration Number
- NCT01559090
- Lead Sponsor
- AstraZeneca
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 MEDI-546 MEDI-546 100 mg IV 2 MEDI-546 MEDI-546 300 mg IV 3 MEDI-546 MEDI-546 1000 mg IV
- Primary Outcome Measures
Name Time Method Overall Summary of Adverse Events Stage I (up to 48 weeks)
- Secondary Outcome Measures
Name Time Method 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) MEDI-546 antibody detection measured by electrochemiluminescence (ECL).
Trial Locations
- Locations (1)
Research Site
🇯🇵Shinjuku-ku, Japan