JPRN-jRCT2080221785未知2 期
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)
适应症
试验速览
- 阶段
- 2 期
- 发起方
- AstraZeneca
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •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.
排除标准
- •- 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.
研究者
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