CTRI/2011/04/001667招募中2 期
AN-SLE3321: A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A-623 Administration in Subjects with Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 600
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
入选标准
- •Diagnosis of SLE by American College of Rheumatology guidelines.
- •On stable SLE treatment
- •Active SLE disease
- •Serologically active
- •18 years of age or older
- •Receiving stable doses of prednisone between 7.5 mg and 40 mg per day
排除标准
- •Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
- •Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C.
- •Liver disease.
- •Anemia, neutropenia, or thrombocytopenia.
- •Malignancy within past 5 years
- •Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
- •History of active tuberculosis or a history of tuberculosis infection.
- •Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
- •Prior administration of any B cell depleting therapy in the past 18 months.
- •Pregnant or nursing
- •History of congenital immunodeficiency
研究者
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