NCT02725515已完成2 期
A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Xencor, Inc.
- 入组人数
- 105
- 试验地点
- 44
- 主要终点
- Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225
研究概览
简要总结
The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus Erythematosus (SLE) disease activity improvement achieved by a brief course of disease-suppressing steroid therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of SLE as defined by the ACR criteria
- •Patients have a history of a (+) ANA, (+) ENA or a (+) anti-dsDNA serology documented within one year prior to randomization
- •Investigator has assessed the patient and in their judgment, the SLE disease activity is not organ threatening
- •Both investigator and patient agree that it is acceptable to discontinue their current immunosuppressant SLE medications and receive a brief course of IM steroid therapy
- •If patients are on oral steroids, they must be on the equivalent of ≤15 mg/day of prednisone to enter screening, and must be able to taper to ≤10 mg/day by randomization
排除标准
- •History or evidence of a clinically unstable/uncontrolled disorder, condition or disease, other than SLE that, in the opinion of the investigator would pose a risk to patient safety or interfere with the study evaluation, procedures or completion
- •Patients who have organ threatening manifestations of SLE including active Class 3 or 4 lupus nephritis requiring induction or maintenance therapy or any other disorder for which stopping SLE therapy is contraindicated
- •Active CNS lupus such as seizures or psychosis that in the opinion of the investigator would preclude participation
- •Unstable hemolytic anemia or thrombocytopenia
- •Patient is pregnant or breast feeding, or planning to become pregnant while participating in the study
- •Use of any biologic therapy (including belimumab) within 6 months of randomization, or prior exposure to a monoclonal antibody directed to CD20 (such as rituximab) within 12 months of randomization
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions
干预措施: Placebo to match XmAb5871 (Biological)
XmAb5871
Experimental
XmAb5871 administered by IV infusion for up to a total of 16 infusions
干预措施: XmAb5871 (Biological)
结局指标
主要结局
Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225
时间窗: Day 225
Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 225
次要结局
- Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169(Day 169)
- Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients(From the date of randomization until the date of loss of Systemic Lupus Erythematosus Disease Activity Improvement, or the date of the final efficacy assessment, up to 239 days.)
研究者
研究点 (44)
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