A Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Seagen Inc.
- 入组人数
- 20
- 试验地点
- 17
- 主要终点
- Number and Percentage of Subjects Having an Adverse Event (AE)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin in adults with active systemic lupus erythematosus (SLE).
详细描述
Systemic lupus erythematosus (SLE) is a chronic, multisystem, disabling autoimmune condition, which predominantly affects women of childbearing years. Treatment options for SLE remain relatively limited. Regardless of the specific therapy chosen, the majority of patients continue to require long term immunomodulatory or cytotoxic therapy, resulting in long-term morbidity and mortality. Brentuximab vedotin is an antibody-drug conjugate (ADC) consisting of: 1) the chimeric immunoglobulin (Ig) G1 antibody cAC10, specific for human CD30, 2) the microtubule disrupting agent monomethyl auristatin E (MMAE), and 3) a protease-cleavable linker that covalently attaches MMAE to cAC10. Since CD30 and/or CD30-expressing immune cells may play significant key roles in the pathogenesis of SLE, brentuximab vedotin may be an efficacious therapy. This study intends to explore the potential for brentuximab vedotin as a therapy for SLE.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 years
- •Diagnosis of SLE for at least 6 months prior to screening
- •Active SLE as indicated by SLE Disease Activity Index (SLEDAI) ≥ 4 at screening
- •Must have failed a treatment for SLE after a trial of at least 3 months
排除标准
- •The subject has any serious health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study
- •Subject has had recent serious or ongoing infection, or risk for serious infection
- •Subject has a history of new or recurrent malignancy within the past 5 years
- •The subject is pregnant and/or breastfeeding
- •The subject fulfills diagnostic criteria for another rheumatic (overlap) disease that may confound clinical assessments in the study
- •The subject has urgent, severe SLE disease activity, which, in the opinion of the Investigator, warrants immediate immunosuppressive therapy and would not be appropriate for the study
研究组 & 干预措施
Brentuximab vedotin
4 dose groups
干预措施: Brentuximab vedotin (Drug)
Placebo
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number and Percentage of Subjects Having an Adverse Event (AE)
时间窗: Up to 127 days (9 weeks after final dose)
Any treatment-emergent adverse events (TEAEs), any drug-related TEAEs, any SAEs, treatment-related serious adverse events (SAE), deaths, adverse events (AEs) leading to study discontinuation, and number of patients experiencing Grade 1, 2, and 3 TEAEs.
次要结局
- Proportion of Subjects Achieving an SRI Response at Day 85(85 days)