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
- 试验地点
- 6
- 主要终点
- SLE response
研究概览
简要总结
A-623 is an Fc-conjugated peptide that is being developed as a treatment for SLE based on its ability to bind to and antagonize the action of human B cell activating factor (BAFF). BAFF is a protein that is a critical survival factor for B cells and is required for B cell development and maintenance. Its involvement in B cell survival has been demonstrated in animal studies. Therefore, A-623 is a potential therapeutic agent for B cell-mediated autoimmune and inflammatory diseases.
This is a double-blind, placebo-controlled study that will enroll serologically active systemic lupus erythematosus (SLE) subjects. Randomization will be stratified by: Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA-SLEDAI) score 6t o 9 vs. ≥10
African descent or indigenous American vs. other.
Up to 600 subjects will be randomized 1:1:1:3 to receive either 100 mg every week, 200 mg every week, 200 mg every 4 weeks or placebo for up to 52 weeks of treatment.
A-623 or placebo will be administered subcutaneously (SC).
Prednisone dose should be stable if possible until Week 12. Efforts to taper dose below the baseline dose should be employed from Week 12 on. If this is not possible, efforts should be made to keep the dose either at the baseline level or at no more than 25% above the baseline level.
Other immunosuppressive doses should be kept stable if possible and doses should be tapered if possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 0.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
SLE response
时间窗: Various timepoints through Week 52
The % of subjects with SLE response compared with baseline at the time of assessment
时间窗: Various timepoints through Week 52
次要结局
- Flare rates(Various timepoints through Week 52)
- B cell reduction(Various timepoints through Week 52)
- FACIT-fatigue score(Various timepoints through Week 52)
- Time to first flare(Various timepoints through Week 52)
- Reduction in prednisone dose(Various timepoints through Week 52)
- Change in IgG, IgM,C3 and C4(Various timepoints through Week 52)
- SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9(Various timepoints through Week 52)