A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 16
- 主要终点
- Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo.
研究概览
简要总结
This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CLASI score greater than or equal to 10 at Baseline
- •Positive for one or more RNA autoantibodies
排除标准
- •severe, active central nervous system (CNS) involvement at Screening;
- •severe renal involvement at Screening (urine protein/creatinine ratio of >200 mg/mmol, or an estimated creatinine clearance of <30 mL/min);
- •use of cyclophosphamide within 3 months of the Baseline visit;
- •use of rituximab within 6 months of the Baseline visit;
- •use of belimumab within 3 months of the Baseline visit;
- •use of background medications within 1 month of Baseline in excess of: i. mycophenolate mofetil > 3 g/day; ii. azathioprine > 200 mg/day; iii. methotrexate > 25 mg/day; iv. hydroxychloroquine > 400 mg/day; v. prednisone (or equivalent) > 15 mg/day;
- •use of an intravenous steroid "pulse" within 2 months of Baseline;
- •use of an intramuscular steroid injection within 1 month of Baseline;
- •change in SLE medications within 1 month of Baseline;
- •the presence of a clinically significant infection in the judgement of the Investigator within seven days prior to the receipt of the first dose of study drug;
- •positive viral load test for hepatitis B, C, or HIV at Screening;
- •participation in another clinical trial with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from Baseline;
- •positive pregnancy test at Screening or at Baseline;
- •female subjects currently breast feeding at Baseline;
- •inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the Investigator, would make the subject unsuitable for study participation.
研究组 & 干预措施
RSLV-132
10 mg/kg RSLV-132
干预措施: RSLV-132 (Drug)
Placebo
Saline placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo.
时间窗: Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169
Mean change from baseline (from baseline to Day 85; or baseline to Day 169) in CLASI activity scores (Last Observation Carried Forward \[LOCF\] post censoring values). The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.
次要结局
- Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score(Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169)