A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 46
- 主要终点
- Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This is Phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics of ALPN-101 (acazicolcept) in adults with moderate to severe active systemic lupus erythematosus (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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ALPN-101 (Acazicolcept)
Participants received a weight-based dose of 3 milligrams/kilogram (mg/kg) ALPN-101 once every 2 weeks (Q2W) up to 24 weeks.
干预措施: ALPN-101 (Drug)
Placebo
Participants received placebo matched to ALPN-101 up to 24 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Day 1 up to Safety follow-up (up to 28 weeks)
Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
时间窗: At Day 169
The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from the SLE Disease Activity Index 2000 (SLEDAI-2K), the British Isles Lupus Assessment Group (BILAG) 2004 Index, and the Physician's Global Assessment (PGA). Participants classified as responder if they met all of the following criteria: 1) ≥ 4-point reduction in the SLEDAI-2K total score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B) compared with baseline; and 3) No worsening from baseline in participants' lupus disease activity (i.e., increase of ≥0.3 0 on a 3-point scale) in PGA. The SLEDAI-2K total score falls between 0 and 105, with higher scores representing increased disease activity. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity (range: A\[severe\] to E\[no disease\]). PGA: assesses worsening in participant's general health.
Percentage of Participants Achieving a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response
时间窗: At Day 169
The BICLA is a responder index developed to measure response to therapy, and it includes scores from the BILAG, SLEDAI-2K, and Physician's Global Assessment (PGA). BICLA response is defined as: 1) at least 1 gradation of improvement in baseline BILAG 2004 scores in all body systems with moderate disease activity at entry (eg, all B \[mild disease\] scores falling to C \[Stable and mild\], or D \[no activity\]); 2) no new BILAG A or more than 1 new BILAG B scores; 3) no worsening of total SLEDAI-2K score from baseline; 4) ≤ 10% deterioration in PGA score. The PGA is measured on a 0 to 100 mm scale with score 0 indicates No Disease Activity and score 100 indicates the most Severe Disease Activity.
次要结局
- Annualized Flare Rate by British Isles Lupus Assessment Group (BILAG)-2004 Flare Index(From Baseline to Day 169)
- Time-to-first Flare by BILAG-2004 Flare Index(From Baseline to Day 169)
- Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)(At Day 169)
- Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score(From Baseline to Day 169)
- Cumulative Prednisone-equivalent Dose Use Through Day 169(From Baseline through Day 169)
- Percentage of Participants With ≥ 50% Reduction In CLASI Activity Score In Participants With Baseline CLASI Activity Score ≥ 8(From Baseline to Day 169)