A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 244
- 试验地点
- 142
- 主要终点
- Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52
研究概览
简要总结
The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.
详细描述
This is a Bayesian adaptive phase 2b, multi-center, double-blind, randomized, placebo-controlled, 52-week, dose-ranging study in subjects with active SLE and inadequate response to SOC therapies including oral corticosteroids (OCS), immunosuppressants and immunomodulators. Previous biologic use is allowed with an adequate washout period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 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
Rozibafusp Alfa, Dose A
Investigational product solution in vial
干预措施: Rozibafusp Alfa (Drug)
Rozibafusp Alfa, Dose B
Investigational product solution in vial
干预措施: Rozibafusp Alfa (Drug)
Rozibafusp Alfa, Dose C
Investigational product solution in vial
干预措施: Rozibafusp Alfa (Drug)
Placebo for Rozibafusp Alfa
Placebo Investigational product solution in vial
干预措施: Placebo for Rozibafusp Alfa (Drug)
结局指标
主要结局
Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52
时间窗: Week 52
SRI-4 response at Week 52 is defined as a ≥ 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score, and no new British Isles Lupus Assessment Group (BILAG) 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3), and no use of more than protocol allowed therapies.
次要结局
- Number of Participants With a SRI-4 Response at Week 24(Week 24)
- Number of Participants Who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24(Week 24)
- Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52(Week 52)
- Number of Participants Who Achieved a BICLA Response at Week 52(Week 52)
- Number of Participants Achieving a SRI-4 Response With a Reduction of Oral Corticosteroids (OCS) to ≤ 7.5 mg/Day by Week 44 and Sustained Through Week 52 In Participants With a Baseline OCS Dose ≥ 10 mg/Day(Up to Week 52)
- Annualized Moderate and Severe Flare Rate Over 52 Weeks as Measured by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment [SELENA] -Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index (SFI)(Up to Week 52)
- Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI(Up to Week 52)
- Annualized Flares Rate Over 52 Weeks as Measured by BILAG Score Designation of "Worse" or "New" Resulting in a B-Score In ≥ 2 Organs or an A-Score in ≥ 1 Organ(Up to Week 52)
- Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52(Week 12, 24, 36, and 52)
- Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52(Week 12, 24, 36, and 52)
- Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52(Week 12, 24, 36, 44, and 52)
- Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52(Week 12, 24, 36, 44, and 52)
- Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52(Week 12, 24, 36, 44, and 52)
- Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52(Week 12, 24, 36, 44, and 52)
- Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52(Week 12, 24, 36, 44, and 52)
- Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52(Week 12, 24, 36, 44, and 52)
- Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52(Week 12, 24, 36, 44, and 52)
- Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52(Week 12, 24, 36, 44, and 52)
- Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52(Week 12, 24, 36, 44, and 52)
- Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52(Week 12, 24, 36, 44, and 52)
- Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52(Week 12, 24, 36, 44, and 52)
- Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52(Week 12, 24, 36, 44, and 52)
- Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52(Week 12, 24, 36, 44, and 52)
- Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)(Up to approximately 68 weeks)
- Serum Concentration of Rozibafusp Alfa(Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 36, Week 44, Week 52, Week 56, Week 60, Week 64, and Week 68)
- Terminal Half-life of Rozibafusp Alfa(Up to Week 68)