NCT04895696进行中（未招募）2 期
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 248
- 试验地点
- 280
- 主要终点
- Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.
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
- •Diagnosed ≥ 12 weeks before the screening visit and qualify as having SLE according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at the screening visit
- •Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody ≥ 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody.
- •Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 points and clinical Hybrid SLEDAI score ≥ 4 points with joint involvement and/or rash
排除标准
- •Active severe lupus nephritis (LN) as assessed by the investigator
- •Active or unstable neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI
- •Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
- •Antiphospholipid Syndrome
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Afimetoran: Dose 2
Experimental
干预措施: Afimetoran (Drug)
Afimetoran: Dose 1
Experimental
干预措施: Afimetoran (Drug)
Afimetoran: Dose 3
Experimental
干预措施: Afimetoran (Drug)
结局指标
主要结局
Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48
时间窗: Up to 48 Weeks
次要结局
- Number of participants with Adverse Events (AEs)(Up to 100 Weeks)
- Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48(Up to 48 Weeks)
- Mean change from baseline in swollen joint count using the 28-joint count at Week 24 and Week 48 in participants with ≥ 2 swollen joints at baseline(Up to 48 Weeks)
- Change from baseline in PGA score of disease activity at Week 24 and Week 48(Up to 48 Weeks)
- Proportion of participants who achieve CS reduction or maintenance to ≤ 7.5 mg per day at Week 48(Up to 48 Weeks)
- Number of participants with physical examination abnormalities(Up to 100 Weeks)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 52 Weeks)
- Proportion of participants who achieve an SRI(4) response at Week 24(Up to 24 Weeks)
- Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index; Activity (CLASI-A) score ≥ 10 at baseline who achieve a decrease of ≥ 50% from baseline CLASI-A score (CLASI-50) response at Week 24 and Week 48(Up to 48 Weeks)
- Proportion of participants with 6 or more swollen joints and 6 or more tender joints at baseline who achieve a ≥ 50% reduction from baseline in both swollen and tender joints at Week 24 and Week 48(Up to 48 Weeks)
- Mean change from baseline in tender joint count at Week 24 and Week 48 using the 28- joint count in participants with ≥ 2 tender joints at baseline(Up to 48 Weeks)
- Change in participant reported disease activity from baseline to Week 24 and Week 48 according to the 36-item Short Form Health Questionnaire (SF-36)(Up to 48 Weeks)
- Number of participants with Serious Adverse Events (SAEs)(Up to 100 Weeks)
- Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48(Up to 48 Weeks)
- Number of participants with clinical laboratory abnormalities(Up to 100 Weeks)
- Number of participants with vital sign abnormalities(Up to 100 Weeks)
研究者
研究点 (280)
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