NCT03252587已完成2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus
Bristol-Myers Squibb179 个研究点 分布在 1 个国家目标入组 363 人开始时间: 2017年9月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 363
- 试验地点
- 179
- 主要终点
- Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32
研究概览
简要总结
This study will investigate BMS-986165 to assess its effects in participants with 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemic lupus erythematosus (SLE) disease diagnosed ≥ 24 weeks before the screening visit
- •Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
- •One of the following: elevated antinuclear antibodies (ANA) ≥ 1:80 or positive anti- double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate results) or positive anti-Smith (anti-Sm) as determined by the central laboratory
- •Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points with joint involvement and/or rash [score must be confirmed by Central Review Services (CRS)]
- •Men and women must agree to follow specific methods of contraception, if applicable
排除标准
- •Drug-induced SLE, certain other autoimmune diseases, and active, severe lupus nephritis
- •SLE overlap syndromes such as scleroderma and mixed connective tissue disease
- •Clinically significant abnormalities on chest x-ray or electrocardiogram (ECG)
- •History of any significant drug allergy
- •Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Placebo oral administration
Placebo Comparator
干预措施: Placebo (Other)
BMS-986165 Dose 1 oral administration
Experimental
干预措施: BMS-986165 (Drug)
BMS-986165 Dose 2 oral administration
Experimental
干预措施: BMS-986165 (Drug)
BMS-986165 Dose 3 oral administration
Experimental
干预措施: BMS-986165 (Drug)
结局指标
主要结局
Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32
时间窗: At week 32
SRI(4) responder is defined as a patient whose disease course fulfills all of the following: 1. A 4-point or greater reduction from baseline in SLEDAI-2K score 2. No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) and not more than 1 new BILAG B (moderate disease activity) organ domain grade 3. No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity
次要结局
- Number of Participants With Laboratory Abnormalities in Specific Liver Tests(From first dose to 30 days post last dose (Up to 52 weeks))
- Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels(From baseline to week 44)
- Percent Change From Baseline in Complement Proteins C3 and C4 Levels(From baseline to week 52)
- BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)(Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12)
- BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)(Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48)
- Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)(At Week 48)
- Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10(At week 48)
- Number of Participants With Abnormalities in Electrocardiograms (ECGs)(From baseline to up to week 48)
- BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)(Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12)
- Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32(From baseline to week 32)
- Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48(At week 48)
- Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response(At week 48)
- Number of Participants With Abnormalities in Vital Signs(From first dose to 30 days post last dose (Up to 52 weeks))
- Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32(From baseline to week 32)
- Change From Baseline in the 40-Joint Count(Baseline and week 48)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From first dose to 30 days post last dose (Up to 52 weeks))
- Percent Change From Baseline in Complement (C3, C4) Levels at Week 32(From baseline to week 32)
- Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status(At week 32)
- Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels(From baseline to week 52)
研究者
研究点 (179)
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