2024-510872-18-00已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 29
- 主要终点
- Cohort A: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Week 16
研究概览
简要总结
To evaluate the dose-response relationship of enpatoran in reducing disease activity based on CLASI-A
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment Period
- 盲法
- Double (Subject, Investigator, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) >= 8
- •Active SLE with presence of: CLASI-A >= 8 and BILAG 2004 1B, C, D (that is [i.e.], No BILAG 2004 A and No BILAG 2004 >= 2B) or BILAG 2004 >= 1A or 2B and 1 or 2 of the following: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI >= 6 at Screening Visit and confirmed clinical hybrid SELENA-SLEDAI >= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A >= 8
- •Receiving a stable dose of at least one of the following standards of care therapies for lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids
- •Other protocol defined inclusion criteria could apply
排除标准
- •Autoimmune or rheumatic disease other than SLE or CLE
- •Dermatological diseases other than cutaneous manifestations of SLE or CLE
- •Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
- •Ongoing or active clinically significant viral, bacterial, or fungal infection
- •History of uncontrolled seizures or other neurological disorder
- •History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
- •History of malignancy
- •Other protocol defined exclusion criteria could apply
结局指标
主要结局
Cohort A: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Week 16
Cohort A: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Week 16
Cohort B: British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24
Cohort B: British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24
次要结局
- Cohort B: Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 24
- Cohort B: Change from Baseline in Physician's Global Assessment at Week 24
- Cohort A and Cohort B: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs of Special Interest, Clinically Significant Abnormalities in Laboratory Parameters and QT Interval Corrected
- Cohort A and Cohort B: Change from Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) at Week 16 and Week 24
- Cohort A and Cohort B: Change from Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity at Week 16 and 24
- Cohort B: Participants with British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response and with Clinically Meaningful Corticosteroids (CS) Reduction
- Cohort A: Clinically Meaningful Corticosteroids (CS) Reduction
- Cohort A: Ocurrence of Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) Score 0 or 1 at Week 16 and Week 24
- Cohort B: Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 24
- Cohort B: Lupus Low Disease Activity State (LLDAS) Attainment at Week 24
- Cohort B: Remission Attainment at Week 24
- Cohort B: Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare
- Cohort B: Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare
- Cohort A and B: Change from Baseline in Skindex 29+3 Symptom Domain Score at Week 24
- Cohort A and B: Change from Baseline in the Skindex 29+3 Functioning and Emotion Domain Scores at Week 24
- Change from Baseline in the Skindex 29+3 Lupus-Specific Domain Score at Week 24
- Cohort A and B: Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scores at Week 24
研究者
Global Regulatory Affairs
Scientific
Merck Healthcare KGaA
研究点 (29)
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