CTIS2024-510872-18-00进行中（未招募）1 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 - MS200569_0003
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 508
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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
研究者
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