PER-004-17招募中未知
A PHASE II, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATETHE SAFETY AND EFFICACY OF M2951 IN SUBJECTS WITHSYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- A
- 入组人数
- 43
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
- 性别
- All
入选标准
- •Eligible male and female subjects, aged 18 to 75 years; must have diagnosis of SLE with either
- •the SLICC criteria for SLE, or at least four of the 11 ACR classification criteria for SLE, of at
- •least six months duration prior to Screening; SLEDAI-2K total score ≥ 6 (including clinical
- •SLEDAI ≥ 4) at Screening Visit; and be positive for anti-double-stranded DNA and/or
- •anti-nuclear antibody (ANA ≥ 1:80) at the time of Screening.
- •Detailed of all inclusion criteria are detailed in Section 5.3.1. of protocol page N° 42
排除标准
- •Subjects are not eligible for this
- •study if they have active, clinically significant interstitial lung disease or pulmonary arterial
- •hypertension; proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg); acutely
- •worsened renal function; central nervous system SLE; or within two weeks prior to Screening
- •or during Screening: use of oral corticosteroids ≥ 30 mg daily prednisone equivalent; use of
- •injectable corticosteroids, or change in dose of corticosteroids.
- •Detailed of all exclusion criteria are detailed in Section 5.3.2 of protocol page N° 44
研究者
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