JPRN-jRCT2011210019已完成2 期
A randomized, double-blind, parallel-group, multicenter, phase 2 study to investigate the safety and PD of cenerimod in Japanese subjects with moderate to severe systemic lupus erythematosus (SLE)
Yokoyama Yoshinari0 个研究点目标入组 17 人开始时间: 2021年6月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
研究概览
简要总结
In this study, the primary and second endpoints were safety and pharmacodynamic, respectively. The results showed that cenerimod 2 or 4 mg was generally well-tolerated with no major safety issues, although there was a need to monitor the decrease in total lymphocyte counts during the treatment period. Pharmacodynamic showed a decrease in lymphocyte counts at both doses.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •(1) Signed ICF prior to any study-mandated procedure.
- •(2) Diagnosis of SLE made at least 6 months prior to Screening, by fulfilling at least 4 of the 11 criteria for SLE as defined by the American College of Rheumatology (ACR) criteria.
- •(3) Male and female subjects, age 18 to 75 years old (both inclusive).
- •(4) A mSLEDAI-2K score >= 6 of at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).
- •Note: The mSLEDAI-2K score does not consider the factor leukopenia in SLEDAI-2K.
排除标准
- •(1) Female subjects who are lactating or planning to become pregnant during the study.
- •(2) Active lupus nephritis (defined by proteinuria > 1.5 g/24 h, or equivalent using spot urine protein-to-creatinine ratio > 150 mg/mmol) or a renal biopsy demonstrating immune complex-mediated glomerulonephritis compatible with lupus nephritis within 90 days prior to Screening.
- •(3) Severe active central nervous system (CNS) lupus requiring therapeutic intervention (including aseptic meningitis, seizures, psychosis, cerebritis, cerebrovascular accident [CVA], organic brain syndrome, CNS vasculitis)
- •(4) Severe forms of vasculitis requiring systemic immunosuppressive treatment (including retinal vasculitis, coronary vasculitis, pulmonary vasculitis, mesenteric vasculitis) within 90 days prior to Screening.
- •(5) A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with rheumatoid arthritis, erosive arthritis, scleroderma or autoimmune hepatitis.
研究者
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