Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
1/2期
已完成
NCT02472795
| 适应症 | Systemic Lupus Erythematosus |
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| 分期 | 1/2期 |
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| 申办方 | Viatris Innovation GmbH |
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| 状态 | 已完成 |
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| 受试者人数 | 105 人 |
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| 干预（药物） | Matching placebo, Cenerimod |
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| 开始日期 | 2015年6月1日 |
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| 完成日期 | 2017年1月23日 |
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| 结果公布日 | 2020年2月26日 |
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摘要
International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.
Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT)
Baseline to end-of-treatment (EOT) (up to 12 weeks) · 10^9 cells/L
| Cenerimod 0.5 mg (Part A) | -0.26 ± 0.48 10^9 cells/L |
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| Cenerimod 1 mg (Part A) | -0.96 ± 0.68 10^9 cells/L |
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| Cenerimod 2 mg (Part A) | -0.86 ± 0.61 10^9 cells/L |
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| Cenerimod 4 mg (Part B) | -0.87 ± 1.24 10^9 cells/L |
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| Matching Placebo | -0.33 ± 0.72 10^9 cells/L |
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| p-value | 0.39 |
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| Mean Difference (Final Values) | -0.17 (95% CI -0.56–0.22) |
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Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment
Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks) · 10^9 cells/L
| Cenerimod 0.5 mg (Part A) | 1.37 ± 0.52 10^9 cells/L |
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| Cenerimod 1 mg (Part A) | 1.71 ± 0.82 10^9 cells/L |
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| Cenerimod 2 mg (Part A) | 1.62 ± 0.75 10^9 cells/L |
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| Cenerimod 4 mg (Part B) | 1.88 ± 0.77 10^9 cells/L |
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| Matching Placebo | 1.65 ± 0.88 10^9 cells/L |
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| Cenerimod 0.5 mg (Part A) | -0.13 ± 0.56 10^9 cells/L |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。