Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
| 适应症 | Systemic Lupus Erythematosus |
|---|---|
| 分期 | 2期 |
| 申办方 | Viatris Innovation GmbH |
| 状态 | 已完成 |
| 受试者人数 | 427 人 |
| 干预（药物） | Cenerimod 0.5 mg, Cenerimod 1 mg, Cenerimod 2 mg, Cenerimod 4 mg, cenerimod 2 mg (ex-4 mg) |
| 开始日期 | 2018年12月21日 |
| 完成日期 | 2021年8月31日 |
| 结果公布日 | 2023年9月22日 |
摘要
The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with systemic lupus erythematosus (SLE).
Change From Baseline to Month 6 in the Modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) Score
| Cenerimod 0.5 mg | -3.2 score on a scale |
|---|---|
| Cenerimod 1 mg | -3.41 score on a scale |
| Cenerimod 2 mg | -2.84 score on a scale |
| Cenerimod 4 mg | -4.04 score on a scale |
| Placebo | -2.85 score on a scale |
| p-value | 0.4749 |
|---|---|
| LS mean difference to placebo | -0.39 (95% CI -1.45–0.68) |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
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