Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
| 対象疾患 | Systemic Lupus Erythematosus |
|---|---|
| 相 | 第2相 |
| スポンサー | Viatris Innovation GmbH |
| ステータス | 完了 |
| 参加者数 | 427 名 |
| 介入（薬剤） | Cenerimod 0.5 mg, Cenerimod 1 mg, Cenerimod 2 mg, Cenerimod 4 mg, cenerimod 2 mg (ex-4 mg) |
| 開始日 | 2018年12月21日 |
| 完了日 | 2021年8月31日 |
| 結果公開日 | 2023年9月22日 |
概要
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) |
BENITIONS で見る ClinicalTrials.gov の原文を見る
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