Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
| 대상 질환 | Systemic Lupus Erythematosus |
|---|---|
| 임상 단계 | 2상 |
| 스폰서 | Viatris Innovation GmbH |
| 상태 | 완료 |
| 참여자 수 | 427 명 |
| 중재(약물) | Cenerimod 0.5 mg, Cenerimod 1 mg, Cenerimod 2 mg, Cenerimod 4 mg, cenerimod 2 mg (ex-4 mg) |
| 시작일 | 2018년 12월 21일 |
| 완료일 | 2021년 8월 31일 |
| 결과 공개일 | 2023년 9월 22일 |
요약
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) |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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