Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Phase 2
Completed
NCT03742037
| Condition | Systemic Lupus Erythematosus |
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| Phase | Phase 2 |
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| Sponsor | Viatris Innovation GmbH |
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| Status | Completed |
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| Enrollment | 427 participants |
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| Interventions | Cenerimod 0.5 mg, Cenerimod 1 mg, Cenerimod 2 mg, Cenerimod 4 mg, cenerimod 2 mg (ex-4 mg) |
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| Start date | Dec 21, 2018 |
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| Completion date | Aug 31, 2021 |
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| Results posted | Sep 22, 2023 |
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Summary
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
Baseline (Day 1) and Month 6 · score on a scale
| Cenerimod 0.5 mg | -3.2 score on a scale |
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| Cenerimod 1 mg | -3.41 score on a scale |
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| Cenerimod 2 mg | -2.84 score on a scale |
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| Cenerimod 4 mg | -4.04 score on a scale |
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| Placebo | -2.85 score on a scale |
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| p-value | 0.4749 |
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| LS mean difference to placebo | -0.39 (95% CI -1.45–0.68) |
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Open in BENITIONS
View on ClinicalTrials.gov
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