Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
3期
已完成
NCT05987423
| 适应症 | Thyroid Eye Disease, TED |
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| 分期 | 3期 |
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| 申办方 | Hoffmann-La Roche |
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| 状态 | 已完成 |
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| 受试者人数 | 131 人 |
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| 干预（药物） | Satralizumab |
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| 开始日期 | 2023年10月26日 |
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| 完成日期 | 2025年7月8日 |
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| 结果公布日 | 2026年7月31日 |
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摘要
The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).
Percentage of Participants in the Active TED Population Who Achieved ≥ 2 Millimeters (mm) Reduction in Proptosis From Baseline at Week 24 in the Study Eye
At Week 24 · percentage of participants
| Part I: Satralizumab | 49.0 percentage of participants |
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| Part I: Placebo | 31.2 percentage of participants |
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| p-value | 0.0715 |
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| Difference in Response Rates at Week 24 | 17.9 (95% CI -1.6–37.3) |
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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。