Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
Фаза 3
Завершено
NCT05987423
| Заболевание | Thyroid Eye Disease, TED |
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| Фаза | Фаза 3 |
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| Спонсор | Hoffmann-La Roche |
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| Статус | Завершено |
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| Участники | 131 участн. |
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| Вмешательство | Satralizumab |
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| Дата начала | 26.10.2023 |
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| Дата завершения | 8.07.2025 |
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| Публикация результатов | 31.07.2026 |
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Кратко
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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