A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid
2/3期
已完成
NCT04206553
| 适应症 | Bullous Pemphigoid |
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| 分期 | 2/3期 |
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| 申办方 | Regeneron Pharmaceuticals |
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| 状态 | 已完成 |
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| 受试者人数 | 106 人 |
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| 干预（药物） | dupilumab, Matching Placebo, Oral corticosteroids (OCS) |
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| 开始日期 | 2020年10月28日 |
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| 完成日期 | 2024年7月12日 |
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| 结果公布日 | 2026年3月6日 |
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摘要
The main purpose of this study is to investigate whether dupilumab is effective and safe for the treatment of bullous pemphigoid. Dupilumab is a type of drug called a "monoclonal antibody". An antibody is a special kind of protein that the immune (defense) system normally makes to fight bacteria and viruses. Bullous pemphigoid is an autoimmune subepidermal blistering disease, predominately affecting the elderly (typical onset after age 60). The study is looking at several other research questions, including: * Side effects that may be experienced by people taking dupilumab * How dupilumab works in the body and affects the body * How dupilumab affects quality of life * How much dupilumab is present in the blood * To see if dupilumab works to wean the patient off oral corticosteroids
Percent of Participants Achieving Sustained Remission at Week 36
At Week 36 · Estimated Percentage of Participants
| Placebo | 4.0 Estimated Percentage of Participants |
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| Dupilumab Q2W | 18.2 Estimated Percentage of Participants |
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| p-value | 0.0250 |
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| Risk Difference (RD) | 14.2 (95% CI 1.97–27.74) |
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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。