NCT05906706Approved For Marketing不适用
An Open-Label, Expanded Access Program of Dupilumab in Adult Patients With Bullous Pemphigoid
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
研究概览
简要总结
The objective of the program is to provide patients with Bullous Pemphigoid (BP), that participated in the R668-BP-1902 (NCT04206553) phase 2/3 study, dupilumab treatment and evaluate the long-term safety of dupilumab.
详细描述
Expanded Access requests are only being considered in response to intermediate size patient population applications. Availability will depend on location.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the end of study (EOS) visit in the parent dupilumab phase 2/3 study, R668-BP-1902 (NCT04206553)
排除标准
- •Patients who, during the parent dupilumab study, R668-BP-1902 (NCT04206553), developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to program drug and which led to discontinuation of investigational product
- •Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit
- •Treatment with BP-directed biologics, as defined in the protocol
- •Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
- •Planned or anticipated use of any prohibited medications or procedures during program treatment
- •Severe concomitant illness(es) that, in the treating physician's judgment, would adversely affect the patient's participation in the program
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
研究者
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