NL-OMON56108尚未招募3 期
An Open-label Extension Study of ARGX-113-2009 to Evaluate the Long term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid - BALLAD+
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- argenx BV
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Has completed the week 36 visit of ARGX-113-2009
- •2. Is capable of providing signed informed consent and complying with protocol
- •requirements
- •3. Agrees to use contraceptive measures consistent with local regulations and
- •the following:
- •a. Male participants: An acceptable method of contraception is a condom. All
- •nonsterilized male participants must use this method from signing of the ICF
- •until the date of the last dose of IMP.
- •b. Women of childbearing potential must have a negative urine pregnancy test at
- •baseline before receiving IMP. Women must use one of the contraception methods
- •described in the protocol from signing the ICF until the last dose of IMP
排除标准
- •1. Clinically significant disease, recent major surgery (within 3 months of
- •baseline), or intention to have surgery during the study; or any other medical
- •condition that, in the investigator*s opinion would confound the results of the
- •study or put the participant at undue risk
- •2. Known hypersensitivity to IMP or 1 of its excipients
- •3. Permanently discontinued IMP in ARGX-113-2009 due to an AE considered
- •related to IMP and for whom the benefit/risk balance is not considered
研究者
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