CTIS2023-503915-14-00招募中1 期
ARGX-113-2211: Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients with primary Sjögren’s Syndrome (pSS) who complete qualifying efgartigimod pSS studies - ARGX-113-2211
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Argenx
- 入组人数
- 27
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 64（—）
- 性别
- All
入选标准
- •The Participant is at least the legal age of consent for clinical trials when signing the ICF, The Participant is capable of providing signed informed consent, and complying with protocol requirements, The Participant agrees to use contraceptive measures consistent with local regulations and the following: a. WOCBP must have a negative urine pregnancy test at baseline before receiving IMP, The Participant has completed the qualifying efgartigimod pSS studies and agrees to continue study drug treatment without interruption in the extension study
排除标准
- •The Participant has clinically significant disease (including newly diagnosed malignancy or cardiovascular disease) 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, The Participant is pregnant or intention to become pregnant during the study, The Participant has any severe systemic pSS manifestation that may put the participant at undue risk based on the investigator’s opinion
研究者
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