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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- argenx
- 入组人数
- 24
- 试验地点
- 11
- 主要终点
- Number of Participants With TEAEs, TESAEs and TEAESIs
研究概览
简要总结
Efgartigimod has the potential to improve disease manifestations by the reduction of IgG autoantibodies in Sjogren's Syndrome (SjD or pSS). This open-label extension study will evaluate the long-term safety of efgartigimod in participants with SjD who have completed the treatment period of the qualifying efgartigimod study (ARGX-113-2106).
详细描述
ARGX-113-2211 is a long-term, single-arm, open-label, multicenter extension study of the pSS-qualifying efgartigimod studies designed to evaluate the long-term safety of efgartigimod in adult patients with pSS. Participants will be enrolled from both active and placebo arms of qualifying efgartigimod studies and receive efgartigimod 10 mg/kg over 48 weeks in the extension study without knowledge of their treatment assignment in the qualifying study. Eligible participants must have completed the treatment period of the qualifying study and must not have permanently discontinued the IMP in that study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Is at least the legal age of consent for clinical trials when signing the ICF
- •Is capable of providing signed informed consent and complying with protocol requirements
- •Agrees to use contraceptive measures consistent with local regulations and the following: WOCBP must have a negative urine pregnancy test at baseline before receiving IMP
- •Has completed the qualifying efgartigimod SjD studies and agrees to continue study drug treatment without interruption in the extension study
排除标准
- •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
- •Pregnant or intention to become pregnant during the study
- •Any severe systemic SjD manifestation that may put the participant at undue risk based on the investigator's opinion
研究组 & 干预措施
Efgartigimod
All participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study.
干预措施: Efgartigimod (Biological)
结局指标
主要结局
Number of Participants With TEAEs, TESAEs and TEAESIs
时间窗: From the first dose of study drug (Day 1) up to 60 days post last study drug, approximately 56 weeks
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration. Adverse events in the 'Infections and infestations' SOC were defined as AE of Special Interest (AESIs) because efgartigimod causes a transient reduction in total IgG levels.
次要结局
- Number of CRESS Responders at Weeks 24 and 48(Weeks 24 and 48)
- Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSDAI at Weeks 24 and 48(Baseline (Day 1) and Weeks 24 and 48)
- Number of Participants With Low Disease Activity in ESSDAI at Weeks 24 and 48(Weeks 24 and 48)
- Number of Participants With Minimal Clinically Important Improvement From Baseline in clinESSDAI at Weeks 24 and 48(Baseline (Day 1) and Weeks 24 and 48)
- Number of Participants With Low Disease Activity in clinESSDAI at Weeks 24 and 48(Weeks 24 and 48)
- Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSPRI at Weeks 24 and 48(Baseline (Day 1) and Weeks 24 and 48)
- Change From Baseline in ESSDAI Score at Weeks 24 and 48(Baseline (Day 1) and Weeks 24 and 48)
- Change From Baseline in clinESSDAI Score at Weeks 24 and 48(Baseline (Day 1) and Weeks 24 and 48)
- Change From Baseline in ESSPRI Score at Weeks 24 and 48(Baseline (Day 1) and Weeks 24 and 48)
- Number of STAR Responders at Weeks 24 and 48(Weeks 24 and 48)
- Percent Change From Baseline in Total IgG Levels in Serum at Week 48(Baseline (Day 1) and Week 48)
- Percent Change From Baseline in Autoantibodies in Serum at Week 48(Baseline (Day 1) and Week 48)
- Serum Concentrations of Efgartigimod(Pre-dose and post-dose at Baseline (Day 1) and pre-dose at Weeks 24 and 48)
- Number of Participants With ADA Against Efgartigimod Over the 48-week Treatment Period(From Baseline (Day 1) up to 48 weeks)