NCT05979441Enrolling By Invitation3 期
A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- argenx
- 入组人数
- 240
- 试验地点
- 153
- 主要终点
- Incidence of AEs, SAEs and AESIs over time
研究概览
简要总结
The main purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in ARGX-113-2007.
The study consists of a treatment period where participants will receive efgartigimod PH20 SC for up to 51 months. The treatment period will be followed by a treatment-free safety follow-up period of 56 days.
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
- •Has completed trial ARGX-113-2007
- •Being capable of providing signed informed consent and complying with protocol requirements
- •Agrees to use contraceptive measures consistent with local regulations and women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the study drug
排除标准
- •Intention to have major surgery during the study period or any other medical condition that has arisen since enrollment in study ARGX-113-2007, that in the investigator's opinion, would confound the results of the study or put the participant at undue risk
- •Known hypersensitivity reaction to the study drug or 1 of its excipients
- •Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness
研究组 & 干预措施
Efgartigimod PH20 SC
Experimental
Participants receiving efgartigimod PH20 subcutaneously
干预措施: Efgartigimod PH20 SC (Biological)
结局指标
主要结局
Incidence of AEs, SAEs and AESIs over time
时间窗: Up to 53 months
AE : adverse event ; SAE : serious adverse event ; AESI : adverse event of special interest.
Incidence of AEs, SAEs and AESIs over time
时间窗: Up to 53 months
AE : adverse event ; SAE : serious adverse event ; AESI : adverse event of special interest.
次要结局
- C-GTI comprising the GTI-MD over time(Up to 51 months)
- TIS over time(Up to 51 months)
- Proportion of TIS responders (minimal, moderate, major) over time(Up to 51 months)
- Individual CSMs of the TIS over time(Up to 51 months)
- Percentage of participants with clinically inactive disease(Up to 51 months)
- Percentage of participants with remission during the study(Up to 51 months)
- PGI-S over time(Up to 51 months)
- CGI-S over time(Up to 51 months)
- Physical Functioning subscale and Physical Component Summary scores of the SF-36v2 over time(Up to 51 months)
- EQ-5D-5L utilities over time(Up to 51 months)
- EQ-5D-5L VAS over time(Up to 51 months)
- Incidence of ADA against efgartigimod (serum levels) over time(Up to 53 months)
- Proportion of participants achieving sustained low disease activity while on IMP, over time(Up to 51 months)
- Proportion of participants with low disease activity over time, while on IMP(Up to 51 months)
- Proportion of participants with low disease activity who continue dosing every 2 weeks at week 52 and every 24 weeks thereafter(Up to 51 months)
- C-GTI comprising the AIS over time(Up to 51 months)
- C-GTI comprising the CWS over time(Up to 51 months)
- C-GTI comprising the AIS over time(Up to 51 months)
- C-GTI comprising the CWS over time(Up to 51 months)
- C-GTI comprising the GTI-MD over time(Up to 51 months)
- Prednisone dose reduction (average monthly dose) over time(Up to 51 months)
- TIS over time(Up to 51 months)
- Proportion of TIS responders (minimal, moderate, major) over time(Up to 51 months)
- Individual CSMs of the TIS over time(Up to 51 months)
- Percentage of participants with clinically inactive disease(Up to 51 months)
- Percentage of participants with remission during the study(Up to 51 months)
- PGI-S over time(Up to 51 months)
- CGI-S over time(Up to 51 months)
- Physical Functioning subscale and Physical Component Summary scores of the SF-36v2 over time(Up to 51 months)
- EQ-5D-5L utilities over time(Up to 51 months)
- EQ-5D-5L VAS over time(Up to 51 months)
- Percent change from baseline in total IgG levels in serum over time(Up to 53 months)
- Incidence of ADA against efgartigimod (serum levels) over time(Up to 53 months)
- Proportion of participants achieving sustained low disease activity while on IMP, over time(Up to 51 months)
- Proportion of participants with low disease activity over time, while on IMP(Up to 51 months)
- Proportion of participants with low disease activity who continue dosing every 2 weeks at week 52 and every 24 weeks thereafter(Up to 51 months)
- Proportion of participants who have marked worsening during the period of dosing every 2 weeks(Up to 51 months)
- Duration of dosing every 2 weeks(Up to 51 months)
研究者
研究点 (153)
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