2023-507379-23-00招募中3 期
ARGX-113-2008: A Long-term, Single-Arm, Open-label, Multicenter Trial to Evaluate Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Argenx
- 入组人数
- 17
- 试验地点
- 18
- 主要终点
- Incidence and severity of adverse events (AEs)
研究概览
简要总结
To evaluate the safety and tolerability of efgartigimod IV and efgartigimod PH20 SC
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Intertreatment Period (IP)
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •The participant completed ARGX-113-2006 or ARGX-113-2207, defined as: a. The participant reached the end of the study in ARGX-113-2006 or ARGX-113-2207 and agreed to participate in the ARGX-113-2008 study. b. The participant qualifies for retreatment in ARGX-113-2006, but cannot complete a Treatment Period (TP) and the required IP visits within the ARGX-113-2006 study's timeframe."
- •The participant and/or the participant's legally authorized representative (LAR) can understand the requirements of the study and provide written informed consent/assent, and demonstrates a willingness and ability to comply with the study protocol procedures.
- •Contraceptive use for sexually active participants of childbearing potential should be consistent with local regulations for those participating in clinical studies. A participant is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children (ie, female participants have started their menses, and male participants have reached the middle of puberty). a. Male participants: contraceptive requirements for male participants are presented in Section 10.4.2.
- •b. Female adolescents of childbearing potential (FAOCBP; defined in Section 10.4.1.1) must have a negative urine pregnancy test at study entry (TP1V1 or IP0V1). The contraceptive requirements for FAOCBP are described in Section 10.4.2.1."
排除标准
- •FAOCBP: Pregnancy or lactation, or the participant intends to become pregnant during their participation in the study
- •Discontinued early from ARGX-113-2006 or ARGX-113-2207 treatment
- •A known hypersensitivity reaction to efgartigimod or any of its excipients
- •Any of the following medical conditions: a. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at study entry not sufficiently resolved in the investigtor's opinion. b. Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of gMG or put the participant at undue risk"
结局指标
主要结局
Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events (AEs)
Incidence and severity of serious adverse events (SAEs)
Incidence and severity of serious adverse events (SAEs)
Incidence and severity of adverse events of special interest (AESIs)
Incidence and severity of adverse events of special interest (AESIs)
Changes in laboratory test results, vital signs, height and weight, and electrocardiogram (ECG) results
Changes in laboratory test results, vital signs, height and weight, and electrocardiogram (ECG) results
次要结局
- Incidence and prevalence of antidrug antibodies (ADAs) against efgartigimod and antibodies against recombinant human hyaluronidase PH20 (rHuPH20).
研究者
Chief Scientific Officer
Scientific
Argenx
研究点 (18)
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