2024-510932-36-00招募中3 期
ARGX-113-2003: A Phase 3B, Randomized, Open-Label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis
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
- 42
- 试验地点
- 17
- 主要终点
- Mean of the average MG-ADL total score change from baseline during the visit of week (W)1 through W21 by regimen arm
研究概览
简要总结
To assess the clinical efficacy of efgartigimod IV 10 mg/kg administered in a q2w continuous regimen compared to that administered in a cyclic regimen
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Capable of providing signed informed consent and following with protocol requirements
- •At least 18 years of age, at the time of signing the informed consent.
- •Diagnosed with Generalized Myasthenia Gravis (gMG) with confirmed documentation and supported by a physical exam and confirmed seropositivity for anti-acetylcholine receptor antibodies (AChR-Abs).
- •Meets the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, or IV
- •Has a Myasthenia Gravis – Activities of Daily Living (MG-ADL) total score ≥5 at the time of the study with more than 50% of the score due to nonocular symptoms
- •Concomitant gMG treatment is permitted. Permitted concomitant gMG treatment includes nonsteroidal immunosuppressive drugs (NSIDs), steroids, and/or acetylcholinesterase (AChE) inhibitors. If receiving corticosteroids and/or NSIDs, must be on a stable dose for at least 1 month before the study.
- •Agrees to use contraceptive measures consistent with local regulations and: o Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before receiving the study drug.
排除标准
- •Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of the clinical symptoms of gMG and/or put the participant at undue risk
- •Clinically significant active infection that is not sufficiently resolved in the investigator’s opinion or positive serum test at time of the study for active infection with any of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV
- •The participant has been institutionalized due to an official or judicial order.
- •History of malignancy unless deemed cured by adequate treatment with no evidence of reoccurrence for ≥3 years before the first administration of the study drug. Participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
- •Clinical evidence of other significant serious diseases, a recent (<3 months) major surgery, or any other condition that, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk
- •A thymectomy within 3 months of screening
- •Pregnant or lactating state or intention to become pregnant during the study or within 90 days of the last dose of the study drug
- •Use of the following prior or concomitant therapies: a. intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) within 14 days of day 1; b. Rituximab within 6 months of day 1; c. Eculizumab within 1 month of day 1; d. Other monoclonal antibodies (eg, adalimumab, tocilizumab, ixekizumab) within 5 half-lives of the monoclonal antibodies before day 1; e. Use of any other investigational product within 3 months or 5 half-lives, whichever is longer, before day 1; f. Receipt of a live or live-attenuated vaccines received within 4 weeks of screening. Previous participation in a clinical study or patient access program during which they were treated with efgartigimod.
- •Known hypersensitivity reaction to efgartigimod or any of its excipients
- •The participant stands in any relationship of dependency with the sponsor.
结局指标
主要结局
Mean of the average MG-ADL total score change from baseline during the visit of week (W)1 through W21 by regimen arm
Mean of the average MG-ADL total score change from baseline during the visit of week (W)1 through W21 by regimen arm
次要结局
- Incidence and severity of AEs, incidence of serious adverse events (SAEs), incidence of AESIs, and changes in laboratory test results, vital sign measurements, and electrocardiogram results
- Change from baseline in the MG-ADL total score over time
- Normalized area under the effect curve (AUEC) of MG-ADL total score improvement from baseline during the following intervals: day 1 through W7; W7 through W14; W14 through W21; W7 through W21
- Characterization of MG-ADL total score change from baseline during the following 5 intervals using mean and standard deviation: W1 through W7; W8 through W14; W15 through W21; W8 through W21; W1 through W21
- Number and percentage of participants who have a ≥ 2, 3, 4, or 5 points improvement in MG-ADL total score from baseline during the following 5 intervals: W1 through W7; W8 through W14; W15 through W21; W8 through W21; W1 through W21
- Percentage of time participants have a reduction in MG-ADL total score of at least 2 points from baseline during W4 through W21
- Number and percentage of participants who achieve minimal symptom expression (MSE), defined as a MG-ADL total score of 0 or 1, in the following 5 intervals: W1 through W7; W8 through W14; W15 through W21; W8 through W21; W1 through W21
研究者
Chief Scientific Officer
Scientific
Argenx
研究点 (17)
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