NCT04346888已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamic and Pharmacokinetic of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
Harbour BioMed (Guangzhou) Co. Ltd.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年7月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline to Day 43
研究概览
简要总结
Primary Objectives: To investigate the efficacy of HBM9161 in patients with attack of MG in China
详细描述
This is a multicenter, randomized, double-blind and placebo-controlled study. The investigational drug is HBM9161 injection, and the indication is MG.
The subjects will be randomized to three dose groups (340mg, 680mg and placebo) for a 6 weeks' double-blind treatment period followed by an open-label extension treatment period. The study will investigate the safety, efficacy and pharmacodynamic and pharmacokinetic of HBM9161 in patients with attack of MG in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
for double-blind period
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form.
- •Male or female ≥ 18 years of age.
- •A female participant is eligible to participate if she is of:
- •Non-childbearing potential (physically infertile, including women who have been menopausal for 2 years or more);
- •Childbearing potential, negative serum pregnancy test results at screening visits, and agree to consistently use acceptable and effective contraceptive methods until 14 days after the final visit.
- •A male participant must take effective contraception during this clinical trial or their heterosexual partner must take effective contraception.
- •Meets MGFA myasthenia gravis clinical classification IIa-IVa (includes types IIa, IIb, IIIa, IIIb, and IVa) at the screening visit and at the baseline visit.
- •Screening and baseline MG-ADL score ≥ 6, and < 50% of them is from ocular muscle.
- •Stable background MG treatments at randomization.
- •Positive serologic test for AChR-Ab or MUSK-Ab at the screening visit and at least 1 of the following:
- •History of abnormal neuromuscular transmission test demonstrated by sign-fiber-electromyography or repetitive nerve stimulation OR
- •History of positive edrophonium chloride test OR
- •Participant has demonstrated improvement in MG signs on oral cholinesterase inhibitors as assessed by the treating physician.
排除标准
- •Use of rituximab, belimumab, eculizumab or any monoclonal antibody/Fc-fusion biologic for immunomodulation within 6 months prior to screening.
- •Immunoglobulins given by SC, IV(IVIG), or intramuscular route, or plasmapheresis/plasma exchange (PE) within 4 weeks before screening.
- •Thymectomy performed < 12 months prior to screening.
- •Total IgG level <6g/L (at screening).
- •Participant has any laboratory abnormality (at screening) that, in the opinion of the investigator, is clinically significant, has not resolved at baseline, and could jeopardize or would compromise the participant's ability to participate in this study.
- •Have known autoimmune disease other than MG that would interfere with the course and conduct of the study (such as uncontrolled thyroid disease).
- •Have an active infection, a recent serious infection (i.e., requiring injectable antimicrobial therapy or hospitalization) within the 8 weeks prior to screening.
- •History of or known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Participants must have negative test results for HBV surface antigen, HBV core antibody, HCV antibody, HIV 1 and 2 antibodies and a negative TB test at screening.
研究组 & 干预措施
HBM9161 (680mg and 340 mg)
Experimental
Subcutaneous injection; Blinded: HBM9161 680mg; Open-label: HBM9161 340mg;
干预措施: HBM9161 Injection (680mg and 340 mg) (Drug)
HBM9161 (340 mg)
Experimental
Subcutaneous injection; Blinded: HBM9161 340mg; Open-label: HBM9161 340mg;
干预措施: HBM9161 Injection (340 mg) (Drug)
Placebo, HBM9161 (340 mg)
Placebo Comparator
Subcutaneous injection; Blinded: Placebo; Open-label: HBM9161 340mg;
干预措施: Placebos (Drug)
结局指标
主要结局
Change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline to Day 43
时间窗: 43 days
The MG-ADL profile provides an assessment of MG symptom severity and measures 8 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the ADL score. The ADL score can range from 0 (least severe) to 24 (most severe)
次要结局
- Change in the Myasthenia Gravis Composite (MGC) score from baseline to Day 43(43 days)
- Change in the Quantitative Myasthenia Gravis (QMG) score from baseline to Day 43(43 days)
- Change in the Myasthenia Gravis Quality of Life 15(MG-QoL15r) score from baseline to Day 43(43 days)
- Proportion of participants with a decrease on the MG-ADL Score by ≥ 2 points from baseline to Day 43(43 days)
- Proportion of participants with an improvement and worse on the MGFA Post-intervention Status (MGFA-PIS) from baseline to Day 43. o Improvement: MGC Score reduce ≥ 3 points o Aggravation: MGC Score increase ≥ 3 points(43 days)
- Change in the MG-QoL15r score from baseline to Day 120(120 days)
- Proportion of participants with persistent improvement on the MG-ADL score from baseline to Day 120(120 days)
- Change in the MG-ADL score from baseline to Day 120(120 days)
- Change in the MGC score from baseline to Day 120(120 days)
- Change in the QMG score from baseline to Day 120(120 days)
- Proportion of participants with persistent improvement on the MGC score from baseline to Day 120(120 days)
研究者
研究点 (1)
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