jRCT2031240175招募中不适用
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm, 3- Period Study to assess the Efficacy and Safety of a New Formulation of Oral Cladribine compared with Placebo in Participants with Generalized Myasthenia Gravis(MyClad)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 主要终点
- Change from Baseline in Myasthenia Gravis - Activities of Daily Living (MG- ADL) Scale Score
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Adults of:18 years of age at the time of signing the informed consent.
- •Diagnosis of Myasthenia Gravis with generalized muscle weakness, meeting clinical criteria for Myasthenia Gravis Foundation of America Class II to !Va classification.
- •In participants positive for Acetylcholine receptor antibody (anti- AChR) or muscle-specific kinase antibody(anti-MuSK)
- •In participants that are autoantibody seronegative and participants who are positive for anti-low-density lipoprotein receptor- related protein 4 antibodies (anti-LRP4)
- •Has a Screening and Baseline MG-ADL score more than or equal to (>=) 6 with at least 50 percentage(%) of the total score due to non- ocular symptoms
- •If treated with oral corticosteroids: should be on a stable daily dose for at least 4 weeks before randomization. In such case, the daily dose of oral steroids should not exceed 20 milligrams(mg)/day for prednisone/ prednisolone or 16 mg/day for methylprednisolone
- •If treated with acetylcholinesterase inhibitor should be on a stable daily dose for at least 4 weeks before randomization
- •Have a body weight >= 40 kilograms
- •Other protocol defined inclusion criteria could apply
排除标准
- •Immunologic disorder other than MG or any other condition requiring chronic oral, intravenous, intramuscular, or intraarticular corticosteroid therapy. Well-controlled thyroid disease, as per the Treating Investigator or the participants regular treating physician recorded in the source documents, is not exclusionary
- •Molecularly characterized or suspected congenital myasthenic
- •syndrome, Lambert-Eaton myasthenic syndrome, inherited myopathy, muscular dystrophy, acquired myopathy or any other neurologic or systematic disease that mimics MG muscular weakness
- •Active, clinically significant viral, bacterial, or fungal infection, including brain MRI findings consistent with signs of infection such as PML, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks before or during Screening, or completion of oral antiinfectives within 2 weeks before or during Screening, or a history of recurrent infections (i.e. 3 or more of the same type of infection in a 12-month rolling period). Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled would not be exclusionary.
- •Has a history of or current diagnosis of active tuberculosis (TB)
- •Active malignancy, or history of cancer
- •Treatment with nonsteroidal immunosuppressants, used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus within 4 weeks prior to randomization
- •Treatment with eculizumab, rozanolixizumab efgartigimod, ravulizumab, or zilucoplan within 8 weeks prior to randomization
- •History of thymectomy within 6 months prior to Screening.
- •History of generalized seizures (except for history of infantile febrile seizures).
- •Negative for Varicella Zoster Virus antibodies at screening.
- •Other protocol defined exclusion criteria could apply
结局指标
主要结局
Change from Baseline in Myasthenia Gravis - Activities of Daily Living (MG- ADL) Scale Score
时间窗: Week 24
Change from baseline in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) scale score during the Double-Blind Placebo Controlled (DBPC) period
次要结局
未报告次要终点
研究者
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