EUCTR2020-004436-21-ES进行中（未招募）1 期
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS
Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd0 个研究点目标入组 240 人开始时间: 2021年9月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age >=12 years at time of signing Informed Consent Form
- •Confirmed diagnosis of gMG
- •MGFA class II, III or IV at screening
- •A total MG-ADL score of >=5 points at screening with more than 50% of this score attributed to non-ocular items
- •Ongoing gMG treatment at a stable dose
- •For female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 208
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •Exclusion Criteria Related to Myasthenia Gravis (MG):
- •History of thymic cysts, thymoma, thymic carcinoma or other neoplasm of the thymus as defined by the 2015 WHO classification of tumors of the thymus unless deemed cured by adequate treatment with no evidence of recurrence for >=5 years before screening
- •History of thymectomy within 12 months prior to screening
- •Ocular MG (Myasthenia Gravis Foundation of America [MGFA] Class I)
- •Myasthenic crisis within the last 3 months prior to screening (MGFA Class V)
- •Known disease other than gMG that would interfere with the course and conduct of the study
- •Exclusion Criteria Related to Previous or Concomitant Therapy:
- •Use of IVIg within 8 weeks prior to randomization (Day 1)
- •Use of PE within 8 weeks prior to randomization (Day 1)
- •Treatment with IL-6 inhibitory therapy (e.g., tocilizumab) at any time,
- •Treatment with total body irradiation, or bone marrow transplantation at any time
- •Treatment with B and/or T cell-depleting agents
- •For patients with prior exposure to anti-CD20 agents, CD19 counts below the normal range, as assessed by the central laboratory at screening, or <6 months since last anti-CD20 treatment till screening
- •Treatment with eculizumab within 6 months prior to screening
- •Treatment with neonatal Fc receptor antagonists, or anti-B-lymphocyte stimulator monoclonal antibody at any time
- •Treatment with cyclophosphamide IV within 6 months prior to screening
- •Treatment with oral cyclophosphamide at any time
- •Treatment with methotrexate within 8 weeks prior to screening
- •Treatment with any investigational agent within 24 weeks prior to screening or 5 drug-elimination half-lives of the investigational drug (whichever is longer)
- •Use of more than one IST as background therapy except for the combination of an oral corticosteroids (OCS) with another permitted IST drug
- •General Safety Exclusion Criteria:
- •Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline
- •Planned surgical procedure (except minor surgeries) during the study
- •Evidence of progressive multifocal leukoencephalopathy
- •Evidence of serious uncontrolled concomitant diseases that may preclude patient participation
- •Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection
- •Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection, excluding fungal infection of nail beds or dental caries
- •Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to baseline visit or oral anti-infective agents within 2 weeks prior to baseline visit
- •Positive screening tests for hepatitis B and C
- •History of drug or alcohol abuse within 1 year prior to baseline
- •History of diverticulitis or concurrent severe gastrointestinal (GI) disorders that, in the investigator’s opinion, may lead to increased risk of complications such as GI perforation
- •Evidence of latent or active tuberculosis
- •Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
- •History of blood donation (1 unit or more), plasma donation or platelet donation within 90 days prior to screening and Day 1
- •History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma
- •History of severe allergic reaction to a biologic agent
- •Active suicidal ideation within 6 months prior to screening or history of suicide attempt within 3 year
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