EUCTR2017-000323-27-NL进行中（未招募）1 期
A Multi-center, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Myasthenia Gravis Active Targeted Immunotherapy CV-MG01 in Patients with Moderate to Severe Myasthenia Gravis - Myasterix Efficacy Phase 2/3 Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
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
- •[1] Male or female Patient, with generalised myasthenia gravis (Grades 2, 3 and 4a) as per myasthenia gravis foundation of America (MGFA)
- •classification system.
- •[2] Quantitative Myasthenia Gravis (QMG) score of 10 or greater at screening and baseline.
- •[3] Age of minimum 18, at the time of the consent form signature.
- •[4] Patient with documented positive antibodies to AChR in one of the available validated laboratory test.
- •[5] Patient may use corticosteroid treatment initiated for at least 3 months before screening, equivalent to a daily dose of 30mg prednisone
- •as maximum, and stable (+/- 5mg change) at least 1 month before the screening and up to the first injection.
- •[6] Patient may use one or two immunosuppressive drugs (initiated for a least 6 months) with or without concomitant use of corticosteroid,
- •providing that the dosage has been stable/unchanged for 3 months before the screening and up to the first injection..
- •[7] Venous access sufficient to allow blood sampling as per the protocol.
- •[8] Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- •[9] Have given written informed consent approved by the relevant Ethics Committee (EC) governing the site.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •[10] MG patients of Grade 5 based on myasthenia gravis foundation of America (MGFA) classification.
- •[11] Patients with history or presence of a primary or recurrent malignant disease including the presence or history of a thymoma.
- •[12] Thymectomy planned during Part A of the study period or performed within 1 year prior to the first dose of study.
- •[13] Any confirmed or suspected immunosuppressive or immunodeficient condition not related to the treatment of MG, including
- •human immunodeficiency virus (HIV) infection, or a family history of congenital or hereditary immunodeficiency.
- •[14] History or evidence of administration of immunoglobulins and/or any blood products within 3 months prior to the first dose of study drug,
- •or a planned administration of immunoglobulins during the first 3 months of the study.
- •[15] History or evidence of rituximab treatment within 6 months prior to first dose of study.
- •[16] History or evidence of plasmapheresis within 3 months prior to the first dose of study, or a planned plasmapheresis during the first 3
- •months of the study.
- •[17] At high risk for aspiration.
- •[18] Pulmonary: forced vital capacity reduced to less than 70% of predicted capacity.
- •[19] History of severe allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •[20] History or evidence of Lambert-Eaton myasthenic syndrome, druginduced myasthenia gravis, hereditary forms of myasthenic syndrome.
- •[21] History of relevant chronic degenerative, psychiatric, or neurological disorder other than MG.
- •[22] Severe hepatic, renal or cardiac insufficiency or uncontrolled hypertension
- •[23] Major congenital defects or serious chronic illness other than MG.
- •[24] Positive pregnancy test or desire to become pregnant during the study.
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the efficacy of CV-MG01 (Myasterix) in Myasthenia GravisMyasthenia Gravis (MG) is a chronic neuromuscular disorder characterized by weakness and fatigability of skeletal muscles.The underlying defect is a decrease in the number of available acetylcholine receptors (AChRs) at neuromuscular junctions due to an antibody-mediated autoimmune attack.MedDRA version: 19.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2017-000323-27-BECuraVac Europe SA66
进行中（未招募）
1 期
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s DiseaseEUCTR2009-013670-41-FRSynosia Therapeutics AG126
进行中（未招募）
不适用
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s DiseaseParkinson´s disease inadequately controlled on a stable regimen of anti-Parkinsonian medications.MedDRA version: 12.0Level: LLTClassification code 10013113Term: Disease Parkinson'sEUCTR2009-013670-41-CZSynosia Therapeutics AG126
进行中（未招募）
不适用
A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. - NDParkinson's Desease patients with Motor Fluctuations who are on optimised and stabilised therapy with Levodopa.MedDRA version: 6.1Level: PTClassification code 10061536EUCTR2005-004314-33-ITEISAI LTD UK900
进行中（未招募）
不适用
A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuationsevodopa treated Parkinson's disease patients with motor fluctuationsMedDRA version: 8.1Classification code 10061536EUCTR2005-004314-33-DEEisai Limited1,260