EUCTR2021-001229-26-DE进行中（未招募）1 期
A Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants with Generalized Myasthenia Gravis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Key Inclusion Criteria:
- •Diagnosed with MG at least 3 months (90 days) prior to the date of the Screening Visit.
- •Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at the Screening Visit.
- •MG-ADL total score must be = 5 (with at least 50% of the score attributed to non-ocular elements) at the Screening Visit and at randomization (Day 1).
- •Participants receiving treatment with protocol-specified immunosuppressive therapies, corticosteroids, or acetylcholinesterase inhibitors must have been receiving treatment and on a stable dose prior to the date of the Screening Visit, with no changes to the regimen expected during screening, the PEP, and/or the ETP.
- •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 20
排除标准
- •Key Exclusion Criteria:
- •Estimated glomerular filtration rate = 30 milliliters/minute/1.73 squared meters during Screening calculated by Chronic Kidney Disease Epidemiology Collaboration.
- •History of thymectomy, thymomectomy, or any other thymic surgery within 12 months prior to the Screening Visit.
- •Any untreated thymic malignancy, carcinoma, or thymoma. Participants with a history of treated thymic malignancy or carcinoma are eligible for enrollment if they meet pre-specified conditions outlined in the protocol.
- •Clinical features consistent with Clinical Deterioration at the time of the Screening Visit or at any time during the Screening Period prior to randomization (Day 1).
- •Use of the following within the time periods specified below:
- •a. Intravenous immunoglobulin G or subcutaneous immunoglobulin within the 4 weeks (28 days) prior to the Screening Visit.
- •b. Use of tacrolimus or cyclosporine within the 4 weeks (28 days) prior to the Screening Visit.
研究者
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