EUCTR2021-001229-26-IT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 withGeneralized Myasthenia Gravis -
ALEXION PHARMACEUTICALS INCORPORATED0 个研究点目标入组 70 人开始时间: 2021年10月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
相似试验
招募中
1 期
A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid ArthritisModerate to Severe Rheumatoid ArthritisMedDRA version: 20.0Level: HLTClassification code: 10039075Term: Rheumatoid arthritis and associated conditions Class: 10021428MedDRA version: 23.1Level: PTClassification code: 10039073Term: Rheumatoid arthritis Class: 100000004859CTIS2023-504564-42-00Anaptysbio Inc.420
进行中（未招募）
1 期
A Phase 2, Randomized, Double Blind, Placebo Controlled, Dose Escalation Study to Assess the Safety and Effects of Intravenous Conivaptan on the Hepatic Hemodynamic Response in Stable Euvolemic or Hypervolemic Cirrhotic PatientsEstudio fase II, randomizado, doble ciego, controlado con placebo, de escalonamiento de dosis para evaluar la seguridad y los efectos de Conivaptan intravenoso sobre la respuesta hemodinámica hepática en pacientes cirróticos euvolémicos o hipervolémicos estables.stable euvolemic or hypervolemic cirrhotic patients with serum sodium 115 – 140 mEq/LPacientes cirróticos euvolémicos o hipervolémicos estables con un valor de sodio sérico comprendido entre 115 y 140 mEq/LMedDRA version: 9.1Level: PTClassification code 10019641Term: Hepatic cirrhosisMedDRA version: 9.1Level: LLTClassification code 10021038Term: HyponatremiaEUCTR2007-001661-15-ESAstellas Pharma US, Inc20
进行中（未招募）
1 期
A Multinational Study to Evaluate the Safety and Activity of Enzalutamide in Combination With Exemestane in Women With Hormone-Positive Breast Cancer That Is Normal for HER-2MedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Breast CancerEUCTR2013-002717-35-ESMedivation, Inc.240
进行中（未招募）
1 期
Phase 2 Study of ALXN2050 in Adult Participants with Generalized Myasthenia GravisMedDRA version: 21.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disordersMyasthenia GravisEUCTR2021-001229-26-DEAlexion Pharmaceuticals70
进行中（未招募）
1 期
A Multinational Study to Evaluate the Safety and Activity of Enzalutamide in Combination With Exemestane in Women With Hormone-Positive Breast Cancer That Is Normal for HER-2MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Breast CancerEUCTR2013-002717-35-GBMedivation, Inc.240