A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis

Alexion Pharmaceuticals Incorporated0 个研究点目标入组 160 人开始时间: 2019年9月13日最近更新: 2020年2月1日

适应症

试验速览

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•Male and female patients = 18 years of age
•Diagnosed with MG at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by protocol-specific criteria
•Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening
•MG-ADL profile must be = 6 at screening and randomization (Day 1)
•Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug to reduce the risk of meningococcal infection (N meningitidis).
•Body weight = 40 kg at the time of screening
•Patients of childbearing potential and patients with partners of childbearing potential must follow protocol-specified contraception guidance for avoiding pregnancy while on treatment and for 8 months after last dose of study drug
•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 144
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 16

•Medical Conditions:
•Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for = 5 years before Screening
•History of thymectomy, thymomectomy, or any thymic surgery within the 12 months prior to screening
•History of N meningitidis infection
•Human immunodeficiency virus (HIV) infection
•History of hospitalization for = 24 hours, for any reason, within the 4 weeks (28 days) prior to screening
•Females who plan to become pregnant during the study, or are currently pregnant or breastfeeding, or who have a positive pregnancy test result at screening or on Day 1
•History of unexplained infections
•Active systemic bacterial, viral, or fungal infection within 14 days prior
•to study drug administration on Day 1
•Presence of fever = 38°C (100.4°F) within 7 days prior to study drug
•administration on Day 1
•Prior/Concomitant Therapy
•Use of the following within the time period specified below:
•- IVIg within the 4 weeks (28 days) prior to randomization (Day 1)
•- Use of PE within the 4 weeks (28 days) prior to randomization (Day 1)
•- Use of rituximab within the 6 months (180 days) prior to screening
•Patients who have received previous treatment with complement-inhibitors (eg, eculizumab)

发起方

Alexion Pharmaceuticals Incorporated