Clareo Health | Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alexion Pharmaceuticals, Inc.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of gMG confirmed by a positive serologic test for anti-AChR antibodies (Abs) obtained at Screening and/or during Screening Period
Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to Class IV at Screening
Participants receiving treatment must be on a stable dosing regimen of adequate duration prior to Screening and during the Screening Period.
Eculizumab-experienced participants must have been enrolled and treated with eculizumab in Study ECU-MG-303 for at least 6 months (180 days) and must have been on a stable dose for ≥ 2 months (60 days) prior to Screening.
All participants must be vaccinated against meningococcal infection
You may not be if
Medical Conditions
Any untreated thymic malignancy, carcinoma, or thymoma.
Participants with a history of treated benign thymoma
History of thymectomy, thymomectomy, or any thymic surgery within the 12 months prior to Screening
History of N meningitidis infection
Known to be human immunodeficiency virus (HIV) positive
History of unexplained infections
Known or suspected history of drug or alcohol abuse or dependence within 1 year prior to the start of the Screening Period
