Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Generalized Myasthenia Gravis
Спонсор: Alexion Pharmaceuticals, Inc.
Налично на:
БГ
Обобщение
The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR).
Кой може да участва
Inclusion Criteria:
* Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV
* Positive serological test for autoantibodies against AChR
Exclusion Criteria:
* History of thymectomy, or any other thymic surgery within 12 months prior to Screening
* Untreated thymic malignancy, carcinoma, or thymoma
* History of Neisseria meningitidis infection
* Pregnancy, breastfeeding, or intention to conceive during the course of the study