A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults with Generalized Myasthenia Gravis.
Phase 3
- Conditions
- Myasthenia Gravismuscle weakness100038161002830210029317
- Registration Number
- NL-OMON56009
- Lead Sponsor
- Alexion Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 3
Inclusion Criteria
- Must be >= 18 years of age at the time of signing the informed consent
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method