A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety and Efficacy of Aritinercept, a Dual BAFF/APRIL Inhibitor, in Patients With Generalized Myasthenia Gravis
Aurinia Pharmaceuticals Inc.
Summary
This clinical study will enroll patients with generalized myasthenia gravis (gMG). The goal of this clinical study is to assess the safety, tolerability, effectiveness, pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug affects the body) of aritinercept.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Adult patients (18-85 years old) * Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG * Additional inclusion criteria are defined in the protocol Key Exclusion Criteria: * Current or medical history of malignancy within the last 5 years * Pregnant, breastfeeding or intending to become pregnant during the Study * Additional exclusion criteria are defined in the protocol
Interventions
- DrugAritinercept
For subcutaneous injection
- OtherPlacebo
For subcutaneous injection
Locations (3)
- Aurinia Investigational SiteAltamonte Springs, Florida
- Aurinia Investigational SiteBoca Raton, Florida
- Aurinia Investigational SiteMiami, Florida