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
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.
Arms & interventions
- DrugAritinercept
For subcutaneous injection
- OtherPlacebo
For subcutaneous injection
Outcome measures
Primary
To assess the safety and tolerability of aritinercept: Incidence of treatment-emergent adverse events
Time frame: Baseline to study completion, up to 73 weeks
Secondary
To assess the efficacy of aritinercept: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score
Time frame: Baseline to 16 weeks
Eligibility criteria
Study locations (3)
Aurinia Investigational Site
Altamonte Springs, Florida, 32714
Aurinia Investigational Site
Boca Raton, Florida, 33487
Aurinia Investigational Site
Miami, Florida, 33173