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
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Adult patients (18-85 years old)
• Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG
• Additional inclusion criteria are defined in the protocol
Locations
United States
Florida
Aurinia Investigational Site
RECRUITING
Altamonte Springs
Aurinia Investigational Site
RECRUITING
Boca Raton
Aurinia Investigational Site
RECRUITING
Miami
Contact Information
Primary
Aurinia Clinical Trials Information
clinicaltrials@auriniapharma.com
833-606-5975
Time Frame
Start Date: 2026-04-22
Estimated Completion Date: 2029-03-02
Participants
Target number of participants: 81
Treatments
Experimental: Aritinercept
Double-Blind Treatment Period: Aritinercept by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection
Placebo_comparator: Placebo
Double-Blind Treatment Period: Placebo by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection
Related Therapeutic Areas
Sponsors
Leads: Aurinia Pharmaceuticals Inc.