Actively Recruiting
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
Led by Aurinia Pharmaceuticals Inc. · Updated on 2026-05-19
81
Participants Needed
3
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying aritinercept in adults with generalized myasthenia gravis (gMG) to assess its safety, tolerability, how the body processes and responds to the drug, and its effectiveness. This study is a Phase 1 and Phase 2 clinical trial conducted by Aurinia Pharmaceuticals Inc. It is designed as a randomized, double-blind, placebo-controlled trial to evaluate aritinercept, a dual BAFF/APRIL inhibitor, in this patient group. Participants will be randomly assigned to receive aritinercept or a placebo through subcutaneous injections during the double-blind treatment period. Afterward, all participants will enter an open-label period where they will receive aritinercept injections. This approach allows researchers to compare the effects of the drug with placebo and then observe responses when all receive the active treatment. Throughout the study, which can last up to 73 weeks, participants will be closely monitored for treatment-emergent adverse events to evaluate safety and tolerability. Researchers will also assess changes in the Myasthenia Gravis Activities of Daily Living (MG-ADL) total score over 16 weeks to evaluate the drug's impact on daily functioning. Regular assessments and evaluations will help ensure participant safety while measuring the study's outcomes.
CONDITIONS
Brief Title
Study of Aritinercept in Patients With Generalized Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 to 85 years
- Diagnosis of generalized myasthenia gravis classified as Myasthenia Gravis Foundation of America (MGFA) Class II-IV
- Additional inclusion criteria as defined in the study protocol
You will not qualify if you...
- Current or history of cancer within the last 5 years
- Pregnant, breastfeeding, or planning to become pregnant during the study
- Additional exclusion criteria as defined in the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 73 weeks
Participants receive aritinercept or placebo by subcutaneous injection in a double-blind manner followed by open-label aritinercept treatment.
Visits occur regularly during the treatment period as per study schedule
Trial Site Locations
Total: 3 locations
1
Aurinia Investigational Site
Altamonte Springs, Florida, United States, 32714
Actively Recruiting
2
Aurinia Investigational Site
Boca Raton, Florida, United States, 33487
Actively Recruiting
3
Aurinia Investigational Site
Miami, Florida, United States, 33173
Actively Recruiting
Research Team
A
Aurinia Clinical Trials Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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