Study of Aritinercept in Patients With Generalized Myasthenia Gravis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aritinercept, Placebo.
- Who it may be relevant to
- Registry conditions: Myasthenia Gravis, Generalized. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug Aritinercept
For subcutaneous injection - Other Placebo
For subcutaneous injection
Primary outcome measures
- 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 outcome measures (1)
- 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
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 11 centers
- Aurinia Investigational Site — Pasadena
- Aurinia Investigational Site — Altamonte Springs
- Aurinia Investigational Site — Boca Raton
- Aurinia Investigational Site — Homestead
- Aurinia Investigational Site — Miami
- Aurinia Investigational Site — Miami
- Aurinia Investigational Site — Chicago
- Aurinia Investigational Site — O'Fallon
- … and 3 more centers
Identifiers
NCT: NCT07596901 · AUR-200-2024-02