Aritinercept for generalized myasthenia gravis
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
Run by Aurinia Pharmaceuticals Inc. · NCT07596901 · Data updated 2026-11-12
This study tests whether aritinercept is safe and helpful for adults with generalized myasthenia gravis compared with placebo.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 81 (estimated) |
| Sponsor | Aurinia Pharmaceuticals Inc. Industry-sponsored |
| Locations | 11 sites (Pasadena, California and 10 other locations) |
| Status | Recruiting |
| Started | April 22, 2026 |
| Main results expected | March 2, 2029 |
| Study ends | March 2, 2029 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT07596901 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-85 with MGFA class II–IV generalized myasthenia gravis who meet protocol criteria.
✕Probably not a fit
Patients with recent malignancy, pregnancy, or those not meeting protocol criteria may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study will enroll adults with generalized myasthenia gravis (MGFA class II-IV) to evaluate aritinercept versus placebo. It will assess safety, tolerability, and how the drug is processed by the body, as well as its effects on the illness. The trial includes phase 1 and phase 2 components to explore initial safety signals and potential effectiveness in a controlled setting. Participants will receive either aritinercept or placebo at investigational sites in California and Florida under defined inclusion and exclusion criteria. Primary goals are to determine tolerability and pharmacokinetic/pharmacodynamic profiles, with secondary aims related to clinical efficacy.
Why it matters
Potential benefit: If successful, aritinercept could offer improved symptom control for adults with generalized myasthenia gravis.
How similar studies have gone: Similar biologic approaches in MG have shown signals of safety and potential efficacy in early-phase trials, but this exact agent is under investigation in this study.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Aurinia Investigational Site
Pasadena, California, United States Recruiting -
Aurinia Investigational Site
Altamonte Springs, Florida, United States Recruiting -
Aurinia Investigational Site
Boca Raton, Florida, United States Recruiting -
Aurinia Investigational Site
Homestead, Florida, United States Recruiting -
Aurinia Investigational Site
Miami, Florida, United States Recruiting -
Aurinia Investigational Site
Miami, Florida, United States Recruiting
Show 5 more locations
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Aurinia Investigational Site
Chicago, Illinois, United States Recruiting -
Aurinia Investigational Site
O'Fallon, Illinois, United States Recruiting -
Aurinia Investigational Site
Dearborn, Michigan, United States Recruiting -
Aurinia Investigational Site
Flint, Michigan, United States Recruiting -
Aurinia Investigational Site
Houston, Texas, United States Recruiting
Study contacts
- Study coordinator: Aurinia Clinical Trials Information
- Email: clinicaltrials@auriniapharma.com
- Phone: 833-606-5975
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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MG patient registry to track long-term experiences and treatment patterns
This registry collects information from adults with myasthenia gravis to see how symptoms and quality of life change over time and how treatments relate to those changes.
-
Panorama: Neuromuscular Organoids to understand refractory AChR+ myasthenia gravis
This study tests neuromuscular organoids built from stem cells to see if they reveal why some people with AChR-positive myasthenia gravis don’t respond to standard treatments.
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Claseprubart in adults with generalized myasthenia gravis
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MyoSense 360 in generalized myasthenia gravis: testing digital monitoring to track change
This study tests whether a digital monitoring system can detect meaningful changes in generalized myasthenia gravis over a year in adult patients using a smartphone app and wearable device.
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Corticosteroid-sparing efgartigimod for elderly AChR-positive generalized myasthenia gravis
This trial tests whether efgartigimod given IV or under the skin helps people 65 and older with AChR-positive generalized myasthenia gravis reduce their corticosteroid dose while keeping symptoms under control.
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Observational study on ravulizumab for generalized myasthenia gravis
This study is looking at how well ravulizumab works for people with generalized myasthenia gravis over three years to see how it helps their health.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.