Clinical trial Recruiting at 11 sites Phase1; Phase2 Interventional Ages 18 to 85

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

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment81 (estimated)
SponsorAurinia Pharmaceuticals Inc.
Industry-sponsored
Locations11 sites (Pasadena, California and 10 other locations)
StatusRecruiting
StartedApril 22, 2026
Main results expectedMarch 2, 2029
Study endsMarch 2, 2029
Registry record updatedAugust 3, 2026
Trial IDNCT07596901 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.