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NCT Number: NCT07596901

Study of Aritinercept in Patients With Generalized Myasthenia Gravis

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.

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Key information

Conditions

Myasthenia Gravis, Generalized Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Myasthenia Gravis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Aurinia Investigational Site, Altamonte Springs, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aritinercept

Drug

For subcutaneous injection

Placebo

Other

For subcutaneous injection

Primary outcomes

  1. 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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Aurinia Clinical Trials Information

CONTACT

[email protected]

833-606-5975

Sponsors and collaborators

Lead sponsor

Aurinia Pharmaceuticals Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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