Study of Aritinercept in Patients With Generalized Myasthenia Gravis

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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07596901

Enrollment

Registered

2026-05-19

Start date

2026-04-22

Completion date

2029-03-02

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia Gravis, Generalized

Keywords

aritinercept

Brief summary

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

DRUGAritinercept

For subcutaneous injection

OTHERPlacebo

For subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of aritinercept: Incidence of treatment-emergent adverse events	Baseline to study completion, up to 73 weeks

Secondary

Measure	Time frame
To assess the efficacy of aritinercept: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score	Baseline to 16 weeks

Countries

United States

Contacts

CONTACTAurinia Clinical Trials Information

clinicaltrials@auriniapharma.com833-606-5975

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026