Study of Aritinercept in Patients With Generalized Myasthenia Gravis

May 13, 2026 updated by: Aurinia Pharmaceuticals Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

81

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Altamonte Springs, Florida, United States, 32714
      • Boca Raton, Florida, United States, 33487
      • Miami, Florida, United States, 33173

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aritinercept
Double-Blind Treatment Period: Aritinercept by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection
Drug: Aritinercept
For subcutaneous injection
Placebo Comparator: Placebo
Double-Blind Treatment Period: Placebo by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection
Drug: Aritinercept
For subcutaneous injection
Other: Placebo
For subcutaneous injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurinia Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2026

Primary Completion (Estimated)

March 2, 2029

Study Completion (Estimated)

March 2, 2029

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUR-200-2024-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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