Recruiting

Phase 1

Phase 2

AritinerceptStudy of Aritinercept in Patients With Generalized Myasthenia Gravis

Sponsor:

Aurinia Pharmaceuticals Inc.

Code:

NCT07596901

Conditions

Myasthenia Gravis, Generalized

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Aritinercept

Placebo

Study Details

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.

Conditions

Myasthenia Gravis, Generalized

Study ID

NCT07596901

Start date

Apr 22, 2026

Status verified date

Jul, 2026

Completion date

Mar 2, 2029

Anticipated

Primary completion date

Mar 2, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

81 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Aritinercept

Double-Blind Treatment Period: Aritinercept by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection

placebo comparator: Placebo

Double-Blind Treatment Period: Placebo by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection

Interventions

Aritinercept

For subcutaneous injection

Placebo

For subcutaneous injection

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Locations

Aurinia Investigational Site

Recruiting

Pasadena, California, United States, 91106

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Aurinia Investigational Site

Recruiting

Altamonte Springs, Florida, United States, 32714

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Aurinia Investigational Site

Recruiting

Boca Raton, Florida, United States, 33487

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Aurinia Investigational Site

Recruiting

Homestead, Florida, United States, 33033

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Aurinia Investigational Site

Recruiting

Miami, Florida, United States, 33155

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Aurinia Investigational Site

Recruiting

Miami, Florida, United States, 33173

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Aurinia Investigational Site

Recruiting

Chicago, Illinois, United States, 60616

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Aurinia Investigational Site

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Aurinia Investigational Site

Recruiting

Dearborn, Michigan, United States, 48126

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Aurinia Investigational Site

Recruiting

Flint, Michigan, United States, 48507

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

Aurinia Investigational Site

Recruiting

Houston, Texas, United States, 77027

Contacts

Aurinia Clinical Trials Information

833-606-5975 clinicaltrials@auriniapharma.com

More Information

Sponsor

Aurinia Pharmaceuticals Inc.

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

aritinercept

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Aurinia Pharmaceuticals Inc. on 2026-08-03.