Aritinercept for Myasthenia Gravis

Recruiting at 2 trial locations

Overseen By Aurinia Clinical Trials Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Aurinia Pharmaceuticals Inc.

Disqualifiers: Malignancy, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

81 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called aritinercept for individuals with generalized myasthenia gravis (gMG), a condition that causes muscle weakness. The main goal is to assess the safety and effectiveness of aritinercept, as well as how the body processes and responds to it. Participants will receive injections of either aritinercept or a placebo (an inactive substance). Individuals with moderate to severe gMG who regularly experience muscle weakness might be suitable for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that aritinercept is likely to be safe for humans?

Research has shown that aritinercept is usually well-tolerated by patients. A previous study found that aritinercept did not cause any severe side effects related to the treatment, even at different dose levels. The absence of major serious side effects suggests that the drug is relatively safe based on current information. However, side effects can vary from person to person, so individual experiences may differ. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for myasthenia gravis, like pyridostigmine or corticosteroids, focus on managing symptoms by boosting communication between nerves and muscles or suppressing the immune system. But Aritinercept works differently, targeting specific immune pathways to prevent the immune system from attacking healthy muscle tissues. This unique mechanism of action could potentially offer more effective control of symptoms with fewer side effects. Additionally, Aritinercept is administered via subcutaneous injection, which might be more convenient for patients compared to some current therapies that require more frequent dosing or hospital visits. Researchers are excited about Aritinercept because it represents a promising new direction in treating myasthenia gravis with hopes for better patient outcomes.

What evidence suggests that aritinercept might be an effective treatment for myasthenia gravis?

Research has shown that aritinercept might help treat generalized myasthenia gravis (gMG). In earlier studies, even a single dose significantly and lastingly reduced certain proteins called antibodies. In gMG, these antibodies mistakenly attack the body's own cells. Reducing them could help ease muscle weakness, a main symptom of gMG. Although detailed information from human studies remains limited, these early results are promising and suggest that aritinercept could be beneficial in managing the condition. During the trial, participants will receive either aritinercept or a placebo in the double-blind treatment period, followed by aritinercept in the open-label treatment period. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with generalized myasthenia gravis (gMG). Participants should have symptoms of gMG and meet specific medical criteria set by the study team. People with other serious health issues or certain previous treatments may not be eligible.

Inclusion Criteria

I have moderate to severe generalized myasthenia gravis.

Additional inclusion criteria are defined in the protocol

I am between 18 and 85 years old.

Exclusion Criteria

I have had cancer within the past 5 years.

Pregnant, breastfeeding or intending to become pregnant during the Study

Additional exclusion criteria are defined in the protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-Blind Treatment

Participants receive either aritinercept or placebo by subcutaneous injection

12 weeks

Open-Label Treatment

All participants receive aritinercept by subcutaneous injection

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aritinercept

Trial Overview

The study compares a new drug called aritinercept to a placebo (inactive treatment) in people with generalized myasthenia gravis, to see how safe and effective aritinercept is. Participants are randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

Group I: Aritinercept Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Aurinia Pharmaceuticals Inc.

Lead Sponsor

Trials

18

Recruited

3,700+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07596901?aggFilters=status%3A

Study of Aritinercept in Patients With Generalized ...

This clinical study will enroll patients with generalized myasthenia gravis (gMG). The goal of this clinical study is to assess the safety, tolerability, ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11846739/

Myasthenia gravis in 2025: five new things and four hopes for ...

Ng WC, Hartley L (2021) Effectiveness of thymectomy in juvenile myasthenia gravis and clinical characteristics associated with better outcomes.

3.

auriniapharma.com

auriniapharma.com/press-releases/aurinia-announces-positive-results-from-phase-1-study-of-aritinercept-aur200

Aurinia Announces Positive Results from Phase 1 Study of ...

Single doses of aritinercept led to robust and long-lasting reductions in immunoglobulins (antibodies). Specifically, mean reductions from ...

4.

ctv.veeva.com

ctv.veeva.com/study/study-of-aritinercept-in-patients-with-generalized-myasthenia-gravis

Study of Aritinercept in Patients With Generalized Myasthenia ...

The goal of this clinical study is to assess the safety, tolerability, effectiveness, pharmacokinetics (how the body processes the drug) and ...

5.

synapse.patsnap.com

synapse.patsnap.com/drug/3d2aae4bf9da4b85b924cb387f46760c

Aritinercept - Drug Targets, Indications, Patents

... Myasthenia Gravis, Active Org.: Aurinia Pharmaceuticals, Inc ... Related. 100 Clinical Results associated with Aritinercept. Login to view more data. 100 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11923026/

the randomized open-label extension MG0004 study - PMC

There are limited data on the safety of rozanolixizumab in patients with short intervals between treatment cycles; a pooled analysis of efficacy ...

7.

auriniapharma.com

auriniapharma.com/science/aritinercept

Aritinercept | Aurinia Pharmaceuticals Inc. (AUPH)

Aritinercept SAD Study: Safety Summary. Aritinercept was well tolerated at all dose levels tested. There were no treatment-related Grade ≥3 adverse events ...