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AUR200 for Patients with Generalized Myasthenia Gravis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is being done in people with Generalized Myasthenia Gravis, a long-term disease that causes weakness in the muscles used for movement, breathing, and other body functions. The study is testing AUR200, also called aritinercept, which is given as a subcutaneous injection under the skin. A placebo is also used in the study. The purpose of the study is to see whether aritinercept is safe and whether it helps with this disease.

The study is double-blind and randomized, which means the treatment is assigned by chance and neither the participants nor the study team knows who receives which treatment during the study. The study has two parts. In the first part, the focus is on safety and how well the treatment is tolerated. In the second part, the focus is on whether the treatment helps improve symptoms over time. During the study, blood samples may be taken to look at levels of certain immune proteins, called IgG, IgM, and IgA, and to check for antibodies against the study drug.

Aritinercept is described as a dual BAFF/APRIL inhibitor, meaning it blocks two signals in the immune system that can help immune cells survive and stay active. This may reduce the immune attack that contributes to symptoms in generalized myasthenia gravis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study treatment begins
After you join the study, you start receiving one of two study products by subcutaneous injection, which means an injection under the skin.
The study product is either aritinercept (aur200) or placebo. the placebo is 0.9% sodium chloride solution, which is a salt solution that does not contain the active study medicine.
The study is double-blind, which means that the study product is assigned without you knowing whether you receive aritinercept or placebo.
Step 2
Phase 1: safety and tolerability
During phase 1, your treatment is used to assess the safety of aritinercept and how well it is tolerated. tolerability means how well your body handles the study treatment.
Your condition is monitored for treatment-emergent adverse events, which are unwanted medical problems that start or worsen after treatment begins.
The study product is given by subcutaneous injection. the exact dose, how often it is given, and how long it is given are not stated in the source data.
Step 3
Phase 2: effect on generalized myasthenia gravis
During phase 2, your treatment is used to assess how well aritinercept works for generalized myasthenia gravis, a disease that causes weakness in muscles throughout the body.
Your muscle-related daily functioning is measured with the myasthenia gravis activities of daily living (mg-adl) total score. this is a score that shows how much the condition affects everyday tasks.
The study product continues to be given by subcutaneous injection. the exact dose, how often it is given, and how long it is given are not stated in the source data.
Step 4
Blood testing during the study
During the trial, blood tests are used to measure aritinercept serum concentrations over time. serum is the liquid part of the blood, and this test shows how much study medicine is present in your blood at different times.
Blood tests are also used to measure changes from the starting level in igg, igm, and iga. these are types of antibodies, which are proteins in the blood that help the body respond to infection.
The study also checks for anti-drug antibodies, which are antibodies your body may make against the study medicine.
Step 5
Trial period
The study is planned to run from 2026-05-12 to 2028-10-31.

Who can join the trial?

15 criteria

Be able and willing to sign the informed consent form (ICF), which means agreeing to join the study after the study has been explained.
Be a male or female and be 18 to 70 years old on the day the informed consent form is signed.
Have a body mass index (BMI) between 18.0 and 36.0 kg/m², and weigh more than 45 kg. BMI is a measure that compares weight and height.
Have Myasthenia Gravis Foundation of America (MGFA) Class II to IV generalized myasthenia gravis, confirmed by at least one of these: a test showing abnormal communication between nerves and muscles, a positive edrophonium chloride test, or improvement in symptoms with oral acetylcholinesterase inhibitors as judged by the doctor. Acetylcholinesterase inhibitors are medicines that help nerve and muscle signals work better.
Have a documented history of anti-AChR, anti-MuSK, or anti-LRP4 antibodies. Antibodies are proteins made by the immune system; these specific antibodies are linked to the condition being studied.
Have a total Myasthenia Gravis Activities of Daily Living (MG-ADL) score of 6 or higher at screening, and more than half of the score must come from non-ocular symptoms (symptoms not related to the eyes).
If taking acetylcholinesterase inhibitors, the dose must have been stable for at least 2 weeks before screening.
If taking steroids, they must have been used for at least 3 months, with no dose change for at least 1 month before screening.
If taking non-steroidal immunosuppressive therapy (NSIST) such as mycophenolate mofetil (MMF), methotrexate, cyclosporine, tacrolimus, or cyclophosphamide, treatment must have lasted at least 6 months, with no dose change for at least 3 months before screening. These medicines reduce immune system activity.
If taking azathioprine (AZA) or cladribine, treatment must have lasted at least 6 months, with no dose change for at least 2 months before screening.
Have received all age-appropriate vaccinations recommended for people with a weakened immune system, based on the investigator's judgment. An investigator is the study doctor or research team member in charge of the study.
If a woman can become pregnant and is sexually active with a man, she must use an acceptable birth control method from screening until 60 days after the last dose of the study drug. Acceptable methods include certain hormonal methods, an intrauterine device (IUD), an intrauterine hormone-releasing system, tubal ligation, abstinence, or sex with a man who has had a vasectomy confirmed to have worked. In some regions, other methods such as condoms, diaphragm, sponge, or combinations of barrier methods may also be allowed.
If a man has a female partner who can become pregnant, he must use an acceptable birth control method from screening until 150 days after the last dose of the study drug. Acceptable methods include male condoms, abstinence, or a vasectomy with medical proof that it worked. It is also recommended that his female partner use birth control.
Men must agree not to donate sperm during the study and for 150 days after the last dose of the study drug.
Be able and willing to follow all study rules and restrictions.

Who cannot join the trial?

42 criteria

MGFA Class I or Class V myasthenia gravis. MGFA is a doctor’s grading system for how severe the muscle weakness is. Class I means only eye muscles are affected, and Class V means the person needs a breathing tube or breathing support.
Muscle weakness that is getting worse because of a current infection or because of certain medicines, such as aminoglycosides, fluoroquinolones, or beta-blockers. These are medicine groups that can affect muscles or nerve signals.
Another autoimmune disease besides myasthenia gravis, if it could make it hard to judge the study results. Autoimmune disease means the immune system attacks the body’s own tissues.
Use of a B cell-targeted therapy within the required time before screening, including blisibimod, belimumab, inebilizumab, or rituximab within 12 months, or ocrelizumab within 18 months. These are treatments that lower certain immune cells called B cells.
Use of a complement inhibitor within 3 months before screening, such as eculizumab, ravulizumab, or zilucoplan. These medicines block part of the immune system called complement.
Use of an FcRn blocker within 3 months before screening, such as efgartigimod alfa, rozanolixizumab-noli, or nipocalimab. These medicines reduce certain antibodies in the blood.
Received IVIg (immunoglobulin given into a vein), immunoglobulin given under the skin or into a muscle, or plasma exchange within 1 month before screening. Plasma exchange is a procedure that removes and replaces part of the blood plasma.
Had a thymectomy within 3 months before screening or planned to have one during the study. A thymectomy is surgery to remove the thymus gland.
Known or suspected allergy, intolerance, or other reason not to use any part of aritinercept, or a history of a severe allergic reaction to any monoclonal antibody. Monoclonal antibodies are lab-made proteins used as medicines.
Pregnant, breastfeeding, or planning to become pregnant during the study.
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Important electrocardiogram (ECG) problems at screening or on Day 1. An ECG is a test of the heart’s electrical activity. This includes:
- QTcF too long: 450 msec or more for males, or 470 msec or more for females. QTcF is a measurement of the heart’s recovery time between beats.
- AV block of second or third degree. This means the electrical signal in the heart is delayed or blocked.
- Complete left bundle branch block or complete right bundle branch block. These are problems with how the heart’s electrical signal moves.
- Signs of new ischemia. Ischemia means the heart muscle may not be getting enough blood.
- Arrhythmia, which means an abnormal heart rhythm, except for occasional early beats called PACs and PVCs.
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  Important liver or kidney problems, including:
  - ALT more than 2 times the upper limit of normal. ALT is a liver enzyme.
  - AST more than 2 times the upper limit of normal. AST is another liver enzyme.
  - Total bilirubin more than 1.5 times the upper limit of normal, except in people with Gilbert’s syndrome. Bilirubin is a substance made when the body breaks down old red blood cells.
  - Serum creatinine above normal. Creatinine is a blood test that helps show kidney function.
  - A history of hypogammaglobulinemia, or low blood levels of IgG, IgM, or IgA at screening. These are types of antibodies that help fight infection.
  - Uncontrolled diabetes, meaning a hemoglobin A1c level above 7.5%. Hemoglobin A1c is a blood test that shows average blood sugar over the past few months.
  - More than 300 mL of blood drawn within 30 days before screening, or receipt of blood products within 30 days before Day 1. Blood products include transfusions or similar treatments.
  - Recent or ongoing treatment for infection, including:
    
    Current use of medicine to keep a long-term infection under control, such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria.
    Hospital stay for infection treatment within 60 days before screening.
    Use of antibiotics, antiviral medicines, antifungal medicines, or antiparasitic medicines given by vein or muscle within 60 days before screening.
    Recent live vaccination within 28 days before the first dose of study medicine, or a planned live vaccine during the study or within 6 weeks after the last dose. A live vaccine contains a weakened form of a germ.
    A positive COVID-19 test within 7 days before Day 1.
    Previous treatment with aritinercept.
    History of alcohol abuse or abuse of other substances, except caffeine or nicotine, within 1 year before screening.
    Current or past conditions that could affect safety or study results, including:
    
    Congenital or acquired immunodeficiency. Immunodeficiency means the immune system does not work normally.
    Demyelinating disease, such as multiple sclerosis, optic neuritis, transverse myelitis, or demyelinating polyneuropathy. Demyelinating disease means damage to the protective covering of nerves.
    Malignancy within 5 years before screening, except some cancers that were treated and considered cured with at least 2 years without return.
    Lymphoproliferative disease or previous total lymphoid irradiation. These are conditions where certain immune cells grow too much, or treatment that affects lymph tissue.
    Active, long-lasting, or severe viral infections within 3 months before screening, such as cytomegalovirus, hepatitis B, or hepatitis C. Severe viral infection means an active infection needing antiviral treatment. Anyone with a positive hepatitis B surface antigen or hepatitis C test at screening is excluded.
    Active tuberculosis or a known past history of tuberculosis. A negative tuberculosis test is required before Day 1.
    Antiphospholipid syndrome or antiphospholipid antibodies at screening. This is a condition where the immune system makes antibodies that can increase clotting risk.
    History of HIV infection or positive HIV antibodies at screening.
    Active central nervous system lupus within 60 days before screening that needed treatment. The central nervous system includes the brain and spinal cord. This includes seizures, psychosis, organic brain syndrome, stroke, brain inflammation, or blood vessel inflammation in the brain.
    Any other serious heart, liver, kidney, lung, hormone, nerve, digestive, blood, cancer-related, or mental health condition that, in the doctor’s opinion, could affect safety or study participation.
    Uncontrolled low blood pressure, meaning systolic pressure below 100 mmHg or diastolic pressure below 60 mmHg. Blood pressure is the force of blood against the artery walls.
    Any other condition or situation that, in the investigator’s opinion, may make the patient unlikely to finish the study or follow the study rules.
    Being an employee of the investigator or study site, if directly involved in this study or other studies under that investigator or site, or being a family member of such an employee or the investigator.

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Verified sites

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Verified
Clinirem Sp. z o.o.
Lublin, Poland
Responsive
Neurologia Slaska Centrum Medyczne
Katowice, Poland

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Investigated drugs

AUR200
This is the study medicine being tested in the trial. It is given as an injection under the skin. The trial is checking whether it is safe and whether it helps people with generalized myasthenia gravis, a disease that causes muscle weakness. The medicine is being studied as a treatment that may reduce the abnormal immune activity thought to play a role in this condition.
Placebo
This is a look-alike injection with no active medicine in it. It is used for comparison so the researchers can see whether AUR200 works better than no active treatment and to help make the study fair and unbiased.

What is already known about the treatment

Sodium Chloride
Sodium chloride in this study is given as a solution for subcutaneous injection, which means it is injected just under the skin. It is a well-known and widely used substance in medicine, mainly as a salt water solution for cleaning, diluting, or serving as a placebo in clinical trials rather than as an active treatment. It does not have a direct disease-targeting mechanism; instead, it serves as a neutral comparison substance in the trial, and it is classified as a solvent and diluting agent.
AUR200
AUR200 is given as a solution for subcutaneous injection, so it is administered by placing the medicine under the skin. At present, it is an investigational substance, meaning it is still being studied in medical research and is not yet an established treatment in routine medical practice or widely described in the medical literature. It is being tested for generalized myasthenia gravis, a condition where the immune system weakens muscle function, and it is designed to affect immune signaling by blocking BAFF and APRIL, two molecules that help certain immune cells survive and make antibodies. This places it in the class of immune system medicines that aim to reduce harmful antibody activity.

Investigated diseases

Generalized Myasthenia Gravis - Generalized myasthenia gravis is a long-term autoimmune disease in which the immune system interferes with the communication between nerves and muscles. It causes weakness that can affect several muscle groups, often including the eyes, face, throat, arms, legs, and breathing muscles. Symptoms often fluctuate during the day and usually worsen with activity and improve with rest. Over time, the weakness may spread beyond one area and become more widespread or more noticeable during physical effort.