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Study of Telitacicept for Treating Generalized Myasthenia Gravis in Patients

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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 focused on studying the effects of a treatment for Generalized Myasthenia Gravis, a condition that causes muscle weakness. The treatment being tested is called Telitacicept, which is given as an injection. The study will compare the effects of Telitacicept to a placebo, which looks the same but does not contain the active medication. The main goal is to see how well Telitacicept works in improving the symptoms of Generalized Myasthenia Gravis.

Participants in the study will receive either Telitacicept or a placebo over a period of time. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the main part of the study. After this period, there will be an "open-label extension," where all participants may receive Telitacicept. The study will last for several months, and participants will have regular check-ups to monitor their health and the effects of the treatment.

The purpose of this study is to evaluate the effectiveness and safety of Telitacicept in treating Generalized Myasthenia Gravis. Participants will be assessed on changes in their ability to perform daily activities and their overall quality of life. The study aims to provide valuable information on whether Telitacicept can be a beneficial treatment option for people with this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide signed informed consent. This means you agree to participate and follow the study procedures.

    You must be at least 18 years old and have a confirmed diagnosis of generalized myasthenia gravis (gMG) with specific symptoms such as muscle weakness that fluctuates in severity.

  2. Step 2

    Screening and baseline assessment

    During this phase, your medical history will be reviewed, and tests will be conducted to confirm your eligibility. This includes checking for positive antibodies against AChR or MuSK.

    Your MG-ADL score and QMG score will be assessed to ensure they meet the required levels for participation.

  3. Step 3

    Randomization and treatment

    You will be randomly assigned to receive either the telitacicept injection or a placebo. The placebo looks the same as the telitacicept injection but contains no active medication.

    The treatment involves receiving a solution for injection in a pre-filled syringe. The frequency and dosage will be determined by the study protocol.

  4. Step 4

    Treatment period

    The treatment period lasts for 24 weeks. During this time, you will continue to receive the assigned treatment and attend regular study visits.

    Your progress will be monitored through various assessments, including changes in your MG-ADL and QMG scores.

  5. Step 5

    Evaluation of results

    At the end of the 24-week treatment period, your results will be evaluated. This includes measuring changes in your MG-ADL score and other health indicators.

    The study aims to determine the effectiveness of telitacicept compared to the placebo in improving symptoms of gMG.

  6. Step 6

    Open-label extension

    After the initial 24-week period, there may be an opportunity to participate in an open-label extension. This means you could receive telitacicept regardless of your initial group assignment.

    Participation in the extension is optional and will be discussed with you at the appropriate time.

Who can join the trial?

10 criteria

  • Patients must provide signed informed consent to participate in the study and agree to follow the study procedures.
  • Patients must be male or female and at least 18 years old at the time of screening.
  • Patients must have a prior confirmed diagnosis of generalized myasthenia gravis (gMG) with generalized muscle weakness. This means having a typical pattern of weakness that is mostly in the upper body, gets worse with activity, varies in severity, is more severe in the evening, and improves with rest. The diagnosis should meet at least one of the following tests:
    • History of abnormal neuromuscular transmission shown by a test called single fiber electromyography or repetitive nerve stimulation.
    • History of a positive edrophonium chloride test.
    • Improvement in myasthenia gravis signs when taking oral acetylcholine esterase (AChE) inhibitors, as assessed by the treating physician.
    • Patients must have positive antibodies against AChR or MuSK at screening. These are specific proteins in the body that are tested to confirm the diagnosis.
    • Patients must have a MG-ADL score of 6 points or more at screening and baseline, with less than 50% of the total score related to eye symptoms. The MG-ADL score is a measure of daily living activities affected by myasthenia gravis.
    • Patients must have a QMG score of 11 points or more at screening and baseline. The QMG score is a measure of the severity of muscle weakness.
    • Patients can take up to 2 other medications if they meet the stability criteria before the start of the study.
    • Patients must agree to use highly effective contraception during the study.

Who cannot join the trial?

4 criteria

  • Patients who do not have Generalized Myasthenia Gravis cannot participate. This is a condition that causes muscle weakness.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
  • Patients who are part of a vulnerable population may not be eligible. This includes groups that might need special protection in research.
  • Patients who do not meet other specific health criteria set by the study may be excluded. These criteria are usually detailed in the study protocol.
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Investigated drugs

Telitacicept is a medication being studied for its potential to help people with generalized myasthenia gravis, a condition that causes muscle weakness. This medication works by targeting specific parts of the immune system that may be overactive in people with this condition. By doing so, it aims to reduce the symptoms and improve muscle strength and function. The study is designed to see how effective and safe telitacicept is for patients with this condition.

What is already known about the treatment

Telitacicept – Telitacicept is administered as an injection, typically under the skin, and is currently being studied in clinical trials for its effectiveness in treating generalized myasthenia gravis, a condition that causes muscle weakness. In medical literature, it is being evaluated for its potential benefits and safety compared to a placebo. The main therapeutic indication for telitacicept is generalized myasthenia gravis. At the molecular level, telitacicept works by targeting specific proteins involved in the immune system, helping to reduce the abnormal immune response that contributes to muscle weakness. It is classified pharmacologically as an immunomodulatory agent, meaning it helps to regulate or normalize the immune system's activity.

Investigated diseases

Generalized Myasthenia Gravis – Generalized Myasthenia Gravis is an autoimmune disorder that affects the communication between nerves and muscles, leading to muscle weakness. It occurs when the immune system mistakenly attacks the body's own tissues, specifically targeting the receptors that receive nerve signals. This disruption causes muscles to become weak and easily fatigued, especially after periods of activity. The condition often affects muscles that control eye and eyelid movement, facial expression, and swallowing, but it can also impact other muscle groups. Symptoms can fluctuate, with periods of improvement and worsening. Over time, the muscle weakness can become more severe and widespread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512126-29-00Protocol codeRC18G006Estimated enrolment171 patientsSponsorVor Biopharma Inc.

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