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Study on the Safety and Effectiveness of Rozanolixizumab and Immunoglobulins in Children 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 focused on studying a condition called generalized myasthenia gravis, which is a chronic autoimmune disorder that causes muscle weakness. The study is investigating a treatment called rozanolixizumab, also known by its code name UCB7665. Rozanolixizumab is a solution for injection that is being tested to see if it is safe and effective for children with this condition. The purpose of the study is to assess the long-term safety and tolerability of multiple treatment cycles with rozanolixizumab in pediatric participants.

Participants in the study will receive treatment cycles with rozanolixizumab over a period of time. The study will monitor for any serious side effects or adverse events that may occur during the treatment. Additionally, the study will look at changes in the levels of a protein in the blood called Immunoglobulin G (IgG), which plays a role in the immune system, as well as changes in the symptoms of myasthenia gravis. The study aims to provide valuable information on how well the treatment works and how safe it is for children with generalized myasthenia gravis.

Throughout the study, participants will be closely observed to ensure their safety and to gather data on the effectiveness of rozanolixizumab. The study is designed to help understand if this treatment can be a viable option for managing symptoms in children with generalized myasthenia gravis, potentially improving their quality of life. The study is expected to continue until 2027, providing a comprehensive evaluation of the treatment's impact over time.

The research process

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

  1. Step 1

    Joining the study

    Participation begins after completing a previous study, MG0006, or if symptoms worsen during the observation period of MG0006.

    Eligibility is confirmed based on specific criteria related to the previous study.

  2. Step 2

    Treatment cycles

    The study involves multiple 6-week treatment cycles.

    The medication used is rozanolixizumab, administered as a solution for injection under the skin (subcutaneous use).

    The main goal is to assess the long-term safety and how well the treatment is tolerated.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the occurrence of serious side effects and any adverse events leading to withdrawal from the study medication are monitored.

    Special attention is given to any adverse events that require close monitoring.

  4. Step 4

    Evaluation of treatment effects

    The study evaluates changes in total Immunoglobulin G (IgG) levels from the start to the end of each 6-week treatment period.

    Changes in scores related to daily living activities and overall myasthenia gravis symptoms are also assessed.

  5. Step 5

    End of study

    The study is expected to conclude by August 16, 2027.

    Final assessments will be conducted to evaluate the overall safety and effectiveness of the treatment.

Who can join the trial?

5 criteria

  • The study is for children with **Generalized Myasthenia Gravis**. This is a condition that affects the muscles, making them weak and tired.
  • Participants must be at least 2 years old at the time of the screening visit.
  • Both boys and girls can participate in the study.
  • The participant must have completed a previous study called MG0006 according to its rules.
  • If the participant completed the treatment part of the MG0006 study and their symptoms got worse during the observation period, they can also join this study.

Who cannot join the trial?

8 criteria

  • Participants who are not diagnosed with Generalized Myasthenia Gravis. This is a condition that affects the muscles, making them weak.
  • Children younger than 2 years old at the time of the screening visit.
  • Participants who have not completed the initial screening visit of the MG0006 study.
  • Individuals who are not able to follow the study procedures or instructions.
  • Participants who have any other medical condition that might interfere with the study or make it unsafe for them to participate.
  • Individuals who are pregnant or breastfeeding.
  • Participants who are currently taking other medications that might interfere with the study treatment.
  • Individuals who have had a recent infection or illness that could affect their participation in the study.
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Investigated drugs

Rozanolixizumab is a medication being studied for its long-term safety and tolerability in children with generalized myasthenia gravis. This condition is a chronic autoimmune disorder that causes muscle weakness. Rozanolixizumab is designed to help manage the symptoms of this disorder by targeting specific parts of the immune system. The study aims to see how well children tolerate this medication over multiple treatment cycles.

What is already known about the treatment

Rozanolixizumab – This medication is administered through subcutaneous injection. It is currently being studied in clinical trials, particularly for its long-term safety and tolerability in treating generalized myasthenia gravis in pediatric patients. The main therapeutic indication is for generalized myasthenia gravis, a condition that causes muscle weakness. Rozanolixizumab works by targeting and reducing the activity of certain antibodies that contribute to the symptoms of this condition. It is classified as a monoclonal antibody, which is a type of medication designed to interact with specific proteins in the body.

Investigated diseases

Generalized Myasthenia Gravis – Generalized Myasthenia Gravis is a chronic 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 results in fluctuating muscle weakness and fatigue, which can affect various muscle groups, including those responsible for eye movement, facial expression, and swallowing. The severity of symptoms can vary, often worsening with activity and improving with rest. Over time, the condition may lead to more persistent muscle weakness, impacting daily activities and quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502075-34-00Protocol codeMG0008Estimated enrolment12 patientsSponsorUCB Biopharma

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