Not recruitingRare disease

Study on the Safety and Effectiveness of Zilucoplan Auto-Injector for Adults with Generalized Myasthenia Gravis

Verified siteInvestigationalNo placebo

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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 Generalized Myasthenia Gravis, a condition that causes muscle weakness. The study will use a treatment called Zilucoplan sodium, which is a medication designed to help manage this condition. The medication is administered through a pre-filled pen that allows for easy self-injection under the skin.

The purpose of the study is to evaluate the safety and effectiveness of using the Zilucoplan auto-injector for self-administration by participants with Generalized Myasthenia Gravis. Participants will be asked to use the auto-injector to administer the medication themselves. The study will monitor how well participants can manage the self-injection process and will also keep track of any side effects or adverse reactions that may occur during the study period.

The study will take place over several visits, where participants will be observed and supported in using the auto-injector. The goal is to ensure that the auto-injector is a safe and effective way for people with Generalized Myasthenia Gravis to manage their treatment independently. Participants will be closely monitored for any serious or non-serious side effects related to the medication or the device used for administration.

The research process

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

Step 1
Joining the study
Upon joining the study, the participant must be at least 18 years old and have a documented diagnosis of generalized myasthenia gravis.
The participant should be currently involved in a zilucoplan study or using commercial zilucoplan on a stable dosing regimen for at least one month before the screening.
Step 2
Vaccination requirements
Participants must be vaccinated with a quadrivalent meningococcal vaccine and, if available, a meningococcal serotype B vaccine at least 14 days before starting the study medication.
Booster vaccinations should be administered as needed, according to local healthcare standards.
Step 3
Self-administration training
Participants must be willing and able to self-administer zilucoplan using the auto-injector device.
If necessary, a caregiver may assist with the injection.
Step 4
Medication administration
The medication, zilucoplan sodium, is provided as a solution for injection in a pre-filled pen for subcutaneous use.
Participants will self-administer the medication from Visit 1 to Visit 8.
Step 5
Monitoring and visits
Participants will attend multiple visits to monitor the effectiveness of self-administration and to check for any adverse effects.
The study will track occurrences of serious adverse events, treatment-emergent adverse events, and any device-related effects.
Step 6
Study duration
The estimated end date for the study is December 23, 2024.
The recruitment for the study is expected to start on July 15, 2024.

Who can join the trial?

10 criteria

The participant must be a male or female who is at least 18 years old.
The participant must be able to give signed consent, agreeing to follow the study's rules and restrictions.
The participant must have a confirmed diagnosis of generalized Myasthenia Gravis, which is a condition affecting the muscles.
The participant must already be involved in a zilucoplan study or using zilucoplan as prescribed for at least one month before the study starts.
If using commercial zilucoplan, the participant must follow the approved local instructions for use.
The participant must be considered reliable and able to follow the study plan, such as understanding and completing questionnaires and attending scheduled visits.
The participant must be willing and able to self-administer the medication using the zilucoplan auto-injector, unless they have a caregiver to assist them.
The participant must have received a meningococcal vaccine at least 14 days before starting the study medication, unless vaccinated within the last three years. Additional booster shots should be given if needed.
Female participants who can have children must have a negative pregnancy test before starting the study medication.
Male participants must agree to use contraception and not donate sperm during the study and for 40 days after the last dose. Female participants must not be pregnant or breastfeeding and must agree to use contraception if they can have children.

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Verified sites

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Responsive
Neurologia Slaska Centrum Medyczne
Katowice, Poland

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Investigated drugs

Zilucoplan is a medication used in this clinical trial to help manage symptoms of generalized myasthenia gravis, a condition that causes muscle weakness. The trial focuses on the use of a zilucoplan auto-injector, which allows patients to self-administer the medication under the skin. This study aims to assess how safe and effective this method of administration is for patients.

Zilucoplan Sodium

What is already known about the treatment

Zilucoplan – Zilucoplan is administered through a subcutaneous auto-injector, allowing patients to self-administer the medication. It is currently being studied in clinical trials for its safety and effectiveness in treating generalized myasthenia gravis, a chronic autoimmune neuromuscular disorder. The medication works by inhibiting the complement system, a part of the immune system that contributes to inflammation and tissue damage in this condition. Zilucoplan is classified as a complement inhibitor, and its development is focused on providing a convenient treatment option for individuals with this disorder.

Investigated diseases

Generalized Myasthenia Gravis – This 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 connections between nerves and muscles, disrupting the transmission of signals. The condition often begins with weakness in the eye muscles, causing drooping eyelids and double vision. As it progresses, it can affect other muscles, leading to difficulties in swallowing, speaking, and breathing. The severity of muscle weakness can vary throughout the day, often worsening with activity and improving with rest. The disease can affect individuals of any age, but it is more common in women under 40 and men over 60.