A Phase 3, open-label extension study to evaluate the long-term safety and efficacy of rozanolixizumab in adult participants with ocular myasthenia gravis
Ocular myasthenia gravis is a condition that causes weakness in the muscles around your eyes. People living with it often struggle with droopy eyelids and double vision. This Phase 3 study looks at a medicine called rozanolixizumab (known by the brand name Rystiggo) to see how well it works and how safe it is over the long term. This is an 'open-label' study, which means there is no dummy treatment (placebo); everyone taking part receives the real medicine. It is given as a gentle injection under the skin. Doctors will monitor participants closely to check for any side effects and to see if their eye symptoms improve over time. They will also check whether the treatment helps stop the muscle weakness from spreading to other parts of the body.
At a glance
What is this study about?
Myasthenia gravis is an autoimmune condition. This means the body's natural defence system mistakenly attacks the connections between nerves and muscles. When it affects only the eyes, it is called ocular myasthenia gravis. People with this condition often experience drooping eyelids, blurred sight, and double vision, which can make everyday tasks like reading or driving difficult.
This trial focuses on a medicine called rozanolixizumab. It works by reducing the levels of harmful antibodies in the blood that cause muscle weakness. Because this is an 'open-label extension study', it is designed to follow people over a longer period to see if the medicine keeps working safely. Every participant in this study receives the active medicine.
Finding safe, long-term options for ocular myasthenia gravis is very important. Current medicines do not always work well for everyone and can cause unwanted side effects. The results of this study will help doctors understand whether rozanolixizumab can offer lasting relief and stop eye weakness from spreading to other muscles throughout the body.
Key takeaways
- Tests the long-term safety of rozanolixizumab for ocular myasthenia gravis.
- Open to adults aged 18 and older who meet specific trial criteria.
- All participants receive the active medicine; there is no dummy treatment (placebo).
- The medicine is given as an injection under the skin during regular clinic visits.
- Taking part is voluntary, and you can leave the study at any time.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with ocular myasthenia gravis. Because this is an 'extension study', it is typically designed for people who have already completed an earlier trial with this medicine.
Both men and women may take part. To be eligible, your muscle weakness must mainly affect your eyes. You must also be well enough to attend regular clinic check-ups and receive injections under the skin.
You may not be able to join if you have other serious medical conditions, an active severe infection, or if your doctor feels taking part would not be safe for you. The study team will look closely at your medical history to make sure the trial is right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with ocular myasthenia gravis (drooping eyelids or double vision).
- I have taken part in an earlier study of this medicine, or my specialist has referred me.
- I am able and willing to attend regular hospital appointments for check-ups and injections.
- I do not currently have a serious active infection.
What does participation involve?
If you take part, you will receive rozanolixizumab as a slow injection just under the skin (subcutaneous injection). You will need to visit a hospital or clinic regularly so the medical team can monitor your health. During these visits, doctors will test your eye movements, check your vision, take blood samples, and ask you to complete short questionnaires about how your symptoms affect your daily life. The study lasts for several months to track your progress over time, and the study team will guide you through each step of the schedule.
Potential risks and benefits
Locations (7)
- —UnverifiedHungary
- —UnverifiedFrance
- —UnverifiedGreece
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedGermany
Common questions
What does 'open-label' mean?
It means both you and your doctor will know that you are receiving the real study medicine. There is no dummy drug (placebo) used in this trial.
How is the medicine given?
It is given as an injection under the skin using a small needle, usually in the tummy or thigh, administered by a trained healthcare professional.
Will taking part cost me anything?
No, the study medicine and all trial tests are provided free of charge. Most trials also help cover reasonable travel expenses to and from the clinic.
What happens if my symptoms get worse?
The study doctors monitor you very closely. If your symptoms worsen or spread to other muscles, your doctor will adjust your care to keep you safe.
Can I leave the study early if I want to?
Yes. Taking part is completely voluntary. You are free to withdraw at any point, and your standard medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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