AuthorisedTherapeutic use (Phase IV)Interventional

OCTAGON:A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients with Generalized Myasthenia Gravis Treated with Ravulizumab

This research study, called OCTAGON, is for adults living with a muscle weakening condition called generalized Myasthenia Gravis (gMG). It's looking at how well patients who are already taking a new treatment called Ultomiris can reduce or even stop their steroid medicines, such as Prednisone or Prednisolone. Steroids are often used to manage gMG symptoms but can have side effects. The main goal is to see how many patients can successfully lower their steroid dose to 5mg a day or less, or stop them completely, and stay well for at least four weeks without their gMG getting worse. The study also examines how these changes affect patients' quality of life, daily activities, and other health markers, while keeping a close eye on any side effects.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Alexion Pharmaceuticals Inc.

Enrolment target

Start

08 Jun 2026

Generalized Myasthenia Gravis

What is this study about?

This study, named OCTAGON, is looking into how adults with a condition called generalized Myasthenia Gravis, or gMG, manage their medication. gMG causes muscle weakness that can affect many parts of the body. Many people with gMG take steroid medicines, like Prednisone, to help control their symptoms. While these steroids can be very helpful, they can also come with unwanted side effects, especially if taken for a long time or at high doses. The study is specifically interested in patients who are already being treated with a newer medicine called Ultomiris.

The main aim of this research is to see if patients taking Ultomiris can safely reduce or even stop taking their steroid medication. The researchers want to know what percentage of patients can either get off steroids completely (down to 0 mg per day) or reduce their daily dose to 5 mg or less, and importantly, keep their gMG symptoms under control for at least four weeks after making these changes. They are also looking at how this process affects patients' overall well-being and daily lives.

Beyond simply reducing steroid doses, the study will also look at several other important things. This includes how a patient’s quality of life changes, how well they can perform daily activities, and if their gMG symptoms stay stable or get worse. They’ll also be checking for any side effects from the treatments and how reducing steroids might affect other health measures like blood sugar and cholesterol levels. This information will help doctors understand the best ways to manage gMG and reduce the side effects of long-term steroid use.

Key takeaways

This study is for adults with generalized Myasthenia Gravis (gMG).
It aims to see if patients taking Ultomiris can safely reduce their steroid medication.
The main goal is to reduce steroids to 5mg/day or less, or stop them completely, for at least 4 weeks without gMG worsening.
Researchers will monitor gMG symptoms, quality of life, and side effects closely.
It's a 'Phase 4' study, meaning Ultomiris is already an approved treatment.

Who may be eligible?

This study is specifically looking for adult patients who have a condition called generalized Myasthenia Gravis (gMG). To join, you need to be 18 years old or older. There is no upper age limit, meaning older adults are welcome to participate if they meet all other requirements.

Both men and women are encouraged to take part in this research. The study needs a wide range of participants to get a clear picture of how the treatment works across different people.

While the main criteria are being an adult with gMG, the full list of requirements will be much more detailed. For example, you would typically need to meet specific health criteria related to your gMG, and probably be already receiving treatment with Ultomiris before joining this particular study. Your doctor would be able to check all the specific details to see if this study is suitable 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.

Are you 18 years old or older?
Do you have a diagnosis of generalized Myasthenia Gravis (gMG)?
Are you currently receiving treatment with Ultomiris for your gMG?
Are you willing to safely reduce your steroid medicine under medical supervision?
Can you attend regular clinic visits for monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you meet all the requirements. If you're eligible, you would then start the study. It involves a process where your doctor would carefully guide you in reducing your steroid medication (like Prednisone) over a period of time. You would already be receiving treatment with Ultomiris.

Throughout the study, you would attend regular visits to the clinic. At these visits, doctors and nurses would monitor your gMG symptoms closely, check your general health, and perform various tests. These tests might include blood tests to check different health markers, and questionnaires about your quality of life, how you're feeling, and your daily activities. They will also be looking out for any side effects you might experience.

The main part of the study focuses on how you manage the reduction of your steroid medicine. You will be monitored to see if you can successfully lower your dose or stop steroids completely for at least four weeks without your gMG symptoms worsening. The total duration of your participation would involve the period of steroid reduction, plus a follow-up period to check on your health and gMG symptoms after these changes.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as very close monitoring of your gMG and overall health by medical experts. If successful, you might be able to reduce or stop steroid medication, which could lead to fewer side effects from long-term steroid use. However, there are also potential risks; for example, reducing your steroid dose could lead to your gMG symptoms temporarily worsening, or you might experience other side effects from the study medication or procedures. All efforts will be made to manage any risks, but they cannot be entirely eliminated. Remember, taking part in any study is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Germany

Common questions

What is generalized Myasthenia Gravis (gMG)?

gMG is a long-term condition that causes muscle weakness in different parts of the body. It happens when your body's immune system mistakenly attacks healthy tissues.

What are 'steroid medicines' mentioned in the study?

These are drugs like Prednisone or Prednisolone. They are often used to reduce inflammation and suppress the immune system in conditions like gMG, but can have side effects with long-term use.

What is Ultomiris?

Ultomiris is a newer medicine for gMG. It works differently from steroids to help control the condition by affecting a specific part of the immune system.

Why is the study trying to reduce steroid medicine?

Reducing or stopping steroids can help patients avoid the common and sometimes serious side effects that can come from taking these medicines for a long time.

What does a 'Phase 4' study mean?

A Phase 4 study happens after a new medicine (like Ultomiris) has already been approved and is being used by patients. It helps researchers gather more information about its effects, benefits, and best uses in a larger group of people.