Ravulizumab and Prednisone/Prednisolone for Oral Corticosteroid Tapering in Adults with Generalized Myasthenia Gravis

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What is this study about?

The study focuses on adults with Generalized Myasthenia Gravis, a rare condition in which the immune system disrupts the communication between nerves and muscles, leading to muscle weakness. Participants receive the medication ravulizumab by infusion together with oral corticosteroids such as prednisone to evaluate whether the steroid dose can be safely lowered or stopped while keeping the disease stable.

The purpose of the study is to assess the effectiveness of a predefined tapering schedule for oral corticosteroids in this patient group.

Participants begin with their usual prednisone dose and then follow a step‑down plan that gradually reduces the amount over several weeks. During the tapering period, they are monitored for signs of adrenal insufficiency and for any worsening of muscle weakness. The study continues for a few weeks after the taper is finished to confirm that the condition remains stable.

1 baseline assessment and initiation of treatment

after joining the study, a baseline evaluation is performed to record the current health status, medication use, and laboratory values.

the first dose of ravulizumab is given as an intravenous infusion. the dose is 3600 mg of the solution for infusion, administered once at the start of the study.

2 start of oral corticosteroid therapy

on the same day as the infusion, oral prednisone is taken at a dose of 100 mg per day.

the medication is taken by mouth once each day.

3 oral corticosteroid tapering schedule

the daily dose of prednisone is reduced gradually according to a predefined schedule.

the goal is to either stop the medication completely (0 mg per day) or lower the dose to 5 mg per day or less.

the taper continues until the target dose is reached and is then maintained for at least four weeks without any worsening of myasthenia gravis symptoms.

4 follow‑up assessments during taper

regular visits are scheduled to check for signs of disease worsening, adrenal insufficiency, and side effects.

each visit includes a clinical examination, questionnaires that measure quality of life and daily activity, and blood tests such as hbA1c and low‑density lipoprotein.

the assessments are performed at baseline and again four weeks after the tapering period is completed.

5 final evaluation and study completion

when the tapering goal has been maintained for four weeks, a final evaluation is performed.

the evaluation confirms that the oral corticosteroid dose is at the target level and that myasthenia gravis has not deteriorated.

the participant continues to receive the initial dose of ravulizumab as part of the study protocol until the study end date.

Who Can Join the Study?

Be 18 years old or older at the time you join the study.
Have a doctor’s diagnosis of Generalized Myasthenia Gravis (gMG), a condition that causes muscle weakness.
Be currently receiving the medication ravulizumab according to the approved instructions for that drug.
Have been taking an oral corticosteroid (OCS) such as prednisone, prednisolone, or methylprednisolone for at least four straight weeks before screening, at a dose that averages at least 7.5 mg of prednisone/prednisolone each day. If you take the medicine on a different schedule (for example, every other day), the average daily amount must still be 7.5 mg, and you must be willing to switch to a daily dose of prednisone/prednisolone when the study begins.
Be assigned male or female at birth (any gender is accepted).
Agree to follow the study’s birth‑control rules (use contraception) if you are able to become pregnant.
If you could become pregnant, you must have a negative, highly sensitive pregnancy test (blood or urine) before the steroid‑tapering part of the study starts, and you must be willing to have additional pregnancy testing as required.
Agree to sign an informed consent form, which explains the study and confirms you understand and accept participation.

Who Cannot Join the Study?

You cannot join if you are already taking part in another research study that tests a new treatment (interventional clinical trial), which means a study where participants receive a new drug or procedure.
You cannot join if you have a history of chronic low adrenal gland function (chronic hypoadrenalism, also called Addison’s disease), a condition where the adrenal glands do not make enough hormones for a long time.
You cannot join if you are using oral steroids (OCS) at the same time for other health problems besides your myasthenia gravis, because OCS are medicines that reduce inflammation.
You cannot join if you have received a special type of medicine called a biologic for myasthenia gravis (for example efgartigimod, rozanolixizumab, inebilizumab, rituximab, or intravenous immunoglobulin) within the period it takes the drug to be reduced by half five times (5 half‑lives) before the study starts; a half‑life is the time it takes for half of a drug to leave your body.
You cannot join if you are pregnant, breastfeeding, or planning to become pregnant at any time during the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country	Status
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Bhrzfvxcyqijjmngosdmlomkel Uehwdhoopxvqxywtacvfd Bnispxamcsahc gygez	Bochum	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	01.06.2026
Italy	Not yet recruiting	01.06.2026

Trial locations

Investigated drugs:

Prednisone is an oral corticosteroid that helps reduce inflammation and suppresses the immune system. In this study, participants take prednisone to control the muscle weakness caused by generalized myasthenia gravis. The trial is testing a plan to gradually lower (taper) the amount of prednisone they use while they receive another treatment, to see if the disease stays under control with less steroid exposure.

Prednisolone is another oral corticosteroid similar to prednisone. It also works by decreasing inflammation and calming an over‑active immune response. In the trial, prednisolone may be used as an alternative steroid option for participants, and it follows the same tapering schedule being studied to determine if patients can safely reduce their steroid dose.

Ravulizumab (brand name Ultomiris) is given by intravenous infusion. It is a targeted therapy that blocks a part of the immune system called the complement pathway, which is involved in the damage to muscle‑controlling nerves in myasthenia gravis. In this study, every participant receives ravulizumab to help control their disease while the researchers evaluate how well they can reduce their oral steroid use.

Investigated diseases:

Myasthenia gravis

Generalized Myasthenia Gravis – Generalized Myasthenia Gravis is a chronic condition that causes weakness of the muscles throughout the body. It occurs because the immune system interferes with the signals that tell muscles to contract. The weakness often starts in the eyes and then spreads to the face, throat, and limbs. Symptoms can become more noticeable with activity and improve with rest. Over time, the muscle weakness may fluctuate, with periods of worsening and improvement. The disease can affect daily tasks such as chewing, speaking, and lifting objects.

Trial ID:

2025-522555-26-00

Protocol code:

ALX-MG-502

NCT ID:

NCT07221838

Trial Phase:

Therapeutic confirmatory (Phase III)

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Ravulizumab and Prednisone/Prednisolone for Oral Corticosteroid Tapering in Adults with Generalized Myasthenia Gravis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?