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Oral corticosteroid tapering with ravulizumab, prednisone and prednisolone in adult patients with generalized myasthenia gravis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

Generalized Myasthenia Gravis is a rare condition that causes weakness in the muscles used for breathing, eye movement, swallowing and other everyday activities. In this study participants receive the intravenous medication ravulizumab, which works by reducing the activity of a part of the immune system that attacks the connection between nerves and muscles. They also take oral steroids such as prednisone or prednisolone, which are pills that lower inflammation and help control symptoms.

The purpose of the study is to assess the effectiveness of a predefined OCS tapering schedule in adult participants with Generalized Myasthenia Gravis treated with ravulizumab and oral steroids. Participants start with a regular dose of the oral steroid and then follow a step‑by‑step plan to gradually lower (taper) the dose over several weeks, while receiving regular check‑ups to monitor muscle strength and overall health. The study follows participants for a few months, including visits at the beginning, after the tapering period is finished, and during a follow‑up phase to see if the steroid dose can be reduced or stopped without worsening the disease or causing problems such as adrenal insufficiency, a condition where the body’s stress‑hormone production is low.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    after you agree to take part, you are officially enrolled in the study.

  2. Step 2

    Baseline evaluation

    a series of initial assessments is performed, including medical history, physical examination, and laboratory tests.

    these evaluations establish your starting condition before any study medication is given.

  3. Step 3

    Initial infusion of <b>ravulizumab</b>

    you receive an intravenous infusion of ravulizumab at a dose of 3600 mg.

    the medication is delivered as a solution for infusion through a vein.

  4. Step 4

    Start of oral corticosteroid therapy

    you begin taking an oral corticosteroid each day.

    the study uses prednisone 100 mg taken by mouth once daily, or an equivalent dose of prednisolone 60 mg taken by mouth once daily.

    the corticosteroid is intended to control symptoms of generalized myasthenia gravis.

  5. Step 5

    Implementation of the tapering schedule

    a predefined tapering plan gradually reduces the daily dose of the oral corticosteroid.

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

    the reduction continues over several weeks according to the schedule provided by the study team.

    once the target dose is reached, you must maintain that dose for at least 4 weeks without any worsening of generalized myasthenia gravis symptoms.

  6. Step 6

    Regular monitoring visits

    throughout the tapering period and the subsequent maintenance period, you attend scheduled clinic visits.

    at each visit, clinical status is assessed, questionnaires such as the MG‑QoL‑15r and MG‑ADL are completed, and laboratory tests (including HbA1c and LDL‑C) are performed.

    any adverse events, including signs of adrenal insufficiency, are recorded.

  7. Step 7

    Final assessment after tapering completion

    after you have maintained the target corticosteroid dose for the required 4‑week period, a final comprehensive assessment is conducted.

    this includes evaluation of myasthenia gravis symptoms, quality‑of‑life questionnaires, and repeat laboratory measurements.

  8. Step 8

    Ongoing safety follow‑up

    following the final assessment, you continue to be monitored for safety outcomes for the remainder of the study period.

    this follow‑up may extend until the overall study end date in june 2028.

Who can join the trial?

10 criteria

  • Be 18 years of age or older at the time of enrollment.
  • Have a clinical diagnosis of Generalized Myasthenia Gravis (gMG), a condition that causes muscle weakness.
  • Be receiving treatment with ravulizumab according to the approved local guidelines.
  • Have taken oral corticosteroids (OCS) at a dose that is the same as at least 7.5 mg of prednisone/prednisolone each day for a continuous period of at least 4 weeks before enrollment.
  • If the steroid medication is taken on an alternate schedule (for example, every other day), the average amount per day must still equal at least 7.5 mg of prednisone/prednisolone, and you must be willing to switch to a daily dose at the first study visit.
  • If you are using a different steroid such as methylprednisolone, you must be willing to change to a daily dose of prednisone/prednisolone at the first study visit.
  • Be male or female as assigned at birth.
  • Agree to follow the study’s contraception guidance, which means using reliable birth control methods as instructed.
  • If you could become pregnant, you must have a negative, highly sensitive pregnancy test (blood or urine) taken before the steroid tapering begins, and you must follow any additional testing requirements during the study.
  • Be willing to sign the study’s informed consent form, confirming that you understand the study and agree to take part.

Who cannot join the trial?

5 criteria

  • Being enrolled in another interventional clinical trial at the same time.
  • Having chronic hypoadrenalism (also called Addison’s disease), a condition where the adrenal glands do not produce enough hormones.
  • Using oral corticosteroids (OCS) for other health problems besides myasthenia gravis.
  • Having received a biologic medication for myasthenia gravis (for example, efgartigimod, rozanolixizumab, inebilizumab, rituximab, or intravenous immunoglobulin) within the time it takes the drug to clear about five half‑lives (roughly several weeks to months).
  • Being pregnant, breastfeeding, or planning to become pregnant during the study period.
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Investigated drugs

  • Prednisone

    is an oral steroid medicine that helps reduce inflammation and control the muscle weakness that occurs in myasthenia gravis. In this study participants take prednisone at first and then gradually lower (taper) the amount they use according to a set schedule, so researchers can see how well the taper works.

  • Prednisolone

    is another oral steroid similar to prednisone. It also works by calming the immune system and easing muscle weakness. In the trial it is given together with prednisone and then reduced in dose as part of the same tapering plan.

  • Ravulizumab

    is a medication given by a short IV infusion. It is a type of antibody that blocks a part of the immune system called the complement pathway, which can help improve muscle strength in people with generalized myasthenia gravis. In this study all participants receive ravulizumab while their oral steroids are being tapered.

What is already known about the treatment

  • Prednisone

    This medication is taken as an oral tablet and works by binding to glucocorticoid receptors inside cells, which reduces inflammation and suppresses the immune system. It is a well‑known, approved drug that has been used for many years to treat conditions such as asthma, arthritis, and autoimmune diseases. The main therapeutic use in this trial is to help control symptoms of generalized myasthenia gravis while the dose is gradually lowered. Pharmacologically, prednisone belongs to the class of glucocorticoid corticosteroids.

  • Prednisolone

    Given as an oral tablet, prednisolone is the active form of prednisone that directly binds to glucocorticoid receptors to lower inflammation and calm an overactive immune response. It is an established medication widely listed in medical literature for treating inflammatory and autoimmune disorders. In this study it serves the same purpose as prednisone, providing steroid support while patients taper their dose. It is classified as a glucocorticoid corticosteroid.

  • Ravulizumab

    This drug is supplied as a solution for intravenous infusion, delivering a monoclonal antibody that attaches to the complement protein C5 and stops it from triggering inflammation. Ravulizumab is an approved therapy for rare blood disorders and is now being investigated for use in generalized myasthenia gravis. Its action blocks a specific part of the immune system, preventing damage to nerve‑muscle connections. It is classified as a complement inhibitor and a humanized monoclonal antibody.

Investigated diseases

Generalized Myasthenia Gravis - Generalized Myasthenia Gravis is an autoimmune disorder that weakens the communication between nerves and muscles. It typically begins with difficulty in eye movements, facial expression, and swallowing, then spreads to affect the arms, legs, and breathing muscles. Muscle weakness worsens with continued activity and improves after rest. The pattern of weakness can change from day to day, with periods of better and worse control. Over time, the affected muscles may become increasingly fatigued, requiring adjustments in daily activities.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522555-26-00Protocol codeALX-MG-502Estimated enrolment72 patientsSponsorAlexion Pharmaceuticals Inc.

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