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Phase 3 Open‑Label Extension Study of Long‑Term Safety and Efficacy of Rozanolixizumab in Adults with Ocular 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

Ocular Myasthenia Gravis is a rare disorder that weakens the muscles that control eye movements, often causing drooping eyelids and double vision. The study evaluates the long‑term safety and how well the medication works in adults with this condition. The treatment under investigation is a subcutaneous (under the skin) injection of rozanolixizumab, supplied as a sterile solution for injection.

The study follows participants for an extended period during which they receive regular injections of the medication and attend scheduled visits for health checks. At each visit, researchers record any side effects, which are referred to as adverse events, and collect questionnaire responses that measure changes in eye muscle strength, daily activity ability, and overall quality of life. The overall aim is to determine whether the medication is safe and tolerable for people living with this eye‑related form of myasthenia gravis.

The research process

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

  1. Step 1

    Enrollment and initial screening

    After agreeing to join the study, you will sign an informed consent form and confirm that you meet the eligibility criteria for ocular myasthenia gravis.

    The study staff will collect basic health information, conduct a physical examination, and review any current medications.

  2. Step 2

    Baseline assessments

    You will complete several questionnaires that measure eye muscle weakness and quality of life, including the mgii ocular score, mg-adl ocular score, mgsp ro ocular muscle weakness scale, and mg-qol15r.

    Blood samples may be taken to establish baseline laboratory values.

    The results from these assessments will be used as reference points for later comparisons.

  3. Step 3

    First dose of rozanolixizumab

    You will receive a single subcutaneous injection of the study medication rozanolixizumab at a dose of 840 mg.

    The injection is administered under the skin by trained study personnel.

    The exact schedule for subsequent doses will be defined by the study protocol.

  4. Step 4

    Regular study visits and assessments

    Approximately 43 days after the first injection, you will return for a study visit where the same questionnaires (mgii ocular score, mg-adl ocular score, mgsp ro ocular muscle weakness scale, mg-qol15r) are repeated to evaluate changes.

    At each visit, the study team will check for any adverse events (side effects) and record their severity.

    Additional laboratory tests may be performed to monitor safety.

  5. Step 5

    Ongoing treatment

    You will continue to receive the prescribed dose of rozanolixizumab by subcutaneous injection at intervals specified in the study plan.

    Each injection is followed by routine safety checks and repeated questionnaire assessments to track your condition over time.

    Any serious or concerning side effects will be evaluated promptly, and the study medication may be stopped if necessary.

  6. Step 6

    End of study visit

    When the study period ends or if you decide to withdraw, you will attend a final visit.

    Final assessments, including the same set of questionnaires and safety evaluations, will be performed.

    The study medication will be discontinued, and all collected data will be finalized for analysis.

Who can join the trial?

6 criteria

  • You must be at least 18 years old when you sign the study consent form.
  • You need to have received at least one dose of the study drug rozanolixizumab (or a placebo) in a previous trial called MG0038.
  • The doctor must think that the possible benefits of joining the study are greater than any possible risks for you.
  • You (or a caregiver helping you) must be reliable and able to follow the study’s visit schedule and take any study medication as instructed.
  • You can be male or female. If you are female, you must not be breastfeeding and you must meet one of these conditions: you are not a woman who could become pregnant, or if you could become pregnant, you agree to use birth control for the entire study period.
  • You must be able to sign the informed consent form, which means you understand and agree to follow the study rules and restrictions.

Who cannot join the trial?

5 criteria

  • If you already meet any of the reasons that would cause a participant to leave the study (known as “withdrawal criteria”), you cannot join.
  • If you have a serious infection that required a hospital stay or needed medicines given through an IV (a tube placed in a vein) within the past 6 weeks, you cannot join. Active infection means an infection that is currently causing symptoms.
  • If you plan to receive a live vaccine (a vaccine that contains a weakened form of the germ) at any time while you are in the study or within 8 weeks after your last dose of the study drug, you cannot join.
  • If you have taken any medicines that are not allowed in the study, such as drugs that lower the immune system (immunosuppressive medications) or special protein‑based treatments called biologics, you cannot join.
  • If you plan to use any medicines that are not allowed in the study (called prohibited medications), you cannot join.
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Investigated drugs

Rystiggo is a medication given as a subcutaneous injection. It contains a special type of protein called rozanolixizumab that works by modifying the immune system. In this study, the drug is being tested to see if it can safely and effectively help adults with ocular myasthenia gravis, a condition that causes weakness in the eye muscles. Researchers will watch participants for a long time to learn how well the medicine works and what side effects might happen. Because it is meant for a rare disease, it is considered an orphan drug.

What is already known about the treatment

Rystiggo - Rystiggo is given as a liquid that is injected under the skin (subcutaneous injection). It is an experimental drug currently in Phase 3 trials and has orphan‑drug status for a rare eye‑muscle disease. The medicine is meant to treat ocular myasthenia gravis, a condition where the immune system attacks the muscles that control eye movement. It works by attaching to a protein called the neonatal Fc receptor, which lowers the amount of harmful antibodies in the blood, and it is classified as a monoclonal antibody that modulates the immune system.

Investigated diseases

Ocular Myasthenia Gravis - Ocular Myasthenia Gravis is an autoimmune disorder that impairs communication between nerves and the muscles that control eye movements. It causes fluctuating weakness of the eyelid and eye muscles, leading to drooping eyelids (ptosis) and double vision (diplopia). Symptoms often worsen with activity and improve with rest. In some individuals, the weakness may remain limited to the eyes, while in others it can gradually involve additional facial or neck muscles. The condition typically develops slowly, with periods of worsening and improvement over days to weeks.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524757-14-00Protocol codeMG0039Estimated enrolment136 patientsSponsorUCB Biopharma

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