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A Phase 3 Randomized Study of Rozanolixizumab for Safety and Efficacy in Adults with Ocular Myasthenia Gravis

Fast replyRegistered drugNo placebo
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What is this trial about?

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

The study focuses on adults who have ocular myasthenia gravis, a rare condition that causes weakness in the eye muscles, leading to drooping eyelids and double vision. The medication being tested is a drug called rozanolixizumab, which is given as a small injection under the skin (subcutaneous injection). A matching placebo, which looks the same but does not contain the active drug, is also used for comparison. The purpose of the study is to determine whether the medication is safe and works in adults with ocular myasthenia gravis.

Participants will receive a series of injections over a period of several weeks, with regular visits to the clinic where doctors will ask about eye symptoms, quality of life, and ability to perform daily activities. Simple questionnaires will be used to measure changes in eye muscle strength and overall well‑being. The study will also monitor any side effects that may occur during the treatment period.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    After you agree to join the study, you are randomly assigned to receive either the active medication or a matching placebo. you will not know which one you receive.

  2. Step 2

    Baseline assessments

    Before any medication is given, study staff record your current eye muscle symptoms, overall quality of life, and daily activity abilities using simple questionnaires. a physical examination of the eye muscles is also performed.

  3. Step 3

    First injection

    You receive a subcutaneous injection (injection under the skin) of either rozanolixizumab at a dose of 840 mg or a matching placebo. the injection is given in a clinic by a trained professional.

  4. Step 4

    Follow‑up visits and additional doses

    You return to the clinic for scheduled visits according to the study timetable. at each visit you may receive another injection of the same product you received at the first visit, and staff will check for any side effects or new symptoms.

  5. Step 5

    Day 43 assessment

    On day 43 after the first injection, you complete a series of questionnaires that measure changes in eye muscle weakness, overall quality of life, and daily activities. a physical examination of the eye muscles is also repeated to assess any improvement.

  6. Step 6

    Ongoing safety monitoring

    Throughout the trial, any side effects or health problems you experience are recorded by the study team. serious problems may lead to stopping the medication for safety reasons.

  7. Step 7

    Final visit and end of treatment

    After the last scheduled injection and the final assessments, you stop receiving the study medication. the study staff perform a final safety check and collect any remaining study information.

Who can join the trial?

8 criteria

  • Must be at least 18 years old when signing the consent form.
  • Must have MGFA Class I ocular weakness, meaning only the eye muscles are weak while all other facial, throat (bulbar), and arm/leg muscles are normal.
  • Must have a diagnosis of Ocular Myasthenia Gravis (oMG) confirmed by either a positive blood test for antibodies against the acetylcholine receptor (AChR) or muscle‑specific kinase (MuSK), or, if those antibodies are absent, abnormal results on a repetitive nerve stimulation (RNS) test or a single‑fiber electromyography (SFEMG) test plus at least one of the following: a positive ice test (drooping eyelid improves > 2 mm after 2 minutes of ice), a positive edrophonium (Tensilon) test, or clear improvement of eye symptoms after treatment with an acetylcholinesterase inhibitor (AChEI), plasma exchange (PLEX), intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin (SCIg), or corticosteroids (CSs).
  • Must have a Myasthenia Gravis Impairment Index (MGII) ocular score of 6 or higher, with at least two eye‑related items scored 2 or more, measured at both the screening and baseline visits.
  • Eye symptoms must have started less than 3 years before screening, or if they started 3 years or more ago, the patient must have shown improvement in drooping eyelid (ptosis) or double vision (diplopia) with treatments such as IVIg, PLEX, SCIg, the medicine pyridostigmine, or corticosteroids in the past year.
  • No abnormal pupil findings are allowed, except those caused by a previous local eye disease or eye surgery.
  • Either currently taking a stable dose of background medication for oMG for at least 30 days before screening, or not taking any background medication at the time of screening.
  • Must weigh at least 35 kg at the baseline visit.

Who cannot join the trial?

8 criteria

  • If you have any serious medical or mental health condition (such as a major illness, severe depression, alcohol or drug use disorder), have had major surgery recently (including removal of the thymus gland, called a thymectomy, within the past 3 months), plan to have major surgery while in the study, or have abnormal lab test results that could make participation unsafe, you cannot join.
  • If you have other diseases that cause drooping eyelids, muscle weakness, or double vision, or have other autoimmune or neurological disorders (for example, congenital myasthenic syndromes, mitochondrial diseases, or muscular dystrophies) that could interfere with measuring the study symptoms, you are excluded.
  • If you are known to be allergic (have a hypersensitivity) to similar anti‑Fc receptor (FcRn) drugs, to any ingredient in the study medication (such as the additive polysorbate 80), or have a condition called hyperprolinemia (high levels of the amino acid proline), you cannot take part.
  • If you have an active cancer (neoplastic disease) or have been treated for cancer within the past 5 years, you are excluded, except for certain low‑risk skin cancers (basal or squamous cell carcinoma), early‑stage cervical or breast cancer (carcinoma in situ), or very small prostate cancer (stage T1a or T1b) that has already been treated.
  • If you have a current serious infection (for example, tuberculosis) or have had a severe infection that required hospitalization or intravenous (IV) antibiotics within 6 weeks before the first study visit, you cannot participate.
  • If your kidney function is reduced, measured as a glomerular filtration rate (GFR) less than 30 mL/min/1.73 m² at screening, you are excluded.
  • If you have previously taken any FcRn inhibitor drugs, you are not eligible.
  • If you have used immunosuppressive medicines, biologic drugs, or other similar therapies during the time period set by the study, you cannot join.
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Investigated drugs

Rystiggo is a liquid medication that is injected under the skin. It contains the active ingredient rozanolixizumab, which is a special type of protein called a monoclonal antibody. This antibody works by lowering the amount of harmful antibodies that attack the muscles that control eye movement in people with ocular myasthenia gravis. In the study, participants receive Rystiggo to see if it can improve eye muscle strength and reduce symptoms compared with a placebo. The drug is being tested as a new treatment option for adults with this condition and has been given orphan‑drug status because the disease is rare.

What is already known about the treatment

Rystiggo 140 mg/ml solution for injection - The drug is given as a subcutaneous injection of a clear solution, typically 840 mg per dose. Rozanolixizumab is a newer biologic that has received approval in several regions and continues to be studied in clinical trials for a rare eye‑muscle weakness. It is used to treat ocular myasthenia gravis, a condition where the eyes become weak because of an immune problem. The medication works by attaching to the neonatal Fc receptor, which speeds up the removal of harmful antibodies that attack the nerve‑muscle connection, and it belongs to the class of monoclonal antibodies that modify the immune system.

Investigated diseases

Ocular Myasthenia Gravis - Ocular Myasthenia Gravis is an autoimmune disorder that weakens the muscles that move the eyes and lift the eyelids, causing drooping eyelids and double vision. The weakness often appears intermittently and becomes more noticeable with continued use of the eye muscles, improving after rest. Over time, the episodes of weakness can last longer and may spread to other facial muscles. Fatigue typically builds throughout the day, making it harder to focus on objects. The condition usually fluctuates, with periods of better and worse eye function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524756-54-00Protocol codeMG0038Estimated enrolment114 patientsSponsorUCB Biopharma

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