New drug shows promise for rare eye muscle disease in Long-Term trial
NCT ID NCT07465289
First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times
Summary
This study looks at the long-term safety and effectiveness of a drug called rozanolixizumab for adults with ocular myasthenia gravis, a condition that causes muscle weakness in the eyes. About 100 people who have already taken the drug in a previous study will continue treatment. The main goal is to track side effects and see if the drug helps control symptoms over time.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF) * Participant must have received at least 1 dose of investigational medicinal product (IMP) (rozanolixizumab or placebo) in MG0038 * Participant for whom the investigator considers a favorable benefit/risk for participation * Participant who, alone or with assistance of the caregiver, is considered reliable and capable of adhering to the protocol visit schedule or medication intake according to the judgement of the investigator * Male or female * A female participant is eligible to participate if she is not, not breastfeeding (including pumping breastmilk to feed a child), and at least 1 of the following conditions applies: * Not a woman of childbearing potential (WOCBP) OR * A WOCBP who agrees to follow the contraceptive guidance for the entire study period * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol Exclusion Criteria: * Participant meets any of the withdrawal criteria defined in MG0038 * Participant has a clinically relevant active infection (resulting in hospitalization or requiring intravenous (IV) antibiotic treatment) within 6 weeks before study entry. * Participant intends to have a live vaccination during the study or within 8 weeks following the final dose of rozanolixizumab * Participant has been administered with the prohibited immunosuppressive medications, biologics, or other therapies * Participant has planned use of prohibited medications
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.