New drug trial aims to ease droopy eyelids and double vision
NCT ID NCT07463521
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This study tests an investigational drug called rozanolixizumab against a placebo in 120 adults with ocular myasthenia gravis, a condition causing eye muscle weakness like droopy eyelids or double vision. Participants receive the drug or placebo by injection, and researchers measure changes in eye symptoms after about 6 weeks. The goal is to see if the drug safely reduces symptom severity.
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 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jan 2029
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.
Show the full entry requirements Hide the full entry requirements
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 has Myasthenia Gravis Foundation of America (MGFA) Class I with any ocular weakness at Screening through Baseline. The participant may have weakness in muscles of eye (ie, extraocular muscles that move the eyeball, including the medial rectus, lateral rectus, superior rectus, inferior rectus, superior oblique, and inferior oblique, orbicularis oculi muscles, and levator palpebrae superioris) but must have normal strength in all other facial, bulbar, and limb muscles. * Study participant has been diagnosed with Ocular Myasthenia Gravis (oMG) with consistent ocular clinical features at Screening and supported by: * Documented presence of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK), OR * Documented absence of autoantibodies against AChR or MuSK; in this case, documented abnormal repetitive nerve stimulation (RNS) or single fiber electromyography (SFEMG) (as defined in the adjudication manual) and at least 1 of the following should be met: * Documented positive ice test (Ptosis recovers with the ice test \[applied 2 minutes (min) to the ptotic lid\] with \>2mm improvement) * History of positive edrophonium chloride (Tensilon) test (or equivalent tests used to establish oMG diagnostic as per current practice) * Demonstrated objective improvement in oMG signs with acetylcholinesterase inhibitor (AChEIs), plasma exchange (PLEX), intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin (SCIg) or corticosteroids (CSs) * Participant has an Myasthenia Gravis Impairment Index (MGII) ocular score (Patient-Reported Outcome (PRO) part) ≥6 with at least 2 ocular items with a score of ≥2 at both Screening and Baseline visits. * Participant reported ocular symptom(s) onset \<3 years before Screening or ≥3 years provided they have demonstrated response (ie, improvement in ptosis or diploplia) to treatment (IVIg, PLEX, SCIg, pyridostigmine, and/or CSs) in the past year. * Participant has no pupillary abnormality except those resulting from prior localized eye disease or surgical intervention. * Participant who: * is currently receiving background treatment for oMG symptoms at the time of Screening and has been receiving treatment for oMG with a stable dose for at least 30 days prior to Screening, OR * is not receiving any background treatment at the time of Screening * Participant has a body weight ≥35kg at Baseline. Exclusion Criteria: * Participant has any clinically significant medical or psychiatric condition (including an alcohol or drug use disorder), recent major surgery (including thymectomy \[within 3 months of Screening\], solid organ, stem cell or marrow transplant), planned major surgery (including thymectomy) during study participation, and/or significant laboratory abnormality that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study. * Participant has been diagnosed with other diseases that lead to eyelid dropping, peripheral muscle weakness, or diplopia, including other autoimmune diseases that would interfere with an accurate assessment of the oMG clinical symptoms or other neurological diseases, such as congenital myasthenic syndromes, mitochondrial diseases, and muscular dystrophies. * Participant has a known hypersensitivity to other anti-Fc receptor (FcRn) medications, to any components of the study medication (including the excipient polysorbate 80) or has a known history of hyperprolinemia, since L-proline is a constituent of the rozanolixizumab formulation. * Participant has active neoplastic disease or has received treatment for neoplastic disease within 5 years of study entry (except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the uterine cervix, carcinoma in situ of the breast, or incidental histological findings of prostate cancer \[Tumor, Node, Metastasis (TNM) stage T1a or T1b\] that has been definitely treated with standard of care approaches). * Participant has a clinically relevant active infection (eg, tuberculosis (TB) infection) or a history of serious infection (resulting in hospitalization or requiring intravenous (iv) antibiotic treatment) within 6 weeks before the Baseline Visit. * Participant has renal impairment, defined as glomerular filtration rate less than 30milliliter/min/1.73m2 at Screening. * Participant has been previously treated with FcRn inhibitors. * Participant has been treated with any of the immunosuppressive medications, biologics, or other therapies, in the specified prohibitive timeframe.
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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 places running it
11 sites in 4 countries. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Mg0038 10103
RECRUITINGColumbus, Ohio, 43210, United States
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Mg0038 10104
RECRUITINGScottsdale, Arizona, 85251, United States
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Mg0038 10105
RECRUITINGO'Fallon, Illinois, 62269, United States
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Mg0038 10106
RECRUITINGAmherst, New York, 14226, United States
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Mg0038 10108
RECRUITINGGreenfield, Wisconsin, 53228, United States
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Mg0038 10201
RECRUITINGMontreal, Canada
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Mg0038 31802
RECRUITINGKobe, Japan
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Mg0038 31901
RECRUITINGBeijing, China
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Mg0038 31902
RECRUITINGSuzhou, China
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Mg0038 31906
RECRUITINGChengdu, China
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Mg0038 31907
RECRUITINGNanchang, China
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