Phase 3 Myasthenia Gravis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You must be at least 18 years old at the time you sign the consent form.
• You have been diagnosed with Ocular Myasthenia Gravis (a condition affecting the muscles of the eyes and eyelids), with weakness only in the eye area — all other muscles in your face, throat, and limbs must have normal strength.
• Your diagnosis is supported by a positive blood test for certain antibodies (AChR or MuSK), OR by abnormal nerve tests plus at least one other confirming test (such as an ice test on a drooping eyelid, a Tensilon test, or a documented improvement with certain treatments).
• Your eye-related symptoms score at least 6 on a specific symptom questionnaire (called the MGII ocular score), with at least 2 eye-related items rated as moderate or worse — measured at both your screening and baseline appointments.
• Your eye symptoms either started less than 3 years ago, OR started 3 or more years ago but you have shown improvement with treatment (such as steroids or immunoglobulin therapy) within the past year.
• You do not have any pupil abnormalities, unless they were caused by a previous eye condition or eye surgery.
• You are either currently taking a stable dose of treatment for your eye condition (unchanged for at least 30 days before screening), or you are not taking any treatment at all.
• You weigh at least 35 kg (approximately 77 lbs) at your baseline appointment.

Who may not be able to join:

• You have a significant medical or psychiatric condition, a recent major surgery (including thymus removal within the past 3 months), a planned major surgery during the study, or seriously abnormal lab results that the study doctor believes could affect your safety or ability to participate.
• You have another condition that also causes drooping eyelids, double vision, or muscle weakness — such as other autoimmune diseases, congenital myasthenic syndromes, mitochondrial diseases, or muscular dystrophies.
• You have a known allergy or sensitivity to similar medications, to any ingredient in the study drug (including an ingredient called polysorbate 80), or you have a condition called hyperprolinemia (a build-up of a certain amino acid in the blood), since the study drug contains L-proline.
• You currently have or have been treated for cancer within the past 5 years (certain minor or fully treated skin cancers and early-stage cancers may be exceptions — confirm with the trial site).
• You currently have an active significant infection (such as active tuberculosis), or you were hospitalised for or required IV antibiotics for a serious infection within the 6 weeks before your baseline visit.
• You have significant kidney problems, specifically a kidney filtration rate below a certain level measured at screening (confirm with trial site).
• You have previously been treated with a type of medication called an FcRn inhibitor.
• You have recently taken certain immunosuppressive medications, biological therapies, or other specific treatments within timeframes that disqualify participation (confirm with trial site for the full list and timeframes).

Important: Always verify eligibility with the trial site directly before applying.