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 are 18 years old or older at the time of signing the consent form
• You have been diagnosed with Myasthenia Gravis (MG) with generalised muscle weakness, falling within a moderate-to-severe range of the condition (MGFA Class II to IVa), whether or not you test positive for certain antibodies linked to MG
• Your MG symptoms score (called MG-ADL) is 6 or higher, with more than half of that score coming from symptoms other than eye problems, and your scores must be stable during the screening period with no MG flare-ups
• If you are taking steroid tablets (such as prednisone), you have been on a stable dose for at least 3 months before and during screening, and the dose does not exceed set limits (confirm with trial site for your specific medication)
• If you are taking a medication to help muscle-nerve communication (such as pyridostigmine up to 480mg/day or neostigmine up to 300mg/day), you have been on a stable dose for at least 3 months before and during screening
• You weigh at least 40 kilograms (approximately 88 pounds)

Who may not be able to join:

• You have another immune system disorder (besides MG) or any condition requiring long-term steroid treatment (well-controlled thyroid disease is generally not a problem — confirm with trial site)
• You have been diagnosed with, or are suspected to have, a different condition that can cause similar muscle weakness to MG, such as Lambert-Eaton syndrome, muscular dystrophy, or inherited muscle conditions
• You currently have an active significant infection (viral, bacterial, or fungal), or you were hospitalised for an infection or received injectable antibiotics/antivirals within the past 8 weeks, or finished a course of oral antibiotics/antivirals within the past 8 weeks (some mild, well-controlled infections may not apply — confirm with trial site)
• You have active tuberculosis (TB), are currently being treated for latent TB, or have untreated latent TB shown by a positive TB test within the past 3 months
• You have or have had cancer, or any signs of cancer were found during screening tests
• You have taken certain immune-suppressing medications (such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, cyclophosphamide, or tacrolimus) within the past 4 weeks before joining the trial
• You have taken certain specific MG treatments (such as eculizumab, efgartigimod, rozanolixizumab, ravulizumab, zilucoplan, or nipocalimab) within the past 8 weeks before joining the trial
• You had your thymus gland surgically removed within the past 6 months
• You have a history of seizures (epileptic fits), not counting fever-related seizures in childhood
• You tested negative or uncertain for chickenpox (Varicella Zoster Virus) antibodies at screening
• You had a serious MG crisis (a sudden severe worsening of MG) in the 12 months before or during screening
• You have had frequent infections (3 or more per year) in the past 2 years
• You stopped taking certain immune-suppressing MG medications (such as those listed above) within the past 6 months before screening
• You are currently taking immune-suppressing MG medications at doses higher than specified limits (confirm with trial site for your specific medication and dose)
• You have taken part in another clinical drug trial within the past 6 months (or longer, depending on the drug used), or you have ever previously been treated with a drug called cladribine
• There may be additional criteria not listed here (confirm with trial site)

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