Testing Cladribine Low Dose against a placebo for generalized myasthenia gravis

Exclusion

• −Immunologic disorder other than MG or any other condition requiring chronic oral, intravenous, intramuscular, or intraarticular corticosteroid therapy. Well-controlled thyroid disease, as per the Treating InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → or the participants regular treating physician recorded in the source documents, is not exclusionary
• −Molecularly characterized or suspected congenital myasthenic syndrome, Lambert-Eaton myasthenic syndrome, inherited myopathy, muscular dystrophy, acquired myopathy or any other neurologic or systematic disease that mimics MG muscular weakness
• −Active, clinically significant viral, bacterial, or fungal infection, including brain MRI or chest X-ray findings consistent with signs of infection such as PML or TB, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 8 weeks prior or during ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →, or completion of oral anti-infectives within 8 weeks prior or during Screening. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled would not be exclusionary
• −Has a history of or current diagnosis of active tuberculosis (TB) or is currently undergoing treatment for latent TB infection or has an untreated latent TB infection as determined by documented results within 3 months of the Screening Visit of a positive TB skin test .
• −Active malignancy, or history of cancer or signs of malignancy in any Screening assessment
• −Treatment with nonsteroidal immunosuppressants, used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, cyclophosphamide, tacrolimus within 4 weeks prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
• −Treatment with FcRn or complement inhibitors (such as eculizumab, rozanolixizumab efgartigimod, ravulizumab, zilucoplan or nipocalimab) within 8 weeks prior to randomization
• −History of thymectomy within 6 months prior to Screening.
• −History of generalized seizures (except for history of febrile seizures during the participant's childhood).
• −Negative or indeterminate for Varicella Zoster Virus antibodies at screening
• −History of myasthenic crisis in the last 12 months prior to and during screening
• −History of recurrent infections (that is 3 or more infections per year documented in available source data) within the last 2 years
• −Discontinuation of treatment with any non-steroidal immunosuppressants used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, cyclophosphamide, tacrolimus within the last 6 months prior to Screening
• −If treated with non-steroidal immunosuppressants for gMG, the dose at Screening higher than 50 mg/day for azathioprine, 500 mg/day for mycophenolate mofetil, 1 mg/day for tacrolimus, 50 mg/day for cyclosporine, 25 mg/day for cyclophosphamide, or 7.5 mg/week for methotrexate
• −Participation in clinical study of any investigational drug within 6 months, or 5 half-lives of the investigational drug used in the previous clinical study prior to randomization, whichever is longer. However, participants with any prior exposure to cladribine may not enter the study regardless of timing of exposure
• −Other protocolProtocolThe detailed plan a study must follow.Read more → defined exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → could apply