Hanamaki

Researchers are evaluating the effects of iptacopan compared with a placebo in adults aged 18 to 85 years who have generalized Myasthenia Gravis positive for acetylcholine receptor antibodies (AChR+ gMG). This Phase III, randomized, double-blind, placebo-controlled, multicenter study aims to assess the efficacy, safety, and tolerability of iptacopan while participants continue their stable standard of care treatments. The study includes participants with moderate to severe gMG symptoms and positive diagnostic criteria. Participants will be randomly assigned in a 1:1 ratio to receive either iptacopan or a matching placebo in the form of hard gelatin capsules for six months (180 days). During this time, they will continue their stable standard of care treatments. After the double-blind treatment period, a maximum 60-month open-label extension phase is offered. Safety follow-up assessments will occur one week and one month after the last dose of study treatment. During the study, participants will be evaluated for changes in their Myasthenia Gravis Activity of Daily Living (MG-ADL) total score from baseline to month 6. Researchers will monitor safety and tolerability throughout the treatment and extension periods. Vaccination status, infection monitoring, and regular clinical assessments will be part of participant evaluations to ensure safety and track disease symptoms over time.

Researchers are evaluating the effectiveness and safety of nipocalimab compared to placebo in adults with generalized myasthenia gravis (gMG), a condition causing muscle weakness. This phase 3, multicenter, randomized, double-blind study also includes a subcutaneous substudy to assess how nipocalimab works in the body when given as an injection under the skin compared to intravenous infusion. Participants will receive nipocalimab or a matching placebo through intravenous infusion. In the subcutaneous substudy, nipocalimab will be administered under the skin. The study includes groups receiving different forms of the drug, with dosing schedules detailed in the protocol. The subcutaneous substudy requires participants to maintain stable doses of corticosteroids and/or immunosuppressants for the first 8 weeks. During the study, participants will undergo assessments including the Myasthenia Gravis - Activities of Daily Living (MG-ADL) score measured at baseline and weeks 22 to 24. Blood samples will be collected to measure antibody levels and total IgG from before the first dose up to week 8 in the sub-study. Safety and efficacy will be closely monitored throughout the trial period.

Researchers are evaluating the effectiveness, safety, and tolerability of remibrutinib compared to a placebo in adults with Generalized Myasthenia Gravis (gMG) who are already receiving stable standard-of-care treatment. This Phase III study is randomized, double-blind, placebo-controlled, and involves multiple centers. The study aims to provide new insights into treatment options for people living with gMG. Participants will be randomly assigned in equal numbers to receive either remibrutinib or a placebo during the Core Part, which lasts 6 months and is double-blinded. After this, there is an Extension Part lasting up to 60 months where all participants may receive open-label remibrutinib. The study treatments are administered according to the study protocol, and the trial compares the active drug with placebo to monitor their effects. During the study, participants will be assessed regularly, including measuring changes in their daily living activities affected by myasthenia gravis over six months. Researchers will monitor safety, tolerability, and adherence to treatment. The total participation can extend up to 66 months, including the core and extension periods, with ongoing evaluations and safety follow-up to understand the long-term effects of remibrutinib.