Last Update: Jul 29, 2026 A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Remibrutinib in Patients With Generalized Myasthenia Gravis, Followed by an Open-label Extension Phase ClinicalTrials.gov Identifier: [NCT06744920](https://clinicaltrials.gov/ct2/show/NCT06744920) Novartis Reference Number:CLOU064O12301 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment. This study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate the efficacy, safety and tolerability of remibrutinib in gMG patients who are on stable SOC treatment. Approximately 180 eligible participants will be randomized in a ratio of 1:1, to receive either remibrutinib or matching placebo. The study consists of a Core Part (6-months double-blind treatment) and an Extension Part (up to 60-month open-label treatment). Condition Generalized Myasthenia Gravis Phase Phase3 Overall Status Recruiting Number of Participants180 Start Date Feb 07, 2025 Completion Date Feb 26, 2033 Gender All Age(s) 18 Years - 85 Years (Adult, Older Adult) ## Interventions Other ### Placebo Placebo Drug ### Remibrutinib (Blinded) Remibrutinib (Blinded) active treatment Drug ### Remibrutinib (Open Label) Remibrutinib (Open Label) active treatment ## Eligibility Criteria Inclusion Criteria: \* Adult patients with gMG (age 18-85 years) \* Confirmed diagnosis of Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG at screening and likely not in need of a respirator for the duration of the study, as judged by the Investigator \* Documented evidence of positive serologic testing for AChR+ antibody or MuSK+ antibody at screening, OR seronegative for both AChR and MuSK antibodies at screening \* Baseline MG-ADL score ≥ 6 with ≥ 50% of the total score due to non ocular symptoms \* Participants who have been receiving a standard-of-care treatment as specified in the protocol \* Able to safely swallow the study medication according to investigator clinical judgement based on a bedside swallowing test or another formal swallowing test in line with local practice, both at Screening and Baseline Exclusion Criteria: \* Prior to baseline have been treated with intravenous immunoglobulins or plasma exchange (IVIg/PLEX) in the past month, with rituximab in the past 6 months, eculizumab in the past 2 months, ravulizumab or other complement inhibitors in the past 3 months, efgartigimod or other anti-FcRn therapies in the past 3 months, or had a thymectomy in the past 6 months or a planned thymectomy during the trial period \* Women of child bearing potential, defined as all women physiologically capable of becoming pregnant, from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of study treatment Other protocol-defined inclusion/exclusion criteria may apply. 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