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A study to evaluate the efficacy, safety, and tolerability of remibrutinib tablets compared with placebo tablets in patients aged 18 to 75 with generalized Myasthenia Gravis who are receiving standard treatment.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	generalized Myasthenia Gravis
Date of first enrollment	30/05/2025
Target sample size	14
Countries of recruitment	US,Japan,France,Japan,Germany,Japan,Poland,Japan,China,Japan,Spain,Japan,India,Japan,Canada,Japan,Taiwan,Japan,Australia,Japan,Korea,Japan,Romania,Japan,Belgium,Japan,Netherland,Japan
Study type	Interventional
Intervention(s)	Remibrutinib arm Core Part: Remibrutinib tablet taken orally [Extension Part: Open-label remibrutinib tablet taken orally] Placebo arm Core Part: Placebo tablet taken orally [Extension Part: Open-label remibrutinib tablet taken orally]

Outcome(s)

Primary Outcome	Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 75age old
Gender	Both
Include criteria	-Adult patients with gMG (age 18-75 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 on a stable dose of 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
Exclude 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, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of study treatment