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 (CLOU064O12301)

Novartis Pharma. K.K.0 个研究点目标入组 14 人开始时间: 待定最近更新: 2025年5月23日

试验速览

暂无简介。

•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

•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

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

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发起方

Novartis Pharma. K.K.