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.

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2021250004

Enrollment

Registered

2025-05-23

Start date

2025-07-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

generalized Myasthenia Gravis

Interventions

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-lab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

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, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of study treatment

Design outcomes

Primary

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

Countries

Australia, Belgium, Canada, China, France, Germany, India, Japan, Korea, Netherland, Poland, Romania, Spain, Taiwan, US

Contacts

Public ContactHideki Maruyama

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026