A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Generalized Myasthenia Gravis

In brief

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.

Key facts

Study ID

NCT06744920

Run by

Novartis Pharmaceuticals

People needed

180

Starts

2025-02-07

Expected to finish

2033-02-26

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Honor Health Research Institute — Scottsdale, Arizona, United States (enrolling)
• Fullerton Neuro and Headache Ctr — Fullerton, California, United States (enrolling)
• University Of Southern California — Los Angeles, California, United States (enrolling)
• Univ Cali Irvine ALS Neuromuscular — Orange, California, United States (enrolling)
• California Pacific Medical Center — Sacramento, California, United States (enrolling)
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• SFM Clinical Research LLC — Boca Raton, Florida, United States (enrolling)
• Homestead Assoc In Research Inc — Homestead, Florida, United States (enrolling)
• Neurology Associates PA — Maitland, Florida, United States (enrolling)
• AdventHealth — Orlando, Florida, United States (enrolling)
• Neurological Services of Orlando PA — Orlando, Florida, United States (enrolling)
• University of Chicago Medical Centr — Chicago, Illinois, United States (enrolling)
• Mid Atlantic Epilepsy and Sleep Ctr — Bethesda, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Michigan State University-Department of Neurology — East Lansing, Michigan, United States (enrolling)
• Dent Neurological Institute — Buffalo, New York, United States (enrolling)
• Univ of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Houston Methodist Hospital — Houston, Texas, United States (enrolling)
• UT Health Science Center — Houston, Texas, United States (enrolling)
• University of WA Division of Cardio — Seattle, Washington, United States (enrolling)
• Center for Neurological Disorders G — Greenfield, Wisconsin, United States (enrolling)
• Novartis Investigative Site — Rosario, Santa Fe Province, Argentina (enrolling)
• Neuromuscular Research Center — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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