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).
Interventions
Placebo
Remibrutinib (Blinded)
Remibrutinib (Open Label)
Eligibility 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:
* 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
Other protocol-defined inclusion/exclusion criteria may apply.
Novartis Investigative Site
Recruiting
Kogarah,New South Wales,2217,Australia
Neurological Services of Orlando PA
Recruiting
Orlando,Florida,32806,United States
Daniel H Jacobs
Univ Cali Irvine ALS Neuromuscular
Recruiting
Orange,California,92868,United States
Ali Habib
Dent Neurological Institute
Recruiting
Buffalo,New York,14209,United States
Bennett Myers
Houston Methodist Hospital
Recruiting
Houston,Texas,77030,United States
Ericka Greene
SFM Clinical Research LLC
Recruiting
Boca Raton,Florida,33487,United States
Marc Feinberg
Neuromuscular Research Center
Recruiting
Phoenix,Arizona,85013,United States
Kumaraswamy Sivakumar
Lucia Rodriguez
University of WA Division of Cardio
Recruiting
Seattle,Washington,98195,United States
Barbara Jane Distad
Homestead Assoc In Research Inc
Recruiting
Homestead,Florida,33033,United States
Christopher Jimenez
Honor Health Research Institute
Recruiting
Scottsdale,Arizona,85258,United States
Anne Hatch
Worldwide Contacts
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