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
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Southport,4215,Australia
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Fitzroy,Victoria,3065,Australia
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Kogarah,New South Wales,2217,Australia
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Leuven,Vlaams Brabant,3000,Belgium
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London,Ontario,N6a 5w9,Canada
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Ottawa,Ontario,K1h 8l6,Canada
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Wuxi,Jiangsu,214023,China
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Shijiazhuang,Hebei,50030,China
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Guangzhou,Guangdong,510030,China
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Shanghai,200040,China
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Shanghai,200080,China
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Paris,75013,France
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Nice,06001,France
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Toulouse,31059,France
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Bordeaux,33076,France
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Nashik,Maharashtra,422005,India
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Ludhiana,Punjab,141001,India
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Mangalore,Karnataka,575002,India
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Vellore,Tamil Nadu,632 004,India
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Hanamaki,Iwate,025-0082,Japan
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Fukushima,Fukushima,960 1295,Japan
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Sapporo,Hokkaido,060-8543,Japan
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Sapporo,Hokkaido,063-0005,Japan
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Suita,Osaka,565 0871,Japan
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Higashi-Matsuyama,Saitama,355-0005,Japan
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Koshigaya,Saitama,343-8555,Japan
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Shinjuku Ku,Tokyo,160-0023,Japan
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Nishinomiya,Hyōgo,663 8501,Japan
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Sendai,Miyagi,983 8520,Japan
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Chiba,Chiba,2608677,Japan
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Hiroshima,734-8551,Japan
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Bydgoszcz,Woj Kujawsko Pomorskie,85-796,Poland
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Warsaw,02 106,Poland
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Warsaw,01-684,Poland
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Katowice,40-689,Poland
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Poznan,61-731,Poland
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Krakow,POL,31 505,Poland
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Lublin,Lublin Voivodeship,20-064,Poland
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Bucharest,040215,Romania
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Brasov,500283,Romania
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Sibiu,550245,Romania
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Busan,49241,South Korea
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Seoul,134 727,South Korea
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Seoul,03080,South Korea
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Seoul,03722,South Korea
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Lleida,25198,Spain
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Málaga,29009,Spain
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Madrid,28034,Spain
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L'Hospitalet de Llobregat,Barcelona,08907,Spain
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Taipei,10002,Taiwan
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Taoyuan District,33305,Taiwan
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Tainan City,70403,Taiwan
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Kaohsiung City,83301,Taiwan
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Taipei,111045,Taiwan
Neurological Services of Orlando PA
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Orlando,Florida,32806,United States
Daniel H Jacobs
Dent Neurological Institute
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Buffalo,New York,14209,United States
Bennett Myers
Neuromuscular Research Center
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Phoenix,Arizona,85013,United States
Kumaraswamy Sivakumar
Lucia Rodriguez
Honor Health Research Institute
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Scottsdale,Arizona,85258,United States
Anne Hatch
Univ Cali Irvine ALS Neuromuscular
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Orange,California,92868,United States
Ali Habib
SFM Clinical Research LLC
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Boca Raton,Florida,33487,United States
Marc Feinberg
Homestead Assoc In Research Inc
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Homestead,Florida,33033,United States
Christopher Jimenez
Mid Atlantic Epilepsy and Sleep Ctr
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Bethesda,Maryland,20817-1807,United States
Salman Hashmi
Jonathan Ross
Center for Neurological Disorders G
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Greenfield,Wisconsin,53228-1321,United States
Tayo Olapo
Bhupendra Khatri
Houston Methodist Hospital
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Houston,Texas,77030,United States
Ericka Greene
University of WA Division of Cardio
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Seattle,Washington,98195,United States
Barbara Jane Distad
Advent Health Cancer Institute
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Orlando,Florida,32804,United States
Anita Fletcher
Fullerton Neuro and Headache Ctr
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Fullerton,California,92835,United States
Jack H Florin
University Of Southern California
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Los Angeles,California,90033,United States
Said R Beydoun
Michigan State University-Department of Neurology
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East Lansing,Michigan,48824,United States
Amit Sachdev
Univ of Cincinnati Medical Center
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Cincinnati,Ohio,45219,United States
Hani Kushlaf
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