RecruitingPhase 3NCT06744920

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

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

Sponsor

Novartis Pharmaceuticals

Enrollment

180 participants

Start Date

Feb 7, 2025

Study Type

INTERVENTIONAL

Conditions

Generalized Myasthenia Gravis

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo, a drug called Remibrutinib (Blinded), and others for people with generalized myasthenia gravis. The study is currently recruiting participants at 129 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRemibrutinib (Blinded)

Remibrutinib (Blinded) active treatment

OTHERPlacebo

Placebo

DRUGRemibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Locations(129)

Neuromuscular Research Center

Phoenix, Arizona, United States

Honor Health Research Institute

Scottsdale, Arizona, United States

Fullerton Neuro and Headache Ctr

Fullerton, California, United States

University Of Southern California

Los Angeles, California, United States

Univ Cali Irvine ALS Neuromuscular

Orange, California, United States

California Pacific Medical Center

Sacramento, California, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

SFM Clinical Research LLC

Boca Raton, Florida, United States

Homestead Assoc In Research Inc

Homestead, Florida, United States

Neurology Associates PA

Maitland, Florida, United States

AdventHealth

Orlando, Florida, United States

Neurological Services of Orlando PA

Orlando, Florida, United States

University of Chicago Medical Centr

Chicago, Illinois, United States

Mid Atlantic Epilepsy and Sleep Ctr

Bethesda, Maryland, United States

Neuromuscular Diagnostic Center

Boston, Massachusetts, United States

Michigan State University-Department of Neurology

East Lansing, Michigan, United States

Dent Neurological Institute

Buffalo, New York, United States

Univ of Cincinnati Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Houston Methodist Hospital

Houston, Texas, United States

UT Health Science Center

Houston, Texas, United States

University of WA Division of Cardio

Seattle, Washington, United States

Center for Neurological Disorders G

Greenfield, Wisconsin, United States

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

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Caba, Argentina

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Capital Federal, Argentina

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San Miguel de Tucumán, Argentina

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Kogarah, New South Wales, Australia

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Fitzroy, Victoria, Australia

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Southport, Australia

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Leuven, Vlaams Brabant, Belgium

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Salvador, Estado de Bahia, Brazil

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Brasília, Federal District, Brazil

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Caxias do Sul, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, Brazil

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Edmonton, Alberta, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Québec, Quebec, Canada

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Hefei, Anhui, China

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Guangzhou, Guangdong, China

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Shijiazhuang, Hebei, China

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Zhengzhou, Henan, China

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Wuhan, Hubei, China

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Wuxi, Jiangsu, China

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Changchun, Jilin, China

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Beijing, China

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Beijing, China

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Qingdao, China

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Shanghai, China

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Shanghai, China

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Bordeaux, France

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Nice, France

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Paris, France

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Paris, France

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Strasbourg, France

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Toulouse, France

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Kutaisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Frankfurt am Main, Hesse, Germany

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Gummersbach, Germany

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Hamburg, Germany

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Münster, Germany

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Gurugram, Haryana, India

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Mangalore, Karnataka, India

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Nashik, Maharashtra, India

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New Delhi, National Capital Territory of Delhi, India

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Ludhiana, Punjab, India

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Vellore, Tamil Nadu, India

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Hyderabad, Telangana, India

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Lucknow, Uttar Pradesh, India

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Bergamo, BG, Italy

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Orbassano, TO, Italy

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Naples, Italy

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Nishinomiya, Hyōgo, Japan

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Hanamaki, Iwate, Japan

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Sendai, Miyagi, Japan

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Suita, Osaka, Japan

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Higashi-Matsuyama, Saitama, Japan

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Koshigaya, Saitama, Japan

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Shinjuku Ku, Tokyo, Japan

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Chiba, Japan

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Fukuoka, Japan

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Fukushima, Japan

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Hiroshima, Japan

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Lublin, Lublin Voivodeship, Poland

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Lublin, Lublin Voivodeship, Poland

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Krakow, POL, Poland

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Bydgoszcz, Woj Kujawsko Pomorskie, Poland

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Bydgoszcz, Poland

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Katowice, Poland

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Lodz, Poland

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Lublin, Poland

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Lublin, Poland

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Poznan, Poland

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Rzeszów, Poland

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Skorzewo, Poland

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Szczecin, Poland

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Warsaw, Poland

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Warsaw, Poland

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Brasov, Romania

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Bucharest, Romania

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Sibiu, Romania

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Belgrade, Serbia

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Niš, Serbia

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Novi Sad, Serbia

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Busan, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Santiago Compostela, A Coruna, Spain

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L'Hospitalet de Llobregat, Barcelona, Spain

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Barcelona, Spain

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Lleida, Spain

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Madrid, Spain

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Málaga, Spain

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Valencia, Spain

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Kaohsiung City, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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London, United Kingdom

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NCT06744920

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