Myasthenia Gravis Clinical Trials

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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

Status: Recruiting
Location: See all (129) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Neuromuscular Research Center
RECRUITING
Phoenix
Honor Health Research Institute
RECRUITING
Scottsdale
California
Fullerton Neuro and Headache Ctr
RECRUITING
Fullerton
University Of Southern California
RECRUITING
Los Angeles
Univ Cali Irvine ALS Neuromuscular
RECRUITING
Orange
California Pacific Medical Center
RECRUITING
Sacramento
Washington, D.c.
Medstar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
SFM Clinical Research LLC
RECRUITING
Boca Raton
Homestead Assoc In Research Inc
RECRUITING
Homestead
Neurology Associates PA
RECRUITING
Maitland
AdventHealth
RECRUITING
Orlando
Neurological Services of Orlando PA
RECRUITING
Orlando
Illinois
University of Chicago Medical Centr
RECRUITING
Chicago
Massachusetts
Neuromuscular Diagnostic Center
RECRUITING
Boston
Maryland
Mid Atlantic Epilepsy and Sleep Ctr
RECRUITING
Bethesda
Michigan
Michigan State University-Department of Neurology
RECRUITING
East Lansing
New York
Dent Neurological Institute
RECRUITING
Buffalo
Ohio
Univ of Cincinnati Medical Center
RECRUITING
Cincinnati
Cleveland Clinic Foundation
RECRUITING
Cleveland
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Texas
Houston Methodist Hospital
RECRUITING
Houston
UT Health Science Center
RECRUITING
Houston
Washington
University of WA Division of Cardio
RECRUITING
Seattle
Wisconsin
Center for Neurological Disorders G
RECRUITING
Greenfield
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Capital Federal
Novartis Investigative Site
RECRUITING
Rosario
Novartis Investigative Site
RECRUITING
San Miguel De Tucumán
Australia
Novartis Investigative Site
RECRUITING
Fitzroy
Novartis Investigative Site
RECRUITING
Kogarah
Novartis Investigative Site
RECRUITING
Southport
Belgium
Novartis Investigative Site
RECRUITING
Leuven
Brazil
Novartis Investigative Site
RECRUITING
Brasília
Novartis Investigative Site
RECRUITING
Caxias Do Sul
Novartis Investigative Site
RECRUITING
Porto Alegre
Novartis Investigative Site
RECRUITING
Porto Alegre
Novartis Investigative Site
RECRUITING
Salvador
Novartis Investigative Site
RECRUITING
São Paulo
Canada
Novartis Investigative Site
RECRUITING
Edmonton
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
Ottawa
Novartis Investigative Site
RECRUITING
Québec
China
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Changchun
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
RECRUITING
Hefei
Novartis Investigative Site
RECRUITING
Qingdao
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Shijiazhuang
Novartis Investigative Site
RECRUITING
Wuhan
Novartis Investigative Site
RECRUITING
Wuxi
Novartis Investigative Site
RECRUITING
Zhengzhou
France
Novartis Investigative Site
RECRUITING
Bordeaux
Novartis Investigative Site
RECRUITING
Nice
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Strasbourg
Novartis Investigative Site
RECRUITING
Toulouse
Georgia
Novartis Investigative Site
RECRUITING
Kutaisi
Novartis Investigative Site
RECRUITING
Tbilisi
Novartis Investigative Site
RECRUITING
Tbilisi
Germany
Novartis Investigative Site
RECRUITING
Frankfurt Am Main
Novartis Investigative Site
RECRUITING
Gummersbach
Novartis Investigative Site
RECRUITING
Hamburg
Novartis Investigative Site
RECRUITING
Münster
India
Novartis Investigative Site
RECRUITING
Gurugram
Novartis Investigative Site
RECRUITING
Hyderabad
Novartis Investigative Site
RECRUITING
Lucknow
Novartis Investigative Site
RECRUITING
Ludhiana
Novartis Investigative Site
RECRUITING
Mangalore
Novartis Investigative Site
RECRUITING
Nashik
Novartis Investigative Site
RECRUITING
New Delhi
Novartis Investigative Site
RECRUITING
Vellore
Italy
Novartis Investigative Site
RECRUITING
Bergamo
Novartis Investigative Site
RECRUITING
Naples
Novartis Investigative Site
RECRUITING
Orbassano
Japan
Novartis Investigative Site
RECRUITING
Chiba
Novartis Investigative Site
RECRUITING
Fukuoka
Novartis Investigative Site
RECRUITING
Fukushima
Novartis Investigative Site
RECRUITING
Hanamaki
Novartis Investigative Site
RECRUITING
Higashi-matsuyama
Novartis Investigative Site
RECRUITING
Hiroshima
Novartis Investigative Site
RECRUITING
Koshigaya
Novartis Investigative Site
RECRUITING
Nishinomiya
Novartis Investigative Site
RECRUITING
Sapporo
Novartis Investigative Site
RECRUITING
Sapporo
Novartis Investigative Site
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Sendai
Novartis Investigative Site
RECRUITING
Shinjuku Ku
Novartis Investigative Site
RECRUITING
Suita
Poland
Novartis Investigative Site
RECRUITING
Bydgoszcz
Novartis Investigative Site
RECRUITING
Bydgoszcz
Novartis Investigative Site
RECRUITING
Katowice
Novartis Investigative Site
RECRUITING
Krakow
Novartis Investigative Site
RECRUITING
Lodz
Novartis Investigative Site
RECRUITING
Lublin
Novartis Investigative Site
RECRUITING
Lublin
Novartis Investigative Site
RECRUITING
Lublin
Novartis Investigative Site
RECRUITING
Lublin
Novartis Investigative Site
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Poznan
Novartis Investigative Site
RECRUITING
Rzeszów
Novartis Investigative Site
RECRUITING
Skorzewo
Novartis Investigative Site
RECRUITING
Szczecin
Novartis Investigative Site
RECRUITING
Warsaw
Novartis Investigative Site
RECRUITING
Warsaw
Republic of Korea
Novartis Investigative Site
RECRUITING
Busan
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Romania
Novartis Investigative Site
RECRUITING
Brasov
Novartis Investigative Site
RECRUITING
Bucharest
Novartis Investigative Site
RECRUITING
Sibiu
Serbia
Novartis Investigative Site
RECRUITING
Belgrade
Novartis Investigative Site
RECRUITING
Niš
Novartis Investigative Site
RECRUITING
Novi Sad
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
L'hospitalet De Llobregat
Novartis Investigative Site
RECRUITING
Lleida
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Málaga
Novartis Investigative Site
RECRUITING
Santiago Compostela
Novartis Investigative Site
RECRUITING
Valencia
Taiwan
Novartis Investigative Site
RECRUITING
Kaohsiung City
Novartis Investigative Site
RECRUITING
Tainan
Novartis Investigative Site
RECRUITING
Taipei
Novartis Investigative Site
RECRUITING
Taipei
Novartis Investigative Site
RECRUITING
Taoyuan
United Kingdom
Novartis Investigative Site
RECRUITING
London
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2025-02-07
Estimated Completion Date: 2033-02-26
Participants
Target number of participants: 180
Treatments
Experimental: Remibrutinib arm
Core Part: Remibrutinib tablet taken orally~\[Extension Part: Open-label remibrutinib tablet taken orally\]
Placebo_comparator: Placebo arm
Core Part: Placebo tablet taken orally~\[Extension Part: Open-label remibrutinib tablet taken orally\]
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov