A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
NCT ID: NCT06744920
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2025-02-07
2033-02-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Evaluation of Belimumab in Myasthenia Gravis (MG)
NCT01480596
Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis
NCT05132569
Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
NCT07039916
Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis
NCT06414954
A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
NCT03772587
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study consists of a Core Part (6-months double-blind treatment) and an Extension Part (up to 60-month open-label treatment).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Remibrutinib arm
Core Part: Remibrutinib tablet taken orally
\[Extension Part: Open-label remibrutinib tablet taken orally\]
Remibrutinib (Blinded)
Remibrutinib (Blinded) active treatment
Remibrutinib (Open Label)
Remibrutinib (Open Label) active treatment
Placebo arm
Core Part: Placebo tablet taken orally
\[Extension Part: Open-label remibrutinib tablet taken orally\]
Placebo
Placebo
Remibrutinib (Open Label)
Remibrutinib (Open Label) active treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Remibrutinib (Blinded)
Remibrutinib (Blinded) active treatment
Placebo
Placebo
Remibrutinib (Open Label)
Remibrutinib (Open Label) active treatment
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
SFM Clinical Research LLC
Boca Raton, Florida, United States
Homestead Assoc In Research Inc
Homestead, Florida, United States
AdventHealth
Orlando, Florida, United States
Neurological Services of Orlando PA
Orlando, Florida, United States
Mid Atlantic Epilepsy and Sleep Ctr
Bethesda, Maryland, 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
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
Novartis Investigative Site
Kogarah, New South Wales, Australia
Novartis Investigative Site
Fitzroy, Victoria, Australia
Novartis Investigative Site
Southport, , Australia
Novartis Investigative Site
Leuven, Vlaams Brabant, Belgium
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Ottawa, Ontario, Canada
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Shijiazhuang, Hebei, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Wuxi, Jiangsu, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Nice, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Kutaisi, , Georgia
Novartis Investigative Site
Tbilisi, , Georgia
Novartis Investigative Site
Tbilisi, , Georgia
Novartis Investigative Site
Mangalore, Karnataka, India
Novartis Investigative Site
Nashik, Maharashtra, India
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative Site
Ludhiana, Punjab, India
Novartis Investigative Site
Vellore, Tamil Nadu, India
Novartis Investigative Site
Hyderabad, Telangana, India
Novartis Investigative Site
Bergamo, BG, Italy
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Nishinomiya, Hyōgo, Japan
Novartis Investigative Site
Hanamaki, Iwate, Japan
Novartis Investigative Site
Sendai, Miyagi, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Higashi-Matsuyama, Saitama, Japan
Novartis Investigative Site
Koshigaya, Saitama, Japan
Novartis Investigative Site
Shinjuku Ku, Tokyo, Japan
Novartis Investigative Site
Chiba, , Japan
Novartis Investigative Site
Fukushima, , Japan
Novartis Investigative Site
Hiroshima, , Japan
Novartis Investigative Site
Lublin, Lublin Voivodeship, Poland
Novartis Investigative Site
Lublin, Lublin Voivodeship, Poland
Novartis Investigative Site
Krakow, POL, Poland
Novartis Investigative Site
Bydgoszcz, Woj Kujawsko Pomorskie, Poland
Novartis Investigative Site
Bydgoszcz, , Poland
Novartis Investigative Site
Katowice, , Poland
Novartis Investigative Site
Lodz, , Poland
Novartis Investigative Site
Lublin, , Poland
Novartis Investigative Site
Lublin, , Poland
Novartis Investigative Site
Poznan, , Poland
Novartis Investigative Site
Skorzewo, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Brasov, , Romania
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Sibiu, , Romania
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Busan, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Lleida, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Málaga, , Spain
Novartis Investigative Site
Valencia, , Spain
Novartis Investigative Site
Kaohsiung City, , Taiwan
Novartis Investigative Site
Tainan, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Taoyuan District, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Novartis Pharmaceuticals
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-510026-32
Identifier Type: OTHER
Identifier Source: secondary_id
CLOU064O12301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.