A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
Condition(s) studied
Investigational drug(s) / intervention(s)
Remibrutinib (Blinded): Remibrutinib (Blinded) active treatment
Placebo: Placebo
Remibrutinib (Open Label): Remibrutinib (Open Label) active treatment
Study 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
Primary outcome measure(s)
- Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score — Baseline to Month 6
The MG-ADL is a categorical scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. Each item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that function (total score 0 to 24).
Trial sites (120)
| Facility | City | Region | Status |
|---|---|---|---|
| Neuromuscular Research Center | Phoenix | Arizona | |
| Honor Health Research Institute | Scottsdale | Arizona | |
| Fullerton Neuro and Headache Ctr | Fullerton | California | |
| University Of Southern California | Los Angeles | California | |
| California Pacific Medical Center | Sacramento | California | |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | |
| SFM Clinical Research LLC | Boca Raton | Florida | |
| Homestead Assoc In Research Inc | Homestead | Florida | |
| Neurology Associates PA | Maitland | Florida | |
| AdventHealth | Orlando | Florida | |
| Neurological Services of Orlando PA | Orlando | Florida | |
| University of Chicago Medical Centr | Chicago | Illinois | |
| Mid Atlantic Epilepsy and Sleep Ctr | Bethesda | Maryland | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Michigan State University-Department of Neurology | East Lansing | Michigan | |
| Dent Neurological Institute | Buffalo | New York | |
| Cleveland Clinic Foundation | Cleveland | Ohio | |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | |
| Houston Methodist Hospital | Houston | Texas | |
| UT Health Science Center | Houston | Texas | |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | |
| University of WA Division of Cardio | Seattle | Washington | |
| Center for Neurological Disorders G | Greenfield | Wisconsin | |
| Novartis Investigative Site | Rosario | Santa Fe Province | |
| Novartis Investigative Site | Buenos Aires | Argentina | |
| Novartis Investigative Site | Caba | Argentina | |
| Novartis Investigative Site | Capital Federal | Argentina | |
| Novartis Investigative Site | San Miguel de Tucumán | Argentina | |
| Novartis Investigative Site | Fitzroy | Victoria | |
| Novartis Investigative Site | Salvador | Estado de Bahia | |
| Novartis Investigative Site | Brasília | Federal District | |
| Novartis Investigative Site | Caxias do Sul | Rio Grande do Sul | |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | |
| Novartis Investigative Site | São Paulo | Brazil | |
| Novartis Investigative Site | London | Ontario | |
| Novartis Investigative Site | Ottawa | Ontario | |
| Novartis Investigative Site | Québec | Quebec | |
| Novartis Investigative Site | Hefei | Anhui | |
| Novartis Investigative Site | Guangzhou | Guangdong | |
| Novartis Investigative Site | Shijiazhuang | Hebei |
+ 80 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in Australia
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06744920 on ClinicalTrials.gov ↗ ← All trials in Australia