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 (64) 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
Florida
SFM Clinical Research LLC
RECRUITING
Boca Raton
Homestead Assoc In Research Inc
RECRUITING
Homestead
Advent Health Cancer Institute
RECRUITING
Orlando
Neurological Services of Orlando PA
RECRUITING
Orlando
Maryland
American Oncology Partners PA Center for Cancer & Blood Disorders
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
Texas
Houston Methodist Hospital
RECRUITING
Houston
Washington
University of WA Division of Cardio
RECRUITING
Seattle
Wisconsin
Center for Neurological Disorders G
RECRUITING
Greenfield
Other Locations
Australia
Novartis Investigative Site
RECRUITING
Fitzroy
Novartis Investigative Site
RECRUITING
Kogarah
Novartis Investigative Site
RECRUITING
Southport
Belgium
Novartis Investigative Site
RECRUITING
Leuven
Canada
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
Ottawa
China
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Wuxi
France
Novartis Investigative Site
RECRUITING
Nice
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Toulouse
India
Novartis Investigative Site
RECRUITING
Ludhiana
Novartis Investigative Site
RECRUITING
Nashik
Novartis Investigative Site
RECRUITING
Vellore
Japan
Novartis Investigative Site
RECRUITING
Chiba
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
RECRUITING
Sendai
Novartis Investigative Site
RECRUITING
Shinjuku Ku
Novartis Investigative Site
RECRUITING
Suita
Poland
Novartis Investigative Site
RECRUITING
Bydgoszcz
Novartis Investigative Site
RECRUITING
Katowice
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
Spain
Novartis Investigative Site
RECRUITING
L'hospitalet De Llobregat
Novartis Investigative Site
RECRUITING
Lleida
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Málaga
Taiwan
Novartis Investigative Site
RECRUITING
Kaohsiung City
Novartis Investigative Site
RECRUITING
Tainan City
Novartis Investigative Site
RECRUITING
Taipei
Novartis Investigative Site
RECRUITING
Taipei
Novartis Investigative Site
RECRUITING
Taoyuan District
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