Recruiting

Phase 3

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

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06744920

Conditions

Generalized Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Remibrutinib (Blinded)

Placebo

Remibrutinib (Open Label)

Study Details

Brief 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.

Conditions

Generalized Myasthenia Gravis

Study ID

NCT06744920

Start date

Feb 7, 2025

Status verified date

Jul, 2026

Completion date

Feb 26, 2033

Anticipated

Primary completion date

Feb 25, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Adult patients with gMG (age 18-85 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 receiving a 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:

Prior to baseline have been treated with intravenous immunoglobulins or plasma exchange (IVIg/PLEX) in the past month, with rituximab in the past 6 months, eculizumab in the past 2 months, ravulizumab or other complement inhibitors in the past 3 months, efgartigimod or other anti-FcRn therapies in the past 3 months, or had a thymectomy in the past 6 months or a planned thymectomy during the trial period
Women of child bearing potential, defined as all women physiologically capable of becoming pregnant, from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of study treatment

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

\[Extension Part: Open-label remibrutinib tablet taken orally\]

Interventions

Remibrutinib (Blinded)

Remibrutinib (Blinded) active treatment

Placebo

Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Primary outcome measure

Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score [ Time Frame: Baseline to Month 6 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Neuromuscular Research Center

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Lucia Rodriguez

nrsresearch@nrcaz.com

Principal Investigator:

Kumaraswamy Sivakumar

Honor Health Research Institute

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Kristy Osgood

+1 480 323 3990 kosgood@honorhealth.com

Principal Investigator:

Anne Hatch

Fullerton Neuro and Headache Ctr

Recruiting

Fullerton, California, United States, 92835

Contacts

Alexandra Vasquez

+1 714 738 0800 avasquez@fullertonneuro.net

Principal Investigator:

Jack H Florin

University Of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Nasrin Ahmed

+1 323 865 3900 nahmed@advmedresearch.com

Principal Investigator:

Said R Beydoun

Univ Cali Irvine ALS Neuromuscular

Recruiting

Orange, California, United States, 92868

Contacts

Karina Bjazevic

+1 714 456 2332 kbjazevi@hs.uci.edu

Principal Investigator:

Ali Habib

California Pacific Medical Center

Recruiting

Sacramento, California, United States, 94115

Contacts

Jamal Baptista

+1 415 600 3604 jamal.baptista@adventhealth.com

Principal Investigator:

Liberty Jenkins

Medstar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010-2975

Contacts

Anu Bhooshan

anu.r.bhooshan@medstar.net

Principal Investigator:

Nicholas Streicher

SFM Clinical Research LLC

Recruiting

Boca Raton, Florida, United States, 33487

Contacts

Gabrielle Demaria

+1 561 939 0300 Gabrielle@sfmresearch.com

Principal Investigator:

Marc Feinberg

Homestead Assoc In Research Inc

Recruiting

Homestead, Florida, United States, 33033

Contacts

Daydene Ordaz

+1 305 246 0873 dordaz@associatesinresearch.com

Principal Investigator:

Christopher Jimenez

Neurology Associates PA

Recruiting

Maitland, Florida, United States, 32751

Contacts

Kelly Holley

+1 407 647 5996 admin@naparesearch.com

Principal Investigator:

Arnaldo Isa

AdventHealth

Recruiting

Orlando, Florida, United States, 32804

Contacts

Samuel Pierre Louis

+1 407 303 6729 samuel.pierrelouis@adventhealth.com

Principal Investigator:

Anita Fletcher

Neurological Services of Orlando PA

Recruiting

Orlando, Florida, United States, 32806

Contacts

Tanya Palafox

+1 941 400 4578 tanya.nso@outlook.com

Principal Investigator:

Daniel H Jacobs

University of Chicago Medical Centr

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Deekshitha Turaka

deekshitha.turaka@bsd.uchicago.edu

Principal Investigator:

Kourosh Rezania

Mid Atlantic Epilepsy and Sleep Ctr

Recruiting

Bethesda, Maryland, United States, 20817-1807

Contacts

Arkady Barber

barbera@epilepsydc.com

Principal Investigator:

Jonathan Ross

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Isaac McCarthy

imccarthy2@mgh.harvard.edu

Principal Investigator:

Amanda Guidon

Michigan State University-Department of Neurology

Recruiting

East Lansing, Michigan, United States, 48824

Contacts

Aubrey Alexander

alexaub@msu.edu

Principal Investigator:

Amit Sachdev

Dent Neurological Institute

Recruiting

Buffalo, New York, United States, 14209

Contacts

Anna Mattle

+1 716 887 4799 amattle@dentinstitute.com

Principal Investigator:

Bennett Myers

Univ of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Kaiya Payne

+1 513 475 8730 payne2ka@ucmail.uc.edu

Principal Investigator:

Hani Kushlaf

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Debbie Hastings

hastind@ccf.org

Principal Investigator:

Yuebing Li

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Gabriela Niizawa

+1 412 692 4920 niizawaga@upmc.edu

Principal Investigator:

Fang Sun

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Delrose Vernon

+1 713 441 9484 davernon@houstonmethodist.org

Principal Investigator:

Ericka Greene

UT Health Science Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Christina Grun Hayes

christina.grunhayes@uth.tmc.edu

Principal Investigator:

Thy Nguyen

University of WA Division of Cardio

Recruiting

Seattle, Washington, United States, 98195

Contacts

Kaycie Opiyo

+1 206 685 1048 tkaycie@uw.edu

Principal Investigator:

Barbara Jane Distad

Center for Neurological Disorders G

Recruiting

Greenfield, Wisconsin, United States, 53228-1321

Contacts

Emily Barraza

Emily.barraza@cndmilwaukee.com

Principal Investigator:

Bhupendra Khatri

Novartis Investigative Site

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Novartis Investigative Site

Recruiting

London, Ontario, Canada, N6A 5W9

Novartis Investigative Site

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Novartis Investigative Site

Recruiting

Québec, Quebec, Canada, G1J 1Z4

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

Myasthenia Gravis
gMG
Generalized Myasthenia Gravis
LOU064
Remibrutinib
placebo-controlled
double-blind
phase III

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-29.