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Clinical Trials in Spain / NCT06744920
Active, not recruiting Phase 3

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

NCT06744920 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2025-02-07
Last updated
2026-09-28

Condition(s) studied

Generalized Myasthenia Gravis

Investigational drug(s) / intervention(s)

Remibrutinib (Blinded) →PlaceboRemibrutinib (Open Label) →

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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (120)

FacilityCityRegionStatus
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 Spain

Other trials for the same condition

Official registry record

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 Spain