NCT06744920

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate the efficacy, safety and tolerability of remibrutinib in gMG patients who are on stable SOC treatment. Approximately 180 eligible participants will be randomized in a ratio of 1:1, to receive either remibrutinib or matching placebo. The study consists of a Core Part (6-months double-blind treatment) and an Extension Part (up to 60-month open-label treatment).

Conditions

• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Remibrutinib (Blinded)	Remibrutinib (Blinded) active treatment
OTHER	Placebo	Placebo
DRUG	Remibrutinib (Open Label)	Remibrutinib (Open Label) active treatment

Timeline

• Start date: 2025-02-07
• Primary completion: 2028-02-25
• Completion: 2033-02-26
• First posted: 2024-12-20
• Last updated: 2026-04-06

Locations

95 sites across 16 countries: United States, Argentina, Australia, Belgium, Canada, China, France, Georgia, India, Italy, Japan, Poland, Romania, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study