Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Details

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).

Keywords

Generalized Myasthenia Gravis, Myasthenia Gravis, gMG, LOU064, Remibrutinib, placebo-controlled, double-blind, phase III, Muscle Weakness, Remibrutinib (Blinded), Remibrutinib (Open Label)

Eligibility

You can join if…

Open to people ages 18-75

  • 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

You CAN'T join if...

  • 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, 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.

Locations

  • Univ Cali Irvine ALS Neuromuscular accepting new patients
    Orange California 92868 United States
  • Neuromuscular Research Center accepting new patients
    Phoenix Arizona 85013 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT06744920
Phase
Phase 3 Myasthenia Gravis Research Study
Study Type
Interventional
Participants
Expecting 180 study participants
Last Updated