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Investigating Remibrutinib for 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

Phase 3 Interventional Novartis · NCT06744920

This study is testing if a new medication called remibrutinib can help adults with generalized myasthenia gravis feel better compared to a placebo while they continue their usual treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsrituximab, eculizumab, ravulizumab, Remibrutinib
Locations100 sites (Phoenix, Arizona and 99 other locations)
Trial IDNCT06744920 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the efficacy, safety, and tolerability of remibrutinib compared to a placebo in adult patients with generalized myasthenia gravis (gMG) who are on stable standard-of-care treatment. The study is randomized, double-blind, and multicenter, involving approximately 180 participants who will be assigned to receive either remibrutinib or a matching placebo in a 1:1 ratio. The trial consists of a 6-month double-blind treatment phase followed by an optional 60-month open-label extension phase.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of gMG and specific serological markers.

Not a fit: Patients who have recently undergone treatment with intravenous immunoglobulins or plasma exchange may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of generalized myasthenia gravis, enhancing patients' quality of life.

How similar studies have performed: Previous studies have shown promise in treating generalized myasthenia gravis with similar approaches, but this specific treatment is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

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, 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.

Where this trial is running

Phoenix, Arizona and 99 other locations

+50 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Generalized Myasthenia GravisMyasthenia GravisgMGLOU064Remibrutinibplacebo-controlleddouble-blindphase III
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.