Investigating Remibrutinib for Generalized Myasthenia Gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Neuromuscular Research Center
  Phoenix, Arizona, United States Recruiting
• Honor Health Research Institute
  Scottsdale, Arizona, United States Recruiting
• Fullerton Neuro and Headache Ctr
  Fullerton, California, United States Recruiting
• University Of Southern California
  Los Angeles, California, United States Recruiting
• Univ Cali Irvine ALS Neuromuscular
  Orange, California, United States Recruiting
• SFM Clinical Research LLC
  Boca Raton, Florida, United States Recruiting

+50 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.