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

Launched by NOVARTIS PHARMACEUTICALS · Dec 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Remibrutinib to see how well it works compared to a placebo (a treatment with no active medication) in adults with Generalized Myasthenia Gravis (gMG). gMG is a condition that affects the muscles, causing weakness, and this study aims to find out if Remibrutinib can improve symptoms safely and effectively for patients who are already on stable standard treatments.

To participate, you must be an adult between 18 and 75 years old with a confirmed diagnosis of gMG and specific test results showing the presence of certain antibodies. Participants should also have a certain level of muscle weakness as measured by a scoring system and must be able to safely swallow the study medication. If you join the study, you will be monitored closely, and you may receive either the study drug or a placebo. It's important to know that there are some exclusions, such as recent treatments that could interfere with the study. If you have any questions about your eligibility or what the trial entails, don't hesitate to ask your healthcare provider.

Gender

ALL

Eligibility 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.