RELIEVE · CLOU064O12301
Research project examining the use of remibrutinib in patients with generalized myasthenia gravis. A placebo-controlled design is used to determine the impact and side effects of the compound, followed by a period of open-label administration.
A phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of remibrutinib in patients with generalized myasthenia gravis, followed by an open-label extension phase.
Sponsor: NOVARTIS
Phase: III
Status: Follow-up
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Public study eligibility criteria
Inclusion
- Adult patients with gMG (age 18-85 years)
- Confirmed diagnosis of 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.
- Baseline MG-ADL score ≥6, with ≥50% of the total score due to non-ocular symptoms
- 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
- 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 childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of study treatment.