ClinicaliQ Trial Snapshot
- A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis — Recruiting • Phase III • Oncology • NCT06744920.
- Treatment being tested: Remibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, is being evaluated as an add-on therapy to standard-of-care treatment in generalised myasthenia gravis (gMG), with efficacy, safety and tolerability compared against placebo.
- Patient eligibility overview: Adult patients with diagnosed generalised myasthenia gravis who are already stabilised on conventional standard-of-care medications are eligible; this ensures a defined baseline population for assessing additional benefit.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.