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

NCT06744920

RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Generalized Myasthenia Gravis

Interventions: Remibrutinib (Blinded), Placebo, Remibrutinib (Open Label)

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, France

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 overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Adult patients with gMG (age 18-85 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 receiving a 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, 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

Other protocol-defined inclusion/exclusion criteria may apply.
Locations (130)
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Fullerton, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • Sacramento, California, United States
  • Washington D.C., District of Columbia, United States
  • Boca Raton, Florida, United States
  • Homestead, Florida, United States
  • Maitland, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Chicago, Illinois, United States
  • Bethesda, Maryland, United States
  • Boston, Massachusetts, United States
  • East Lansing, Michigan, United States
  • Buffalo, New York, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Seattle, Washington, United States
  • Greenfield, Wisconsin, United States
  • Rosario, Santa Fe Province, Argentina
  • Caba, Argentina
  • Capital Federal, Argentina
  • San Miguel de Tucumán, Argentina
  • Kogarah, New South Wales, Australia
  • Fitzroy, Victoria, Australia
  • + 100 more on CT.gov