RECRUITINGPhase 3INTERVENTIONAL
A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Remibrutinib in Patients With Generalized Myasthenia Gravis, Followed by an Open-label Extension Phase
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Remibrutinib (Blinded)
Remibrutinib (Blinded) active treatment
OTHER
Placebo
Placebo
DRUG
Remibrutinib (Open Label)
Remibrutinib (Open Label) active treatment
Locations (20)
Neuromuscular Research Center
Phoenix, Arizona, United States
Honor Health Research Institute
Scottsdale, Arizona, United States
Fullerton Neuro and Headache Ctr
Fullerton, California, United States
University Of Southern California
Los Angeles, California, United States
Univ Cali Irvine ALS Neuromuscular
Orange, California, United States
SFM Clinical Research LLC
Boca Raton, Florida, United States
Homestead Assoc In Research Inc
Homestead, Florida, United States
AdventHealth
Orlando, Florida, United States
Neurological Services of Orlando PA
Orlando, Florida, United States
Mid Atlantic Epilepsy and Sleep Ctr
Bethesda, Maryland, United States
Michigan State University-Department of Neurology
East Lansing, Michigan, United States
Dent Neurological Institute
Buffalo, New York, United States
Univ of Cincinnati Medical Center
Cincinnati, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Houston Methodist Hospital
Houston, Texas, United States
UT Health Science Center
Houston, Texas, United States
University of WA Division of Cardio
Seattle, Washington, United States
Center for Neurological Disorders G
Greenfield, Wisconsin, United States
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
Caba, Argentina