Myasthenia Gravis

Myasthenia Gravis is an adult neuromuscular disorder that affects approximately 5 in 100,000 people.

It is due to a dysfunction of the immune system: the autoimmune reaction is directed against constituents of the neuromuscular junction, the interface between the nerve and the muscle, which results in a defect of transmission of the nerve impulse. This is manifested by fatigability and a lack of muscle strength.

 

Clinical trials ongoing at the Institute:

  • ARGX113-2308 ADAPT (Seroneg) ADAPT: A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod IV in Adult Participants With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
  • ARGX-113-2003 – ADAPT NXT: A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis
  • R3918-MG-2018 : Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic Generalized Myasthenia Gravis
  • MOM-M281-011 : Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis
  • MYAPATH: Creation of a collection of biological resources for the study of pathologies that can lead to Myasthenia Gravis
  • MS700568_0183: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm, 3-Period Study to Assess the Efficacy and Safety of a New Formulation of Oral Cladribine Compared with Placebo in Participants with Generalized Myasthenia Gravis
  • LOU064O1230: A randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of Novartis’ Bruton’s tyrosine kinase inhibitor (BTKi) IMP in patients with generalized myasthenia gravis followed by an open label extension phase
  • IMCOMG: Immediate Corticosteroid Therapy and Rituximab to Prevent Generalization in Ocular Myasthenia: a PROBE Multicenter Open-label Randomized Controlled Trial. (IMCOMG)

 

Acronym

ARGX113-2308 ADAPT (Seroneg) ADAPT

ARGX-113-2003 – ADAPT NXT

Intervention efgartigimod efgartigimod
Principal investigator
Sophie Demeret Sophie Demeret
Sponsor Argenx Argenx
Study status Active Active
Recruitment status Ongoing Ongoing
Population Adult Adult
  + infos on clinicaltrials.gov + infos on clinicaltrials.gov

 

 

Acronym

R3918-MG-2018

MOM-M281-011

MYAPATH

Intervention pozelimab and cemdisiran nipocalimab
Principal investigator Sophie Demeret Sophie Demeret Anthony Béhin
Sponsor Regeneron Jannsen-Cilag AIM
Study status Active Active Active
Recruitment status Not started Ongoing Ongoing
Population Adult Adult Adult
  + infos on clinicaltrials.gov + infos on clinicaltrials.gov

 

 

Acronym

MS700568_0183

LOU064O12301

IMCOMG

Intervention cladribine remibrutinib corticoĂŻdes and rituximab
Principal investigator Anthony Béhin Anthony Béhin Sophie Demeret
Sponsor Merck Novartis Fondation Rothschild
Study status In preparation In preparation In preparation
Recruitment status Not started Not started Not started
Population Adult Adult Adult
  + infos on clinicaltrials.gov + infos on clinicaltrials.gov

Contact : essais-adultes@institut-myologie.org