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 | corticoïdes 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
