A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
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
Sponsor: argenx
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
MG-ADL total score change from baseline
Time frame: Up to 29 days (part A)
Secondary Endpoints
QMG total score change from baseline
Proportion of participants who are both MG-ADL and QMG responders in part A
Proportion of participants with MSE
Eligibility Criteria
Inclusion Criteria: * The participant is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF. * The participant is capable of providing signed informed consent and following with protocol requirements. * The participant agrees to use contraceptive measures consistent with local regulations and the women of child-bearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at baseline before receiving the study drug. * The participant has no known weakness in infancy and later develop fatigable weakness after aged 16 years and diagnosed with acquired gMG of both of the following: 1. History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation (RNS) or is anti-muscle-specific kinase antibodies (MuSK-Ab) seropositive 2. Either a history of positive edrophonium chloride test OR a demonstrated improvemen…
Read full criteria on CT.gov →✦ Analyst Commentary
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