About this trial
The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).
Eligibility criteria
Qualifiers
Must have given written informed consent before any study-related activities are carried out
Weight range between 40-130 kg at Screening
Acetylcholine receptor antibody (AChR Ab) positive, and
Myasthenia Gravis Foundation of America (MGFA) Class II-IVa
Disqualifiers
History or presence of significant medical/surgical condition including any acute illness, mental illness, or major surgery considered to be clinically significant or that could have potential impact on safety/efficacy or study procedures
Known complement deficiency
Prior history (at any time) of N. meningitidis infection
Participants with known seropositivity or who test positive for an active viral infection with human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B (HBV; except participants who are seropositive because of HBV vaccination) or hepatitis C virus (HCV) during Screening
Trial design
Treatments tested in this trial
- Claseprubart
- Placebo
- Claseprubart
- Placebo