Active — Not RecruitingPhase 3

A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

United States119 participantsStarted 2024-04-16

Plain-language summary

The primary purpose of this study is to measure the efficacy and safety of efgartigimod IV compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). The study consists of a Part A where participants will be randomized to receive either efgartigimod IV or placebo IV and a Part B where participants completing part A will receive open-label efgartigimod IV. Participants will be in the study for up to (approximately) 2.5 years.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓. Either a history of positive edrophonium chloride test OR a demonstrated improvement in MG signs with treatments such as oral acetylcholinesterase (AChE) inhibitors, plasma exchange (PLEX), immunoabsorption, or intravenous immunoglobulin (IVIg)/ subcutaneous immunoglobulin (SCIg) treatment

What they're measuring

MG-ADL total score change from baseline

Timeframe: Up to 29 days (part A)

Trial details

NCT IDNCT06298552

Sponsorargenx

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Generalized Myasthenia Gravis trials