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

Generalized Myasthenia Gravis Clinical Trial

Official title:
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

Clinical Trial Summary

The primary purpose of this study is to measure the efficacy and safety of efgartigimod intravenously (IV) compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). Other objectives are to assess long-term efficacy, safety, and tolerability of efgartigimod. Study will consist of: - Screening - Part A: participants will be randomized to receive either efgartigimod IV or placebo - Part B: participants completing part A will receive open-label efgartigimod IV

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06298552
Study type Interventional
Source argenx
Contact Sabine Coppieters, MD
Phone 857-350-4834
Email clinicaltrials@argenx.com
Status Recruiting
Phase Phase 3
Start date April 16, 2024
Completion date July 23, 2027
View Details
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