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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

NCT06298552 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2025-11-05

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Efgartigimod IV

Intravenous infusion of efgartigimod

OTHER

Placebo IV

Intravenous infusion of placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-16
Primary Completion
2025-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • China
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • France
  • Georgia
  • Germany
  • Greece
  • Hungary
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Saudi Arabia
  • Serbia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06298552 on ClinicalTrials.gov