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Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis

NCT04818671 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2026-01-22

Study results available
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Summary

The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection.

Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment periods

Health measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).

Conditions

Interventions

BIOLOGICAL

efgartigimod PH20 SC

Subcutaneous injection with efgartigimod PH20 SC

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • Georgia
  • Germany
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Russia
  • Spain

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 NCT04818671 on ClinicalTrials.gov