MedTrace Logo

Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis

NCT04735432 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-02-28

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in patients with generalized myasthenia gravis (gMG). The study duration is approximately 12 weeks. After screening, patients will be randomized to receive either efgartigimod infusions or efgartigimod PH20 subcutaneously (SC)

Conditions

Interventions

BIOLOGICAL

efgartigimod PH20 SC

Subcutaneous injection with efgartigimod PH20 SC

BIOLOGICAL

efgartigimod IV

Intravenous infusion of efgartigimod

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-05
Primary Completion
2021-11-02
Completion
2021-12-13
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • 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 NCT04735432 on ClinicalTrials.gov