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An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

NCT03669588 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2022-02-08

Study results available
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Summary

A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.

Conditions

Interventions

BIOLOGICAL

ARGX-113

Intravenous administration of ARGX-113

BIOLOGICAL

Placebo

Intravenous administration of placebo

Sponsors & Collaborators

Principal Investigators

  • Antonio Guglietta, MD · argenx

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-22
Primary Completion
2020-04-06
Completion
2020-04-06
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Georgia
  • Germany
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Russia
  • Serbia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT03669588 on ClinicalTrials.gov