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A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

NCT02965573 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-08-28

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled, multicenter Phase II study to evaluate the safety, efficacy, and pharmacokinetics of ARGX-113 for the treatment of autoimmune Myasthenia Gravis (MG) with generalized muscle weakness.

Conditions

Interventions

BIOLOGICAL

ARGX-113

DRUG

Placebo

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • argenx

    lead INDUSTRY

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
2016-12-30
Primary Completion
2017-10-20
Completion
2017-10-20
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Sweden

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 NCT02965573 on ClinicalTrials.gov