A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness.

argenx0 sites151 target enrollmentFebruary 4, 2020

ConditionsGeneralized Myasthenia Gravis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Generalized Myasthenia Gravis
Sponsor: argenx
Enrollment: 151
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

ong-term treatment with repeated cycles of 1 infusion per week for 4 infusions of efgartigimod IV 10 mg/kg was safe and well tolerated, with most AEs being mild to moderate in severity. The overall benefit-risk profile was positive. The AChR-Ab seropositive, AChR-Ab seronegative, and overall populations had consistent improvements in MG-ADL and QMG scores over repeated cycles.

Registry

who.int

Start Date

February 4, 2020

End Date

June 30, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

argenx

Eligibility Criteria

Inclusion Criteria

•1\. Patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
•2\.Patients who participated in trial ARGX\-113\-1704 and are eligible for roll over, as specified in the protocol.
•Other more specific inclusion criteria are further defined in the protocol.

Exclusion Criteria

•1\.Patients who discontinued early from trial ARGX\-113\-1704 or patients who discontinued early from randomized treatment for pregnancy or rescue reasons or an (S)AE that might jeopardize the safety of the patient in that trial. 2\.Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing. Women or childbearing potential should have a negative urine pregnancy test at SEB.
•3\.Male patients who are sexually active and do not intend to use effective methods of contraception during the trial or within 90 days after the last dosing or male patients who plan to donate sperm during the trial or within 90 days after the last dosing.
•4\.Patients with known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) seropositivity. Other, more specific exclusion criteria are further defined in the protocol.