A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.

Completed · Phase 3

Conditions studied: Generalized Myasthenia Gravis

In brief

This is a Long-Term, Single-Arm, Open-Label, Multicenter Phase 3 follow-on trial of the ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients with gMG. Patients who have completed at least 1 cycle of treatment and at least 1 year of trial ARGX-113-1705 and have started Part B are eligible to enroll in the open-label trial ARGX-113-2002 to receive efgartigimod by SC administration.

Key facts

Study ID

NCT03770403

Run by

argenx

People needed

151

Starts

2019-03-01

Expected to finish

2022-06-30

Last updated by the study team

2023-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
• 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.

You may not qualify if…

• 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.
• 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.
• 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.
• 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.

Where it is running

• Investigator Site 8 — Los Angeles, California, United States
• Investigator Site 33 — Orange, California, United States
• Investigator Site 21 — Palo Alto, California, United States
• Investigator Site 41 — Jacksonville, Florida, United States
• Investigator Site 4 — Tampa, Florida, United States
• Investigator Site 14 — Kansas City, Kansas, United States
• Investigator Site 32 — Detroit, Michigan, United States
• Investigator Site 2 — Chapel Hill, North Carolina, United States
• Investigator Site 18 — Cleveland, Ohio, United States
• Investigator Site 12 — Portland, Oregon, United States
• Investigator Site 1 — Cordova, Tennessee, United States
• Investigator Site 3 — San Antonio, Texas, United States
• Investigator Site 37 — Charlottesville, Virginia, United States
• Investigator Site 11 — Edegem, Belgium
• Investigator Site 7 — Ghent, Belgium
• Investigator Site 20 — Toronto, Ontario, Canada
• Investigator Site 25 — Montreal, Quebec, Canada
• Investigator Site 16 — Brno, Czechia
• Investigator Site 19 — Ostrava-Poruba, Czechia
• Investigator Site 30 — Prague, Czechia
• Investigator Site 49 — Aarhus, Denmark
• Investigator Site 17 — Copenhagen, Denmark
• Investigator Site 50 — Bordeaux, France
• Investigator Site 51 — Marseille, France
• Investigator Site 42 — Carlsbad, California, United States

Full record on ClinicalTrials.gov

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