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

Completed · Phase 3 · Has a placebo group

Conditions studied: Generalized Myasthenia Gravis

In brief

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.

Key facts

Study ID

NCT03669588

Run by

argenx

People needed

167

Starts

2018-08-22

Expected to finish

2020-04-06

Last updated by the study team

2022-02-08

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.
• Male or female patients aged ≥ 18 years.
• Diagnosis of MG with generalized muscle weakness meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, IVa and IVb.
• Other, more specific inclusion criteria are defined in the protocol

You may not qualify if…

• Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing.
• 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.
• MGFA Class I and V patients.
• Patients with worsening muscle weakness secondary to concurrent infections or medications.
• Patients with known seropositivity or who test positive for an active viral infection at Screening with:
• Hepatitis B Virus (HBV) (except patients who are seropositive because of HBV vaccination)
• Hepatitis C Virus (HCV)
• Human Immunodeficiency Virus (HIV)
• Other, more specific exclusion criteria are further defined in the protocol.

Where it is running

• Investigator Site 66 — Carlsbad, California, United States
• Investigator Site 5 — Los Angeles, California, United States
• Investigator Site 49 — Los Angeles, California, United States
• Investigator Site 18 — Orange, California, United States
• Investigator Site 40 — Palo Alto, California, United States
• Investigator Site 59 — San Francisco, California, United States
• Investigator Site 58 — Aurora, Colorado, United States
• Investigator Site 34 — Jacksonville, Florida, United States
• Investigator Site 4 — Tampa, Florida, United States
• Investigator Site 30 — Springfield, Illinois, United States
• Investigator Site 25 — Iowa City, Iowa, United States
• Investigator Site 21 — Kansas City, Kansas, United States
• Investigator Site 27 — Boston, Massachusetts, United States
• Investigator Site 48 — Detroit, Michigan, United States
• Investigator Site 53 — Buffalo, New York, United States
• Investigator Site 3 — Chapel Hill, North Carolina, United States
• Investigator Site 20 — Cleveland, Ohio, United States
• Investigator Site 9 — Portland, Oregon, United States
• Investigator Site 17 — Charleston, South Carolina, United States
• Investigator Site — Cordova, Tennessee, United States
• Investigator Site 44 — Houston, Texas, United States
• Investigator Site 6 — San Antonio, Texas, United States
• Investigator Site 2 — Charlottesville, Virginia, United States
• Investigator Site 16 — Seattle, Washington, United States
• Investigator Site 29 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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