Purpose

This is 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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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. Male or female patients aged ≥ 18 years.
  3. 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

Exclusion Criteria

  1. Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing.
  2. 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.
  3. MGFA Class I and V patients.
  4. Patients with worsening muscle weakness secondary to concurrent infections or medications.
  5. Patients with known seropositivity or who test positive for an active viral infection at Screening with:
  6. Hepatitis B Virus (HBV) (except patients who are seropositive because of HBV vaccination)
  7. Hepatitis C Virus (HCV)
  8. Human Immunodeficiency Virus (HIV)

Other, more specific exclusion criteria are further defined in the protocol.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ARGX-113
  • Biological: ARGX-113
    Intravenous administration of ARGX-113
    Other names:
    • efgartigimod
Placebo Comparator
Placebo
  • Biological: Placebo
    Intravenous administration of placebo

More Details

Status
Active, not recruiting
Sponsor
argenx BVBA

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.