Efgartigimod Expanded Access for Generalized Myasthenia Gravis

Status:

APPROVED_FOR_MARKETING

Efgartigimod Expanded Access for Generalized Myasthenia Gravis

Lead Sponsor:

argenx

Conditions:

Generalized Myasthenia Gravis

Eligibility:

All Genders

18+ years

Brief Summary

This expanded access protocol applies to patients with gMG who are not enrolled in an ongoing clinical trial. The aim of the trial is to provide patients with generalized myasthenia gravis (gMG), who ...

Eligibility Criteria

Inclusion

Patient is ≥18 years of age, at the time of signing the informed consent
Patient has a diagnosis of MG (AChR-Ab seropositive or seronegative) with generalized muscle weakness
Patient has been vaccinated against COVID-19 or has had a negative COVID-19 test result in the 2 weeks before enrollment
Patient has documented IgG \>6 g/L within one month of screening
Patient agrees to contraceptive use consistent with local regulations and scientific rationale regarding the methods of contraception and:
Male patients: must agree to use an acceptable method of contraception and to not donate sperm from the time of providing informed consent until the end of the program
Female patients: Women of childbearing potential must use a highly effective or acceptable method of contraception and have a negative serum pregnancy test at screening
Patient provides signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol
Patients with a history of hepatitis B, hepatitis C, or HIV must have a documented negative test for an active viral infection.

Exclusion

Patient has clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening
Patient has a known autoimmune disease that, in the opinion of the treating physician, would interfere with an accurate assessment of clinical symptoms of gMG or put the patient at undue risk
Patient has a history of malignancy unless it is deemed to be cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of the IMP. Patients with documentation of adequate treatment of the following cancers can be included at any time: basal cell or squamous cell skin cancer; carcinoma in situ of the cervix; carcinoma in situ of the breast; incidental histological finding of prostate cancer (TNM stage T1a or T1b)
Patient has clinical evidence of other significant serious diseases, has recently had major surgery, or has any other condition that, in the opinion of the treating physician, could put the patient at undue risk
Patient may be excluded based upon review of clinical medical records and screening clinical safety laboratory test results
Patient has received a live or a live-attenuated vaccination during the month before screening
Patient is pregnant and/or lactating or intends to become pregnant during the program or within 90 days after the last dose
Patient is an unsterilized male who is sexually active while participating in the program and does not intend to use effective methods of contraception during the program through 90 days after the last dose or plans to donate sperm during the program or through 90 days after the last dose.
The patient has previously received rituximab, and the last rituximab dose was received less than 6 months before the first dose of efgartigimod

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04777734

Last Update

April 29 2022

Active Locations (6)

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Page 1 of 2 (6 locations)

Investigator site 12 - Approved for Marketing

Chicago, Illinois, United States, 60611

Investigator site 16 - Approved for Marketing

Lexington, Kentucky, United States, 40506

Investigator site 1 - Approved for Marketing

Ann Arbor, Michigan, United States, 41809