Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

argenx

Stanford Investigator(s):

Intervention(s):

  • Biological: ARGX-113

Phase:

Phase 3

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting