Status:
COMPLETED
A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.
Lead Sponsor:
argenx
Conditions:
Generalized Myasthenia Gravis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT03770403
Start Date
March 1 2019
End Date
June 30 2022
Last Update
July 14 2023
Active Locations (52)
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1
Investigator Site 42
Carlsbad, California, United States, 92011
2
Investigator Site 8
Los Angeles, California, United States, 90033
3
Investigator Site 33
Orange, California, United States, 92868
4
Investigator Site 21
Palo Alto, California, United States, 94304