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NCT03770403 · ClinicalTrials.gov registry record · Phase 3
A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.
A Phase 3 study, sponsored by argenx.
- Completed
- Registry status
- Phase 3
- Development phase
- 151
- Enrollment target
NCT03770403: Completed Phase 3 study, sponsored by argenx.
NCT03770403 is a Phase 3 study that has completed, run by argenx. The registered enrollment target is 151 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03770403, a Phase 3 study, has completed, sponsored by argenx.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 151 participants
- Enrollment target
Study 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 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.
Primary Outcome
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any clinically significant abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (electrocardiogram \[ECG\], radiological scans, vital signs measurements) were collected as AEs. All AEs starting on or after first dose administered and until completion of pa
Interventions
- BIOLOGICAL ARGX-113
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 3 |
What the finished NCT03770403 record still lists
NCT03770403 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which ARGX-113 is the first listed.
NCT03770403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03770403 about?
NCT03770403 is a clinical study titled "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 ...
What is the current status of trial NCT03770403?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 151 participants. The study started on 2019-03-01. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT03770403?
The interventions under investigation include: ARGX-113 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03770403?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03770403's enrollment target sits among peer trials
151 1517th of 2000 higher than 482 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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