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NCT03669588 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
A Phase 3 study of Generalized Myasthenia Gravis, sponsored by argenx.
- Completed
- Registry status
- Phase 3
- Development phase
- 167
- Enrollment target
- 20
- Study locations
NCT03669588: Completed Phase 3 study of Generalized Myasthenia Gravis, sponsored by argenx.
NCT03669588 is a Phase 3 study of Generalized Myasthenia Gravis that has completed, run by argenx. The registered enrollment target is 167 participants, above the 125-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (34% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03669588, a Phase 3 study of Generalized Myasthenia Gravis, has completed, sponsored by argenx.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 167 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The MG-ADL is an 8-item patient-reported scale to assess MG symptoms and their effects on daily activities. The scale comprises 2 items on daily life activities and 6 items on symptoms. The MG-ADL total score range is 0-24, with higher scores indicative of greater disease severity. A patient was considered an MG-ADL responder during C1 if there was a reduction of ≥2 points on the MG-ADL total score (compared to baseline of C1 \[C1B\]) for ≥4 consecutive weeks with the first reduction occurring n
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL ARGX-113
Study Locations (20)
California
- Investigator Site 66 - Carlsbad
- Investigator Site 5 - Los Angeles
- Investigator Site 49 - Los Angeles
- Investigator Site 18 - Orange
- Investigator Site 40 - Palo Alto
- Investigator Site 59 - San Francisco
Florida
- Investigator Site 34 - Jacksonville
- Investigator Site 4 - Tampa
Arizona
- Investigator Site 29 - Phoenix
Colorado
- Investigator Site 58 - Aurora
Illinois
- Investigator Site 30 - Springfield
Iowa
- Investigator Site 25 - Iowa City
Kansas
- Investigator Site 21 - Kansas City
Massachusetts
- Investigator Site 27 - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2018-08-22 |
| Est. Completion | 2020-04-06 |
| Phase | Phase 3 |
What the finished NCT03669588 record still lists
NCT03669588 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, above the 125-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (34% higher).
The record links to 1 condition, with Generalized Myasthenia Gravis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03669588 names 20 study sites across 14 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT03669588 about?
NCT03669588 is a clinical study titled "An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness". 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.
What is the current status of trial NCT03669588?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 167 participants. The study started on 2018-08-22. Estimated completion is 2020-04-06.
What conditions does trial NCT03669588 study?
This clinical trial studies the following conditions: Generalized Myasthenia Gravis.
What interventions are being tested in trial NCT03669588?
The interventions under investigation include: Placebo (BIOLOGICAL), ARGX-113 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03669588?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03669588 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03669588's enrollment target sits among peer trials
167 11th of 26 higher than 16 of 26 other Generalized Myasthenia Gravis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Generalized Myasthenia Gravis 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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