Trials / Completed
CompletedNCT03669588
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 and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 167 (actual)
- Sponsor
- argenx · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ARGX-113 | Intravenous administration of ARGX-113 |
| BIOLOGICAL | Placebo | Intravenous administration of placebo |
Timeline
- Start date
- 2018-08-22
- Primary completion
- 2020-04-06
- Completion
- 2020-04-06
- First posted
- 2018-09-13
- Last updated
- 2022-02-08
- Results posted
- 2022-02-08
Locations
66 sites across 16 countries: United States, Belgium, Canada, Czechia, Denmark, France, Georgia, Germany, Hungary, Italy, Japan, Netherlands, Poland, Russia, Serbia, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03669588. Inclusion in this directory is not an endorsement.