Trials / Completed
CompletedNCT04225156
A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).
A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 101 (actual)
- Sponsor
- argenx · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label long-term multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in adult patients with primary ITP.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | efgartigimod | Intravenous infusion of efgartigimod |
Timeline
- Start date
- 2020-06-02
- Primary completion
- 2026-03-11
- Completion
- 2026-03-11
- First posted
- 2020-01-13
- Last updated
- 2026-03-16
Locations
87 sites across 18 countries: United States, Austria, Belgium, Bulgaria, Czechia, France, Georgia, Germany, Hungary, Italy, Japan, Netherlands, Poland, Russia, Spain, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04225156. Inclusion in this directory is not an endorsement.