Trials / Completed
CompletedNCT04188379
A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).
A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 131 (actual)
- Sponsor
- argenx · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in participants with primary ITP.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | efgartigimod | Intravenous infusion of efgartigimod |
| OTHER | Placebo | Intravenous infusion of placebo |
Timeline
- Start date
- 2019-12-16
- Primary completion
- 2022-02-03
- Completion
- 2022-02-03
- First posted
- 2019-12-05
- Last updated
- 2025-03-13
- Results posted
- 2025-03-13
Locations
121 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 NCT04188379. Inclusion in this directory is not an endorsement.