At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 131 enrolled
Drug / intervention
efgartigimod +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating efgartigimod and Placebo for Primary Immune Thrombocytopenia. Completed, enrolled 131 participants across 121 sites in 18 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immune Thrombocytopenia
CountriesAustria, Belgium, Bulgaria, Czechia, France, Georgia, Germany, Hungary, Italy, Japan, Netherlands, Poland, Russia, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 2019
Enrollment StartDec 2019
Primary CompletionFeb 2022
TodayJul 2026
First PostedDec 5, 2019
Enrollment StartDec 16, 2019
Primary CompletionFeb 3, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.6 years ago
Interventions
efgartigimodbiological
Intravenous infusion of efgartigimod
Placeboother
Intravenous infusion of placebo