At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 207 enrolled
Drug / intervention
Efgartigimod PH20 SC +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 the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
In Brief
A Phase 3 clinical trial evaluating Efgartigimod PH20 SC and Placebo PH20 SC for Primary Immune Thrombocytopenia. Completed, enrolled 207 participants across 200 sites in 32 countries.
Detailed Summary
This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Immune Thrombocytopenia
CountriesArgentina, Australia, Bulgaria, Chile, China, Denmark, France, Georgia, Germany, Greece, Ireland, Israel, Italy, Japan, Jordan, Mexico, New Zealand, Norway, Poland, Portugal, Romania, Russia, Serbia, South Africa, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
Enrollment StartDec 2020
First PostedDec 2020
Primary CompletionOct 2023
TodayJul 2026
First PostedDec 29, 2020
Enrollment StartDec 16, 2020
Primary CompletionOct 9, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 5.5 years ago
Interventions
Efgartigimod PH20 SCbiological
Subcutaneous injection with efgartigimod PH20 SC
Placebo PH20 SCother
Subcutaneous injection with placebo PH20 SC