NCT04812925

A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3 study to evaluate the safety and efficacy of efgartigimod PH20 subcutaneous in adult patients with primary immune thrombocytopenia

Conditions

• Primary Immune Thrombocytopenia

Interventions

Type	Name	Description
BIOLOGICAL	efgartigimod PH20 SC	Subcutaneous injection with efgartigimod PH20 SC

Timeline

• Start date: 2021-11-17
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2021-03-24
• Last updated: 2026-01-12

Locations

83 sites across 25 countries: United States, Argentina, Australia, Bulgaria, Chile, China, Georgia, Greece, Ireland, Italy, Japan, Jordan, Mexico, New Zealand, Norway, Poland, Portugal, Romania, Russia, South Africa, South Korea, Thailand, Tunisia, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study