NCT04687072

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Immune Thrombocytopenia

Interventions

Type	Name	Description
BIOLOGICAL	Efgartigimod PH20 SC	Subcutaneous injection with efgartigimod PH20 SC
OTHER	Placebo PH20 SC	Subcutaneous injection with placebo PH20 SC

Timeline

• Start date: 2020-12-16
• Primary completion: 2023-10-09
• Completion: 2023-10-09
• First posted: 2020-12-29
• Last updated: 2024-10-31
• Results posted: 2024-10-31

Locations

200 sites across 32 countries: United States, Argentina, 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

Regulatory

• FDA-regulated drug study