NCT04280718

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP. Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.

Conditions

• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Interventions

Type	Name	Description
BIOLOGICAL	Efgartigimod PH20 SC	Subcutaneous administration of efgartigimod

Timeline

• Start date: 2020-09-18
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2020-02-21
• Last updated: 2025-06-29

Locations

147 sites across 24 countries: United States, Austria, Belgium, Bulgaria, China, Czechia, Denmark, France, Georgia, Germany, Israel, Italy, Japan, Latvia, Netherlands, Poland, Romania, Russia, Serbia, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study