NCT04281472

A Study to Assess the 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)

A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.

Conditions

• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Interventions

Type	Name	Description
BIOLOGICAL	efgartigimod PH20 SC in stage B	Stage A: efgartigimod PH20 SC, Stage B: efgartigimod PH20 SC
OTHER	placebo in stage B	Stage A: N/A, stage B: placebo

Timeline

• Start date: 2020-04-15
• Primary completion: 2023-05-11
• Completion: 2023-05-11
• First posted: 2020-02-24
• Last updated: 2024-08-20
• Results posted: 2024-08-20

Locations

216 sites across 25 countries: United States, Austria, Belgium, Bulgaria, China, Czechia, Denmark, France, Georgia, Germany, Hungary, Israel, Italy, Japan, Latvia, Netherlands, Poland, Romania, Russia, Serbia, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study