drugset / Trial / NCT07638566

A Study to Assess the Correct Dose, Safety and Efficacy of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

NCT07638566

Phase 2/3 Not yet recruiting 6 enrolled argenx
NaSingle-groupOpen-labelTreatment

Summary

The main purpose of the study is to determine the correct dose of empasiprubart in adolescent participants. It also aims to evaluate if empasiprubart may work and how safe it is for the use in children living with CIDP. The study consists of an open label treatment phase where participants will receive empasiprubart for up to 27 months approximately. After the final dose of empasiprubart, participants will enter a safety follow-up period for up to 14 months approximately. The overall study duration for each participant is up to 43 months. More information can be found here: clinicaltrials.argenx.com/emlight

Timeline

Start
2026-09
Primary completion
2028-04
Completion
2031-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Empasiprubart Monoclonal antibody Intravenous