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NOT YET RECRUITING
NCT07638566
PHASE2/PHASE3

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

Sponsor: argenx

View on ClinicalTrials.gov

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

Official title: An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2026-09

Completion Date

2031-08

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

Empasiprubart IV

Intravenous infusions of empasiprubart