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 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2026-06-10
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
Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)
- CIDP
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Interventions
- BIOLOGICAL
-
Empasiprubart IV
Intravenous infusions of empasiprubart
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2028-04-30
- Completion
- 2031-08-31
- FDA Drug
- Yes
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