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 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: ARGX-117-6-CIDP-20012025-524153-14-00
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief 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

CIDP; Chronic Inflammatory Demyelinating Polyradiculoneuropathy; CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy); Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Outcome Measures

Primary Outcomes (2)

• Empasiprubart serum concentrations as input for a population PK-driven analysis to determine the effect of age and body size on CL and Vd

  CL = Clearance; Vd = apparent volume of distribution.

  Up to 8 weeks

• Free and total C2 levels as input for PK/PD modeling analysis

  C2 = complement component 2.

  Up to 8 weeks

Secondary Outcomes (4)

• Incidence of AEs, SAEs and AESIs

  Up to 180 weeks

• Empasiprubart serum concentrations over time

  Up to 180 weeks

• Percentage reductions from baseline of free and total C2 levels over time

  Up to 180 weeks

• Incidence of ADA and NAb against empasiprubart in serum

  Up to 180 weeks

Study Arms (1)

Empasiprubart IV

EXPERIMENTAL

Participants will receive empasiprubart IV

Biological: Empasiprubart IV

Interventions

Empasiprubart IV BIOLOGICAL

Intravenous infusions of empasiprubart

Empasiprubart IV

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Is aged 12 to \<18 years.
• Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021).
• Has a diagnosis of either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP.

You may not qualify if:

• Possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021).
• Sensory CIDP (including sensory-predominant CIDP).
• Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP, or that puts the participant at undue risk.
• Prior use of other long-acting immunomodulatory treatment.

Sponsors & Collaborators

• argenx: lead

Related Links

• Study website

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; clinicaltrials@argenx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): August 1, 2031
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share