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NCT Number: 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

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

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Key information

Conditions

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

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Empasiprubart IV

Biological

Intravenous infusions of empasiprubart

Primary outcomes

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

    Time frame: Up to 8 weeks

    CL = Clearance; Vd = apparent volume of distribution.

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

    Time frame: Up to 8 weeks

    C2 = complement component 2.

Secondary outcomes

  1. Incidence of AEs, SAEs and AESIs

    Time frame: Up to 180 weeks

    AE = Adverse event ; SAE = Serious adverse event ; AESI = Adverse event of special interest.

  2. Empasiprubart serum concentrations over time

    Time frame: Up to 180 weeks

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

    Time frame: Up to 180 weeks

    C2 = complement component 2.

  4. Incidence of ADA and NAb against empasiprubart in serum

    Time frame: Up to 180 weeks

    ADA = antidrug antibody(ies); NAb = neutralizing antibody(ies).

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Coppieters, MD

CONTACT

[email protected]

857-350-4834

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study 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

Acronym: emlight

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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