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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

ConditionsChronic Inflammatory Demyelinating PolyradiculoneuropathyCIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)CIDPChronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age12-17
Sponsorargenx

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Empasiprubart IV

    Biological/Vaccine

    Intravenous infusions of empasiprubart

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Empasiprubart IVExperimental treatment 1 intervention

Trial outcomes

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

CL = Clearance; Vd = apparent volume of distribution.

Time frame
Up to 8 weeks
2

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

C2 = complement component 2.

Time frame
Up to 8 weeks

Secondary outcomes

1

Incidence of AEs, SAEs and AESIs

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

Time frame
Up to 180 weeks
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

C2 = complement component 2.

Time frame
Up to 180 weeks
4

Incidence of ADA and NAb against empasiprubart in serum

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

Time frame
Up to 180 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

argenx

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: