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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Intravenous infusions of empasiprubart
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
Free and total C2 levels as input for PK/PD modeling analysis
C2 = complement component 2.
Time frame: Up to 8 weeks
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
Empasiprubart serum concentrations over time
Time frame: Up to 180 weeks
Percentage reductions from baseline of free and total C2 levels over time
C2 = complement component 2.
Time frame: Up to 180 weeks
Incidence of ADA and NAb against empasiprubart in serum
ADA = antidrug antibody(ies); NAb = neutralizing antibody(ies).
Time frame: Up to 180 weeks
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