Trial intelligence / Profile preview

Empasiprubart in Adolescent Participants With CIDP

NCT07638566Phase 3

Key facts

Status: Not yet recruiting
Start: Sep 2026
Primary completion: Apr 2028
Sponsor: argenx

Drugs: empasiprubart
Conditions: chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Overview

Phase 3, open-label, single-arm trial of empasiprubart in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), sponsored by argenx. Primary endpoints: Empasiprubart serum concentrations at 8 weeks and Free and total C2 levels at 8 weeks. Planned start Sep 2026; status: not yet recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Empasiprubart IV
Participants will receive empasiprubart IV

Who it enrols

Adolescents aged 12 to <18 years with typical or specific variants of CIDP, excluding those with sensory CIDP, possible CIDP, or prior use of other long-acting immunomodulatory treatments.

Endpoints

Primary

Empasiprubart serum concentrations8 weeks
Free and total C2 levels8 weeks

Secondary

Incidence of AEs, SAEs and AESIs180 weeks
Empasiprubart serum concentrations over time180 weeks
Percentage reductions from baseline of free and total C2 levels over time180 weeks
Incidence of ADA and NAb against empasiprubart in serum180 weeks

Beyond the preview

Go deeper on NCT07638566.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT07638566.