About this trial

The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6 months). Following part A, participants will enter part B in which all participants will receive empasiprubart for 96 weeks (24 months).

More information can be found here: https://clinicaltrials.argenx.com/emnergize

Eligibility criteria

Qualifiers

Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)

Has 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

Has residual disability and active disease

Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)

Disqualifiers

Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)

Sensory CIDP (including sensory-predominant CIDP)

Polyneuropathy of other causes

Clinical diagnosis of systemic lupus erythematosus (SLE)

Trial design

Treatments tested in this trial

  • Empasiprubart IV
  • Placebo IV

Treatment groups

160 Participants
are divided into 3 treatment groups

Locations

61
Argentina
INECO Neurociencias Oroño Rosario Argentina
Austria
Kepler Universitätsklinikum Linz - Med Campus III4021, LinzUpper Austria, Austria
Universitätsklinikum AKH Wien1090, Vienna Austria
Bulgaria
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD1113, SofiaSofia, Bulgaria

Sponsors and collaborators

argenx

Lead sponsor