A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
Sponsorargenx

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

Sponsors and collaborators