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