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
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)
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)
Parallel
Empasiprubart IV
Biological/VaccineIntravenous infusion of empasiprubart
Placebo IV
Other interventionIntravenous infusion of placebo
Reduction of ≥1 point compared with baseline in aINCAT score at week 24
The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).
Change from baseline in I-RODS centile points score
Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome).
Change from baseline in MRC-SS at week 24
The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome)
Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24
Time to reduction of ≥1 point from baseline in aINCAT score
The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).