Home › Chronic Inflammatory Demyelinating Polyradiculoneuropathy › NCT07091630
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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) * Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP Exclusion Criteria: * 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) * Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation
About the study
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
What is being tested
- Empasiprubart IV (biological)
- Placebo IV (other)
Sponsor: argenx · Participants: 160 · Started: Sep 16, 2025
Contact the study team
- Sabine Coppieters, MD · Phone: 857-350-4834
Official record on ClinicalTrials.gov — NCT07091630
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.