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Taking people in BrazilPhase 3

Tests empasiprubart against placebo in adults with CIDP

Tests empasiprubart, or a placebo, in adults with chronic inflammatory demyelinating polyneuropathy.

Plain-language title generated from the registry record
Registry title: A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP

Key facts

Where
Brasília, Porto Alegre, Ribeirão Preto, Rio de Janeiro, Salvador, and São Paulo, BrazilSee the 7 sites
Phase
Phase 3

Where in Brazil

  • L2 Ip Instituto de Pesquisas Clinicas Ltda MEBrasília, BrazilTaking people
  • Hospital de Clinicas de Porto Alegre HCPA PPDSPorto Alegre, BrazilTaking people
  • Hospital Moinhos de VentoPorto Alegre, BrazilTaking people
  • Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - UPS - PPDSRibeirão Preto, BrazilTaking people
  • Unidade de Pesquisa Clinica e Inovacao da EstacioRio de Janeiro, BrazilTaking people
  • Escola Bahiana de Medicina e Saude PublicaSalvador, BrazilTaking people
  • PSEG Centro de Pesquisa ClinicaSão Paulo, BrazilTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
argenx
Trial code
NCT07091630EU 2025-520805-10-00
Record updated
9 November 2026
Original description
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).Read full original descriptionShow less

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

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

Inclusion: 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: Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation; 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).

ClinicalTrials.gov NCT07091630 · EU CTIS 2025-520805-10-00