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

NCT07091630

RecruitingPhase 3

Sponsor: argenx

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions: Empasiprubart IV, Placebo IV

Countries: United States, Argentina, Austria, Brazil, Bulgaria, China, Czechia, Denmark

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (78)
  • Birmingham, Alabama, United States
  • Rancho Mirage, California, United States
  • Colorado Springs, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Miami, Florida, United States
  • Naples, Florida, United States
  • Slidell, Louisiana, United States
  • Philadelphia, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Austin, Texas, United States
  • Houston, Texas, United States
  • Córdoba, Argentina
  • Rosario, Argentina
  • Rosario, Argentina
  • Linz, Upper Austria, Austria
  • Vienna, Austria
  • Brasília, Brazil
  • Porto Alegre, Brazil
  • São Paulo, Brazil
  • Sofia, Sofia, Bulgaria
  • Pleven, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Fuzhou, Fujian, China
  • Beijing, China
  • Guangzhou, China
  • Guangzhou, China
  • Xi'an, China
  • Brno, Czechia
  • + 48 more on CT.gov