A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
NCT07091630 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2026-05-08
Summary
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
Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy
- CIDP
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Interventions
- BIOLOGICAL
-
Empasiprubart IV
Intravenous infusion of empasiprubart
- OTHER
-
Placebo IV
Intravenous infusion of placebo
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-16
- Primary Completion
- 2027-10-07
- Completion
- 2031-01-23
- FDA Drug
- Yes
Countries
- United States
- Austria
- Bulgaria
- China
- Czechia
- Estonia
- Georgia
- Italy
- Japan
- Poland
- Romania
- Slovakia
- South Korea
Study Locations
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