Trials / Recruiting
RecruitingNCT06920004
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 218 (estimated)
- Sponsor
- argenx · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart 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/emvigorate
Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy
- CIDP
- CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | empasiprubart | Intravenous infusion of empasiprubart |
| BIOLOGICAL | IVIg | Intravenous infusion of IVIg |
| OTHER | empasiprubart-placebo | A placebo resembling the empasiprubart treatment |
| OTHER | IVIg-placebo | A placebo resembling the IVIg treatment |
Timeline
- Start date
- 2025-08-22
- Primary completion
- 2027-09-01
- Completion
- 2030-09-01
- First posted
- 2025-04-09
- Last updated
- 2026-03-06
Locations
46 sites across 15 countries: United States, Czechia, Estonia, Germany, Greece, Israel, Italy, Japan, Poland, Portugal, Romania, Slovakia, South Korea, Spain, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06920004. Inclusion in this directory is not an endorsement.