Trials / Recruiting
RecruitingNCT07091630
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- Sponsor
- argenx · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Empasiprubart IV | Intravenous infusion of empasiprubart |
| OTHER | Placebo IV | Intravenous infusion of placebo |
Timeline
- Start date
- 2025-09-16
- Primary completion
- 2027-10-07
- Completion
- 2031-01-23
- First posted
- 2025-07-29
- Last updated
- 2026-03-11
Locations
19 sites across 5 countries: United States, China, Georgia, Japan, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07091630. Inclusion in this directory is not an endorsement.