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NCT06920004 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
A Phase 3 study of Chronic Inflammatory Demyelinating Polyneuropathy and CIDP, sponsored by argenx.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 218
- Enrollment target
- 20
- Study locations
NCT06920004: Recruiting Phase 3 study of Chronic Inflammatory Demyelinating Polyneuropathy and CIDP, sponsored by argenx.
NCT06920004 is a Phase 3 study of Chronic Inflammatory Demyelinating Polyneuropathy and CIDP that is actively recruiting participants, run by argenx. The registered enrollment target is 218 participants, above the 141-participant average among 11 other Chronic Inflammatory Demyelinating Polyneuropathy trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06920004, a Phase 3 study of Chronic Inflammatory Demyelinating Polyneuropathy and CIDP, is actively recruiting participants, sponsored by argenx.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 218 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).
Conditions Studied
Interventions
- OTHER IVIg-placebo
- BIOLOGICAL empasiprubart
- BIOLOGICAL IVIg
- OTHER empasiprubart-placebo
Study Locations (20)
Other
- Fakultni nemocnice Brno - Brno
- Astra Kliinik - Tallinn
- Tartu University Hospital - Tartu
- Charité - Universitätsmedizin Berlin - Berlin
- University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA - Chaïdári
- The Barzilai University Medical Center - Ashkelon
- Hadassah Medical Center- Ein Kerem - Jerusalem
- The Chaim Sheba Medical Center - Tel Litwinsky
- AUSL di Bologna - Ospedale Bellaria - Bologna
- Aomori Prefectural Central Hospital - Aomori
Florida
- Homestead Associates in Research Inc - Homestead
- Visionary Investigators Network - Miami
Michigan
- University of Michigan Hospital - Ann Arbor
- University of Michigan Hospital - Ann Arbor
Texas
- NeuroCarePlus - Houston
- National Neuromuscular Research Institute - Irving
Colorado
- Colorado Springs Neurological Associates - Colorado Springs
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Louisiana
- Paradigm Health System - Slidell
Maryland
- Erlanger Health System - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2025-08-22 |
| Est. Completion | 2030-09 |
| Phase | Phase 3 |
What NCT06920004 shows while recruiting
NCT06920004 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, above the 141-participant average among 11 other Chronic Inflammatory Demyelinating Polyneuropathy trials with a reported enrollment target (55% higher).
The record links to 3 conditions, with Chronic Inflammatory Demyelinating Polyneuropathy appearing as the primary indexed condition, and to 4 interventions - of which IVIg-placebo is the first listed.
NCT06920004 names 20 study sites across 8 states, led by Other, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT06920004 about?
NCT06920004 is a clinical study titled "A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP". 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 Par...
What is the current status of trial NCT06920004?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 218 participants. The study started on 2025-08-22. Estimated completion is 2030-09.
What conditions does trial NCT06920004 study?
This clinical trial studies the following conditions: Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy.
What interventions are being tested in trial NCT06920004?
The interventions under investigation include: IVIg-placebo (OTHER), empasiprubart (BIOLOGICAL), IVIg (BIOLOGICAL), empasiprubart-placebo (OTHER).
Who is sponsoring clinical trial NCT06920004?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06920004 being conducted?
This trial has 20 study locations across Colorado, District of Columbia, Florida, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06920004's enrollment target sits among peer trials
218 3rd of 11 higher than 9 of 11 other Chronic Inflammatory Demyelinating Polyneuropathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Inflammatory Demyelinating Polyneuropathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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