Clinical Trials in the UK / NCT06920004
Recruiting
Phase 3
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
NCT06920004 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Chronic Inflammatory Demyelinating PolyneuropathyCIDPCIDP - Chronic Inflammatory Demyelinating Polyneuropathy
Investigational drug(s) / intervention(s)
empasiprubart: Intravenous infusion of empasiprubart
IVIg: Intravenous infusion of IVIg
empasiprubart-placebo: A placebo resembling the empasiprubart treatment
IVIg-placebo: A placebo resembling the IVIg treatment
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
Eligibility
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, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
* Has responded to IVIg in the past 5 years
* Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg
* Has residual disability and active disease
Exclusion Criteria:
* Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes
* Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
* Use of other long-acting immunomodulatory treatment
Primary outcome measure(s)
- Reduction of ≥1 point compared with baseline in aINCAT score at week 24 — up to 24 weeks
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).
Trial sites (103)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama | Birmingham | Alabama | Recruiting |
| Samir Macwan, M.D., Inc. | Rancho Mirage | California | Recruiting |
| Colorado Springs Neurological Associates | Colorado Springs | Colorado | Recruiting |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | Recruiting |
| Homestead Associates in Research Inc | Homestead | Florida | Recruiting |
| Visionary Investigators Network | Miami | Florida | Recruiting |
| University of South Florida | Tampa | Florida | Recruiting |
| Baptist Health Medical Group Neurology | Nicholasville | Kentucky | Recruiting |
| Paradigm Health System | Slidell | Louisiana | Recruiting |
| Erlanger Health System | Columbia | Maryland | Recruiting |
| University of Michigan Hospital | Ann Arbor | Michigan | Recruiting |
| University of Cincinnati Health | Cincinnati | Ohio | Recruiting |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | Recruiting |
| Jefferson Health Honickman Center | Philadelphia | Pennsylvania | Recruiting |
| University Neurology | Knoxville | Tennessee | Recruiting |
| NeuroCarePlus | Houston | Texas | Recruiting |
| National Neuromuscular Research Institute | Irving | Texas | Recruiting |
| Instituto Privado Kremer | Córdoba | Argentina | Recruiting |
| INECO Neurociencias Oroño | Rosario | Argentina | Recruiting |
| Liverpool Hospital | Liverpool | New South Wales | Recruiting |
| Kepler Universitätsklinikum Linz - Med Campus III | Linz | Austria | Recruiting |
| Universitätsklinikum AKH Wien | Vienna | Austria | Recruiting |
| PSEG Centro de Pesquisa Clinica - Rua Borges Lagoa 1060 | São Paulo | São Paulo | Recruiting |
| PSEG Centro de Pesquisa Clinica | São Paulo | Brazil | Recruiting |
| University of Calgary | Calgary | Alberta | Recruiting |
| Black Tusk Research Group | Vancouver | British Columbia | Recruiting |
| Hospital Universitario San Ignacio | Bogotá | Colombia | Recruiting |
| Hospital Alma Máter de Antioquia | Medellín | Colombia | Recruiting |
| Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico | Medellín | Colombia | Recruiting |
| Fakultni nemocnice Brno | Brno | Czechia | Recruiting |
| Astra Kliinik | Tallinn | Estonia | Recruiting |
| Tartu University Hospital | Tartu | Estonia | Recruiting |
| AP-HM- Hôpital de La Timone | Marseille | Bouches-du-Rhone | Recruiting |
| AP-HP - Hôpital de la Pitié Salpétrière | Paris | Paris | Recruiting |
| CHU de Bordeaux - Hôpital Pellegrin | Bordeaux | France | Recruiting |
| AP-HP - Hôpital Bicêtre | Le Kremlin-Bicêtre | France | Recruiting |
| CHU de Nice-Hôpital Pasteur | Nice | France | Recruiting |
| CHU de Strasbourg - Hôpital de Hautepierre | Strasbourg | France | Recruiting |
| CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan | Toulouse | France | Recruiting |
| Charité - Universitätsmedizin Berlin | Berlin | Germany | Recruiting |
+ 63 more sites — see the full list on the official registry below.
More argenx trials in the UK
A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06920004 on ClinicalTrials.gov ↗ ← All trials in the UK