A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
NCT06920004 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218
Last updated 2026-05-08
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
- 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
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
- 2025-08-22
- Primary Completion
- 2027-09-30
- Completion
- 2030-09-30
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Austria
- Czechia
- Estonia
- France
- Germany
- Greece
- Israel
- Italy
- Japan
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Serbia
- Singapore
- Slovakia
- Slovenia
- South Korea
- Spain
- Sweden
- Switzerland
- Turkey (Türkiye)
Study Locations
More Related Trials
-
Immunoadsorption Versus Immunoglobulins for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT04881682 ·Status: RECRUITING ·Phase: PHASE2
-
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy
NCT00004772 ·Status: COMPLETED ·Phase: PHASE3
-
Subcutaneous Immunoglobulin Therapy Effectiveness Monitoring in CIDP Patients Using Smart Devices
NCT07273903 ·Status: RECRUITING
-
A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT06752356 ·Status: RECRUITING ·Phase: PHASE3
-
Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT02027701 ·Status: COMPLETED ·Phase: PHASE3
-
Study of CIDP Patients During IVIG Treatment
NCT00305266 ·Status: COMPLETED
-
A Study to Assess Adults With CIDP Transitioning From IVIg to Efgartigimod PH20 SC
NCT06637072 ·Status: COMPLETED ·Phase: PHASE4
-
Immunoadsorption for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT07154524 ·Status: RECRUITING
-
A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
NCT04281472 ·Status: COMPLETED ·Phase: PHASE2
-
Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT07032662 ·Status: RECRUITING ·Phase: PHASE2
-
Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg
NCT01349270 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.
NCT01625182 ·Status: COMPLETED ·Phase: PHASE3
-
Transcriptome Analysis of the Peripheral Blood in CIDP
NCT02404298 ·Status: UNKNOWN ·Phase: NA
-
Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy
NCT00004286 ·Status: COMPLETED ·Phase: PHASE3
-
Intravenous Immunoglobulin (IVIG) for Resistant Neuropathic Pain
NCT00850005 ·Status: UNKNOWN ·Phase: PHASE2
-
Safety and Efficacy of Avonex in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
NCT00099489 ·Status: COMPLETED ·Phase: PHASE2
-
Alemtuzumab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIPD)
NCT01757574 ·Status: WITHDRAWN ·Phase: PHASE4
-
The Impact of IVIG Treatment on Critical Illness Polyneuropathy and/or Myopathy in Patients With MOF and SIRS/Sepsis
NCT01867645 ·Status: TERMINATED ·Phase: PHASE1
-
Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
NCT06325943 ·Status: COMPLETED ·Phase: PHASE3
-
Do IgG Level Variations in CIDP and MMN Patients Following Initial Intravenous IVIg Treatment Correlate With Ultimate Dosing
NCT04356781 ·Status: COMPLETED
-
Safety, Tolerability, and Efficacy of NVG-2089 in Participants With CIDP
NCT07027111 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
NCT04280718 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP
NCT02955355 ·Status: COMPLETED ·Phase: PHASE3
-
IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements
NCT02414490 ·Status: COMPLETED
-
Subcutaneous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
NCT01017159 ·Status: COMPLETED ·Phase: PHASE2